chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash that was located on the neck,chest and back area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 08Jan2021 10:00 at a single dose on right arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced a rash that was located on the neck,chest and back area on 08Jan2021 14:00. No treatment was given for the event. The patient has not been tested for COVID post vaccination. The patient recovered from the event on Jan2021.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Petechiae
Clinical narrative: Transient numbness inside mouth buccal mucosa for about 3-5 minutes; Slight swelling upper left lip; 2cm petechia on border of left upper lip stopping at the midline; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), Intramuscular at left arm on 15Jan2021 11:00 at SINGLE DOSE for covid-19 vaccination. Medical history was reported as none.  The patient's concomitant medications were not reported. On 15Jan2021 11:15, the patient experienced transient numbness inside mouth buccal mucosa for about 3-5 minutes, slight swelling upper left lip, 2cm petechia on border of left upper lip. Stopping at the midline. No treatment received for the events. No covid-prior-vaccination, no covid-tested-post-vaccination, no known allergies. The outcome of the events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Product use issue
Clinical narrative: Myalgias; She was nursing her infant; She was nursing her infant; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported for herself and her infant. This is mother report. A 37-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 11Jan2021 at 18:15 at single dose in left arm for covid-19 immunization. Medical history included hypothyroid, and known allergies: penicillin. Concomitant medication included levothyroxine, biotin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ergocalciferol (VIT D), lactobacillus acidophilus (PROBIO). The patient previously received the first dose bnt162b2 (lot number: EK5730) on 22Dec2020 at 06:15 pm in right arm for covid-19 immunization. The patient experienced myalgias on 12Jan2021 at 11:00. Event details: The patient experienced myalgias 16 hours after receiving the 2nd vaccine. She was nursing her infant and the infant developed fever for 3 days without any other symptoms following her vaccination. The patient did not received treatment for event myalgias. The patient did not have COVID prior vaccination, and have not been tested for COVID post vaccination. The outcome of the event myalgias was resolved in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051876 infant case
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: got his first vaccine/antibody test done and came back non reactive; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose as COVID-19 vaccine. Medical history included lupus and RA. Concomitant medications were not reported. The patient got his first vaccine last 23Dec2020. After his first done, he had his antibody test done and came back non reactive on Jan2021. He got his second dose last 13Jan2021 and would still be undergoing an antibody test to see if he has traces of the antibodies. The patient was asking if it would show zero efficacy. Does he need a third dose or revaccination? The outcome of the event was unknown.  Information about lot and batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood pressure abnormal, Dehydration, Dyskinesia
Clinical narrative: temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Malaise, Movement disorder, Pyrexia
Clinical narrative: temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Thirst, Urine abnormality, Vision blurred
Clinical narrative: temperature of 105.5 and stated it would fluctuate between 104-105; blurred vision; balance was off; first it was up around 163/71 and then over time it was really low 118/58; HR was high; body was jerking; arm that she got the injection in was dropping; dehydrated; urine is darker; real thirsty; extremely weak; tired and exhausted; feeling horrible; couldn't stay awake, fell asleep; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 14Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included left hip replaced on 16Nov2020 and had her right hip replaced on 29Dec2020. There were no concomitant medications. Patient reported that she got the shot at 1:30 pm and on the way home she started getting tired and exhausted on 14Jan2021. She got home and went right to bed. She felt like she couldn't stay awake, fell asleep and woke up about 6 pm then with a temperature of 105.5 and stated it would fluctuate between 104-105. She was just feeling horrible. At 7:30 pm, patient had a temperature of 103.5 and at 7:45 pm, her temperature was 104. On 14Jan2021, patient stated that she couldn't see straight, had blurred vision, having trouble walking, her balance was off and falling into walls. Her body was jerking and the arm that she got the injection in was dropping. Patient called her cardiology office, and was advised to take Tylenol 3-4 times per day and alternate it with Motrin. She was also taking coated 325 mg aspirin. She can hold her head up and was not jerking as much as she was. She was doing noticeably better. Patient had put ice bags on her groin, stomach and throat to try to cool down through the night. This brought temperature down to 103. She woke up at 12 am she was 102. Her temperature at the time of report was around 101-102. She took her blood pressure it was going crazy, first it was up around 163/71 