chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Vasovagal response. Pt requested to lie down following vaccination. Reported feeling faint, nauseous and "seeing stars." Team applied cool compresses, patient instructed to lie on the floor with feet on a chair. Vitals were BP: 124/82, hr 53, o2 97% at 1200. Pt moved to sitting shortly thereafter. Then, at approximately 1210 requested to lie down 2/2 ringing in ears, sweating, and feeling nauseous again. At 1212 vitals were bp 124/78, hr 58, o2 97%. At approximately 12:25 symptoms abated, pt moved to sitting. Continued to monitor until 12:50 with no recurrence of symptoms.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Feeling abnormal, Headache, Nausea
Clinical narrative: 12/23/2020 - VACCINATION 12/24/2020 - WOKE UP AT 6AM WITH HEADACHE. LASTED 12 HOURS; NO RELIEF WITH TYLENOL (TOOK 2 BRANDS); NAUSEOUS. 'WAS NOT THE NORM'. FELT BETTER AFTER THE 12 HOURS.  PREGNANCY HISTORY; 12 WEEKS,; DUE DATE JULY 11/12TH 2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Heart rate increased, Paraesthesia oral
Clinical narrative: About 45 minutes post injection I experiences the sensation of heat all over my body, my heart rate increased rapidly and I had tingling in my mouth.  This passed after about 10 minutes, since then I have been experiencing exhaustion and feeling foggy.  No additional reactions at this time.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Left arm had tingling feeling down to fingertips
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fall, Headache, Pain
Clinical narrative: Feeling of wanting to pass out, dizziness and fell at home, severe headache, body aches, scratchy throat  and SOB.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Feeling of wanting to pass out, dizziness and fell at home, severe headache, body aches, scratchy throat  and SOB.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Tenderness, Urticaria
Clinical narrative: Localized urticaria on day 7 post vaccine with generalized swelling, itching, and tenderness. No prior reaction until day 7.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Patient states that immediately after receiving the flu shot she started having pain in her arm and shoulder.  She states that she thought it would get better in 2-3 days but it didn't.  She didn't come to the pharmacy to discuss this until 3 months after receiving the shot.  She describes the pain as one that radiates from her shoulder to her neck.  Patient denies any numbness or weakness in the arm.  She states that she does get better after taking an NSAID or using topical creams like Aspercreme and then applying the Salon-Pas patches.  Instructed patient to see her doctor about it but she stated that she doesn't have an appointment with her PCP until late January.  I advised her to go to the urgent care which she did on 12/28/20.  They did an X-Ray and told the patient that they couldn't see anything on the X-Ray.  They recommended that she see a surgeon to get a MRI. The patient stated that she will call her PCP today and try to get in sooner than her next appointment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Electrocardiogram normal, Hypertension
Clinical narrative: She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.  She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out." Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12  repeat at 16:30 BP=139/100, P=99 pulse OX 100%  She then C/O chills later. Paramedics were called and transferred in to ED. She takes AMLODIPINE 5 MG DAILY FOR  HTN. She has family HX of HTN.  Negative for headache, + palpitations, + presyncope, + shortness of breath, slight difficulty brathing. She did not experience any loss of consciousness. Never had any chest pain,  angioedema, rash, pruritus, throat swelling, hoarse voice. The patient has had no recent illnesses, fevers, chills, nausea, vomiting, diarrhea, or flu-like illnesses. She has had no cough, rhinorrhea, or congestion. She denies any recent vaginal bleeding, or abdominal pain. Denies any history of cardiac disease, or history of arrhythmias. Denies any history of prolonged immobility, recent travels, or history of clots.   In ED: 36 year old  female presents with dizziness and presyncopal like symptoms approximately 15 minutes after receiving the Medina vaccine at this hospital the patient who is mildly tachycardic mildly hypertensive but otherwise normal and stable vital signs and is overall nontoxic appearing.  Of note the patient's oxygen saturation was 97% while I was in the room and not the 2% that is documented here.   EKG notable for a rate of 87 normal axis normal sinus rhythm T-wave inversion in V1 otherwise no evidence of Brugada interval abnormality or evidence of electrolyte abnormality that would require further workup at this time.  Patient counseled to follow up with her primary care.  Patient given EpiPen given her EpiPen has expired.  Patient requested to go back to work I feel this is fair given patient will be on campus and can return to the emergency department should she develop any further symptoms.   Patient states her symptoms have completely resolved and she has normal vital signs currently heart rate in the 80s blood pressure 138 systolic feeling well and requesting to be discharged.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Presyncope, Tachycardia
