chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: my arm became swollen in a 2-3 inch area surrounding the injection site. The same area was also red and mildly tender to the touch; my arm became swollen in a 2-3 inch area surrounding the injection site. The same area was also red and mildly tender to the touch; The same area was also red and mildly tender to the touch; This is a spontaneous report from a contactable Other Health Professional, the patient.  A 28-year-old non-pregnant female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection, Lot number: EL3246) via intramuscular route on arm right on 25Jan2021 11:00 (Age at vaccination: 28 Years) at a single dose for COVID-19 immunization at Hospital. The patient medical history was 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 medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications included: Bactrim, Doxycycline and penicillin. Concomitant medication was not reported. The patient had not received any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (COMIRNATY Formulation: Solution for injection, Lot number: ELD140) via unspecified route on arm left on 04Jan2021 14:30 at a single dose for COVID-19 immunization. On 2-3 days) after receiving the vaccine on 27Jan2021 12:00 AM, her arm became swollen in a 2-3 inch area surrounding the injection site. The same area was also red and mildly tender to the touch. The swelling and redness was something she never experienced with any other IM injections. The red spot is still there. It doesn't bother her at all, but she just wanted to report it for data purposes. Patient didn't received treatment for the events. Outcome of events is not recovered.  The events was considered as non-serious.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms; This is Spontaneous report from a contactable Pharmacist via Medical Information Team. This Pharmacist reported similar events for himself and 1 patient. This is a 1st of 2 reports. This male pharmacist reported for himself.  A male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced a sore arm. The patient got vaccinated along with wife. The outcome of the event sore arm was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122438 Same reporter/drug/AE and different patients.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Feeling hot, Hyperhidrosis
Clinical narrative: If this is normal due to her steroid injections and causing an interaction with the vaccine; Sweating; She has had hot sensations in her back where she had trigger point injection shots/became very warm; This is a spontaneous report from a contactable consumer or other non hcp.     A 41-years-old female patient received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 12:30 (Batch/Lot Number was EL9264) as 2ND DOSE, single for an unspecified indication. Caller stated she got her second dose today of the vaccine, caller states she got trigger point cortisone shots last week, did not mention it to the people administering the vaccine, states after she got the vaccine, the sites where she got the injections for her trigger points became very warm, she states at one point she began sweating. States she got her second dose of the Covid vaccine today, 28Jan2021 at 12:30PM in her left arm, states the injections for the trigger spots are on the same side as the vaccine in her arm and shoulder, states it feels like her whole back is warm now, states it has improved some since about 30 minutes after the vaccine was administered. Caller clarifies the medication she received last week in her trigger areas in shoulder and back is called Bupivacaine, no further information provided. Medical history included none, Concomitant medication(s) included bupivacaine taken for an unspecified indication, start and stop date were not reported. On 28Jan2021, the patient experienced she has had hot sensations in her back where she had trigger point injection shots/became very warm with outcome of recovering if this is normal due to her steroid injections and causing an interaction with the vaccine, sweating with outcome of unknown.   Follow-up (28Jan2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (patient) reported, Information was added.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high pressure; This is a spontaneous report from a contactable consumer. A 72-years-old female (who was not pregnant at time of vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: unknown), via an unspecified route administration on an unspecified date as single for COVID-19 immunization at a medical center. The patient medical history and the concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had experienced high pressure on an unspecified date. The patient did not receive any treatment for the adverse event. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Rash on inner from armpit to wrist itchy, red, blotchy; Rash on inner from armpit to wrist itchy, red, blotchy; Rash on inner from armpit to wrist itchy, red, blotchy; This is a spontaneous report from a contactable consumer (patient). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: Elo142), via an unspecified route of administration on 21Jan2021 at 12:00 PM as a single dose for covid-19 immunisation at Doctor's office/urgent care. The patient medical history and concomitant medications 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 vaccines within four weeks. On 21Jan2021, the patient experienced rash on inner from armpit to wrist itchy, red, blotchy. No treatments were received for events. The patient was not recovered from the events.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Ear pain, Eye swelling