and then over time it was really low 118/58 and heart rate was 130 for a while and went to 103. The back of her neck still felt so weak and she still feels extremely weak and exhausted. She went on to report that her HR was high and B/P was up but since then it has come down. The night of 14Jan2021, her b/p was low.On 14Jan2021, patient was also real thirsty and her urine was darker and was probably dehydrated and thought that she was real jerky muscle-wise, like she is not in control of anything last night. That she has not taken BP or heart rate on 15Jan2021, but it was not pounding today though. She was doing better today at the time of report. Patient was recovering from the events of fever, blurred vision, and balance was off; not recovered from tired, jerking, and dehydration. Outcome of remaining events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in jaw, Paraesthesia
Clinical narrative: Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3248), via an unspecified route of administration at site of left arm at 13:15 on 15Jan2021 at single dose for COVID-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), obesity and known allergies: Sulfa. Concomitant medication included cannabidiol (CBD OIL) and paracetamol (TYLENOL), both received within two weeks of vaccination. The patient experienced tight/sore jaw and tingling in cheeks, both at 13:30 on 15Jan2021. The patient was not pregnant at time of vaccination. Facility type vaccine was in workplace clinic. No other vaccine in four weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pain, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: numbness; tingling; shooting pain in her left trapezius; nerve pain in this area, mostly on the left medial trap next to her spine; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730, expiry date unknown), intramuscular (right arm), on 12Dec2020 21:00 at single dose, for covid-19 immunization. Medical history includes unresolved dystonic reaction as of 2016 secondary to taking Lamictal (not fully resolved, currently being treated with baclofen and gabapentin). Concomitant medications in two weeks included gabapentin for unresolved dystonic; methylphenidate hydrochloride (CONCERTA); clonidine; vilazodone hydrochloride (VIIBRYD); ondansetron (ZOFRAN [ONDANSETRON]); doxycycline; and baclofen for unresolved dystonic. The patient previously took lamotrigine (LAMICTAL) and experienced dystonic reaction and allergies. The patient experienced numbness, tingling, and shooting pain in her left trapezius one day on 17Dec2020, after the first injection; and these lasted two weeks. While the numbness and tingling have resolved, the patient sometimes still experiences nerve pain in this area, mostly on the left medial trap next to her spine from 17Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse events. The patient was recovering from the events shooting pain in her left trapezius and; nerve pain in this area, mostly on the left medial trap next to her spine. The patient recovered from the events numbness and tingling on an unspecified date. The patient had no other vaccine in four weeks. The patient had a nasal swab test post-Covid vaccination on 02Jan2021 with results of negative.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Injection site urticaria
Clinical narrative: allergic reaction; hives and itching in the administration site; hives and itching in the administration site; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked for information if she should be administrated with the second dose of the Pfizer's COVID-19 vaccine if she developed side an allergic reaction to the first dose of the vaccine. The patient reported that after the first dose of the Pfizer's COVID-19 vaccine she had hives and itching in the administration site on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia, Hypoaesthesia eye, Paraesthesia, Swelling face
Clinical narrative: Facial tingling; facial tingling and numbness/cheek and eye feel swollen or numb; eye feel swollen or numb; eye feel swollen or numb; cheek and eye feel swollen; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received the first dose of the COVID-19 vaccine yesterday morning at 9:00AM. The patient was experiencing facial tingling and numbness on unspecified date. He would like to know if this is a common side effect. He wanted to ask if numbness and tingling in the face a common side effect? The patient does not know if slept on his face or what but his left cheek and eye feel swollen or numb and stated that it was hard to describe. The patient noticed this this morning 15Jan2021. The patient stated, "it sort of feels like when you go to the dentist". The outcome of the event cheek swollen and eye feel swollen or numb was not recovered. The outcome of the remaining events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Palpitations, Vaccination site pain
