chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Oropharyngeal pain, Pruritus
Clinical narrative: anaphylactic reaction , -- shortness of breath, cough, sore throat, swelling, itching.  Treatment Epi pen injection and 2 rounds or benadryl outcome : resolved
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: anaphylactic reaction , -- shortness of breath, cough, sore throat, swelling, itching.  Treatment Epi pen injection and 2 rounds or benadryl outcome : resolved
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Injection site reaction, Injection site swelling, Lymphadenopathy
Clinical narrative: About a week after the vaccine, and following a swollen lymph node in the armpit of the injection arm about 5 days after vaccination, had a delayed skin reaction in the injection arm around the injection site.  Skin was swollen and raised largely in an approximate 3-in ring around the injection site, with a few raised areas outside of the ring. Minimal itching and discomfort. Two 25mg capsules of antihistamine resulted in the elimination of the raised areas and reduced swelling in about 24-hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: About a week after the vaccine, and following a swollen lymph node in the armpit of the injection arm about 5 days after vaccination, had a delayed skin reaction in the injection arm around the injection site.  Skin was swollen and raised largely in an approximate 3-in ring around the injection site, with a few raised areas outside of the ring. Minimal itching and discomfort. Two 25mg capsules of antihistamine resulted in the elimination of the raised areas and reduced swelling in about 24-hours
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Cough, Fatigue, Listless
Clinical narrative: Sore arm, chills, Very sore throat, run down,  listless, coughing, lost my voice
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore arm, chills, Very sore throat, run down,  listless, coughing, lost my voice
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Patient developed a small 1mm blister at injection site. Blister in area of bandage/adhesive. Outline of adhesive seen on arm. Patient reports slight itching at the site. She received the vaccine at the clinic on 3/12/2021 and noticed the blister and itching the next day. She reports the blister has decreased in size since that time.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal discomfort, Paraesthesia oral, Swelling face
Clinical narrative: I stayed for 15 minutes and when I was driving home my face started to swell.  I had tingling in  my teeth and lips.  My throat felt full and I was coughing slightly.  Within an hour and 10 minutes after the injection, I started to feel back to normal.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood test abnormal, Discomfort, Dizziness, Electrocardiogram normal
Clinical narrative: Moderately rapid heart rate when at rest, that would occur occasionally throughout the day generally resolving itself in approximately 1/2 an hour. Dizzy sensation and felt pressure ie could feel my heart beat in my neck. This symptom persists but seems to have lessen in frequency.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Moderately rapid heart rate when at rest, that would occur occasionally throughout the day generally resolving itself in approximately 1/2 an hour. Dizzy sensation and felt pressure ie could feel my heart beat in my neck. This symptom persists but seems to have lessen in frequency.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Approximately 6 hours after receiving the vaccine I began having chills. Within 2 hours, I had a severe headache, muscle aches, and nausea. I took 1 Extra strength Tylenol at 4:00pm but it didn?t seem to help. At 7:00 pm I took 2 ibuprofen, again didn?t seem to help.  Finally fell asleep around  10:30 pm. Woke at 12:00am chills and body aches gone,fatigue,  headache and nausea remained- slightly diminished. Fell asleep and slept through until 7:00am, felt better with a  mild headache , fatigue, and upset stomach through the day(March 14).  Low energy and slight headache remain on March 15th.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Approximately 6 hours after receiving the vaccine I began having chills. Within 2 hours, I had a severe headache, muscle aches, and nausea. I took 1 Extra strength Tylenol at 4:00pm but it didn?t seem to help. At 7:00 pm I took 2 ibuprofen, again didn?t seem to help.  Finally fell asleep around  10:30 pm. Woke at 12:00am chills and body aches gone,fatigue,  headache and nausea remained- slightly diminished. Fell asleep and slept through until 7:00am, felt better with a  mild headache , fatigue, and upset stomach through the day(March 14).  Low energy and slight headache remain on March 15th.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cellulitis, Computerised tomogram abnormal, Gangrene, Incorrect route of product administration
Clinical narrative: Was given shot in top of right shoulder straight into joint.  Had infectious cellulitis in elbow turn into gangrene.  Was hospitalised for 4days and had to have surgery to remove dead tissue and clean out infection!
