chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Paraesthesia oral, Pharyngeal swelling, Swelling face
Clinical narrative: throat started getting swollen; hard for me to swallow; face started getting flush and started to swell too; face started getting flush and started to swell too; tongue started to feel funny; This is a spontaneous report from a contactable other health care professional (patient). A 30-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 18:30 hours (Batch/Lot Number: EM9810) as DOSE 1, SINGLE (at the age of 30-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 09Feb2021, the patient's throat started getting swollen, it was hard for the patient to swallow. The patient's face started getting flush and started to swell too. The patient's tongue started to feel funny. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The patient received treatment for the events with Benadryl, steroids, and Pepcid. The patient did not have any other vaccine in four weeks and was on no other medications in two weeks. The patient had not had COVID prior to vaccination and was not COVID tested post vaccination. The patient was recovering from the events.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: 102 fever; headache; chills; restlessness; muscle and joint aches; muscle and joint aches; brain fog; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:15 (at the age of 70-year-old) (Batch/Lot Number: EC9265) as dose 1, single for covid-19 immunisation. Medical history included lymphoedema, hypothyroidism, atrial fibrillation, sleep apnoea syndrome and milk allergy. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); rivaroxaban (XARELTO); biotin (BIOTIN); tolnaftate (CLARUS [TOLNAFTATE]); ascorbic acid, biotin, colecalciferol, dexpanthenol, folic acid, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin sodium phosphate, tocopherol, vitamin b1 nos, vitamin b12 nos (12 VITAMINS FOR INJECTION) all taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim, augmentine [amoxicillin;clavulanic acid], flagyl [metronidazole], cipro [ciprofloxacin] and experienced allergies to all. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced 102 fever, headache, chills, muscle and joint aches, brain fog, restlessness on 03Feb2021 23:30. The patient underwent lab tests and procedures which included pyrexia: 102 on 03Feb2021 23:30. No treatment received for the adverse events. The clinical outcome of the events were recovered with sequelae on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness
Clinical narrative: 102 fever; headache; chills; restlessness; muscle and joint aches; muscle and joint aches; brain fog; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:15 (at the age of 70-year-old) (Batch/Lot Number: EC9265) as dose 1, single for covid-19 immunisation. Medical history included lymphoedema, hypothyroidism, atrial fibrillation, sleep apnoea syndrome and milk allergy. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); rivaroxaban (XARELTO); biotin (BIOTIN); tolnaftate (CLARUS [TOLNAFTATE]); ascorbic acid, biotin, colecalciferol, dexpanthenol, folic acid, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin sodium phosphate, tocopherol, vitamin b1 nos, vitamin b12 nos (12 VITAMINS FOR INJECTION) all taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim, augmentine [amoxicillin;clavulanic acid], flagyl [metronidazole], cipro [ciprofloxacin] and experienced allergies to all. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced 102 fever, headache, chills, muscle and joint aches, brain fog, restlessness on 03Feb2021 23:30. The patient underwent lab tests and procedures which included pyrexia: 102 on 03Feb2021 23:30. No treatment received for the adverse events. The clinical outcome of the events were recovered with sequelae on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Arm soreness; general congestion; This is a spontaneous report from a non-contactable consumer (patient himself). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581), via an unspecified route of administration, administered in left arm on 09Feb2021 15:00 (age at vaccination: 38 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included colitis ulcerative. Concomitant medication(s) included vedolizumab (ENTYVIO); loperamide hydrochloride (IMODIUM); cetirizine hydrochloride (ZYRTEC). The patient have no known allergies. On 09Feb2021 15:30, the patient experienced arm soreness, general congestion. The patient on 11Feb2021, underwent sars-cov-2 test (nasal swab, PCR) which was negative. The patient did not have other vaccine in four weeks. No treatment was received for the adverse events. The patient did not have covid before vaccination. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pain in extremity