Clinical narrative: Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the left arm, on 15Jan2021 16:15, at single dose, for COVID-19 immunization, in a public health clinic. The patient medical history and concomitant medications were not reported. Past drug included sulfamethoxazole, trimethoprim (BACTRIM) which the patient has allergies to. The patient did not have COVID-19 prior to vaccination and is not pregnant. The patient did not receive other vaccines in four weeks. The patient experienced heart palpitations, sore throat, and hurt when vaccination was injected on 15Jan2021 at 16:15. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: a mass grew within the muscle at the forearm region; minor pain; swelling; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 22Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included shellfish allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had first shot of BNT162B2 on 22Dec2020 09:00 then two weeks later a mass grew within the muscle at the forearm region, no ecchymosis with minor pain on 04Jan2021 11:45. The patient had heat pad applied to lower the swelling 04Jan2021 11:45. The outcome of the events was recovering. No treatment was given to the patient for the events minor pain and mass in forearm. The patient did not receive 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 not been tested for COVID-19.  Information about lot/batch number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Dizziness, Fatigue, Frostbite
Clinical narrative: cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Nausea
Clinical narrative: cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Face was tingling around her mouth; Face was tingling around her mouth; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 14Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. 25 minutes after the vaccination on 14Jan2021 (16:55), the patient's face was tingling around her mouth. It lasted for about 30 minutes. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events on 14Jan2021 at 17:25.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: soreness in her arm getting worse, goes up to her neck and shoulder, also down in her elbow; soreness in her arm getting worse, goes up to her neck and shoulder, also down in her elbow; soreness in her arm getting worse, goes up to her neck and shoulder, also down in her elbow; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number unknown, via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received her first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021 (Wednesday) and she reported "soreness in her arm getting worse, goes up to my neck and shoulder, also down in her elbow" on an unspecified date in Jan2021. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: rigors/teeth chattering/chills; body aches for 12 hours; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as age: 50, unit: unknown) received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 18Dec2020 and had no side effects. On 08Jan2021, after receiving the second vaccine, the patient developed rigors, teeth chattering, body aches for 12 hours, took tylenol, well the day after and then the next evening body aches and chills, and then morning after that was fine. The outcome of the events was recovered.   Information on the lot/ batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Pain in extremity
Clinical narrative: Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Fatigue, Muscle spasms
Clinical narrative: Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nipple pain, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: vagina returned to post-menopausal moisture level and hot flashes stopped; nipples/breasts became extremely tender/sore; This is a spontaneous report from a contactable Other HCP (patient). A 57-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E112884/6022728) intramuscular at left arm on 04Jan2021 10:15 AM for COVID-19 immunization. Medical history included mild COPD (Chronic obstructive pulmonary disease) and diagnosis of DCIS (Ductal carcinoma in situ), had breast implants. No covid prior vaccination. No other vaccine in four weeks. No other medications in two weeks. Patient was 57 years old and am 6+ years post-menopausal. The day after vaccine, on 05Jan2021 08:00 AM, her nipples/breasts became extremely tender/sore, her vagina returned to post-menopausal moisture level and hot flashes stopped. Patient was 11 days out from vaccine and the symptoms have not stopped. She has not experienced these symptoms at any time after going through menopause. Events resulted in emergency room visit. No treatment received. The outcome of "nipples/breasts became extremely tender/sore" was not recovered. Covid test via Nasal Swab on 04Jan2021, 07Jan2021, 11Jan2021 was Negative, result of Nasal Swab covid test on 14Jan2021 was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Dizziness, Feeling abnormal, Headache
Clinical narrative: pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neck pain, SARS-CoV-2 test
Clinical narrative: pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: itchy on upper buttocks and lower back; redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); redness began and now I have red blotches and a rash from upper buttocks, up my back and on the sides (flanks.); itchy red rash spots on stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 06:30 AM at left arm at single dose for COVID-19 immunization. Medical history included known allergies to milk products and seasonal allergies. Patient is not pregnant. Other medications in two weeks included fexofenadine hydrochloride (ALLEGRA). No other vaccine in four weeks. 8 hours after the first dose of vaccine (15Jan2021 02:30 PM) patient became itchy on upper buttocks and lower back. Then, redness began and now patient have red blotches and a rash from upper buttocks, up her back and on the sides (flanks.) Also, itchy red rash spots on stomach. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy a little bit; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 72 without unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date of Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy a little bit, it did not last for very long. Feeling a little better. The outcome of event was recovering.  