chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some pain in the arm after the 1st vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (Solution for injection), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history included unspecified cardiac history. Concomitant medications were not reported. On an unspecified date, the patient experienced some pain in the arm after the first vaccine. The outcome of the event was unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Injection site bruising, Pain, Pain in extremity
Clinical narrative: Short of breath/SOB; It hurt really bad going in, like she hit a nerve; I was exhausted; I had a big knot on my arm where the shot was given; my arm was sore; This is a spontaneous report from a contactable consumer via a sales representative. A patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Lot number unknown) intramuscular on 26Jan2021 as a single dose for COVID-19 Immunization.  The patient relevant medical history and concomitant medication were unknown. It was reported that after the first dose of vaccine on an unspecified date, the patient had experienced hurt really bad going in, like hit a nerve. Patient was exhausted went to bed from noon until about 5pm, arm was sore but not bad when went to sleep and then when woke up, patient had a big knot on arm where the shot was given. Patient rubbed it out and it lasted for 2 days. Then, 3-4 days after the shot, patient was taking the garbage can to the curb, it is on wheels, and had to stop twice in the driveway because was so short of breath.  It got better and then it happened again the next day walking into another room and was very SOB. Patient asked if this was normal. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Feeling abnormal, Pain, SARS-CoV-2 test
Clinical narrative: achy joints, aching all over; started feeling bad, but no fever; feeling achy and had a little diarrhea; feeling achy and had a little diarrhea; This is a spontaneous report from a contactable consumer. A 73-year-old female consumer (patient) received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on 25Jan2021 as 1st dose, single dose for covid-19 immunization. The medical history and concomitant medication were not reported. Patient reported that she had the first Covid vaccine a week ago this past Monday. This past Saturday, she started feeling bad, but no fever. On 30Jan2021 she started to have achy joints and aching all over and had some diarrhea on Sunday and Monday that is all the symptoms she had. Also patient went to have the Covid test done to see if she had it and just wants to know the vaccine after a week show any Covid symptoms. The outcome of the event was unknown.  Information on lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pollakiuria, Vaccination site pain
Clinical narrative: he had a tremendous amount of fatigue set in; he has body aches all over as well; frequent urination; punched in the left arm on the bicep where the injection site was. Caller stated it hurt a lot; This is a spontaneous report from A contactable other health care professional reported that a 42-year-old male received first dose of bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on 28Jan2021 at 16:15 as single dose in left arm for covid-19 immunisation. Medical history and concomitant medications were not reported. Caller stated he received the first dose of vaccine on Thursday 28Jan2021 at 4:15 pm. Caller stated he felt fine he went to class. Caller stated he went to bed and he didnt really have any site contact for the point of needle in the left arm. Caller stated it didn't hurt that bad. Caller stated the next morning he work up and it felt like he got punched in the left arm on the bicep where the injection site was. Caller stated it hurt a lot more than any flu shot he had ever received before. Caller stated he went about his day on Friday and then by Friday evening he had a tremendous amount of fatigue set in. Caller also stated he has body aches all over as well. Caller stated he thought his symptoms would go away after a day or so but here he was at day 5 and he was still experiencing a high degree of fatigue and he had to skip out on his internship today. Caller stated he was also experiencing frequent urination. Caller stated he was scheduled for his second dose on 08Feb2021. Outcome of event fatigue was not recovered and for remaining events it was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; Headache; This is a spontaneous report received from a contactable consumer reported for his wife. A 75-year-old female patient received BNT162B2 (Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 10:30 (at the age of 75-year-old) as single dose for COVID-19 immunization. The patient medical history included positive for covid on an unspecified date in Jul2020. The patient's concomitant medications were not reported. Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine was reported as none. No history of problems with vaccines in past. No additional vaccines administered on same date of the suspect. About 24 hours later (on 30Jan2021), the patient had headache and chills that probably lasted for 24 hours. The events did not require a visit to emergency room and physician office. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Fatigue, Pain
Clinical narrative: Sore shoulder- localized to left arm; Body aches; Tired; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received second dose bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Feb2021 at 16:30 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient was 46-years-old at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot Number: unknown) dose 1 via an unspecified route of administration, administered in Arm Left  12Jan2021 at 09:30 AM for COVID-19 immunization. Patient relevant medical history included high blood pressure. The patient concomitant medication(s) included valsartan (DIOVAN) taken for an unspecified indication. It was reported that on 02Feb2021 at 18:00, the patient experienced sore shoulder- localized to left arm, body aches, tired. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement was high. The outcome of event was recovered.  Information about batch/lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pyrexia, Vomiting