Clinical narrative: She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.  She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out." Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12  repeat at 16:30 BP=139/100, P=99 pulse OX 100%  She then C/O chills later. Paramedics were called and transferred in to ED. She takes AMLODIPINE 5 MG DAILY FOR  HTN. She has family HX of HTN.  Negative for headache, + palpitations, + presyncope, + shortness of breath, slight difficulty brathing. She did not experience any loss of consciousness. Never had any chest pain,  angioedema, rash, pruritus, throat swelling, hoarse voice. The patient has had no recent illnesses, fevers, chills, nausea, vomiting, diarrhea, or flu-like illnesses. She has had no cough, rhinorrhea, or congestion. She denies any recent vaginal bleeding, or abdominal pain. Denies any history of cardiac disease, or history of arrhythmias. Denies any history of prolonged immobility, recent travels, or history of clots.   In ED: 36 year old  female presents with dizziness and presyncopal like symptoms approximately 15 minutes after receiving the Medina vaccine at this hospital the patient who is mildly tachycardic mildly hypertensive but otherwise normal and stable vital signs and is overall nontoxic appearing.  Of note the patient's oxygen saturation was 97% while I was in the room and not the 2% that is documented here.   EKG notable for a rate of 87 normal axis normal sinus rhythm T-wave inversion in V1 otherwise no evidence of Brugada interval abnormality or evidence of electrolyte abnormality that would require further workup at this time.  Patient counseled to follow up with her primary care.  Patient given EpiPen given her EpiPen has expired.  Patient requested to go back to work I feel this is fair given patient will be on campus and can return to the emergency department should she develop any further symptoms.   Patient states her symptoms have completely resolved and she has normal vital signs currently heart rate in the 80s blood pressure 138 systolic feeling well and requesting to be discharged.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Upon registration, pt informed staff she normally gets hives and itching with flu vaccine. Pt received COVID vaccine at 1205. Pt sat down in monitor area at 1209. At 1221, pt stated she started to feel slight itching. At 1230, pt stated itching had increased. RN also noted redness to neck. Pt denied any SOB, difficulty breathing, tingling in mouth, or any other anaphylactic symptoms. At 1234, RN gave 25mg Benadryl orally. Pt requested to receive smaller dose instead of the entire 50mg. Pt stayed to be monitored until 1255. No other symptoms noted. Pt educated to monitor for further signs of anaphylaxis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives approximately 12 hours after injection, resolved with oral diphenhydramine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, SARS-CoV-2 test negative, Throat tightness, Wheezing
Clinical narrative: Shortness of breath, wheezing, throat tighness, body aches without fever beginning 3 days ago lasting 2 days resolved spontaneously overnight
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: reported throat closing
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She stated she had hives appear on her face and had to take Benadryl.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site bruising, Injection site warmth, Mass, Tenderness
Clinical narrative: Large red lump that was very sore to the touch, the site is warm and 7 days later a bruise has formed. Lump appears to be very slowly getting smaller.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Periorbital swelling, Pruritus, Sensation of foreign body, Skin exfoliation
Clinical narrative: I woke up on the morning of Dec 26th with significant eye swelling. It was somewhat relieved with loratidine anithistimine 10 mg po daily x 3 days . The swelling was bilateral, symmetrical and was not accompanied by significant reddening of the eyes. Swelling was above and below the eyes. Swelling is slowly resolving but still present  today 12/29. A small amount of skin sloughing occurred below the eyes and on the eyelids. Swelling was accompanied by watery eyes,  itching with foreign body sensation.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Pyrexia
Clinical narrative: Fever- Started in the middle of the night around 1:00 am and dizziness felt like I was going to pass out.  Woke up at 8 with a slight cough, dizziness and faint feeling.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Paraesthesia, Tachycardia
Clinical narrative: Patient felt lightheaded and dizzy about 5-10 minutes after receiving his first COVID vaccine. His blood pressure was elevated (160/96 mmHg) and he was tachycardic (143 bpm). He said he felt some tingling in his arm. The injection site appeared normal. The patient sat for 30 minutes and his blood pressure and pulse normalized (134/86 mmHg and 84 bpm). He said he began to feel better and eventually left the building.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Injection site pain, Nausea