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint injection, Pain in extremity, Pyrexia, Surgery
Clinical narrative: Was given shot in top of right shoulder straight into joint.  Had infectious cellulitis in elbow turn into gangrene.  Was hospitalised for 4days and had to have surgery to remove dead tissue and clean out infection!
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cellulitis gangrenous, Joint swelling, Product administered at inappropriate site, Vaccination site joint erythema
Clinical narrative: Was given shot in top of right shoulder straight into joint.  Had infectious cellulitis in elbow turn into gangrene.  Was hospitalised for 4days and had to have surgery to remove dead tissue and clean out infection!
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Contusion, Laboratory test, Mean cell haemoglobin concentration decreased, Metabolic function test
Clinical narrative: Very vascular starting day after the vaccine, bruising easily. Right arm, elbow swollen, bruised and arm puffy, still. March 12 2021 Blood work, arm bled for a day, very bruised. Bruise easily. Blood work shows low platlets, low MCHC and low RBC. Was off RA meds prior to shot, Xjelzane.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Platelet count decreased, Red blood cell count decreased
Clinical narrative: Very vascular starting day after the vaccine, bruising easily. Right arm, elbow swollen, bruised and arm puffy, still. March 12 2021 Blood work, arm bled for a day, very bruised. Bruise easily. Blood work shows low platlets, low MCHC and low RBC. Was off RA meds prior to shot, Xjelzane.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Lip pruritus, Lip swelling, Throat clearing, Throat irritation
Clinical narrative: 9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and throat itching, lips swelling. Given sip of water - difficulty swallowing but denies difficulty breathing. Patient states she is allergic to multiple meds. 9:55 am - Itching in multiple places and repeatedly clearing throat with difficulty swallowing.  Lip swelling noted - patient now moved to a bed and 911 is called. 10:00 am - Fire medics arrive and patient assessed. Patient taken to hospital via ambulance.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: 9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and throat itching, lips swelling. Given sip of water - difficulty swallowing but denies difficulty breathing. Patient states she is allergic to multiple meds. 9:55 am - Itching in multiple places and repeatedly clearing throat with difficulty swallowing.  Lip swelling noted - patient now moved to a bed and 911 is called. 10:00 am - Fire medics arrive and patient assessed. Patient taken to hospital via ambulance.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pain, Pulmonary thrombosis, Thrombosis
Clinical narrative: 9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and throat itching, lips swelling. Given sip of water - difficulty swallowing but denies difficulty breathing. Patient states she is allergic to multiple meds. 9:55 am - Itching in multiple places and repeatedly clearing throat with difficulty swallowing.  Lip swelling noted - patient now moved to a bed and 911 is called. 10:00 am - Fire medics arrive and patient assessed. Patient taken to hospital via ambulance.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills
Clinical narrative: Weakness, chills
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: chills, headache, generally not feeling well.   resolved on own.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rash, Skin discolouration, Vasculitis
Clinical narrative: 3-11-21 C/O RASH TO BOTH LEGS & ABD SINCE 9:30AM. NO SOB OR DYSPNEA. 1:42PM BENADRYL 50MG GIVEN PO.  STATES SHE WILL SPEND THE REST OF THE WORK DAY SITTING DOWN AND HUSBAND WILL DRIVE HER HOME. 3-15-21 10:46AM:  STATES SHE DID GO TO ER X2, FACILITY ADMITTED HER FOR VASCULITIS X1DAY. 'THOUGHT IT MAY BE A DELAYED VACCINE REACTION.'  RASH ON LEGS, ABD & NOW FOREARMS IS NOW 'PURPLE'. HAD LOTS OF JOINT PAIN ALSO.  SHE WAS GIVEN SOLUMEDRAL AND PREDNISONE AND IS FEELING BETTER NOW, WILL RETURN TO WORK TOMORROW.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypersensitivity, Sensation of foreign body, Throat tightness
Clinical narrative: Within a couple of minutes of vaccine administration, the patient began experiencing throat tightness and stated that it felt like "there was a lump in my throat". BP initially was 168/81 and then continued to increase to 217/94.  O2 sats remained stable but Benadryl 50mg administered PO for potential allergic reaction. RN remained with pt for approximately 1 hour and pt eventually returned to baseline and was allowed to go home.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cachexia, Condition aggravated, Dementia, Dysphagia
Clinical narrative: Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Odynophagia, Ultrasound scan, X-ray
Clinical narrative: Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Hypertension
Clinical narrative: Pt seen ER 3/12/2021  Dr for vaccine reaction, initial encounter, evaluation for possible vaccine reaction, pt received first dose COVID vaccine today in clinic, episode where became lightheaded, possibly near syncopal.  On arrival to ER back to baseline, monitored on heart monitor with out changed, initially hypertensive but came down, discharged home. Follow up in 1 week with PCP Dr to discuss whether he should receive second dose or not,   pt felt just got hot and anxious about the shot, history of CVA which required crainiotomy and led to seizure disorder, wife thought he might be having a seizure, blanking out. No other s/s noted.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Severe, Systemic: Tachycardia-Medium, Additional Details: Patient's heart rate is typically in the 80's. After vaccination, night of and morning after, patient's heart rate went up to 113.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation, No adverse event, Syringe issue, Underdose
