chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: experiencing headache and chills.; experiencing headache and chills.; This is a spontaneous report received from a contactable consumer (patient herself) via Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 08Feb2021 (Batch/Lot number: Not Provided) as dose number unknown single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine Yesterday (08Feb2021) and now experiencing headache and chills on an unspecified date in Feb2021. Outcome of the events was unknown.  Information about batch/lot number requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia, Spinal pain
Clinical narrative: numbness; tingling; dizziness; grain like headache; Spinal pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 05Feb2021 10:30 (age at the vaccination 68-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gastrointestinal issues and mild wheat allergy (causes some congestion). Concomitant medications included calcium carbonate (TUMS), acetylsalicylic acid (ALKA SELTZER), calcium and joint supp taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced allergy (Known allergies: Vicodin, mild wheat allergy (causes some congestion). Patient received vaccine in four weeks that Shingles, other vaccine dose number 2 via unspecified route Left arm on 21Jan2021. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Patient experienced severe morning grain like headache with spinal pain, numbness and tingling, accompanied by dizziness on 07Feb2021 06:00 PM. Patient had beaches like this before, but they last for a day or two at the most. After the shot, he his came on two days later and patient still have it 10 days later. Patient did not received treatment for the adverse events. The outcome of the events was not recovered.  Information about Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing and cold like symptoms (runny nose, watery eyes); cold; runny nose; watery eyes; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for her self. A 68-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 13Feb2021 14:00 as dose 1, single (age at vaccination: 68 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination and did not tested COVID post vaccination. On 13Feb2021 18:30, the patient experienced sneezing and cold like symptoms runny nose, watery eyes. No treatment was received. The clinical outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 13Feb2021 at 11:15 AM (Batch/Lot number was not reported) (at the age of 37 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache on 13Feb2021 at 01:00 PM. The patient has taken acetaminophen as treatment for the event. The patient recovered from headache on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Swelling
Clinical narrative: experiencing swelling; knee pain; This is a spontaneous report from a contactable Nurse. A patient of an unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that nurse calling on behalf of employee who just received the first dose of the Pfizer COVID 19 vaccine and was experiencing swelling and knee pain on 09Feb2021 and was asking this was a side effect of the vaccine. Caller stated she was a nurse on the floor and does not have time to answer questions. Stated she has called before and just keeps getting the run around and she was losing her patience. Stated she just wants to be transferred to someone who can answer her question then disconnects the call. The outcome of events was unknown.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Flushing, Investigation, Laboratory test
Clinical narrative: funny feeling/awful feeling; burning shoulder, down her arm that was injected, and down her back/burning sensation; her face was flushed; arm pain; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration administered on arm left on 11Feb2021 (at the age of 72 years) as single for an unspecified indication. Medical history included High Blood Pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 (Thursday) after vaccination patient was in the waiting room for ten minutes and started burning, like burning in my arm, my shoulder, all the way across the other shoulder and across the path on my neck. patient got her shot on the left side and that part of back was burning, so patient went to these 'EMS' (not clarified) guys and spoke with them and he looked down my shirt and he said yes, your back was red and it does not seems well. He said that patient could take Benadryl. So, she went and had Benadryl, as she had water in her car, on the way home patient took the Benadryl. When patient got home, she was great at about 8 o'clock and then studied book at 11. And then in the morning, 8 o'clock, she took another Benadryl and then my arm was hurting, so she took two Tylenol (treatment). next day was wonderful and okay. Yesterday, she was fine until about 3 o'clock and then this awful feeling came across her from head to toe then it was passed and then, the burning started again and burning was so bad at 8 o' clock that she took one Benadryl but it makes sleepy. Then in morning she got up at 7 and by 11 o'clock, the burning started again and now she was concerned because what about her second vaccine and how long will burning be and what can be done for it, perhaps see a doctor, and questioned about what can be done or was this a normal reaction to it. On unspecified date the patient underwent lab tests and procedures which included blood test, urine test and lab with unknown results. Patient was treated with Tylenol and Benadryl for adverse events. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: funny feeling/awful feeling; burning shoulder, down her arm that was injected, and down her back/burning sensation; her face was flushed; arm pain; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration administered on arm left on 11Feb2021 (at the age of 72 years) as single for an unspecified indication. Medical history included High Blood Pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 (Thursday) after vaccination patient was in the waiting room for ten minutes and started burning, like burning in my arm, my shoulder, all the way across the other shoulder and across the path on my neck. patient got her shot on the left side and that part of back was burning, so patient went to these 'EMS' (not clarified) guys and spoke with them and he looked down my shirt and he said yes, your back was red and it does not seems well. He said that patient could take Benadryl. So, she went and had Benadryl, as she had water in her car, on the way home patient took the Benadryl. When patient got home, she was great at about 8 o'clock and then studied book at 11. And then in the morning, 8 o'clock, she took another Benadryl and then my arm was hurting, so she took two Tylenol (treatment). next day was wonderful and okay. Yesterday, she was fine until about 3 o'clock and then this awful feeling came across her from head to toe then it was passed and then, the burning started again and burning was so bad at 8 o' clock that she took one Benadryl but it makes sleepy. Then in morning she got up at 7 and by 11 o'clock, the burning started again and now she was concerned because what about her second vaccine and how long will burning be and what can be done for it, perhaps see a doctor, and questioned about what can be done or was this a normal reaction to it. On unspecified date the patient underwent lab tests and procedures which included blood test, urine test and lab with unknown results. Patient was treated with Tylenol and Benadryl for adverse events. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Furuncle
Clinical narrative: sores on her buttocks; This is a spontaneous report from a Pfizer Sponsored Program via contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on 22Jan2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sores on her buttocks on an unspecified date of 2021. Patient was prescribed Valacyclovir 500mg. Patient was wondering if she can take this in the middle of the vaccination series. The outcome of the event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swollen tongue, Tongue biting
Clinical narrative: headache; bitten her tongue; tongue somehow felt larger, and different; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took sulfur and had an allergic reaction. She said it caused her tongue, and throat to swell. On an unspecified date, the patient experienced headache, bitten her tongue, and tongue somehow felt larger, and different. It was reported that through the night, the patient must have bitten her tongue because when she woke up, it somehow felt larger, and different. The patient wasn't sure if it was a reaction associated with the vaccine, or if she just bit her tongue when she was asleep. The patient wanted to know if she could take Benadryl and Tylenol to treat these reactions. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 12, 2021, patient experienced a rash and spreading now. They called the hospital, and told her to take Benadryl. The event considered non-serious, with outcome of unknown. Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Myalgia, Pruritus
Clinical narrative: Full body rash; Hives and redness on entire body; Intense itching; Hot, tight skin; Muscle ache; Fatigue; Hives and redness on entire body; Hot, tight skin; This is a spontaneous report from a contactable Other healthcare professional. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included depression, drug hypersensitivity, allergy to chemicals, allergy to arthropod sting. The patient's concomitant medications were not reported. The patient had allergies with penicillins, nickle, bee stings. The patient had no other vaccine within four weeks. 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 11Feb2021, the patient experienced Full body rash 6 days after vaccination. Hives and redness on entire body, intense itching. Hot, tight skin. Muscle aches and fatigue. The adverse event resulted in patient to visit doctor or other healthcare professional office/clinic. The patient received treatment with hydrocortisone cream for rash, hives and redness on entire body, intense itching, hot, tight skin. Outcome of the event was not recovered, at the time of this report.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin tightness, Urticaria
Clinical narrative: Full body rash; Hives and redness on entire body; Intense itching; Hot, tight skin; Muscle ache; Fatigue; Hives and redness on entire body; Hot, tight skin; This is a spontaneous report from a contactable Other healthcare professional. A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included depression, drug hypersensitivity, allergy to chemicals, allergy to arthropod sting. The patient's concomitant medications were not reported. The patient had allergies with penicillins, nickle, bee stings. The patient had no other vaccine within four weeks. 