Clinical narrative: Approximately 2 and a half hours after vaccine administration, I had the sudden onset of abdominal cramping, multiple episodes of diarrhea, nausea, and tingling in my hands and lips. I recognized these symptoms as a potential allergic reaction and took cetirizine 20 mg and famotidine 20 mg. These symptoms subsided approximately one hour after onset. Approximately 4 hours later, I experienced moderate fatigue and mild muscle soreness of my left arm (where the vaccine was administered). The fatigue and soreness persisted into the next day and gradually subsided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Approximately 2 and a half hours after vaccine administration, I had the sudden onset of abdominal cramping, multiple episodes of diarrhea, nausea, and tingling in my hands and lips. I recognized these symptoms as a potential allergic reaction and took cetirizine 20 mg and famotidine 20 mg. These symptoms subsided approximately one hour after onset. Approximately 4 hours later, I experienced moderate fatigue and mild muscle soreness of my left arm (where the vaccine was administered). The fatigue and soreness persisted into the next day and gradually subsided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Sudden onset.  Chills, low-grade fever.  Myalgia, arthralgia I did have the Covid virus in June.  I still have adequate IgG.  This began while I was seeing patients today.  I do not feel very good.  No cough, nasal congestion, no fear of contamination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema
Clinical narrative: Redness of both arms, mild cough, temp 99F
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 12/22/2020 Received vaccination at approximately 1000 in left deltiod area.  Approximately 1700 12/22/2020 developed parethesia 3rd, 4th and 5th fingers diagonally to ulnar area of left palmar surface.  12/23/2020 noted paresthesia alone vertebrea with outward extension to all areas of back.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breath sounds abnormal, Chest discomfort, Chills, Cough, Dizziness
Clinical narrative: c/o tingling in nose/throat, dizziness, Chills administered 25mg Benedryl PO @ 1225 v/s 98% RA HR 81 126/82 c/o Cough and itching of throat @ 1246 93% RA, 124/84, HR 83 c/o Tightness in R/chest, symmetrical chest, diminished throughout, with wheezes and faint crackes on RUL clears with cough. 1306 1306 called EMS - sent to ER for Eval
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal paraesthesia, Rales, Throat irritation, Wheezing
Clinical narrative: c/o tingling in nose/throat, dizziness, Chills administered 25mg Benedryl PO @ 1225 v/s 98% RA HR 81 126/82 c/o Cough and itching of throat @ 1246 93% RA, 124/84, HR 83 c/o Tightness in R/chest, symmetrical chest, diminished throughout, with wheezes and faint crackes on RUL clears with cough. 1306 1306 called EMS - sent to ER for Eval
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Palpitations
Clinical narrative: Very tired the first day; pain in my arm for two days; sporadic palpitations; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: Ek5730, via an unspecified route of administration in the left arm, first dose on 18Dec2020 08:15 at a single dose for immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took oral aspirin but had intolerance. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with covid-19 prior to vaccination and she has not been tested since the vaccination. The patient was very tired the first day, she had pain in her arm for two days and sporadic palpitations that continued. The events started on 18Dec2020 at 10:30 AM. The outcome of the events 'very tired the first day, she had pain in her arm for two days and sporadic palpitations' was unknown.  The patient did not receive any treatment for the events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Tachycardia
Clinical narrative: High Blood pressure; tachycardia; This is a spontaneous report from a contactable nurse (patient). A 36-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK 5730) intramuscular in the left arm on 18Dec2020 17:00 at a single dose for COVID-19 immunization. The patient received COVID-19 vaccine in a hospital facility. Medical history included asthma, high blood pressure, and allergy to seafood. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is taking unspecified concomitant medications.  The patient previously had allergies to acetylsalicylic acid (ASPIRIN) and iodine (IODO). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced high blood pressure and tachycardia then 2 minutes after receiving the vaccine. The patient did not receive treatment for the adverse events. The outcome of the events was recovered in Dec2020. The report is considered non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Pain and numbness in the left arm, from the shoulder to the fingers.; Pain and numbness in the left arm, from the shoulder to the fingers.; Pain and numbness in the left arm, from the shoulder to the fingers.; Cannot raise arm, nor leave it down.; This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 17Dec2020 14:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The COVID-19 vaccine was administered at Hospital.  Medical history included Right breast cancer. Concomitant medication included vitamin Vitamin C, Vitamin D, anastrozole (ARIMIDEX). The patient experienced pain and numbness in the left arm, from the shoulder to the fingers. Can not raise arm, nor leave it down on 19Dec2020. Relief with a sling. Also, to manage pain she was taking Tylenol every four hours. By medical order she started diclofenac potassium 50 mg tablet. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was been tested for COVID-19. The outcome of the events was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: joint pain in both knees and elbows/pain in both hips/some joint pain on the right knee and hip; This is a spontaneous report from a contactable physician(patient). A 35-year-old male patient received the first dose of BNT162B2 (lot number: EKS730), via intramuscular in left arm, on 18Dec2020 09:45 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history was none. No allergies to medications, food, or other products. No other vaccines were received within 4 weeks prior to the COVID vaccine. The medications received within 2 weeks of vaccination included CBD oil drops. On Monday 21Dec2020 06:00 AM the patient started experiencing joint pain in both knees and elbows. Pain was moderate and fluctuating, the patient took some Tylenol and intensity of pain improved. On Tuesday, 22Dec2020 pain intensity decreased, however at night time the patient started experiencing pain in both hips, mostly on the right side. Today 23Dec2020 pain has disappeared from both elbows, left hip and left knee. The patient was still experiencing some joint pain on the right knee and hip, mostly when he was walking, if he was sitting down or not moving at all, pain is not present. Treatment Tylenol 500 mg P.O. (oral) q (every) 8 hours and CBD oil was received for the events. The outcome of the event was recovering.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: no AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), dose: 0.5 milliliter, lot# S030211, expiry date: 25-MAR-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), dose: 0.5 milliliter, lot# S021326, expiry date: 05-JAN-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003543:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly Stored RECOMBIV AX HB was administered to patient; This spontaneous report as received from a other registered nurse referring to a neonate patient of unknown gender. The patient's pertinent concurrent conditions, medical history and concomitant medications were not reported.      On 19-DEC-2020, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (thimerosal- free)((RECOMBIVAX HB) as prophylaxis (concentration, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot # T004378 and expiration date reported 01-NOV-2022). No adverse events were reported for the patient.  According to the reporter, the temperature excursion was above 47 degrees Fahrenheit (73.6 degrees Fahrenheit) for a time frame of 6 hours On 19-DEC-2020(product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 04-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 08-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 07-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Fatigue, Headache, Insomnia, Mobility decreased
Clinical narrative: Headache for 4 days now; 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift; 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift; At times her face will feel tight; 30 min post starting itching very bad; Have experienced insomnia since the injection, followed by exhaustion; Have experienced insomnia since the injection, followed by exhaustion; eyes itch and have been red; eyes itch and have been red; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration (left arm) from 18Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included migraine, depression, anxiety, allergies, poly cystic ovary syndrome, asthma, different food allergy and sensitivity to all antibiotics. It was reported that 30 min post vaccination, patient started itching very bad and none of her allergy meds would calm it. Have experienced insomnia since the injection, followed by exhaustion. The itching decreases daily but even 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift. She had headache for 4 days now. At times her face will feel tight. She added that she has allergies and sensitivity to many medications/ environmental/ scents. Outcome of events was recovering. No treatment was received due to events.  Follow-up attempts are completed. The following information on the batch/lot number has been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Headache for 4 days now; 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift; 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift; At times her face will feel tight; 30 min post starting itching very bad; Have experienced insomnia since the injection, followed by exhaustion; Have experienced insomnia since the injection, followed by exhaustion; eyes itch and have been red; eyes itch and have been red; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration (left arm) from 18Dec2020 09:45 at a single dose for COVID-19 immunization. Medical history included migraine, depression, anxiety, allergies, poly cystic ovary syndrome, asthma, different food allergy and sensitivity to all antibiotics. It was reported that 30 min post vaccination, patient started itching very bad and none of her allergy meds would calm it. Have experienced insomnia since the injection, followed by exhaustion. The itching decreases daily but even 10 hours post vaccination, patient's entire arm (not injection site) hurt horribly, unable to lift. She had headache for 4 days now. At times her face will feel tight. She added that she has allergies and sensitivity to many medications/ environmental/ scents. Outcome of events was recovering. No treatment was received due to events.  Follow-up attempts are completed. The following information on the batch/lot number has been obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches in legs; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 18Dec2020 07:45 to 18Dec2020 07:45 at a single dose for COVID-19 immunisation. Medical history included sinusitis, HLD, and penicillin (PCN) allergy. Concomitant medication included vitamin c [ascorbic acid], tocopheryl acetate (VITAMIN-E), ergocalciferol (VIT D), magnesium and calcium. The patient experienced muscle aches in legs from 2 to 12 hours post vaccine administration (18Dec2020 10:00). Outcome of event was reported as recovered. No treatment was received due to the event.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Tremor