Clinical narrative: Arm numb; Vomiting; Fever; This is a spontaneous report from a contactable consumer. An adult non pregnant female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 31Jan2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. It was unknown that the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown. On 31Jan2021, the patient experienced arm numb, vomiting, fever. Treatment was received for the adverse event was unknown. The outcome of events were recovered.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: had a flare up with her back problems; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient had a flare up with her back problems before the 2nd dose on 05Feb. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is really sore; This is a spontaneous report from a Pfizer-sponsored program Pfizer first connect. A non-contactable female consumer reported for herself.  An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number and expiration date were not reported), dose 2 via an unspecified route of administration, on 01Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, the patient experienced arm is sore. The outcome of event is unknown.  Reporter have some correction with the date event instead of 03Feb2021 it should be 02Feb2021.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: antibiotic for skin condition; This is a spontaneous report from a contactable male consumer (patient) via Pfizer-sponsored program. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number not reported), via an unspecified route on an unspecified date in Jan2021, as a 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient stated that he received his 1st dose last week, today he was prescribed an antibiotic for skin condition and wanted to know if it was advisable to wait to finish the 2nd dose before taking the antibiotic. The outcome of the event was Unknown.    Follow-up attempts are completed. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site was possible. That happened last night. It did not hurt as much as the step 1 vaccine but took a little longer to manifest; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL3248; expiration date: Apr2021), via an unspecified route of administration on 01Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (LEVOXYL); atorvastatin calcium (ATORVASTIN); and montelukast at daily frequency for an unspecified indication. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient previously took Shingrix vaccine and it hurt. The clinical course of the event was reported as: the patient got step 2 of the COVID-19 vaccine and had local soreness at injection site was possible. That happened last night. It did not hurt as much as the step 1 vaccine but took a little longer to manifest. Neither hurt as much as the Shingrix vaccine got in the fall. The outcome of the event was unknown.  Information on about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: has been worn out; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number/Expiration Date: unavailable after follow-up), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she got vaccinated on Friday and she has been worn out since then, she was wondering if she should get the second shot if this would be the result she gets. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Myalgia
Clinical narrative: pain in the back; She is feeling tired, being light headed; her legs also have muscular pain; She is feeling tired, being light headed; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she experienced side effects today w/c was 6 days after the 2nd dose. The patient stated that she was feeling tired, being lightheaded, pain in the back and her legs also have muscular pain. The patient wanted to know if it was normal to have them. The outcome of the events was unknown.  Information on the lot/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Malaise, Off label use, Product use issue
Clinical narrative: She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; she is lactating, and is currently weaning her 19 month old son; she is lactating, and is currently weaning her 19 month old son; This is a spontaneous report from a Non contactable Nurse. This Nurse reported events for mother and baby. This case is for the mother. A 34-year-old female patient (mother) received a 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, on 29Jan2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. At the time of vaccination, the patient was lactating and was currently weening her 19-month-old son. The reporter stated that on Saturday (30Jan2021) and Sunday (31Jan2021) the patient ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021). Reporter does not know exact date of birth, but reporter believe she was 34 years old. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122449 Child and Maternal case
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; she is lactating, and is currently weaning her 19 month old son; she is lactating, and is currently weaning her 19 month old son; This is a spontaneous report from a Non contactable Nurse. This Nurse reported events for mother and baby. This case is for the mother. A 34-year-old female patient (mother) received a 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, on 29Jan2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. At the time of vaccination, the patient was lactating and was currently weening her 19-month-old son. The reporter stated that on Saturday (30Jan2021) and Sunday (31Jan2021) the patient ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021). Reporter does not know exact date of birth, but reporter believe she was 34 years old. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122449 Child and Maternal case