Clinical narrative: Patient was administered second dose of Moderna CIVID-19 vaccine 03/01/2021, IM 0.5 ml in left deltoid.  According to the nurse administering the vaccine, a small drop of the vaccine came out of the syringe where the needle hub attaches to the syringe.  The patient was concerted that she did not receive the entire dose of vaccine.   Consult done it was suggested that the patient be offered a third dose.  Patient wanted a third dose and it was administered on  03/04/2021 without incident.  Dose # 1 administered on 03/03/2021
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Palpitations
Clinical narrative: On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an hour and didn't happen again until the next evening, around 5pm. That episode lasted for hours, and I finally went to bed at 9pm due to being so tired. The palpitations stopped sometime in the night. The next afternoon, I decided to lay down for a bit as I was still feeling quite a lot of fatigue and SOME body aches since the day after the injection. When I laid down, palpitations started again within just a few minutes. I got up, and they stopped in a few minutes. Since that last episode, I have only had the occasional "flip-flop" in my heart. I've never had palpitations prior to this, (beta blocker is for a too fast heart rate with no palpitations)so thought it might be a reaction.  I'm scheduled for the 2nd dose on 3/27 and want to make sure it is safe for me to get that. Contacted my Doctor's office this morning, but haven't heard back as yet.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Palpitations
Clinical narrative: On day 3 after the injection, I started experiencing heart palpitations. That lasted for about an hour and didn't happen again until the next evening, around 5pm. That episode lasted for hours, and I finally went to bed at 9pm due to being so tired. The palpitations stopped sometime in the night. The next afternoon, I decided to lay down for a bit as I was still feeling quite a lot of fatigue and SOME body aches since the day after the injection. When I laid down, palpitations started again within just a few minutes. I got up, and they stopped in a few minutes. Since that last episode, I have only had the occasional "flip-flop" in my heart. I've never had palpitations prior to this, (beta blocker is for a too fast heart rate with no palpitations)so thought it might be a reaction.  I'm scheduled for the 2nd dose on 3/27 and want to make sure it is safe for me to get that. Contacted my Doctor's office this morning, but haven't heard back as yet.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Influenza like illness, Pharyngeal swelling, Pruritus
Clinical narrative: Pt has called office to report reaction after vaccination. Pt. reports that approximately 30 minutes after vaccination (she was already home), she became very itchy, all over. She then noted her lips were numb. Her throat was itchy and then felt to be swelling. She did not have trouble breathing, but did feel it was difficult to swallow. Pt did take benadryl which helped lessen the reaction. After the benadryl wore off, the symptoms would return. She took the benadryl every 6 hrs for 24 hours per patient until symptoms resolved. She did also develop flu-like symptoms the evening of the vaccine, which persist still 3/15/21. She did not go to the ER or to see a doctor through this. Patient questioning taking second vaccine - advised to speak with her PCP.  After speaking with PCP, patient is opting out of second vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Pt has called office to report reaction after vaccination. Pt. reports that approximately 30 minutes after vaccination (she was already home), she became very itchy, all over. She then noted her lips were numb. Her throat was itchy and then felt to be swelling. She did not have trouble breathing, but did feel it was difficult to swallow. Pt did take benadryl which helped lessen the reaction. After the benadryl wore off, the symptoms would return. She took the benadryl every 6 hrs for 24 hours per patient until symptoms resolved. She did also develop flu-like symptoms the evening of the vaccine, which persist still 3/15/21. She did not go to the ER or to see a doctor through this. Patient questioning taking second vaccine - advised to speak with her PCP.  After speaking with PCP, patient is opting out of second vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: 3 DAYS EXHAUSTION EXPLOSIVE DIARRHEA
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vasovagal syncope. Felt better after laying down for a while and then slowly drinking water and eating granola bar.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Headache, Pyrexia
Clinical narrative: chills, fever, headache, delirium
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt got very diaphoretic and felt lightheaded. BP 173/84 with HR of 55 and O2sats 96%. Pt observed by RN until returned to baseline.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Person received Modernal Vaccine when they had previously gotten Pfizer. No adverse reactions happened. They were monitored for 15 mins and then were released to go home.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site began to itch 10 days after COVID shot given.  Red circle, about 3" in diameter, on arm at injection site.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain, Pain in extremity, Somnolence