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 11Feb2021, the patient experienced Full body rash 6 days after vaccination. Hives and redness on entire body, intense itching. Hot, tight skin. Muscle aches and fatigue. The adverse event resulted in patient to visit doctor or other healthcare professional office/clinic. The patient received treatment with hydrocortisone cream for rash, hives and redness on entire body, intense itching, hot, tight skin. Outcome of the event was not recovered, at the time of this report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; fatigue; chills; This is a spontaneous report from a non-contactable female consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fatigue, chills on an unspecified date. Caller got her 1st dose last Thursday (04Feb2021) and started to feel headache, fatigue, and chills, asking if it was normal. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: wanted to know that if there is a leeway from 3weeks to 5 weeks on the second dose; This case has been considered invalid as there is no event experienced by the patient under BNT162B2.  This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), 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 medical history and concomitant medications were not reported. The patient wanted to know that if there is a leeway from 3weeks to 5 weeks on the second dose of vaccination leading to off label use on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypersensitivity, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: dizziness; sore throat; allergic reaction; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 10:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. It was reported that after receiving second dose of vaccine on 11Feb2021 at 22:00 pm the patient experienced dizziness, headache and a sore throat and he experienced these after both doses which he believes may be an allergic reaction. His physician has told him to take Benadryl for the next 4 days. Patient had no covid prior vaccination. The adverse event results in doctor or other healthcare professional office/clinic visit. Patient has been tested for covid post vaccination. The patient underwent lab tests and procedures which included nasal swab covid test (sars-cov-2 test) which result was negative and PCR covid test (SARS-CoV-2 test) which result was pending and both tests were on 14Feb2021. The patient was not recovered from the events at the time of report.   Information on batch/lot number was requested.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood electrolytes, Full blood count, Investigation, Monocyte count
Clinical narrative: I have a little bit of pain; My nose has like a little bit irritation and little bit asthma; My nose has like a little bit irritation and little bit asthma; This is a spontaneous report from a contactable consumer (patient reported for herself). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: E or FJ168), dose 1 via an unspecified route of administration on 11Jan2021 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune Auto immune condition, sjogren's syndrome from 2015 to an unknown date, fibromyalgia and covid-19 from Apr2020 to an unknown date. The patient was a respiratory therapist. Concomitant medication(s) included Ciclosporin (RESTASIS) taking for her eyes; Famotidine (PEPCID [FAMOTIDINE]); Albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) and Estradiol (ESTROGEN), all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Jan2021, after the first dose of vaccination, the patient experienced a little bit of pain, her nose had like a little bit irritation and little bit asthma, which the patient thought it was a weather. The patient underwent lab tests and procedures on an unspecified date in 2021 included blood electrolytes: unknown results, full blood count: unknown results, Hormone test: unknown results, absolute monocyte count: normal. The patient outcome of the events was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Pain
Clinical narrative: I have a little bit of pain; My nose has like a little bit irritation and little bit asthma; My nose has like a little bit irritation and little bit asthma; This is a spontaneous report from a contactable consumer (patient reported for herself). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: E or FJ168), dose 1 via an unspecified route of administration on 11Jan2021 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune Auto immune condition, sjogren's syndrome from 2015 to an unknown date, fibromyalgia and covid-19 from Apr2020 to an unknown date. The patient was a respiratory therapist. Concomitant medication(s) included Ciclosporin (RESTASIS) taking for her eyes; Famotidine (PEPCID [FAMOTIDINE]); Albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) and Estradiol (ESTROGEN), all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Jan2021, after the first dose of vaccination, the patient experienced a little bit of pain, her nose had like a little bit irritation and little bit asthma, which the patient thought it was a weather. The patient underwent lab tests and procedures on an unspecified date in 2021 included blood electrolytes: unknown results, full blood count: unknown results, Hormone test: unknown results, absolute monocyte count: normal. The patient outcome of the events was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypersensitivity, Neuralgia, Urticaria