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable consumer (patient, self-reported).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unknown date, patient experienced arm soreness following both vaccine injections. The outcome of event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer or other non HCP reported, A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expiration Date: unknown) via unspecified route of administration on an unspecified date as first dose single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after first dose, the patient experienced Sore arm. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Headache
Clinical narrative: Second dose delayed; High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old non-pregnant female patient received second dose of BIONTECH (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her right arm on 22Jan2021 04:00 PM (Lot number: EL1283) as single dose for Covid-19 immunization. Age at vaccination: 49-year-old. Facility-type-vaccine: Workplace clinic. Covid was not tested prior vaccination. The patient's medical history included asthma and back injury. Known allergies included sodium benzoate, ASA, NSAIDS, mushrooms and seafood. Concomitant medications included Betacarotene/bioflavonoids NOS/biotin/calcium ascorbate/calcium pantothenate/calcium phosphate/choline bitartrate/chromic chloride/colecalciferol/copper sulfate/cyanocobalamin/folic acid/hesperidin/inositol/iron amino acid chelate/lycopene/lysine hydrochloride/magnesium oxide/manganese sulfate, molybdenum trioxide/nicotinamide/phytomenadione/potassium iodide/potassium sulfate/pyridoxine hydrochloride/retinol acetate/riboflavin/selenomethionine/silicon dioxide/colloidal/sodium borate decahydrate/thiamine mononitrate/tocopheryl acid succinate/ubidecarenone/zinc oxide (MULTIVITAMIN), colecalciferol (D3), iron, magnesium citrate and linum usitatissimum seed oil (FLAX SEED OIL) (other medications in two weeks). The patient previously took first dose of BIONTECH administered to her right arm on 22Dec2020 03:15 PM (Lot number: E49899) as single dose for Covid-19 immunization and experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea, and loss of taste and smell (for almost 2 weeks post first dose). The patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, and loss of taste and smell (48 hours for second dose). Second dose delayed, RT-PCR Covid-19 and Influenza, SARS-COV-2 aB test on on 5 Jan, 13 all negative. AE resulted in doctor or other healthcare professional office/clinic visit. Covid-test-post-vaccination: Covid test type: nasal swab, test name: RT-PCR PAN-SARS CORONAVIRUS, SARS-COV-2 (COVID-19), test date: 05Jan2021, result: Negative. The patient did not receive any treatment in response to the events. Outcome of the event second dose delayed was unknown, whereas other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza, Insomnia, Pain, Pyrexia
Clinical narrative: Second dose delayed; High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old non-pregnant female patient received second dose of BIONTECH (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her right arm on 22Jan2021 04:00 PM (Lot number: EL1283) as single dose for Covid-19 immunization. Age at vaccination: 49-year-old. Facility-type-vaccine: Workplace clinic. Covid was not tested prior vaccination. The patient's medical history included asthma and back injury. Known allergies included sodium benzoate, ASA, NSAIDS, mushrooms and seafood. Concomitant medications included Betacarotene/bioflavonoids NOS/biotin/calcium ascorbate/calcium pantothenate/calcium phosphate/choline bitartrate/chromic chloride/colecalciferol/copper sulfate/cyanocobalamin/folic acid/hesperidin/inositol/iron amino acid chelate/lycopene/lysine hydrochloride/magnesium oxide/manganese sulfate, molybdenum trioxide/nicotinamide/phytomenadione/potassium iodide/potassium sulfate/pyridoxine hydrochloride/retinol acetate/riboflavin/selenomethionine/silicon dioxide/colloidal/sodium borate decahydrate/thiamine mononitrate/tocopheryl acid succinate/ubidecarenone/zinc oxide (MULTIVITAMIN), colecalciferol (D3), iron, magnesium citrate and linum usitatissimum seed oil (FLAX SEED OIL) (other medications in two weeks). The patient previously took first dose of BIONTECH administered to her right arm on 22Dec2020 03:15 PM (Lot number: E49899) as single dose for Covid-19 immunization and experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea, and loss of taste and smell (for almost 2 weeks post first dose). The patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, and loss of taste and smell (48 hours for second dose). Second dose delayed, RT-PCR Covid-19 and Influenza, SARS-COV-2 aB test on on 5 Jan, 13 all negative. AE resulted in doctor or other healthcare professional office/clinic visit. Covid-test-post-vaccination: Covid test type: nasal swab, test name: RT-PCR PAN-SARS CORONAVIRUS, SARS-COV-2 (COVID-19), test date: 05Jan2021, result: Negative. The patient did not receive any treatment in response to the events. Outcome of the event second dose delayed was unknown, whereas other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Second dose delayed; High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old non-pregnant female patient received second dose of BIONTECH (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her right arm on 22Jan2021 04:00 PM (Lot number: EL1283) as single dose for Covid-19 immunization. Age at vaccination: 49-year-old. Facility-type-vaccine: Workplace clinic. Covid was not tested prior vaccination. The patient's medical history included asthma and back injury. Known allergies included sodium benzoate, ASA, NSAIDS, mushrooms and seafood. Concomitant medications included Betacarotene/bioflavonoids NOS/biotin/calcium ascorbate/calcium pantothenate/calcium phosphate/choline bitartrate/chromic chloride/colecalciferol/copper sulfate/cyanocobalamin/folic acid/hesperidin/inositol/iron amino acid chelate/lycopene/lysine hydrochloride/magnesium oxide/manganese sulfate, molybdenum trioxide/nicotinamide/phytomenadione/potassium