Clinical narrative: Migraine, body aches, sleepy, fatigued, pain in left arm.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Night sweats
Clinical narrative: Very bad headache overnight first night after injection.   Night sweats and fever 2nd and 3rd night after injection.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, the administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger. On 15-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in a temperature excursion for prophylaxis (product storage error). No additional adverse event reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007563: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 16-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA005232: US-009507513-2102USA005231: US-009507513-2102USA005230: US-009507513-2102USA005229: US-009507513-2102USA005228: US-009507513-2102USA005227: US-009507513-2102USA007564: US-009507513-2102USA007563: US-009507513-2102USA007562: US-009507513-2102USA007561: US-009507513-2102USA007568: US-009507513-2102USA007559: US-009507513-2102USA007558: US-009507513-2102USA007557: US-009507513-2102USA003923:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 29-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion (on 01-JAN-2021) for prophylaxis (product storage error). No additional adverse event reported.   The administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA005232: US-009507513-2102USA005231: US-009507513-2102USA005230: US-009507513-2102USA005229: US-009507513-2102USA005228: US-009507513-2102USA005227: US-009507513-2102USA007564: US-009507513-2102USA007563: US-009507513-2102USA007562: US-009507513-2102USA007561: US-009507513-2102USA007559: US-009507513-2102USA007558: US-009507513-2102USA007557: US-009507513-2102USA007556: US-009507513-2102USA003923:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX that underwent a temperature excursion was administered; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 19-FEB-2021, varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength and route were not reported, lot # T022315 has been verified as valid, expiration date 30-JUN-2022) that underwent a temperature excursion was administered to the patient for prophylaxis (product storage error).  The vaccines administered experienced a temperature excursion of minus 10 degrees Celsius to 8 degrees Celsius (minus 3.7 degrees Celsius) for a time frame of 22 hours. There were no previous temperature excursions. Digital data logger was involved.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune anaemia, Feeling hot, Illness, Incomplete course of vaccination, Night sweats
Clinical narrative: had autoimmune anemia / hemoglobin was lower than 8 / Hematocrit was 9.3; physical rash over her entire body; fever of 103; was sick; low hematocrit; first dose of Shingrix in June 2019.  She never received the second dose; low hemoglobin; night sweats; hives with heat; hives with heat; This case was reported by a consumer via call center representative and described the occurrence of autoimmune anemia in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for rash and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's disease.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Tylenol at an unknown dose and frequency and the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced autoimmune anemia (serious criteria GSK medically significant), night sweats, feeling hot, hives, rash, fever, sickness, hemoglobin decreased, hematocrit decreased and incomplete course of vaccination. The action taken with Tylenol was unknown. In November 2019, the outcome of the hematocrit decreased was recovered/resolved. On an unknown date, the outcome of the autoimmune anemia, night sweats, feeling hot, hives, rash, fever, sickness and hemoglobin decreased were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the autoimmune anemia, night sweats, feeling hot, hives, rash, fever, sickness, hemoglobin decreased and hematocrit decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 69 or 70 years. The patient received 2nd dose of vaccine in her right arm. The patient never received the second dose due to the side effects she experienced, which led to incomplete course of vaccination. The patient was sick, had a fever of 103 for more than one week. She had a physical rash over her entire body and she took Tylenol. She had hives with heat that lasted for 8 days. She had night sweats for 2 weeks. Her doctor drew blood and it was determined with hemoglobin that she had autoimmune anemia. Her hemoglobin was lower than 8 which resolved after 6 months. Her Hematocrit was 9.3 which resolved in late November 2019.  The patient was unsure if the physical rash she experienced was related to the Shingrix or the Tylenol.  All of the patient's side effects had resolved till the time of reporting. It was unknown if the reporter considered the Tylenol to be related to reported events. The reporter consented to follow up
