chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: itching still a problem; Breakingout neck and back; This is a spontaneous report received from a contactable consumer or other non hcp. A 83-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EM9810; Expiration Date: 02Nov2021), via an unspecified route of administration, administered in Arm Left on 11Feb2021,at the age of 83 years old, as Dose 2,single for covid-19 immunization.Medical history included psoriasis from an unknown date and unknown if ongoing,mother- only skin condition in family.The patient's concomitant medications were not reported.The patient experienced breakingout neck and back on 12Feb2021 08:00 and itching still a problem on 02Mar2021.Therapeutic measures were taken as a result of breakingout neck and back and itching still a problem.The patient previously received her 1st dose of Pfizer covid vaccine on 21Jan2021,07:41.The patient received treatment with Triamcinolone acetonide cream husband had this med.The patient was not admitted to the hospital due to this adverse events.There was no culture done.The outcome of the event breaking out neck was recovered and itching was unknown.  No follow up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus, Urticaria
Clinical narrative: hives; itchy; tired; achy; This is a spontaneous report from a contactable consumer. This consumer reported for a 88-year-old female patient (wife) in response to Non-HCP letter sent via follow-up letter. A 88-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267; Expiration Date: May2021) via an unspecified route of administration on 10Feb2021 (at the age of 88-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN), acetylsalicylic acid (ASPIRIN LOW), lisinopril (LISINOPRIL) and apixaban (ELIQUIS) taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248; Expiration Date: Apr2021) via an unspecified route of administration on 20Jan2021 (at the age of 88-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of first dose vaccination. It was reported that, patient was tired plus achy the first 48hours on an unspecified date in Feb2021. Then became itchy on the third day she had red raised spots (Hives) on upper back on 12Feb2021. Treated with Benadryl and Calamine lotion. It did not help saw doctor after four days of hives prescribed seven days of prednisone. That helped, but as soon as regiment ended the hives spread over trunk of body. Doctor prescribed two weeks on prednisone. Her last dose will be 10Mar2021. She feel much better. Therapeutic measures were taken as a result of AEs. The outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Somnolence
Clinical narrative: fever 99.1 degree F.; Fatigue; felt sleepy; Chills; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on 11Mar2021 (last Thursday) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced fever 99.1degree F, fatigue, felt sleepy, chills and wanted guidance on what to do, specifically asked about if he can take Tylenol or Ibuprofen. The events were assessed as non-serious. On unspecified date in 2021, patient underwent lab tests and procedures which included fever: 99.1 Fahrenheit. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: felt like her chest had fluid and pressure; This is a spontaneous report from a contactable consumer (patient) via Pfizer.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history concomitant medications were not reported. Patient reported she had her first dose of the covid-19 vaccine on 25Feb2021, afterwards felt like her chest had fluid and pressure on an unspecified date inquiring if she should receive the second dose. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Large raised; Red at the site of the injection; Painful area at the site of the injection; This is a spontaneous report received from a contactable other healthcare professional (patient reported for herself). A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:15 (at the age of 38-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism, attention deficit disorder, known allergies: penicillin, cephalosporins from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received vaccine facility in hospital. The patient experienced large raised, red at the site of the injection, painful area at the site of the injection on 08Mar2021 18:00. No treatment was received for the events. The outcome of the events was reported as not recovered.  No follow up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: My skin is itchy all over but not too itchy that it creates a rash. The itch is very slight but all over my body; This is a spontaneous report from a contactable consumer (patient). A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:45 (at the age of 21 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication received within two weeks of COVID vaccine included acetaminophen (ACETAMINOPHEN), etonogestrel (NEXPLANON), cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]), and iron supplements, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:45 (at the age of 21 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced my skin is itchy all over but not too itchy that it creates a rash. the itch is very slight but all over my body on 09Mar2021 14:30. No treatment given for the event. Patient did not tested for COVID post vaccination. Outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm; sore shoulder; This is a spontaneous report from a non-contactable pharmacist (patient). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration, administered in left arm on 06Mar2021 at 16:00 pm (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included Hypothyroidism from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included (within two weeks) Junel and Levothyroxine for unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient administered no other vaccine four weeks prior to vaccination. It was reported that on 06Mar2021 22:00 patient experienced Sore arm and Sore shoulder. Patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202; Expiration Date: Jun2021), via an intramuscular route of administration (at the age of 61-years), administered in arm left on 02Mar2021 at 14:00 as dose 2, single for COVID-19 immunization. Medical history included, none from an unknown date and unknown if ongoing. The patient had no family history. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9809; Expiration Date: Jun2021), via an intramuscular route of administration (at the age of 61-years), administered in arm left on 11Feb2021 as dose 1, single for COVID-19 immunization. No prior vaccinations (within 4 weeks) aside from first dose of covid vaccine. The vaccination facility type was reported as hospital. The patient did not receive any other products. On 03Mar2021, the patient experienced high fever, severe body aches, headache. It was further stated that She was calling about the covid vaccine. She received second Pfizer covid vaccine on 02Mar2021. 12 hours later she got a high fever of 101.7, which is a high fever for her. She had severe body aches and a headache. She still has symptoms and her doctor suggested to call. She was asking what she should do. She had a low-grade fever as of now, her severe body aches recovered within in 24 hours. Her headache is not as bad. She will let her doctor know that she called to report this. The treatment was received for all the adverse events. The duration of event severe body aches was reported as 1 day. The adverse events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included body temperature: 101.7 on 03Mar2021 high fever of 101.7. The patient was taking the Covid vaccine as a preventative. The clinical outcome of the event severe body aches was reported as recovered on 04Mar2021 while for the events high fever, headache was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Headache, Neck pain
Clinical narrative: aches and pains across shoulders and neck; aches and pains across shoulders and neck; periodic Headaches; In bed for 3 days; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received historical first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) for covid-19 immunisation. On an unspecified date, patient was in bed for 3 days with aches and pains across shoulders and neck, periodic headaches since the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash from her head to toe that was itching; This is a spontaneous report from a contactable consumer. This 38-years-old female consumer (patient) reported for herself that:  A 38-year-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an unspecified route of administration on 28Feb2021 (at the age of 38 years old) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High Blood pressure. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient previously took antibiotic as Bactrim and experienced allergic reaction to antibiotic, she broke out in hives. The patient previously took antihistamines and experienced hives (Was taking antihistamines when she broke out in hives). The patient experienced rash from her head to toe that was itching on 04Mar2021. Caller stated did not know if had actual possible side effects to the first Covid vaccine or that something else but caller was trying to find out who can speak to regarding this. When paraphrased the concern, Caller stated, "Correct, because of the situation that had with it could possibly be connected to the first shot but caller not sure." caller was calling because she wanted information on if it was safe to get her second vaccine. She concerned about getting the second dose. Wants to know who she could speak to see if it safe. Caller stated that she called earlier and spoke with Pfizer and reported this. Caller was unsure if it was her immune system or if had an allergy. Caller did not know if it was too soon after the allergic reaction to get the COVID vaccine and her immune system went into panic mode. Therapeutic measures were taken with antihistamines and steroid shot as a result of event.The outcome of event was unknown.  Follow-up (10Mar2021): The initial case was missing the following minimum criteria: -Unspecified AE. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported for self that: event and case narrative was added.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: did not feel well; Cough; Sore throat; Low-grade fever; Little stuffy/runny nose; Little stuffy/runny nose; This is a spontaneous report from contactable consumer or other non-healthcare professional (patient).A 40-years-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Mar2021 patient experienced cough, sore throat, low-grade fever and little stuffy/runny nose. The patient did not feel well and is not sure if these are side effects to vaccine or covid symptoms. The reported stated that, may have been exposed to COVID prior to getting vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unknown date. The outcome for the all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: did not feel well; Cough; Sore throat; Low-grade fever; Little stuffy/runny nose; Little stuffy/runny nose; This is a spontaneous report from contactable consumer or other non-healthcare professional (patient).A 40-years-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Mar2021 patient experienced cough, sore throat, low-grade fever and little stuffy/runny nose. The patient did not feel well and is not sure if these are side effects to vaccine or covid symptoms. The reported stated that, may have been exposed to COVID prior to getting vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unknown date. The outcome for the all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Nausea