Clinical narrative: Eye swollen; nauseated; Fever; chills; coughing; Body ache; Muscle ache; Tired; Ear ache; This is a spontaneous report was received from a contactable other hcp. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 27Jan2021 12:00 as single dose for covid-19 immunisation.  The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had history of promethazine allergy. The patient was not pregnant at the time of vaccination. The patient did not take any other vaccine in four weeks and did not take other medications in two weeks. On 27Jan2021 at 20:15, the patient was feeling nauseated, fever, chills, coughing, body ache, muscle ache, tired, earache, eye swollen. The patient did not take any treatment. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 06Jan2021 12:00 as single dose for covid-19 immunisation. The patient had no covid prior vaccination. On 28Jan2021, (post vaccination), the patient underwent lab tests and procedures which included covid-19 and the results were pending. The outcome of the events was recovering.  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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Eye swollen; nauseated; Fever; chills; coughing; Body ache; Muscle ache; Tired; Ear ache; This is a spontaneous report was received from a contactable other hcp. A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 27Jan2021 12:00 as single dose for covid-19 immunisation.  The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had history of promethazine allergy. The patient was not pregnant at the time of vaccination. The patient did not take any other vaccine in four weeks and did not take other medications in two weeks. On 27Jan2021 at 20:15, the patient was feeling nauseated, fever, chills, coughing, body ache, muscle ache, tired, earache, eye swollen. The patient did not take any treatment. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported), via intramuscular route of administration, administered in arm left on 06Jan2021 12:00 as single dose for covid-19 immunisation. The patient had no covid prior vaccination. On 28Jan2021, (post vaccination), the patient underwent lab tests and procedures which included covid-19 and the results were pending. The outcome of the events was recovering.  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: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pain, Pyrexia
Clinical narrative: 102-103 degree fever; shivering; body aches; insomnia; This is a spontaneous report from a contactable Consumer. A 71-years-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date: not reported) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient received vaccine yesterday and is experiencing 102-103 degree fever, shivering, body aches and insomnia.  Temperature is not coming down with Tylenol, seeing doctor tomorrow. The patient underwent lab tests and procedures which included body temperature: 102-103 degree.  Patient received treatment as tylenol for event temperature. 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.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: had an allergic reaction (tongue swelling and throat closing) after taking the vaccine; This is a spontaneous report from a contactable consumer. The consumer reported similar events for 2 patients. This is 1st of two reports.  An elderly female patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 22Jan2021 as a single dose for Covid-19 immunization in Hospital. Medical history and concomitant medications were not reported. It was unknown whether patient had COVID prior vaccination or post vaccination. On 22Jan2021, the patient experienced allergic reaction (tongue swelling and throat closing) after taking the vaccine, which resulted in emergency room/department or urgent care. Patient self administered Epi-pens as treatment for the event. The adverse reaction was reversed by the single use of the individual epipens. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021088128 same reporter/ drug, different patient/ similar AE
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) as SINGLE DOSE for covid-19 immunisation. Patient only had a headache and minor aches after the first dose. The reporter mentioned her son is a surgeon and had bad flu like symptoms after second shot. Outcome of the event was 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Rhinorrhoea, Vaccination site inflammation
Clinical narrative: The day following the 2nd dose, runny nose again but also joint achiness; The day following the 2nd dose, runny nose again but also joint achiness; injection site became inflamed: red, firm, hot to touch, and itchy - measured 4 inch in diameter; After the 2nd dose: arm (deltoid) was sore; This is a spontaneous report from a non-contactable other hcp (Patient, self-reported). A 50-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 18:15 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included hypertension, blood cholesterol increased, latex sensitivity and GI upset from eggs and soy. Concomitant medications included atorvastatin; fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient had received bnt162b2 (Batch/Lot number=EH9899), via an unspecified route of administration, administered in Arm Left on 18Dec2020 18:15, 1 ST DOSE, SINGLE. After first dose patient had extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use. Throbbing and painful to move/lift. I also had a runny nose the day after first dose. Symptoms resolved by 3rd day after injection. After the 2nd dose patient had arm (deltoid) was sore, but not as bad. Woke me first night, after taking Tylenol. The day following the 2nd dose, runny nose again but also joint achiness. Symptoms resolved by 2nd day after injection. However, on 3rd day after injection, injection site became inflamed: red, firm, hot to touch, and itchy - measured 4 inch in diameter. Lasted for 2 full days - treatment with ibuprofen (day) and Benadryl at night. On 11Jan2021, the patient experienced the day following the 2nd dose, runny nose again but also joint achiness, injection site became inflamed: red, firm, hot to touch, and itchy - measured 4 inch in diameter and after the 2nd dose: arm (deltoid) was sore. Therapeutic measures were taken as a result of the adverse events as Ibuprofen and Benadryl for inflammation/itchiness. The clinical outcome of the events were recovered on an unspecified date.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) similar report from same reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Feeling abnormal, Pyrexia