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: had autoimmune anemia / hemoglobin was lower than 8 / Hematocrit was 9.3; physical rash over her entire body; fever of 103; was sick; low hematocrit; first dose of Shingrix in June 2019.  She never received the second dose; low hemoglobin; night sweats; hives with heat; hives with heat; This case was reported by a consumer via call center representative and described the occurrence of autoimmune anemia in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for rash and Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's disease.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Tylenol at an unknown dose and frequency and the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced autoimmune anemia (serious criteria GSK medically significant), night sweats, feeling hot, hives, rash, fever, sickness, hemoglobin decreased, hematocrit decreased and incomplete course of vaccination. The action taken with Tylenol was unknown. In November 2019, the outcome of the hematocrit decreased was recovered/resolved. On an unknown date, the outcome of the autoimmune anemia, night sweats, feeling hot, hives, rash, fever, sickness and hemoglobin decreased were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the autoimmune anemia, night sweats, feeling hot, hives, rash, fever, sickness, hemoglobin decreased and hematocrit decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however could be 69 or 70 years. The patient received 2nd dose of vaccine in her right arm. The patient never received the second dose due to the side effects she experienced, which led to incomplete course of vaccination. The patient was sick, had a fever of 103 for more than one week. She had a physical rash over her entire body and she took Tylenol. She had hives with heat that lasted for 8 days. She had night sweats for 2 weeks. Her doctor drew blood and it was determined with hemoglobin that she had autoimmune anemia. Her hemoglobin was lower than 8 which resolved after 6 months. Her Hematocrit was 9.3 which resolved in late November 2019.  The patient was unsure if the physical rash she experienced was related to the Shingrix or the Tylenol.  All of the patient's side effects had resolved till the time of reporting. It was unknown if the reporter considered the Tylenol to be related to reported events. The reporter consented to follow up
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Fatigue, Meniere's disease, Presyncope
Clinical narrative: Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise).   The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter.  On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided).  On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill.  On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell.  Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication.  Action taken with mRNA-1273 in response to the events was unknown.  The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise).   The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter.  On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided).  On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill.  On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell.  Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication.  Action taken with mRNA-1273 in response to the events was unknown.  The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Pins and needles throughout my body; I dont want to feel like this, because it hurts; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced pins and needles throughout her body, "started pinky and ring finger", "getting worse". Caller asked if the 2nd dose will make this happen again, or make the symptoms worse.  Caller said, "I dont want to feel like this, because it hurts". The outcome of the events was unknown. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: tingling in her lips; numbness in her tongue; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  She had the first Pfizer vaccine in the morning and about 30 min later noticed some tingling in her lips and partial numbness in her tongue. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 20Jan2021 at 12:30 (at the age of 45-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After the first dose (Jan2021), the patient just had a slight headache. No treatment was provided for the event headache. The outcome of the event headache was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first dose of the vaccination, the patient tested positive for COVID-19. She questioned if she can take the 2nd dose of the vaccine (her schedule would be more than 21 days). The clinical outcome of tested positive for COVID-19 was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 25Jan2021, and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: slight bump in my arm where I received the vaccine; It is also slighty tender to the touch; This is a spontaneous report from a non-contactable consumer.  A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 28Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown.  The patient reported that 'last night' she noticed that there was a slight bump in her arm where she received the vaccine. It was also slighty tender to the touch.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: arm pain; body aches; chills; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. Medical history and patient's concomitant medications were not reported. Historical vaccine included BNT162B2 on 31Dec2021 for Covid-19 immunization and patient tested positive for COVID-19, nausea, diarrhea, fatigue, loss of taste and smell and stomach upset. The patient reported symptoms of arm pain, body ache and chills after receiving the second f=dose of vaccine that lasted 12 hours. The patient recovered from the events on 26Jan2021.  Information about Batch/Lot number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Pyrexia, Vaccination site pain