Clinical narrative: Low grade fever; headache; body aches; chills; nausea; Swollen lymph nodes; injection site pain; swelling 12 hours after injection; patient administered first dose on 03Feb2021 and second dose on 20Feb2021; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 20Feb2021 09:30 (at the age of 19-year-old) as dose 2, single for covid-19 immunisation. Medical history included Lichens Sclerosis and supraventricular tachycardia from an unknown date. Patient reported having known allergies from amoxicillin. Concomitant medications in two weeks included CLOBETASOL PROPIONATE and Paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration, administered in left arm on 03Feb2021 09:30 (at the age of 19-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines 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 20Feb2021 21:45 (same day of vaccination), the patient experienced low grade fever, headache, body aches, chills, nausea, swollen lymph nodes, injection site pain and swelling 12 hrs after injection, patient administered first dose on 03Feb2021 and second dose on 20Feb2021 was considered as Inappropriate schedule of vaccine administered. All symptoms subsided within 26 hrs. No treatment was given for the events. Outcome of the event Inappropriate schedule of vaccine administered was unknown and on an unspecified date in 2021, outcome of low grade fever, headache, body aches, chills, nausea, swollen lymph nodes, injection site pain and swelling 12 hrs after injection was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Low grade fever; headache; body aches; chills; nausea; Swollen lymph nodes; injection site pain; swelling 12 hours after injection; patient administered first dose on 03Feb2021 and second dose on 20Feb2021; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 20Feb2021 09:30 (at the age of 19-year-old) as dose 2, single for covid-19 immunisation. Medical history included Lichens Sclerosis and supraventricular tachycardia from an unknown date. Patient reported having known allergies from amoxicillin. Concomitant medications in two weeks included CLOBETASOL PROPIONATE and Paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration, administered in left arm on 03Feb2021 09:30 (at the age of 19-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines 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 20Feb2021 21:45 (same day of vaccination), the patient experienced low grade fever, headache, body aches, chills, nausea, swollen lymph nodes, injection site pain and swelling 12 hrs after injection, patient administered first dose on 03Feb2021 and second dose on 20Feb2021 was considered as Inappropriate schedule of vaccine administered. All symptoms subsided within 26 hrs. No treatment was given for the events. Outcome of the event Inappropriate schedule of vaccine administered was unknown and on an unspecified date in 2021, outcome of low grade fever, headache, body aches, chills, nausea, swollen lymph nodes, injection site pain and swelling 12 hrs after injection was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dyspnoea, Fatigue, Feeling abnormal, Muscle spasms
Clinical narrative: Foggy brain; fatigue; inability to concentrate; episodic racing heart; episodic breathing difficulty; muscle cramps in legs & feet despite drinking a lot of water; This is a spontaneous report from a non-contactable consumer (Patient). A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6201, Expiry date was not reported), via an unspecified route of administration on 22Feb2021 09:30 (at the age of 68-years-old) in Arm Left as dose 1, single for COVID-19 immunization at hospital. The Patient Medical history and concomitant medications were not reported. Patient had no known allergies. The Patient did not receive other mediation in two weeks and in four weeks. Patient had no COVID-19 prior vaccination and tested COVID-19 post vaccination. On 22Feb2021 16:30, the patient experienced Starting 7 hours after vaccine & lasting for 2.5 more days. Foggy brain, fatigue, inability to concentrate, episodic racing heart, episodic breathing difficulty, muscle cramps in legs & feet despite drinking a lot of water. The patient did not take the treatment for the events and took the treatment for the event muscle cramps in legs & feet despite drinking a lot of water. The patient underwent lab tests and procedures which included saliva (sars-cov-2 test) : negative on 05Mar2021. The outcome for the events Foggy brain, fatigue, inability to concentrate, episodic racing heart, episodic breathing difficulty, muscle cramps in legs & feet despite drinking a lot of water was recovered on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Foggy brain; fatigue; inability to concentrate; episodic racing heart; episodic breathing difficulty; muscle cramps in legs & feet despite drinking a lot of water; This is