Clinical narrative: left arm began having generalized weakness and difficulty holding pen.; Mild tremors of left hand and fingers.; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscular on 18Dec2020 at a single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient's medical history and concomitant medications were not reported. Around 6 hours post-administration on 18Dec2020, patient's left arm began having generalized weakness and difficulty holding pen. Mild tremors of left hand and fingers. Lasted approximately 2-3 hours and resolved spontaneously. No other symptoms. No treatment was given. The events were reported as non-serious. Outcome of the events was recovered in Dec2020.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Was exposed to someone positive and then 2 days later tested positive; Was exposed to someone positive and then 2 days later tested positive; Was exposed to someone positive and then 2 days later tested positive; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first COVID-19 vaccine last week in Dec2020, then was exposed to someone positive and then 2 days later, patient tested positive. Reporter inquired whether they can vaccinate patient on schedule 3 weeks after the first dose or if they have to wait 90 days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: Extreme dizziness that is still ongoing; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (Pfizer Biontech COVID 19 vaccine), Lot number: EK5730, via an unspecified route of administration at the left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. The patient medical history includes migraine and known allergies to Latex and sulfa drugs. Concomitant medication included levothyroxine, gabapentin, calcium, colecalciferol (CALCIUM & VITAMIN D). On 05Dec2020 03:00 (pending clarification), the patient experienced extreme dizziness that is still ongoing. The patient was not hospitalized for the event, did not receive any treatment for the event and event was reported as non-serious. The vaccine was administered in the workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (Dec2020-unknown results). On 14Dec2020, Nasal Swab (COVID 19) Result was Negative.  The outcome of the event was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, SARS-CoV-2 test negative
Clinical narrative: Red itchy rash around injection site; Red itchy rash around injection site; Red itchy rash around injection site; This is a spontaneous report from a contactable nurse.  A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular (Arm Left) from 18Dec2020 18:45 at a single dose for COVID-19 immunisation. Medical history included hypothyroidism and pre diabetes. Patient had no known drug allergies (NKDA). Concomitant medication included levothyroxine. On 20Dec2020 23:45, the patient experienced red itchy rash around injection site. The patient underwent lab tests and procedures on 16Dec2020 which included nasal swab with negative result. Outcome of events was recovered. No treatment was required/involved.  Follow-up attempts are completed. Information on the batch/lot number has been obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: throat tightness; This is a spontaneous report from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number HE9899, intramuscular Right arm (right deltoid muscle) from 18Dec2020 12:45 to 18Dec2020 12:45 as single dose for COVID-19 immunization. Medical history included mild anxiety. The patient's concomitant medications were not reported. Patient was given the Pfizer vaccination in the right deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, difficulty breathing, hoarseness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Review of Systems Constitutional: Negative for activity change, appetite change and fever. HENT: Negative for congestion, facial swelling, rhinorrhea and trouble swallowing. Initially with some throat tightness. Resolved within 10 min Respiratory: Negative for cough and shortness of breath. Neurological: Negative for dizziness, weakness, light-headedness and headaches. The outcome of the event was recovered on 18Dec2020.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: 31Mar2021), intramuscular on the left deltoid on 17Dec2020 13:22 at 0.3 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had tachycardia on 17Dec2020 13:25, post vaccine but it went away quickly. Reporter stated that she didn't know if patient was anxious. Outcome of the event of tachycardia was recovered on 17Dec2020.  The reporter assessed the event as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable physician, the patient.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Dec2020 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient was diagnosed with COVID-19.  The clinical outcome of diagnosed with COVID-19 was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The patient was diagnosed with COVID-19 one day after he received vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). There was not a reasonable possibly that the event was related to vaccination considering the temporal gap between the vaccination and the event onset.