Clinical narrative: Allergic reaction to the vaccine; Have like a nerve down on my shoulder and down my arm and down my forearm; It is like a pain on my back down; Have like a nerve down on my shoulder and down my arm and down my forearm; It is like a pain on my back down; I broke out in hives. I had it on my left back, on my left arm; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL9264), dose 1 via an unspecified route of administration on 30Jan2021 at noon (at the age 79-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included blood cholesterol increased (High Cholesterol), gout and hypertension (High Blood Pressure) from an unknown date and unknown if on-going. Concomitant medications included allopurinol (ALLOPURINOL) taken for gout, losartan (LOSARTAN) and simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported. Patient got a hold of somebody today and talked to her here at Pfizer (Further clarification was unknown, hence checked as initial report). She said she wanted patient to talk to the medical group and so patient call this number. Patient did not know, could find patient in computer because patient typed everything told her. Patient had a Pfizer vaccine on 30Jan first vaccine. Patient had it at noon, next day, broke out in hives. Patient had it on left back, on left arm. Patient had lot of hives. Patient called up a nurse at ER hospital and went to (Hospital name withheld). The doctor told, he said, patient have an allergic reaction to the vaccine. He said he gave prednisone but he said that would kill the vaccine. So he said what I want you to do is if you can wait till Monday and take it around noon and then you will have 48 hours for vaccine in you. Patient waited for Monday and he said if you get any-more hives make sure you take it then. Well, Patient got more hives. So patient had 5 days of 40 mg on each day, each morning patient took that for 5 days. Patient still have the hives. Patient was doing okay. Patient had like a nerve down on my shoulder and down arm and down forearm, that developed that patient never had before. It was like a pain on back down. So, patient just want to know Patient did not want to take second shot. Patient was afraid to take the second shot because patient was allergic to this one. Treatment include Prednisone. The outcome of the event urticaria was unknown while other events were unknown.   Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy red bump/rash around injection site; Itchy red bump/rash around injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration in left arm on 12Feb2021 at 18:30 (at the age of 34-year-old) as single dose for COVID-19 immunization. Medical history of the patient included seasonal allergies. Concomitant medications/other medications in two weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate [LO LOESTRIN FE], cetirizine hydrochloride [ZYRTEC], montelukast sodium [SINGULAIR], naproxen sodium [ALEVE] all taken for unspecified indications. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Sulfa drug on an unspecified date and experienced allergy. Patient previously received first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EJ9262) via an unspecified route of administration in right arm on 21Jan2021 at 18:15 as single dose for COVID-19 immunization. On 13Feb2021 at 22:00 patient experienced Itchy red bump/rash around injection site. No treatment was received in response to the event. Outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Caller heard a doctor state he had a fever for 24 hours after the covid vaccine (doesn't specify which one); This is a spontaneous report from a contactable other HCP. A male patient of an unspecified age 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 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced caller heard a doctor state he had a fever for 24 hours after the covid vaccine (doesn't specify which one) on an unspecified date. She has two questions. She is getting the second vaccine today. When they were there getting the first one, the nurse said she had reaction from the second shot. She advised caller to take Tylenol before the second. Since then caller has read that you are not supposed to take Tylenol, Advil, or pain medication because it will decrease the effectiveness of the vaccine. She doesn't want to do that. She wanted to know what Pfizer's protocol or recommendation would be. Her neighbor said she had heard not to take it, but then read that the county said you can't take it before but you can take it after. How long is the effectiveness. She read something two days ago that said it is only good for 3 months. It didn't say Pfizer specifically. Caller clarified product as COVID19 Vaccine. The doctor that put caller on the list, because she is over 65 and it is hard to get the vaccine, said he had a fever and it was the best fever he ever had because it was helping him. Caller is a 65 y/o female. She received her first dose of the Pfizer Covid vaccine and reports she had a sore arm and swollen neck glands the following day. She says it lasted for several days and also experienced fatigue. She is getting her second dose of the vaccine 12Feb2021 and wants to know if it's ok to take a pain reliever before or after the vaccine is given. Additional AE information: caller reports a nurse at the vaccination site is telling recipients to take tylenol before the vaccine because she had a fever after the Pfizer vaccine. Caller's aunt was freezing after receiving the Moderna vaccine. Caller heard a doctor state he had a fever for 24 hours after the covid vaccine (doesn't specify which one). Caller wants to know if Pfizer is creating a booster to address the new variants of the Covid virus. Outcome of the event was unknown.  Information about the Lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: significant right armpit lymph node swelling; fatigue; headache; lymph node swelling is quite large, painful and concerning; This is a spontaneous report from a non-contactable other hcp (patient). A non-pregnant 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date were not reported), via an unspecified route of administration  administered in the right arm on 11Feb2021 00:15 (at the age of 46-years-old), as dose 2, single for COVID-19 immunisation. Medical history included Environmental allergies and topical product allergies in soaps and cosmetics but no medications. The patient had no concomitant medications. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL8982, Expiration date were not reported), via an unspecified route of administration  administered in the right arm on 21Jan2021 00:00 (at the age of 46-years-old), as dose 1, single for COVID-19 immunization and experienced injection site rash. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced significant right armpit lymph node swelling, fatigue, headache, and lymph node swelling is quite large, painful and concerning on 11Feb2021 19:00. No treatment was received as a result of the events. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Pain radiating from lower back to backside of left leg (mostly thigh but also calf). Particularly when getting up after rest or sitting.; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number: EN6201; Expiration date was not reported), via an unspecified route of administration in the right arm on 11Feb2021 08:00 AM (at the age of 40-years-old) as dose 1, single for COVID-19 immunisation. Medical history included polycystic kidney disease from an unknown date and unknown if ongoing. The patient has no concomitant medications. No other vaccine was received by the patient in four 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. The patient has no known allergies. The patient experienced pain radiating from lower back to backside of left leg (mostly thigh but also calf), particularly when getting up after rest or sitting on 12Feb2021 08:00 AM. Treatment with ibuprofen and paracetamol was taken for the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Electrolyte imbalance, Pain in extremity, Paraesthesia
Clinical narrative: I am still having like arm pain in my left arm; I get like tingling and now it is little weak; I get like tingling and now it is little weak; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL0142, Expiration date: 21Mar2021), via an unspecified route of administration on 07Jan2021 (at the age of 52-years) as dose 2, single for covid-19 immunisation. The patient medical history included high blood pressure. The patient concomitant medications included Vitamins from an unknown date and unknown if ongoing. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK5730, Expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 (at the age of 52-years) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced still having like arm pain in my left arm and get like tingling and now it was little weak. The patient received treatment for events with Advil, Tylenol. Patient stated that "After the second vaccine I noticed, but then like 2 days after the second one and then it just has not stopped, like sometimes it start tingling so bad that I have to open up my hand few times and almost like it went to the sleep, it just, I don't know it just hurts, yes few days after the vaccine. Recently yes, I have, yeah, they actually just checked it just to make sure my electrolyte is good, which was fine. It is just under control, I am taking medication for it." The outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Sleep disorder
Clinical narrative: Low grade fever (99.4); Couldn't sleep after second dose/Woke up feeling just like I haven't slept; Got progressively achy in joints as day went on; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 26-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3247), via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:30 (Age at vaccination: 26-years-old) as single dose for covid-19 immunization. Medical history included prior solid organ transplant from an unknown date and unknown if ongoing. Concomitant medication included ciclosporin (NEORAL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2, PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Lot number el3247), via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 PM (Age at vaccination: 26-years-old) as single dose for covid-19 immunization (Vaccination facility: Workplace clinic). The patient previously took azithromycin and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient had no covid prior vaccination. It was reported that on 12Feb2021, patient could not sleep after second dose. Woke up feeling just like she have not slept. Got progressively achy in joints as day went on. Low grade fever (99.4) at 7 pm day following second dose. It was unknown if patient received treatment for the events. Patient did not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.4 on 12Feb2021. The outcome for the events was reported as recovering at the time of this report.