Clinical narrative: top lip swollen; soreness on his right arm; This is a spontaneous report from a contactable consumer (patient himself). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN9581, expiry date: unknown) via unspecified route of administration, in right arm on 10Feb2021 08:00 (age at vaccination: 66-years-old) as dose 1, single for covid-19 immunisation. Vaccination facility was at hospital and not facility. Patient did not have any illnesses at the time of vaccination. He had no family medical history. Medical history included blood pressure, cholesterol, and gout from an unspecified date and unknown if ongoing. Concomitant medications included lisinopril 40 mg, 1x/day, oral (ongoing) and amlodipine 5 mg, 1x/day oral taken for blood pressure, atorvastatin 10 mg, 1x/day oral (ongoing) taken for cholesterol, and allopurinol 100 mg, 2x/day oral taken for gout. Patient stated he was 66 years old and received the first dose of the Pfizer-BioNTech COVID-19 vaccine last Wednesday morning. He mentioned he woke up the next morning with his "top lip swollen". He asked if his reaction was reported as a side effect of the COVID-19 vaccine. He added that he had some soreness on his right arm right away but his wife advised him to put a warm towel on it and it was fine. He mentioned that he knew you could have some swelling on your face. He was asking is that normal? He mentioned his second dose was scheduled on 03Mar2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) was administered. There was no requirement of physicians office visit or emergency room visit for the adverse events. Treatment was given for soreness on his right arm. The outcome of event for soreness on his right arm was recovered on 11Feb2021 and for top lip swollen it was not recovered.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Feeling abnormal, Feeling drunk
Clinical narrative: Drunk feelings; Light headed/dizzy; slightly nauseous; lower back pain (kidney area); very tired; in a fog state of mind; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 57-years-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9267), via an unspecified route of administration on 10Feb2021 10:00 (age at the vaccination 57-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included uterine cancer, heart murmur, hepatitis, kidney issue (hepatitis as a child and kidney issues as a result of radiation) and Known allergies: latex from an unknown date and unknown if ongoing. Patient concomitant medication includes Prenatal vitamins and enzymes. The patient previously took morphine and experienced Known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 10Feb2021 10:30 patient experienced drunk feelings, lightheaded/dizzy, slightly nauseous, lower back pain (kidney area), very tired and in a fog state of mind. The patient did not receive any other treatment for the events. The outcome of the events was not recovered.  Follow-up (07MAY2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Drunk feelings; Light headed/dizzy; slightly nauseous; lower back pain (kidney area); very tired; in a fog state of mind; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 57-years-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9267), via an unspecified route of administration on 10Feb2021 10:00 (age at the vaccination 57-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included uterine cancer, heart murmur, hepatitis, kidney issue (hepatitis as a child and kidney issues as a result of radiation) and Known allergies: latex from an unknown date and unknown if ongoing. Patient concomitant medication includes Prenatal vitamins and enzymes. The patient previously took morphine and experienced Known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 10Feb2021 10:30 patient experienced drunk feelings, lightheaded/dizzy, slightly nauseous, lower back pain (kidney area), very tired and in a fog state of mind. The patient did not receive any other treatment for the events. The outcome of the events was not recovered.  Follow-up (07MAY2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her husband only experienced a sore arm; This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's wife) reported for a male patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her husband only experienced a sore arm on an unspecified date. Outcome of the event was unknown  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: experienced 8 hours of numbness around her lips after receiving her first dose of the Pfizer Covid vaccine on 19Jan2021.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single (at 53 year old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced 8 hours of numbness around her lips after receiving her first dose of the pfizer covid vaccine on 19Jan2021. The patient had second dose scheduled next week. The outcome of the event numbness lips was unknown.  Follow-up attempts completed. No further information expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure systolic, Eye swelling, Fatigue
Clinical narrative: bumped up blood pressure; Swelling around her eyes; Fatigue; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable nurse reported for the patient. A 86-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter is a nurse calling about her mother. Asking if there have been reports of elevated blood pressures following administration of the covid vaccine, Patient had her first covid vaccine 8 days ago and experienced swelling around her eyes, a bumped-up blood pressure and fatigue. Caller reports that her mother normally has a and it systolic b/p of 120/130 went up to 180 with activity and walking the other day. She questioned if elevated blood pressures were reported during the clinical trials and if it will be worse with the second dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: mild fever of ~100*F; general mild flu like symptoms; caused trouble sleeping; headache; tiredness; chills; nausea; joint pain (specifically in hips); body aches; This is a spontaneous report from a non-contactable consumer or other non hcp. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 11:45 (Age at vaccination26 Years old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, etynodiol diacetate (KELNOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 01:30 the patient experienced 13-14 hours post-vaccination chills, nausea, joint pain (specifically in hips), mild fever of ~100*F (fever came around 2:30 am, woke up at 6 am with no fever), body aches, general mild flu like symptoms which caused trouble sleeping; 24 hours post-vaccination: body aches, joint pain (mostly in hips), headache, tiredness. Side effects were only mild to moderate, nothing serious or severe. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on 10Feb2021 mild fever of ~100*F (fever came around 2:30 am, woke up at 6 am with no fever). Outcome of events was recovered on unspecified date of Feb2021.    No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: mild fever of ~100*F; general mild flu like symptoms; caused trouble sleeping; headache; tiredness; chills; nausea; joint pain (specifically in hips); body aches; This is a spontaneous report from a non-contactable consumer or other non hcp. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 11:45 (Age at vaccination26 Years old) (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ethinylestradiol, etynodiol diacetate (KELNOR), ascorbic acid, betacarotene, biotin, calcium, chromium, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin d nos, vitamin e nos, xantofyl, zinc (CENTRUM WOMEN), biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 01:30 the patient experienced 13-14 hours post-vaccination chills, nausea, joint pain (specifically in hips), mild fever of ~100*F (fever came around 2:30 am, woke up at 6 am with no fever), body aches, general mild flu like symptoms which caused trouble sleeping; 24 hours post-vaccination: body aches, joint pain (mostly in hips), headache, tiredness. Side effects were only mild to moderate, nothing serious or severe. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on 10Feb2021 mild fever of ~100*F (fever came around 2:30 am, woke up at 6 am with no fever). Outcome of events was recovered on unspecified date of Feb2021.    No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Investigation, Swelling face, Tension headache, Vaccination site pain
Clinical narrative: Event: Left arm injection site pain was reported as worsened; had swelling in both temples; Tension headache; Left arm injection site pain; This is a spontaneous report from a contactable consumer (patient himself). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809), via intramuscular route, administered in left arm on 11Feb2021 09:00 (age at vaccination: 49 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included joint infection on his right elbow from a surgery that he had in 2020, which was in a different arm than injection. This is why he is taking the Penicillin VK and oral herpes. Concomitant medication(s) included phenoxymethylpenicillin potassium (PENICILLIN VK), 500 mg three times daily taken for arthritis infective from 05Jan2021; valaciclovir hydrochloride 2 grams every 12 hours by mouth as needed taken for oral herpes. The patient started valaciclovir hydrochloride 5 years ago. He took two doses the night before he received the vaccine. Finished it the morning of 11Feb2021. The patient received the vaccination in Health Department. On 11Feb2021 17:30, the patient experienced had swelling in both temples. On 11Feb2021, the patient had tension headache, left arm injection site pain, left arm injection site pain was reported as worsened. The tension headache got worse and it was just off and on. It felt like overworked muscles. The patient did not require emergency room or physician's office visit's urgent care to look at swelling. No medical treatment was received and was advised to go to the ER if it got worse. The patient did not receive any prior vaccination in 4 weeks. On an unknown date in 2020, the patient underwent investigation (unspecified) which was looking good. He was considered a high risk patient. The outcome of the swelling face was recovering, condition aggravated was unknown and all the other events were unknown. There was no product quality complaint present.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising on her legs; This is a spontaneous report from a contactable pharmacist via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced bruising on her legs. Reportedly, patient received the first dose of the Pfizer COVID 19 vaccine last Friday and ended up with bruising on her legs. Patient questioned any information about platelet issues and on whether she should receive her 2nd dose. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain every day since vaccination; This is a spontaneous report from a contactable physician (patient). A 53-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El3249), via an unspecified route of administration in arm left on 13Jan2021 at 12:30 PM (at the age of 53-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergies: Egg. The patient's concomitant medications in two weeks were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Eh9899), via an unspecified route of administration in arm left on 22Dec2020 at 12:30 PM as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 13Jan2021 at 14:00, the patient experienced joint pain every day since vaccination. The AE resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included NSAID. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Non-stop headaches; muscle aches; arm pain; joint pain; chills; fever; itchiness; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable other HCP (patient). A 26-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3242), via an unspecified route in the left arm on 08Feb2021 at 13:45 (age at vaccination: 26-year-old), as a single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies, and allergies to mold/tree/pollen/grass/animal dander and the likes (enough to be advised to have an epipen). Other medical history included she may have PCOS, in process of finalizing a diagnosis, she does have ADHD/Anxiety and a history of asthma from her childhood that flares up every few years. The patient concomitant medications were not reported. Patient has no history of allergies to medications or foods. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3247), via an unspecified route in the left arm on 18Jan2021 at 10:15, as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 09Feb2021 at 15:30, patient experienced every possible symptom on the list concurrently and still continue to experience a few today. Non-stop headaches, muscle aches, arm pain, joint pain, chills, fever, itchiness, fatigue, swollen lymph nodes and probably more. All of these occurred at the same time and she was still on bed rest with fatigue, headaches, and swollen lymph nodes. Adverse events have required her to take a significant amount of time off work. She was unsure of why her body was responding this way but now she was on day 5 of this experience and believe it should be worth noting. Therapeutic measures taken as a result of the events included ibuprofen, but her headaches and pains seem to persist even with medicine. The clinical outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Non-stop headaches; muscle aches; arm pain; joint pain; chills; fever; itchiness; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable other HCP (patient). A 26-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3242), via an unspecified route in the left arm on 08Feb2021 at 13:45 (age at vaccination: 26-year-old), as a single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies, and allergies to mold/tree/pollen/grass/animal dander and the likes (enough to be advised to have an epipen). Other medical history included she may have PCOS, in process of finalizing a diagnosis, she does have ADHD/Anxiety and a history of asthma from her childhood that flares up every few years. The patient concomitant medications were not reported. Patient has no history of allergies to medications or foods. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3247), via an unspecified route in the left arm on 18Jan2021 at 10:15, as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 09Feb2021 at 15:30, patient experienced every possible symptom on the list concurrently and still continue to experience a few today. Non-stop headaches, muscle aches, arm pain, joint pain, chills, fever, itchiness, fatigue, swollen lymph nodes and probably more. All of these occurred at the same time and she was still on bed rest with fatigue, headaches, and swollen lymph nodes. Adverse events have required her to take a significant amount of time off work. She was unsure of why her body was responding this way but now she was on day 5 of this experience and believe it should be worth noting. Therapeutic measures taken as a result of the events included ibuprofen, but her headaches and pains seem to persist even with medicine. The clinical outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was a little hurt (right arm, at the injection site) other than that; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 75 years). The patient medical history and concomitant medications were not reported. On 04Feb2021 caller stated don't have any problems after I take the vaccine, the next day I had it, my arm was a little hurt (right arm, at the injection site) other than that, have not experienced any other symptom/side effect. Caller asked that I am going to fly on the 19th, can I receive it earlier. My second dose is supposed to be on 24Feb2021. The outcome of the event was unknown.  Information on batch/lot number was requested.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Illness, Pyrexia, Vomiting
Clinical narrative: She is sick to her stomach; has 102F temperature/fever; vomiting; This is a spontaneous report from contactable consumer via a Pfizer-sponsored program. A consumer reported for patient (mother).  A 64-year-old female patient received BNT162B2 (Pfizer-BioNtech Covid-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 64-years-old) as dose, 1 single for COVID-19 immunisation. Medical history included diabetes (reporter does not know what type of diabetes his mom has, but she does not use insulin for it). Concomitant Medications were nothing new, but she has not been able to take her medication (unspecified medication) on day of report. On 11Feb2021, the patient was experiencing 102 F temperature/fever, and vomiting, on an unspecified date, patient was sick to her stomach. The reporter would like to know what to do and if this was related to the vaccine. Patient went to the doctor office for 102 F temperature/fever, and vomiting, and the doctor said that it sounded like she had a stomach bug, he did not even test her for Covid or do any tests. The patient second dose of the vaccine was scheduled for the day of this report, so reporter would like to know if they should wait until she feels better or get tested for Covid-19. The patient underwent lab tests which included Height: 5 feet 3 inches or 5 feet 4 inches, Weight: 120 lbs (she was about 120lbs, give or take) on an unspecified date and Body Temperature: 102 Fahrenheit on 11Feb2021. The outcome of the events 102 F temperature/fever and vomiting was not recovered and event sick to her stomach was unknown.