chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Fatigue, Menstruation delayed
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 23Mar2021 11:15 as 1st dose, single dose (at the age of 51-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729, Expiration Date- 31 Jul 2021) via an unspecified route of administration in left arm on 13Apr2021 11:15 as 2nd dose, single dose for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included that she was over-weight. The concomitant medications were not reported. Patient is the only girl in the house and she noticed after her first dose she skipped her period that month (Apr2021), her period did not come, which does not happen to her. Patient added her period is every 26 days pretty reliably. She had a period 09Feb2021 and 06Mar2021 and she did not have period again until 29Apr2021 which was 28 days later. She skipped it sometime in early April, clarifies she should have had her period on 01Apr2021. After 29Apr2021 she got it 16 days later and now she is waiting for her next period. She did not know if her next period would be normal or not. She did not know if her body was readjusting. She did not think anything of it until she started hearing things here and there about vaccines affecting periods and vaccine shedding. On 23Mar2021, patient experienced soreness in her arm which was hurting. On 24Mar2021, she was also very tired and had joint aches/body aches. Around 11 days after first vaccine (on 03Apr2021) she had stomach issues, like diarrhea for 4 days or something. She did not eat anything weird or unusual. No one else had it so it could not be a virus. She mentioned it to them and asked could it be a side effect of the vaccine and they said sure, it could be. The adverse events did not result in the emergency room visit of physician office visit. The outcome of the event skipped period was unknown, of the event stomach issues/diarrhea was resolved on 07Apr2021, while for other events was resolved on an unspecified date in Mar 2021 (reported as 25Mar2021 or 26Mar2021). No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 23Mar2021 11:15 as 1st dose, single dose (at the age of 51-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729, Expiration Date- 31 Jul 2021) via an unspecified route of administration in left arm on 13Apr2021 11:15 as 2nd dose, single dose for COVID-19 immunization. Vaccine was not administered at Military Facility. Patient did not receive any prior vaccinations within 4 weeks. Patient medical history included that she was over-weight. The concomitant medications were not reported. Patient is the only girl in the house and she noticed after her first dose she skipped her period that month (Apr2021), her period did not come, which does not happen to her. Patient added her period is every 26 days pretty reliably. She had a period 09Feb2021 and 06Mar2021 and she did not have period again until 29Apr2021 which was 28 days later. She skipped it sometime in early April, clarifies she should have had her period on 01Apr2021. After 29Apr2021 she got it 16 days later and now she is waiting for her next period. She did not know if her next period would be normal or not. She did not know if her body was readjusting. She did not think anything of it until she started hearing things here and there about vaccines affecting periods and vaccine shedding. On 23Mar2021, patient experienced soreness in her arm which was hurting. On 24Mar2021, she was also very tired and had joint aches/body aches. Around 11 days after first vaccine (on 03Apr2021) she had stomach issues, like diarrhea for 4 days or something. She did not eat anything weird or unusual. No one else had it so it could not be a virus. She mentioned it to them and asked could it be a side effect of the vaccine and they said sure, it could be. The adverse events did not result in the emergency room visit of physician office visit. The outcome of the event skipped period was unknown, of the event stomach issues/diarrhea was resolved on 07Apr2021, while for other events was resolved on an unspecified date in Mar 2021 (reported as 25Mar2021 or 26Mar2021). No follow-up attempts possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt extra sore after the second shot.; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old female patient and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 13Apr2021 11:15 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient medical history included that she was over-weight. The concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7534, Expiration Date- 31Jul2021) via an unspecified route of administration in left arm on 23Mar2021 11:15 as 1st dose, single dose for COVID-19 immunization and experienced "She had a period 09Feb2021 and 06Mar2021 and she did not have period again until 29Apr2021", body aches (ended on 25Mar2021 or 26Mar2021), very tired (from 23mar2021 or 24Mar2021 End date: 25Mar2021 or 26Mar2021), joint aches (End date: 25Mar2021 or 26Mar2021), sore arm, hurting (End date: 25Mar2021 or 26Mar2021) and diarrhea. Vaccine was not administered atFacility. Patient did not receive any prior vaccinations within 4 weeks. The patient reported on an unknown date Apr2021 that felt extra sore after the second shot. The adverse event did not result in the emergency room visit of physician office visit. The outcome of the event was unknown.   No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: sore arm; fatigue; nausea; headache; This is a spontaneous report from a contactable pharmacist (patient) received via a sales representative.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced sore arm, fatigue, nausea, and headache on an unspecified date in Jun2021. Adverse events resolved within 24-48 hours. This adverse event was reported within the 24 hour time frame. Reporter reported as, "I found out about it late afternoon on 08Jun2021 and reported very early morning on 09Jun2021". Outcome of all the events were recovered on an unspecified date in Jun2021.  