Clinical narrative: slight fever; sore joints; sore injection site; a slight sore throat; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular in the left arm on 10Feb2021 at 11:45 (at the age of 45-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 20Jan2021 and experienced headache. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 05:00 (after second dose), the patient experienced slight fever, sore joints, sore injection site and a slight sore throat. No treatment was provided for the events fever, sore joints, sore injection site and sore throat. The outcome of the events fever, sore joints, sore injection site and sore throat was recovering. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148082 same patient, different vaccine dose/AE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised after she got the injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9262, first dose) solution for injection intramuscular in the left arm on 08Feb2021 at 12:00 (at the age of 60-years-old) at single dose for COVID-19 vaccination. Medical history included obesity, arrhythmia (that was fairly under control, and was not life threatening) and palpitations (palpitations from time to time, but this medication did not cause that). Concomitant medications included escitalopram oxalate (LEXAPRO) and lisinopril. Historical vaccine included flu vaccine in Oct2020 and experienced bruised after the injection. After the vaccination, the patient experienced injection site warm, raised, and red on 08Feb2021. The patient experienced left arm felt bruised after she got the injection in Feb2021. The patient has had no treatment for her arm yet. The outcome of the events injection site warm, raised, and red and left arm felt bruised after injection was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain in knuckles on fingers, knees, ankles, and wrists; slight headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the left arm, on 22Jan2021 at 13:45 (at the age of 37-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, high cholesterol, and allergies to mushrooms. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced slight headache on 22Jan2021 at 21:00 and joint pain in knuckles on fingers, knees, ankles, and wrists on 29Jan2021. The events were reported as non-serious. The clinical course was reported as follows: The patient started to feel a slight headache a few hours after vaccination, which had gotten worse and at the time of reporting, it was week 3. The patient also experienced joint pain in knuckles on fingers, knees, ankles, and wrists. The joint pain started a week after vaccine administration. The patient never felt joint pain before until now. The patient did not receive any treatment for the events. The clinical outcome of slight headache and joint pain in knuckles on fingers, knees, ankles, and wrists was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pain in jaw, Trismus
Clinical narrative: Severe pain in my left jaw; it (jaw) locked up/face froze; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202), via an unspecified route of administration in the left arm on 25Feb2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history included diagnosed with COVID-19. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but had other unspecified medications within 2 weeks of vaccination. On 25Feb2021 20:00, the patient experienced severe pain in her left jaw then it (jaw) locked up. Her face froze. She had difficulty swallowing. The patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events and included treatment with muscle relaxer, heat and ice, and rest. Outcome of the events was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Woke up with subconjunctival hemorrhage in left eye; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via an unspecified route of administration into the left arm on 26Feb2021 09:15 at a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN9581), via an unspecified route of administration into the left arm on 05Feb2021 09:30 at a single dose for COVID-19 immunization. The patient woke up with subconjunctival hemorrhage in left eye on 28Feb2021 06:00. The patient did not receive treatment for the event reported. Outcome of event was not recovered.
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Feeling abnormal, Pain in extremity
Clinical narrative: His arm was very sore; His arm was red; the whole left side of his body was bad; needed booster after a year; This is a spontaneous report from a contactable consumer (patient).  An elderly male patient received the second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot/batch number and expiration date were unknown) via an unspecified route of administration at arm left on an unspecified date at single dose for immunization.  Medical history included blood pressure abnormal about 20 years ago, asthma diagnosed in his 40s, blood cholesterol abnormal about a year and a half ago. The patient's concomitant medications were not reported. Patient previously received first dose with no reaction. The patient needed booster after a year. After the second dose, he actually had to go to bed for a day. His arm was very sore after that, red and the whole left side of his body was bad. He just had to go to bed for the whole day. First time he ever had reaction to anything. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.