Clinical narrative: meaning fever and chills; meaning fever and chills; felt generally terrible; Diarrhea; cough/dry cough; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration on 26Jan2021 (at an age of 63-years-old) as single dose for covid-19 immunisation. Medical history included covid-19 from 23Dec2020 (23Dec2020 she tested positive for Covid-19). There were no concomitant medications. The patient previously took bnt162b2 (batch/lot number: EK9231) and experienced chills, fever, arm hurt real bad. On an unspecified date the patient experienced meaning fever and chills, felt generally terrible. On 28Jan2021, the patient experienced cough/dry cough. Caller reported that she is a healthcare worker and just retired. She clarified that she is a Dietician. She called yesterday and reported the fact that she had COVID in Dec2020, after having COVID, she had both doses of the Pfizer Vaccine. Second dose this week. She had Adverse reactions to both doses, meaning fever and chills. Yesterday, she started with a cough. She wants to make sure that this is all reported correctly. When she talked with someone yesterday and talked with someone who's accent she could not understand. Not hearing that any coughs were supposed to be a potential side effect of the vaccine. Patient had the first vaccine on 05Jan2021, Lot EK9231, and the 2nd dose on 26Jan2021, Lot EL3248. She had it at the (State name). Yesterday, she had 1 episode of Diarrhea and this morning another episode of Diarrhea. The cough started yesterday and that is biggest concern. She has not been able to see where it was a noted side effect. She spoke to nurse in Pfizer Drug Safety yesterday and then he put her through to next department and that is where she wanted to find more about if there has been any research or if there is in fact an association with the cough. She is now concerned because she again started to develop a dry cough today and wanted to know if this is something she should be worried about since she previously had Covid last Dec2020. "How long will it last?". The patient did not receive any treatment for the events. The clinical outcome of the meaning fever and chills (fever) was recovered on an unspecified date in 2021. Clinical outcome for cough/dry cough, meaning fever and chills (chills), felt generally terrible, diarrhea were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Swollen, sore spot in armpit; Swollen, sore spot in armpit; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL1283), via an unspecified route of administration on left arm on 26Jan2021 08:00 as single dose for COVID-19 Immunization. Medical history included ongoing high blood pressure, ongoing prediabetes and allergic to sulfa. Concomitant medications included ethinylestradiol/norgestimate (TRI-SPRINTEC 28), losartan, metformin, vitamin D3 daily, ascorbic acid (VITAMIN C) daily and calcium, magnesium. The patient previously took lisinopril and experienced allergy. The patient historical vaccine included first dose of BNT162B2 (Lot number: EK5730) on 06Jan2021 (at 43-year-old) on right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient experienced red, swollen, sore/tender, itchy on injection site and swollen, sore spot in armpit. The Patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Swollen, sore spot in armpit; Swollen, sore spot in armpit; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL1283), via an unspecified route of administration on left arm on 26Jan2021 08:00 as single dose for COVID-19 Immunization. Medical history included ongoing high blood pressure, ongoing prediabetes and allergic to sulfa. Concomitant medications included ethinylestradiol/norgestimate (TRI-SPRINTEC 28), losartan, metformin, vitamin D3 daily, ascorbic acid (VITAMIN C) daily and calcium, magnesium. The patient previously took lisinopril and experienced allergy. The patient historical vaccine included first dose of BNT162B2 (Lot number: EK5730) on 06Jan2021 (at 43-year-old) on right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient experienced red, swollen, sore/tender, itchy on injection site and swollen, sore spot in armpit. The Patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discomfort
Clinical narrative: slight discomfort at injection site; feeling of fatigue, not severe but noticeable; This is a spontaneous report from a non-contactable consumer (patient). A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: WN5318, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 29Jan2021 at 11:45 (age at vaccination was 31 years) as a 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history included peanut allergy. Concomitant medications the patient received within 2 weeks of vaccination included cyanocobalamin (VITAMIN B12) (50 ug vitamin B12/day) and colecalciferol (VITAMIN D) (1000 IU vitamin D/day). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) which caused drug allergy. On 29Jan2021 at 12:00 pm, the patient experienced slight discomfort at injection site, feeling of fatigue, not severe but noticeable. The patient responded "not recovered" but kept in mind that a very short time had elapsed between the adverse event and reporting. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse events. The events were reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphagia
Clinical narrative: metallic taste in her mouth; difficulty swallowing; This is a spontaneous report from a non-contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9262) via an unspecified route of administration in left arm on 27Jan2021 14:00 as 1st dose single (at the age of 66-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient medical history was not reported. Patient had no allergies to medications, food, or other products. The concomitant medications included lisinopril; amlodipine besilate; esomeprazole magnesium (NEXIUM); betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, chromium amino acid chelate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, nicotinamide, oenothera biennis oil, panax ginseng, riboflavin phosphate, royal jelly, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (WOMEN'S MULTIVITE). On 27Jan2021 15:00, about 45 minutes after receiving the vaccine patient noticed a metallic taste in her mouth and had difficulty swallowing. The difficulty swallowing lasted about an hour. The metallic taste lasted for a day. The patient did not receive any treatment for the adverse events. On 27Jan2021 16:00, the outcome of the event of swallowing difficulty and on 28Jan2021 of the event metallic taste in her mouth was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: deltoid myalgia; This is a spontaneous report from a contactable 74-year-old physician reported for himself.  