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Nausea; Short of breath; weird sensation in head; racing heart; headache; slight tremor in head, arms and hands; extreme fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of admin-istration (at the age of 64-years), administered in arm left on 11Feb2021 at 12:00 as dose 1, single for COVID-19 immunization. Medical history included allergies to medications, food, or other products from an unknown date and unknown if ongoing. The patient concomitant medications were not re-ported. The patient did not take any other vaccine in four weeks. Patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 11Feb2021 within 15 minutes after dose administration at 12:15, the patient experienced short of breath, weird sensation in head, racing heart, headache, slight tremor in head, arms and hands. Next day on 12Feb2021, experienced nausea. On an unknown date in Feb2021, experienced extreme fatigue. The treatment was not received for the all the events. The vaccination facility type was reported as school. The clinical outcome for all the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Nausea; Short of breath; weird sensation in head; racing heart; headache; slight tremor in head, arms and hands; extreme fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of admin-istration (at the age of 64-years), administered in arm left on 11Feb2021 at 12:00 as dose 1, single for COVID-19 immunization. Medical history included allergies to medications, food, or other products from an unknown date and unknown if ongoing. The patient concomitant medications were not re-ported. The patient did not take any other vaccine in four weeks. Patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 11Feb2021 within 15 minutes after dose administration at 12:15, the patient experienced short of breath, weird sensation in head, racing heart, headache, slight tremor in head, arms and hands. Next day on 12Feb2021, experienced nausea. On an unknown date in Feb2021, experienced extreme fatigue. The treatment was not received for the all the events. The vaccination facility type was reported as school. The clinical outcome for all the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: eventually broke out into massive rash of armpits and torso; skin irritation itchiness; skin irritation itchiness; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 at 12:00 hours as dose 1, single (at the age of 50-years-old) for COVID-19 immunisation. Medical history included hypothyroid from an unknown date and unknown if ongoing. Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medication(s) included metronidazole benzoate (Flagyl) and doxycycline (both taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19 post vaccination. On 26Jan2021 at 15:00 hours, patient had skin irritation, itchiness which eventually broke out into massive rash of armpits and torso. Patient had doctor or other healthcare professional office/clinic visit for the events. Therapeutic measures were taken as a result of all the events and treatment included fluconizole oral and hydrocortisone topical. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: I have a swelling under my left arm; like about the size of half of an orange; it hurts; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiry date was not reported), via an unspecified route of administration on 09Feb2021 in Arm left as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL0142 and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On 10Feb2021, patient received the second dose of her/his vaccine (Covid-19 Vaccine by Pfizer) on Tuesday morning and he/she felt yesterday and this morning, he/she have a swelling under his/her left arm where it was given on the left arm like about the size of half of an orange and he/she know its listed swollen lymph node as possible side effects but he/she expected something like size of an almond not an orange, so he/she wondering if that was a problem and it hurts, so patient wondering if there was something that he/she can do about it and also stated that Well, patient assuming he/she can still go to work or probably patient should be getting ready do that So,he/she can take Ibuprofen. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea
Clinical narrative: Pain on my right side of the back. Pain during movement of my back.; Pain during deep breathings; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 10Feb2021 at 10:30 AM (age at vaccination: 46 years), as a single dose for COVID-19 immunization at workplace clinic. The patient's medical history included Type 2 diabetes. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 20Jan2021 at 09:30 AM (age at vaccination: 46 years), as a single dose for COVID-19 immunization at workplace clinic. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Feb2021 at 06:30 AM, the patient experienced pain on his right side of the back. Pain during movement of his back. Pain during deep breathings. The patient did not received any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; low grade temperature of 99.0 /fever; pain at the injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: EL3302) as dose 1, single (age at vaccination 54-year-old) for covid-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication(s) included dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported. The patient experienced headache, low grade temperature of 99.0 /fever, pain at the injection on Jan2021. The first dose was given on 21Jan2021 and was the same lot as her second dose. When she got the first one, she had a low-grade temperature of 99.0 and a headache. The headache lasted 2-3 days and the fever lasted 2 days but she didn't have it during the day, only at night. There was also pain at the injection and this lasted about a week. Treatment: she had been taking Advil and Tylenol. She also spoke to one of the girls in her doctor's office and was told to speak to the place she got the vaccine, they would tell her what to do. It was also relayed if her fever got too high go to the ER. The patient underwent lab tests and procedures which included body temperature: 99.0 on an unknown date. Therapeutic measures were taken as a result of events includes Advil and Tylenol. The outcome for all events was unknown.   Follow-up attempts are completed. No further information is expected.