Information on the lot/ batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and tender; injection site soreness; painful swollen lymph nodes/Lymph nodes on base of my neck started to become swollen and tender; kind of a side effect it was worst; my right deltoid is really very sore and my neck has really become sore.; my right deltoid is really very sore and my neck has really become sore.; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Brand=Pfizer; lot number: EL3248) via an unspecified route of administration at right arm on 13Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. No other vaccine in four weeks. Other medications in two weeks included hydrochlorothiazide/losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), pantoprazole sodium sesquihydrate (PROTONIX), multivitamins/plain (reported as MVI), biotin, docusate sodium (COLACE), Adde (to be clarified). The patient was not pregnant. Facility type vaccine was at Hospital. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced adverse events included tiredness, painful swollen lymph nodes, injection site soreness; all with start date on 13Jan2021 and with outcome of not resolved. No treatment received for events. It was also reported right deltoid had been sore, lymph nodes on base of her neck started to become swollen and tender; kind of a side effect it was worst, and neck had really become sore; all on 13Jan2021 and with outcome of unknown. The patient stated she had the vaccine on 13th and her right deltoid had been sore. Yesterday (15Jan2021) her lymph nodes on base of my neck started to become swollen and tender, she knew it's a kind of a side effect but it was worst today than it was yesterday and she just wanted to know how long those side effect last because her right deltoid was really very sore and her neck had really become sore.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tiredness; painful swollen lymph nodes/lymph nodes on base of her neck started to become swollen and tender; injection site soreness; painful swollen lymph nodes/Lymph nodes on base of my neck started to become swollen and tender; kind of a side effect it was worst; my right deltoid is really very sore and my neck has really become sore.; my right deltoid is really very sore and my neck has really become sore.; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Brand=Pfizer; lot number: EL3248) via an unspecified route of administration at right arm on 13Jan2021 at 09:15 AM at a single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. No other vaccine in four weeks. Other medications in two weeks included hydrochlorothiazide/losartan potassium (LOSARTAN/HYDROCHLOROTHIAZIDE), pantoprazole sodium sesquihydrate (PROTONIX), multivitamins/plain (reported as MVI), biotin, docusate sodium (COLACE), Adde (to be clarified). The patient was not pregnant. Facility type vaccine was at Hospital. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced adverse events included tiredness, painful swollen lymph nodes, injection site soreness; all with start date on 13Jan2021 and with outcome of not resolved. No treatment received for events. It was also reported right deltoid had been sore, lymph nodes on base of her neck started to become swollen and tender; kind of a side effect it was worst, and neck had really become sore; all on 13Jan2021 and with outcome of unknown. The patient stated she had the vaccine on 13th and her right deltoid had been sore. Yesterday (15Jan2021) her lymph nodes on base of my neck started to become swollen and tender, she knew it's a kind of a side effect but it was worst today than it was yesterday and she just wanted to know how long those side effect last because her right deltoid was really very sore and her neck had really become sore.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chills, Myalgia, Pain
Clinical narrative: Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ear discomfort, Fatigue, Pain in jaw, Toothache
Clinical narrative: I had sore shoulder, extreme tiredness; I had sore shoulder, extreme tiredness; I soon had "crinkle' sounds in my left ear; mild tooth/jaw pain on the left side of the mouth; mild tooth/jaw pain on the left side of the mouth; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received first dose of bnt162b2 (BNT162B2, Lot number EL1283), via an unspecified route of administration on 13Jan2021 12:00 at SINGLE DOSE on Left Shoulder for COVID-19 immunisation. Medical history included artery disease, sleep apnea, acid reflux. No known allergies. Concomitant medication included amlodipine (AMLODIPINE), armodafinil (ARMODAFINIL), rosuvastatin calcium (CRESTOR), clopidogrel bisulfate (PLAVIX), potassium (POTASSIUM). The patient reported i soon had "crinkle' sounds in my left ear, mild tooth/jaw pain on the left side of the mouth on 13Jan2021 15:45; had sore shoulder, extreme tiredness on 14Jan2021. The event outcome of had "crinkle' sounds in my left ear was not recovered, outcome of other events were recovering. No treatment was received for event. The consumer also reported his wife had slow onset of left earache, and she soon had "crinkle' sounds in left ear, and both experienced mild tooth/jaw pain on the left side of the mouth. If she had not matched he symptoms, he would not have attributed these two things to the vaccine. No Covid prior vaccination, no Covid tested post vaccination.