A 74 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EL3249), via Intramuscular route of administration, administered Left arm on 29Jan2021 11:15 AM at a 1st dose, single for COVID-19 immunization. The patient's medical history included DJD, ASHD s/p angioplasty/stent, dyslipidemia, and concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 since the vaccination. On 29Jan2021 21:00, patient experienced mild deltoid myalgia. Patient did not receive any treatment for events. Outcome of the events was recovered.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes in neck/the swelling had grown from a pearl size to the size of medium size marble; extreme fatigue; This is a spontaneous report from a contactable consumer via Pfizer. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot number: Unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes in neck and extreme fatigue 10 days post her first vaccination. She mentions the swelling had grown from a pearl size to the size of medium size marble. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I am pregnant and I got the Covid vaccine.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she was pregnant and got the covid-19 vaccine on an unspecified date. The outcome of event was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: having little confusion since the vaccine shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2) at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced having little confusion since he/she got the vaccine shot on an unspecified date. The outcome of event was unknown.  Amendment (PSSR): This follow-up report is being submitted to allow appropriate reporting to health authorities.  Follow-up attempts have been completed and no further information is expected. The batch/lot number is not available despite the follow-up attempts made.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pain in extremity, Pruritus
Clinical narrative: experienced pruritis over her entire body, even inside her ears; she felt sores on her feet and started to itch; Her eyes were draining; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history included excessive histamine response to a variety of modalities- medications/antibiotics, foods, pets/animals, etc. She was also status post craniotomy due to hydrocephalus and had a VP shunt; from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. As per the description, In Jan2021, on her way home from the initial vaccine administration she felt sores on her feet and started to itch. Shortly thereafter, she experienced pruritis over her entire body, even inside her ears. Her eyes were draining. All of this occurred despite using diphenhydramine 25mg q3 hours. Her symptoms finally resolved on 24Jan2021. She was also inquiring of whether she should receive the second dose of vaccine. The outcome of the events was resolved on 24Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Peripheral swelling, Throat irritation
Clinical narrative: Scratchy throat; Swelling in left arm; lymphedema; This is a spontaneous report from a contactable consumer (patient). A 82-years-old non pregnant female patient received BNT162B2 (COMIRNATY, formulation solution for injection) via an unspecified route of administration, administered in right arm on 26Jan2021 14:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. Medical history included Knee replacement surgery.Breast cancer for several years from 1996 surgery. Patient did not had allergies to medications, food, or other products. Concomitant medication included simvastatin taken for an unspecified indication, dorzolamide hydrochloride/timolol maleate (COZOPT) taken for an unspecified indication, acetylsalicylic acid (ZORPRIN) taken for an unspecified indication, ubidecarenone (COQ 10) taken for an unspecified indication. On 29Jan2021 the patient experienced scratchy throat, swelling in left arm, lymphedema. The events were considered as non-serious by reporter. No treatment was given to patient.The outcome of events was unknown. The action taken in response to the events for bnt162b2 was not applicable. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills and muscle aches; running a fever; chills and muscle aches; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced running a fever, chills and muscle aches. Verbatim and event description was mentioned as, Phone call received from the patient regarding Pfizer-BioNTech COVID-19 Vaccine. During the call, the patient stated, "I'm reporting a side effect from a Pfizer vaccine. The first shot and I haven't read about this anywhere as a side effect. I've been running a fever ever since I got it. Fever, chills and muscle aches. Aches and pains and it's almost been a week." 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Mild headache; Mild pain in some of the muscles; Mild pain joints of the left hand; This is a spontaneous report from a non-contactable 31-year-old male consumer reported for himself that: A 31-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection ;Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:45 as SINGLE DOSE for covid-19 immunisation.Medical history included food allergy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took bactrim and experienced drug hypersensitivity.The patient experienced mild headache  on , mild pain in some of the muscles mild pain joints of the left hand on 31Jan2021  The events were assessed as serious Non serious by health authority on 31Jan 2021 outcome of events was recovered.   