a spontaneous report from a non-contactable consumer (Patient). A 68-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6201, Expiry date was not reported), via an unspecified route of administration on 22Feb2021 09:30 (at the age of 68-years-old) in Arm Left as dose 1, single for COVID-19 immunization at hospital. The Patient Medical history and concomitant medications were not reported. Patient had no known allergies. The Patient did not receive other mediation in two weeks and in four weeks. Patient had no COVID-19 prior vaccination and tested COVID-19 post vaccination. On 22Feb2021 16:30, the patient experienced Starting 7 hours after vaccine & lasting for 2.5 more days. Foggy brain, fatigue, inability to concentrate, episodic racing heart, episodic breathing difficulty, muscle cramps in legs & feet despite drinking a lot of water. The patient did not take the treatment for the events and took the treatment for the event muscle cramps in legs & feet despite drinking a lot of water. The patient underwent lab tests and procedures which included saliva (sars-cov-2 test) : negative on 05Mar2021. The outcome for the events Foggy brain, fatigue, inability to concentrate, episodic racing heart, episodic breathing difficulty, muscle cramps in legs & feet despite drinking a lot of water was recovered on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: nausea; HEADACHE; cough; muscle pain also at injection sight; exhaustion; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via unspecified route of administration, administered in right arm on 06Mar2021 11:30 as dose 1, single for COVID-19 im-munization (age at vaccination: 56-years-old). Medical history included breast cancer. Concomitant medications included anastrozole (ARIMIDEX), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) and meloxicam all were taken for an unspecified indication, start and stop date were not reported. On 06Mar2021 23:00 the patient experienced nausea, headache, cough, muscle pain also at injection sight and exhaustion. Patient not tested for covid post vaccination and no covid prior vaccination. The patient had no other vaccine in four weeks. Ther-apeutic measures were taken as a result of all events with rest, fluids and ibuprofen. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient received bnt162b2 (BNT162B2 Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration, administered in right arm on 08Mar2021 13:30 as dose 2, single dose for covid-19 immunization. Patient had known allergies to penicillin. The patient's concomitant medications was not reported. Historical vaccine included BNT162B2 (solution for injection, Lot number: ELB8982) via an unspecified route of administration, administered in right arm on 15Feb2021 01:30 PM as dose 1 single for COVID-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. On an unspecified date in 2021 the patient experienced face swollen under left eye second shot. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash macular, SARS-CoV-2 test
Clinical narrative: Had a couple of little spots on my chest and on the top of my thighs, red spots; One or two red spots on my back; There are couple on my face, little red; I have Sulfur allergy and I was a baby and I broke out in rash; This is a spontaneous report from a contactable Consumer. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 06Mar2021 as SINGLE DOSE (at the age of 73-year-old) for covid-19 immunisation; sulfur (SULFUR), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included diabetes mellitus (Verbatim: Diabetic I am diabetic and I take a number of medications, I take some heart medication (not clarified further), I take a lot of medication). Reporter stated, patient had the Pfizer COVID shot on Saturday. Yesterday, Tuesday (09Mar2021) patient noticed that, had a couple of little spots on chest and on the top of thighs, red spots. Also, one or two red spots on back and on morning there were couple on the face, little red. And patient felt fine but did not know if it was something else or that needed to do anything or whatever. Patient did not know what to do. Patient did not feel funny, not itchy, it was just there and this was her first shot. Reporter stated, In the last two weeks like on March 1st, patient had Covid test and it was negative. Reporter stated, as treatment Last night patient took a Benadryl. Reporter further stated, her big question was, patient not sure this was related to the shot but it was one of the symptoms. And in two to three weeks she have second shot coming up. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Product administered at inappropriate site, Pruritus, Vaccination site erythema
Clinical narrative: Arm is hot, running fever in it, red, itchy; Arm is hot, running fever in it, red, itchy/ It is reddish in the area got the vaccine and down below where the the needle was stuck; Arm is hot, running fever in it, red, itchy; Nurse did not give the vaccine in the muscle, it was given in back of her arm; This is a spontaneous report from a contactable consumer (patient reported for herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6205 and expiration date: Jun2021) via intramuscularly, in left arm on 05Mar2021 at 09:04 AM (at the age of 62-year-old) as dose 2 0.3 ml, single for COVID-19 immunization. The patient had no medical history and concomitant medication. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318 and expiration date: 31May2021) via an unspecified route of administration, in left arm on 12Feb2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient had not received additional vaccines on same date of the Pfizer suspect. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no AEs following prior vaccinations. The patient went on Friday 05Mar2021 to take her second vaccine. However, the nurse did not give the vaccine in the muscle. It was given in the back of her arm. Now, on 06Mar2021, her arm was hot, running a fever in it, red, and itchy. She did not remember what time she noticed her arm was hot, running fever in it, red, and itchy. Patient confirmed all events still ongoing, but better. It did not itch as much. It was still warm, but better. That area was reddish. It was reddish in the area got the vaccine and down below where the needle was stuck. Patient indicated she was calling because she wanted to report these events. She never got these before. She did not see where she got the actual vaccine, where she was stuck because she turned her head because she did not want to see the stick. She just noticed later that the Band-Aid was on the back of her arm instead of on top where the muscle part is in the deltoid. The AEs did not require a visit to the Emergency Room or Physician's Office. The patient had no relevant tests. The outcome of the events arm was hot, running fever in it, red, and itchy was recovering.  No follow-up attempts are possible; No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: her face was swollen; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration on 09Mar2021 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included leukaemia from Feb2016, stem cell transplant from Aug2017 and blood clot from an unknown date. Concomitant medications included rivaroxaban (XARELTO) taken for thrombosis and unspecified oral chemo, start and stop date were not reported. The patient experienced her face was swollen on 10Mar2021. It was further reported that the patient got the COVID vaccine yesterday. She was pretty okay yesterday and today she woke up and her face was swollen, and it was still swollen. The reporter was concerned that it could get worse with the patient's throat closing up since she was a cancer patient, had stem cell transplant 3 and a half years ago and takes oral chemo. The reporter clarified that the patient's throat was not closing up but that was a concern of his that he was afraid it could progress to that. The patient took BENDARYL at 11 something and her face was still swollen. The reporter was trying to see if there was anything he could do to help or if this was a normal thing, they have heard of people having. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Start to shows like a red part; itching; This is a spontaneous report received from a contactable consumer (patient). A 78-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 25Feb2021 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that everything worked okay and patient did not have any reaction nothing, but on an unspecified date in Mar2021 (reported as 9 or 10 days later), the patient experienced started to showed like a red part and it was itching. The patient called the pharmacy and they don't have any information about that. They refer to her primary doctor and he does not know anything about that also. It was reported that the patient was supposed to go back there on 18th for the second one but doesn't know if she should get it or not as she was really afraid; she doesn't know what was going on. 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: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes all over me/ they are on both legs, and top of his head, arm, elbow, and his back (on the left side); This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A male patient of an unspecified age received dose 1 and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), both given via an unspecified route of administration on an unspecified dates as dose 1, single and dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified dates, the patient had both of his Pfizer COVID-19 doses, but they left him with "rashes all over me" (as reported). The reporter stated that he's already being treated (unspecified treatment) for the rashes, but that they are on both legs, and top of his head, arm, elbow, and my back (on the left side). 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: burning rash on her face and chin; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 09Mar2021 (at the age of 77-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on 16Feb2021 for as dose 1, single for COVID-19 immunisation. On 09Mar2021 (yesterday), the patient had a rash on her face and chin that burned and rashy looking. The patient questioned Pfizer to tell her what to do and wanted to know if Pfizer has any treatment recommendations for her condition. The clinical course reported as follows, caller took the Pfizer covid vaccine on the 16Feb2021 and had her last one 09Mar2021, yesterday but she seems to have a rash. Last Thursday on 04Mar2021, she noticed a rash, and yesterday when she got her second injection she had a rash on her face and chin that burned and rashy looking. And she has a rash on her stomach and back but it is not burning on her stomach or back. Can Pfizer tell her what to do.  The outcome of the event was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes that hurt; Swollen lymph nodes that hurt; Little bit fever; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on 07Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient was having swollen lymph nodes that hurt and a little bit fever and stuff. The reporter stated that they got the vaccine three days prior. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: Began having pain on right side of my neck (lymph node area); low grade fever; This is a spontaneous report from a contactable consumer reported for herself that. A 53-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 18:30 (Batch/Lot Number: EN6202) as DOSE 1 SINGLE for covid-19 immunizations(Age at vaccination 53 years). The patient past Medical history included Hashimoto's Disease from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing and mitral valve prolapse from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing known allergies Latex. Concomitant medication(s) included l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE]) taken for an unspecified indication, start and stop date were not reported; alendronate sodium (ALENDRONATE) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient experienced began having pain on right side of my neck (lymph node area) and low-grade fever on 08Mar2021 07:00. The event outcome was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Peripheral swelling
Clinical narrative: right leg swelled; difficulty in walking; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified gender in 70s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the left arm (reported as left shoulder) on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the next morning, patient experienced right leg swelled to point of difficulty in walking. Patient needed assistance. It was reported that the patient never had such a reaction to any vaccine ever in the past. Paracetamol (Tylenol) was taken for the events but seems to have done nothing for the swelling. 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: Chills, Fatigue, Oral pain, Pain in extremity, Pyrexia
Clinical narrative: chills; fever; arm sore; mouth ache; tired; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 (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. On an unspecified date, the patient experienced chills, fever, arm sore, mouth ache, and tired. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Pyrexia
Clinical narrative: Pain in my arm/ pain in the injection arm; 99.8 fever/ had fever about 100°F; Chills; pain in the injection arm like it was numb; This is a spontaneous report from a contactable consumer(patient). A 51-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 (Lot Number: EN6206, At the age of 51-year-old) as single dose for COVID -19 immunization. Medical history included Arthritis, sjogren's syndrome from an unknown date. Concomitant medication included methotrexate taken for an unspecified indication, start and stop date were not reported. Last Thursday, the patient got her first vaccine (Covid Vaccine) and she just have pain in her arm like they said and Friday, patient got a 99.8 fever and chills. One more thing, Yesterday, patient got chills again and it was just 99.8 fever but patient do not know if this thing is because of the vaccine, she do not know. The patient mentions that she need to get the second dose of the Pfizer covid vaccine and she would like to know which medication she can take since her physician told her that she cannot use Tylenol and she uses a lot of medications currently. She comments that after getting the first dose she had pain in the injection arm like it was numb and it went away next day. Next day she had fever about 100°F and it went away as well but this one came back 3 different occasions at the same time of the day after 3 days. She mentions that when she had this side effects she call Pfizer to report her experience and she had to talk with an agent but she doubts that everything she wanted to say was understood. Possible AE duplicate. The patient underwent lab tests and procedures which included Fever: 99.8/100 Fahrenheit on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Influenza, Influenza like illness
Clinical narrative: not feel well; headache; nauseous; fever-elevated temperature; fatigue; body aches; her arm was sore after receiving the vaccine; daughter also felt very anxious; Felt like she had the flu; she experienced flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp.    A 37-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration on 23Feb2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing tobacco user, covid-19 from an COVID-19 symptoms started on 08Dec2020, she tested positive for COVID on 10Dec2020. Concomitant medication(s) included ascorbic acid (VIT-C); ergocalciferol (VIT D). The patient previously took Lexapro for anxiety. It was reported that, The patient experienced she experienced flu like symptoms on 23Feb2021 with outcome of unknown, nauseous on 24Feb2021 with outcome of recovered , body aches on 23Feb2021 with outcome of recovered , fever-elevated temperature on 24Feb2021 with outcome of recovered , fatigue on 24Feb2021 with outcome of unknown , not feel well on an unspecified date with outcome of unknown , headache on 24Feb2021 with outcome of recovered , her arm was sore after receiving the vaccine on 23Feb2021 with outcome of unknown , daughter also felt very anxious on 23Feb2021 with outcome of unknown , felt like she had the flu on 23Feb2021 with outcome of recovered.  The patient underwent lab tests and procedures which included covid-19: positive on 10Dec2020.   No follow-up attempts are needed. No further information is expected.