iodide/potassium sulfate/pyridoxine hydrochloride/retinol acetate/riboflavin/selenomethionine/silicon dioxide/colloidal/sodium borate decahydrate/thiamine mononitrate/tocopheryl acid succinate/ubidecarenone/zinc oxide (MULTIVITAMIN), colecalciferol (D3), iron, magnesium citrate and linum usitatissimum seed oil (FLAX SEED OIL) (other medications in two weeks). The patient previously took first dose of BIONTECH administered to her right arm on 22Dec2020 03:15 PM (Lot number: E49899) as single dose for Covid-19 immunization and experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea, and loss of taste and smell (for almost 2 weeks post first dose). The patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, and loss of taste and smell (48 hours for second dose). Second dose delayed, RT-PCR Covid-19 and Influenza, SARS-COV-2 aB test on on 5 Jan, 13 all negative. AE resulted in doctor or other healthcare professional office/clinic visit. Covid-test-post-vaccination: Covid test type: nasal swab, test name: RT-PCR PAN-SARS CORONAVIRUS, SARS-COV-2 (COVID-19), test date: 05Jan2021, result: Negative. The patient did not receive any treatment in response to the events. Outcome of the event second dose delayed was unknown, whereas other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Pain in extremity, Rash, Rhinorrhoea
Clinical narrative: Arm sore; wrist pain; hand cramps; runny nose; rash on stomach; This is a spontaneous report from a contactable other HCP (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number EL3249), via an intramuscular route in the arm right on 26Jan2021 (at the age of 37-year-old) as 2nd dose, single dose for covid-19 immunization in Public Health Clinic. Medical history included allergy to sulfa drugs, supraventricular tachycardia and high blood pressure. Concomitant medications in two weeks included metoprolol succinate, losartan, atomoxetine hydrochloride (STRATTERA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulphate (ADDERALL) and fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number- EK4176), via an intramuscular route in the arm left on 06Jan2021 (at the age of 37-year-old) as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 27Jan2021, patient experienced arm sore, wrist pain, hand cramps, runny nose and rash on stomach. Patient did not receive any treatment for the events. On 10Jan2021 patient underwent nasal swab test with result as negative (POC COVID-19). The clinical outcome of the events was recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Smear test
Clinical narrative: Arm sore; wrist pain; hand cramps; runny nose; rash on stomach; This is a spontaneous report from a contactable other HCP (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number EL3249), via an intramuscular route in the arm right on 26Jan2021 (at the age of 37-year-old) as 2nd dose, single dose for covid-19 immunization in Public Health Clinic. Medical history included allergy to sulfa drugs, supraventricular tachycardia and high blood pressure. Concomitant medications in two weeks included metoprolol succinate, losartan, atomoxetine hydrochloride (STRATTERA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulphate (ADDERALL) and fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number- EK4176), via an intramuscular route in the arm left on 06Jan2021 (at the age of 37-year-old) as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 27Jan2021, patient experienced arm sore, wrist pain, hand cramps, runny nose and rash on stomach. Patient did not receive any treatment for the events. On 10Jan2021 patient underwent nasal swab test with result as negative (POC COVID-19). The clinical outcome of the events was recovered at the time of this report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: UTI; tested positive for covid; This is a spontaneous report from a contactable consumer. This consumer (granddaughter) reported for a female patient (grandmother) that a 92-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: unspecified) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was taken to emergency room yesterday. She was acting funny because she had urinary tract infection (UTI) on an unspecified date.  She had no symptoms but tested positive for COVID while in emergency room on 07Feb2021. The caller was asking if grandmother should be tested again for covid. The patient underwent lab test which included covid test (Sars cov-2 test) and the results were positive on 07Feb2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: A huge fever blister appeared on day 2 after vaccine. I haven't had one in; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in  left arm on 05Feb2021 12:30 PM as 1st dose single for an unspecified indication. Medical history included hypertension, obesity, drug hypersensitivity and known allergies: Penicillin. Concomitant medications included Zoloft (sertraline hydrochloride),  taken for an unspecified indication, vitamin C taken for an unspecified indication,  vitamin D (colecalciferol) taken for an unspecified indication. The patient not had covid prior vaccination and post vaccination. On 07Feb2021 07:00AM, The patient experienced A huge fever blister appeared on day 2 after vaccine. Patient stated she haven't had one in years and this one was bigger than ever. Treatment was not reported. The outcome of the event was not recovered.    Follow-up (13May2021): Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: tiredness; headache; muscle pain; nausea; ear infection; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as for the last weeks), patient experienced tiredness, headache, muscle pain and nausea and had to go on an antibiotic for an ear infection. Patient had Covid test, and it came back negative. Patient was scheduled for 2nd dose on Monday. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tiredness; headache; muscle pain; nausea; ear infection; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as for the last weeks), patient experienced tiredness, headache, muscle pain and nausea and had to go on an antibiotic for an ear infection. Patient had Covid test, and it came back negative. Patient was scheduled for 2nd dose on Monday. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit lymph nodes; This is a spontaneous report from a non-contactable other HCP (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 28Jan2021 at 15:15 in left arm as a single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received in two weeks included multi vitamin and vitamin c (VITAMIN C [ASCORBIC ACID]) both taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug allergy. The patient experienced swollen armpit lymph nodes on 30Jan2021 at 10:00. Patient did not receive any treatment. The outcome of the event was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Nausea