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: She is sick to her stomach; has 102F temperature/fever; vomiting; This is a spontaneous report from contactable consumer via a Pfizer-sponsored program. A consumer reported for patient (mother).  A 64-year-old female patient received BNT162B2 (Pfizer-BioNtech Covid-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 64-years-old) as dose, 1 single for COVID-19 immunisation. Medical history included diabetes (reporter does not know what type of diabetes his mom has, but she does not use insulin for it). Concomitant Medications were nothing new, but she has not been able to take her medication (unspecified medication) on day of report. On 11Feb2021, the patient was experiencing 102 F temperature/fever, and vomiting, on an unspecified date, patient was sick to her stomach. The reporter would like to know what to do and if this was related to the vaccine. Patient went to the doctor office for 102 F temperature/fever, and vomiting, and the doctor said that it sounded like she had a stomach bug, he did not even test her for Covid or do any tests. The patient second dose of the vaccine was scheduled for the day of this report, so reporter would like to know if they should wait until she feels better or get tested for Covid-19. The patient underwent lab tests which included Height: 5 feet 3 inches or 5 feet 4 inches, Weight: 120 lbs (she was about 120lbs, give or take) on an unspecified date and Body Temperature: 102 Fahrenheit on 11Feb2021. The outcome of the events 102 F temperature/fever and vomiting was not recovered and event sick to her stomach was unknown.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain
Clinical narrative: pain; arthritis pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown, at the age of 75 years), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of vaccine on an unspecified date and took Aleve days later due to pain she experienced and her arthritis pain. She would like to know the information on if it is okay to take pain relievers before or after vaccination. Therapeutic measures were taken as a result of pain, arthritis pain. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Caller had a circle rash around the site of injection/ Rash; if she rubbed the area it becomes raised and It is also hot; if she rubbed the area it becomes raised and It is also hot; itching started first time around; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 74-year-old female patient received (COMIRNATY, solution for injection, Batch/Lot Number: EL9269, expiration date: not reported) on her left arm via intramuscular route on 03Feb2021 16:55 (at the age of 74-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included blood pressure. Historical vaccine included that patient previously took tetanus vaccine for immunization and experienced that her arm got as big as a golf ball. Concomitant medications were not reported. The patient did not take prior Vaccinations within 4 weeks. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. No additional Vaccines Administered on Same Date of the Pfizer Suspect. On 06Feb2021, the patient had a circle rash around the site of injection. Patient stated that if she rubbed the area it becomes raised and It is also hot. Patient questioned is it normal or Should she worry. It has been about 10 days since she had the first vaccination, clarified it was the Pfizer covid vaccine. She did not have any effects till the third day. She had a rash and a circle around the site and then it went away. Now it is a bigger circle, and it is hot. Asking if this is normal. She clarified that she had the rash for about two days, then the rash went away, she had 24 hours of nothing, then all of a sudden the rash appeared again. The itching started first time around, she took Allegra for a day or two and the itching stopped, then when the itching started again, she took Allegra so she did not get the itching again, states she is trying to get ahead of the itching. The patient stated that she does not think her medication is relevant to add and she takes stuff the elderlies get. She mentioned blood pressure. Therapeutic measures were taken as a result of the events. The outcome of the event caller had a circle rash around the site of injection/ Rash was not recovered, itching started first time around was recovered on an unspecified date in 2021 and if she rubbed the area it becomes raised and It is also hot was unknown.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Nausea, Pyrexia
Clinical narrative: fever; congestion; nausea; chills; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old female patient received 1st dose of bnt162b2 (Comirnaty,Batch/Lot Number: EL9264),via an unspecified route of administration, administered in Arm Right on 03Feb2021 14:00 ,at the age of 23 years old,as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever,congestion and nausea, chills on 04Feb2021.The patient had not received any other vaccines within 4 weeks.The patient had no known allergies.The patient had not received any treatment for the event.The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination.The outcome of the events was not recovered.The adverse events didn't resulted in patient visit to hospital or physician.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild pain at injection side; Chills; fatigue; muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 11Feb2021 15:15 (at the age of 37-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history was not reported. Concomitant medication included valacyclovir [valaciclovir] taken for an unspecified indication, from an unknown date. Other medications received in two weeks included valacyclovir. The patient historical vaccine included first dose of BNT162B2 (lot number: EL3247, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 21Jan2021 03:15 PM (at the age of 37-years-old) as dose 1, single for covid-19 immunization. The patient does not have any allergies. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 12Feb2021 11:45 AM the patient experienced mild pain at injection side. Chills, fatigue, muscle aches the day after the second dose. Patient did not receive any treatment for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Lymphadenopathy, Positron emission tomogram