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program and medical information team. A female patient of an unspecified age (age: 80; unit: unknown) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included allergic to eggs and having a sensitivity to formaldehyde and phenol from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced an allergic reaction to the pneumonia vaccine on unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed. Information regarding batch and lot number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Urticaria
Clinical narrative: hives; she had an achy left arm (injection arm); fatigue; This is a spontaneous report from a contactable nurse (patient). A 67-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number was not provided, unspecified route on 17Dec2020 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 vaccination.  Medical history and concomitant medication were not reported. On unspecified date in Dec2020, the patient experienced she had an achy left arm (injection arm) and fatigue which she states that she expected. On 22Dec2020, the patient experienced hives. She woke up and had hives. Outcome of the event fatigue was recovered in Dec2020. Outcome of the events hives and she had an achy left arm (injection arm) were unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Genital rash, Rash, Rash erythematous, Rash papular
Clinical narrative: rash to both forearms, thigh and private area/developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy/rash now is flat, red, and pinkish; rash to both forearms, thigh and private area/developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy/rash now is flat, red, and pinkish; rash to both forearms, thigh and private area/developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy/rash now is flat, red, and pinkish; This is a spontaneous report received from a contactable nurse (who is also the patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date unknown), intramuscular in left deltoid, on 19Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported she received the COVID-19 vaccine on Saturday (19Dec2020). Everything was fine all day on Saturday and when she took a shower on Sunday morning (20Dec2020), she noticed she developed a rash on both arms, thighs, and kind of near the private area. Areas are red and bumpy, and she still has the rash on the arms. She called her primary care provider and was instructed to use Benadryl at bedtime and Zyrtec in the morning to help. She was wondering because in 20 some odd days she is to get the second shot and wants to know if she should expect this type of adverse reaction. She mentioned that the rash now is flat, red, and pinkish. She stated she has never had COVID-19 testing or symptoms. Just this rash from the vaccine. The reporter assessed the events as non-serious. The outcome of the events was not recovered (reported as ongoing).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Patient woke up with forehead and back of hand rash; she had swelling in the morning after being vaccinated; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: unknown, via an unspecified route of administration on 21Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient woke up with forehead and back of hand rash and she had swelling in the morning after being vaccinated. She took a BENADRYL and went to the ED (Emergency Department). Event onset date was on 22Dec2020. The event was reported as non-serious. The outcome of forehead and back of hand rash and she had swelling was unknown.  Information on Lot/Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: my lt. arm felt like lead , so heavy and very sore; my lt. arm felt like lead , so heavy and very sore/felt soreness if she lifted up her arm; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EUA), intramuscular in the left arm on 21Dec2020 16:45 at single dose for COVID-19 immunization. Medical history included the patient being pre-diabetic. The patient's concomitant medications were not reported. The patient previously took epinephrine, norethindrone, and comtrex cold medicine and experienced drug allergy. The patient didn't have anything until around 2:00am on 22Dec2020 - her lt. arm felt like lead, so heavy and very sore. Her arm felt better after getting up - having shower around 6:30am. By 2 pm she only felt soreness if she lifted up her arm. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine and have not received any other medication within 2 weeks of vaccination. The outcome of the events was recovering.  Information on the Lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achiness; Fatigue; patient was administered 0.3ml of undiluted covid vaccine intramuscularly.; patient was administered 0.3ml of undiluted covid vaccine intramuscularly.; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a 28-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899; NDC number of Covid vaccine: 59267-1000-1 Expiry Date of Covid vaccine: Mar2021), intramuscular on right deltoid on 18Dec2020 at 0.3 mL for COVID-19 immunization. There were no medical history and concomitant medications. On 18Dec2020, a patient was administered 0.3ml of undiluted covid vaccine intramuscularly. The patient experienced achiness, fatigue. The patient received the covid vaccine injection Friday afternoon. When querying seriousness regarding the patient receiving the undiluted dose, he states she has not had very many side effects from it thus far. Clarifies that achiness and fatigue were her main side effects which started Friday night and continued into Saturday. Treatment: She received IV fluids this weekend in the ER as a precautionary measure He does not have time to continue with report and requested to be transferred. No further details. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: localized tingling at the injection site that radiated into her 4th and 5th digits and proximally along the sternomastoid muscle; localized tingling at the injection site that radiated into her 4th and 5th digits and proximally along the sternomastoid muscle; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899; expiration date: unknown), intramuscularly left arm on 22Dec2020 11:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15-minute (22Dec2020 11:30) waiting period after the injection, the patient began to experience localized tingling at the injection site that radiated into her 4th and 5th digits and proximally along the sternomastoid muscle. The patient denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This reporter was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension and chest pain. The patient was observed for approximately 30 minutes post injection with no evolution of symptom. Injection site tingling that extended along the ulnar nerve distribution was improving at the time of discharge. The outcome of the events was recovering.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.