Clinical narrative: Nausea; cold sweat; This is a spontaneous report from a contactable consumer (patient). This 25-year-old male consumer reported that he received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via intramuscular route of administration in left arm on 01Feb2021 at 14:35 (at the age of 25-year-old), as unknown, single dose for COVID-19 immunization. Medical history included gallbladder removed about 5 years ago and covid around Dec2020 to an unknown date. Family Medical History Relevant to AE includes his mom was allergic to penicillin. There were no concomitant medications. It was mentioned that the patient did not receive any other products and had no investigation assessment. There was none additional vaccines administered on same date of the pfizer suspect. Adverse event prior vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. On 01Feb2021, 10 minutes after receiving the injection patient reported that he had nausea for about 40 minutes and said that he broke into a cold sweat when he got nauseated and when that cold sweat subsided, he started to feel better. He stated that the cold sweat only lasted about 1-2 minutes. The patient mentioned that he rarely gets sick. The patient did not require emergency room or physician office visit. He said that the last time he went to the doctor was when he had his gallbladder removed about 5 years ago. There were none relevant tests. The events recovered on the same day (01Feb2021).   Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: our arm was a bit sore; This is a spontaneous report from a contactable female consumer reported for herself. A 70-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient stated there arm was a bit sore. The outcome of the event was unknown.  Information about lot/batch number has been requested.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunizations. The patient past medical history and concomitant medication was not reported. The patients previous vaccine was a flu shot 4-5 months before for immunization and he took some herbs. The patient also took 1st dose of BNT162B2 and experienced adverse events. He was doing his own investigation as well and need to know if there's a virus in the vaccine after the 2nd dose he experienced flu like symptoms on an unspecified date. first dose of the Pfizer vaccine and right after experienced lower right side back pain and joint pain, but it subsided. The event outcome is unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue 24-48 hours after injection; Pain at the injection site up to 3 days; This is a spontaneous report received from a contactable consumer (patient). A 34-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 on 27Jan2021 at 13:00(at the age of 34 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient does not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue 24-48 hours after injection, pain at the injection site up to 3 days on an unspecified date on Jan2021. The patient did not receive any treatment for events. Outcome of all the events were recovered.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Sleep disorder, Vaccination site pain
Clinical narrative: Experienced pain in my left arm around the site of injection; Not sleeping well; Pain in the left clavicle and shoulder; My arm still hurts a little bit; This is a spontaneous report received from a non-contactable consumer. A 50-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 as single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included metoprolol, vitamin D3, multivitamins. Patient had no known allergies. On 27Jan2021, the patient experienced pain in my left arm around the site of injection. First night I was not sleeping well because of the pain. Next day there was also pain in the left clavicle and shoulder. My arm still hurts a little bit but now I was able to sleep on the left side again. No treatment was received for the events. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The outcome of the events was reported as recovered on unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The caller stated her arm always gets sore, even with the first dose of the vaccine and with flu shots.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took flu shots. On an unspecified date, the patient experienced that her arm always got sore, even with the first dose of the vaccine and with flu shots. The patient stated she received the second dose of the vaccine on Saturday and had absolutely no side effects. The patient wanted to know if it was normal to not have any side effects at all. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm soreness; This is a spontaneous report from a contactable pharmacist and a contactable physician (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EH9899) via intramuscularly on 26Dec2020 at 10:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no significant preexisting medical conditions prior to the vaccine. Concomitant medications were not reported. It was unknown, whether the patient was diagnosed with COVID-19 prior to vaccination and it was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, after the first dose the patient experienced mild arm soreness. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.