Clinical narrative: flu like symptoms; headaches; swollen lymph nodes; fever of 100.2F; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced flu like symptoms, headaches, swollen lymph nodes, fever of 100.2f. Reporter, male, aged 69, received vaccine last Wednesday. Friday, he had a PET scan. Friday and Saturday, he developed flu like symptoms. He developed headaches, swollen lymph nodes and a fever of 100.2F. He has been having symptoms for 9 days. Is this normal. The patient underwent lab tests and procedures which included fever: 100.2 fahrenheit on an unspecified date in Feb2021, PET scan: unknown results on 05Feb2021. Outcome of the events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up (03Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; headaches; swollen lymph nodes; fever of 100.2F; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced flu like symptoms, headaches, swollen lymph nodes, fever of 100.2f. Reporter, male, aged 69, received vaccine last Wednesday. Friday, he had a PET scan. Friday and Saturday, he developed flu like symptoms. He developed headaches, swollen lymph nodes and a fever of 100.2F. He has been having symptoms for 9 days. Is this normal. The patient underwent lab tests and procedures which included fever: 100.2 fahrenheit on an unspecified date in Feb2021, PET scan: unknown results on 05Feb2021. Outcome of the events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up (03Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nightmare
Clinical narrative: nightmares; joint pain; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient on an unspecified date experienced nightmares and joint pain. The clinical outcome for the events was unknown.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Sensation of foreign body
Clinical narrative: large lump or phlegm in throat; Trouble swallowing at about 2 hours after vaccination; Hoarse voice within the hour after vaccination; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. A 85-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Left arm on 04Feb2021 at 02:00 am (85-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included hbp (high blood pressure) from an unknown date and unknown if ongoing. The patient had allergies to various medications and products. The patient's concomitant medications were none. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 04Feb2021, the patient experienced hoarse voice within the hour after vaccination, trouble swallowing at about 2 hours after vaccination, at 16:00 pm, 14 hrs after vaccination, the patient experienced large lump or phlegm in throat. No treatment was received for the events. The outcome of the events were recovered on Feb2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema
Clinical narrative: she experienced redness on her arm and the redness had already gone down to her elbow/His wife's arm is pink from where she got the shot down to her elbow.; It is a little bit tender; This is a spontaneous report from a contactable consumer. A 90-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (age at vaccination 90-years-old) (Batch/Lot Number: EN9581) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (age at vaccination 90-years-old) (Batch/Lot Number: EL3249) as dose 1, single for covid-19 immunization. In Feb2021, the patient experienced redness on her arm and the redness had already gone down to her elbow/his wife's arm was pink from where she got the shot down to her elbow and little bit tenderness. It was reported that the patient got the second dose of the COVID-19 vaccine on 04Feb2021. After 1 week, the patient experienced redness on her arm and the redness had already gone down to her elbow and arm is now pink, it kept getting worse as it came down and tender. Reporter wanted to know if the color will diminish and will it go away. The events were not treated. The outcome of the event little bit tenderness was unknown, and patient not recovered from another event.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a weird rash 10 days after the first dose and it went away; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 21Jan2021 at 14:15 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation at drive through. Medical history included hashimoto's disease from an unknown date and unknown if ongoing (taking for four years). Concomitant medications included levothyroxine taken for hashimoto's disease from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Investigation assessment was not provided. Reports after the first dose, 10 days (31Jan2021) after, she had a weird rash for two days then it went away, and she was fine. The adverse event was not resulted in a visit to physician or emergency room. The outcome of the rash was reported as resolved on 02Feb2021.  Follow-up attempts are completed. No further information is expected.