No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Severe body aches (flu-like); Severe body aches (flu-like); This is a spontaneous report from a contactable Other HCP. A 33-years-old non pregnant female patient received second dose of BNT162B2 (COMIRNATY, formulation solution for injection), intramuscular, administered in Left arm on 01Feb2021 07:15 (Batch/Lot Number: EL3246) (Age at vaccination: 33 Years old) as single dose for covid-19 immunisation. Medical history included asthma. Patient did not had allergies to medications, food, or other products. The patient previously received first single dose of BNT162B2 on 04Jan2021 09:00 AM intramuscularly on left arm at single for Covid-19 immunization (Lot number: EL3246).On 01Feb2021 16:00 the patient experienced severe body aches.The events were considered as non-serious by reporter. No treatment was given to patient. The outcome of events severe body aches was not recovered. The action taken in response to the events for bnt162b2 was not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Symptoms is a sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:00 as second dose single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reports they just received the second Pfizer Covid vaccine at 9am. Patient did not have any reactions to the first or second dose expect for a sore arm. Inquiring if vaccine is effective because her only symptom is a sore arm. The side effects she has read about indicates it is working. The outcome of the event was unknown.  Information about 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021126380 same reporter, drug, event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had severe soreness on her arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 20Jan2021 as first dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose on the 20th of January and patient was asking if when she can take the prolia medicine. patient had severe soreness on her arm after she got the first dose on an unspecified date in 2021. The outcome of the event was unknown.  Information about 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: Arthritis
Clinical narrative: Tylenol every morning for her arthritis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid 19 Vaccine, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient just finished the two doses of the vaccine but has been taking Tylenol every morning for her arthritis on an unspecified date. patient read somewhere that you should not take Tylenol which patient is not aware of. Therapeutic measures were taken as a result of tylenol every morning for her arthritis. The outcome of the event was unknown.  Information about 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; This is a spontaneous report from a contactable consumer. A 79-years-old male patient received BNT162B2 (COMIRNATY, formulation solution for injection) via an unspecified route of administration on 27Jan2021 20:30 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that no underlying Heath conditions. Patient in good overall health. On 28Jan2021 8:00 the patient experienced injection site soreness. The event was considered as non-serious by reporter. The outcome of event was unknown. The action taken in response to the event for bnt162b2 was not applicable.  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: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Hard time hearing; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he got the Covid vaccine yesterday (27Jan2021) and has a hard time hearing on an unknown date in Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible; Information on Lot/Batch cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate, Heart rate increased, Influenza like illness
Clinical narrative: tired; flu like symptoms; lightheaded; rapid heart beat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose1, via an unspecified route of administration on 28Jan2021 (Batch/Lot number not reported) as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced feeling flu like symptoms, lightheaded, tired and a rapid heartbeat. The clinical outcomes of the events were 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: Skin discolouration
Clinical narrative: has a white spot; This is a spontaneous report from a contactable consumer or other non hcp Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced has white spot on an unspecified date. The reporter stated the site where her mom got the vaccine, has a white spot. States its not painful and that it was hard yesterday but today its normal. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A 90 (Age: 90; unit: unknown) male patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 27Jan2021, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.   The reporter stated that the patient received vaccine yesterday and have only developed a sore arm. Reporter asked, if this means the vaccine isn't working? The outcome of event sore arm was not reported.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085223 Same reporter/drug/event, different patient.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Hypertension
Clinical narrative: Chills; High Blood Pressure at 180/60 first dose; This is a spontaneous report from a contactable consumer. This 87-year-old non pregnant female consumer reported for herself that she received first dose of bnt162b (BNT162B2, Solution for injection, Lot number: EH9899) on 06Jan2021 at 12:00 Right arm, as single dose for covid-19 immunisation. Medical history includes COPD (chronic obstructive pulmonary disease), High Blood Pressure, Pacemaker, Aortic stenosis, Liver Disease, Hip Replacement Surgery from an unknown date and unknown if ongoing. The patient had allergies of Pork and Shellfish. Concomitant medications includes Losartan, Eliquis, Montelukast, Amlodipine. No other vaccine in four weeks. No covid prior to vaccination. No covid post vaccination. The patient had Chills and high blood pressure at 180/60 first dose.  The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity, Rheumatic disorder, Sciatica
Clinical narrative: severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A female 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 an unspecified date as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe pain in back and right side thigh, knee and leg, diagnosed as either rheumatism or sciatica. The pain was started within one day of shot and had not stopped. The outcome of events was not recovered.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085061 same reporter/ drug/ AE, different patient