Information about batch/Lot number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I had first shot 01Apr2021 and then I had Covid am diagnosed with Covid 05Apr2021; This is a spontaneous report received from a contactable consumer (patient) A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ERE734 and Expiration date was unknown), dose 1 via an unspecified route of administration on 01Apr2021 (age at the time 75-year-old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021, the patient had tested for COVID-19, but never had any problem. It happened a couple of month 60 days since. She wants to know that she still needs to receive her second dose and wants to know how to proceed. The patient wanted the timing of the 2nd shot. There was a product complaint. The patient underwent lab tests and procedures which included COVID-19 SARS cov-2 test was positive on 05Apr2021 and unspecified lab data also performed. The outcome of event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Ear disorder, Vertigo
Clinical narrative: First dose: Matter coming out of left ear; First dose: Vertigo; Felt dizzy.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9265) via an unspecified route of administration, administered in arm left on 15Apr2021 15:20 (at the age of 63-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism (It is an autoimmune illness. She has had it for a long time, since she was in her thirties. She has had it for over half of her life. She has had it for maybe 30 years. It is a hereditary cause). Concomitant medication included levothyroxine (LEVOTHYROXINE) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date to ongoing at approximately 68mg to 75mg every day for hypothyroidism (Perhaps there wasn't enough research for people with autoimmune problems. She has had it for a long time, since she was in her thirties. She has had it for over half of her life. She has taken the Levothyroxine for about 30 years also). Patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient did not have adverse event following prior vaccinations. On an unspecified date the patient experienced first dose: matter coming out of left ear, first dose: vertigo, felt dizzy. Adverse event did not require visit to emergency room or physician office. Actually, after the first shot patient noticed some of this matter coming out of her left ear 2 weeks after. It didn't register with her. One day patient had some vertigo. She was washing the floor and felt dizzy. Thank god that went away. More of this problem occurred 2 weeks after the second shot. First dose matter coming out of left ear: It started the second week after her first dose. It seems like everything starts 2 weeks after the vaccine, it did go away. Patient thought if it was temporary patient could deal with that. If patient knows it will go away patient will bear it. Patient knows that the vaccine is supposed to be helping. It went away within the day in the evening. It didn't linger. First dose vertigo: the vertigo happened on the same day that she had matter coming out of her ear. It was 2 weeks after the vaccine, later Saturday evening. It went away and did not stick. The patient underwent lab tests and procedures which included blood test: normal. Investigations: patient had tests that all came out normal. Apparently, her blood pressure went up, and her doctor wants to put her on blood pressure medication. Patient thinks it was because of all of this. Patient had bloodwork, and it all checked out fine. Everything was unremarkable, nothing patient had to go back to address. It was a normal blood panel. The clinical outcome of the first dose: matter coming out of left ear, first dose: vertigo, felt dizzy were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Otorrhoea
Clinical narrative: Matter coming out of ear; This is a spontaneous report from a contactable consumer or other non hcp (patient's friend). A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced matter coming out of ear. He dunked his head under water, and it helped him, but it didn't work for her. Her friend said his has gotten better. On an unspecified date, the outcome of the event was recovering.  Communication: Report 2 of 3. Caller declines to complete a full report. Additional details unable to be obtained.  Information about batch no/lot no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: had a swollen lymph node in her left arm pit; This is a spontaneous report from a contactable consumer (patient's husband). A 50-years-old female patient (wife of reporter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. The patient 's medical history and concomitant medications were not reported. It was reported that after receiving the vaccine, the patient had a swollen lymph node in her left arm pit, but it went away after a few days. He does not have lot Number or vaccination dates for his wife. The outcome of the event was recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Took the first dose, after 9 days she got it, she got the Covid; This is a spontaneous report received from a contactable Registered Nurse (who is the patient, reported for self).   A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number and Expiration date: Not Provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Reason for no lot number: of unspecified vaccine: Reporter was unwilling to complete the report. The patient medical history and concomitant medications were not reported. Other Products: Not Provided.   Reporter (the patient) was reporting on an adverse event of family member then reports adverse event on herself. Reporter stated that She herself took the first dose after 9 days she got it she got the Covid and its really not bad at all. Investigation Assessment was not Provided. Reporter declined to complete report for herself. The outcome of event was unknown.  Information on lot/batch number has been request
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My son got sick from the 1st vaccine; This is a spontaneous report from a Pfizer Sponsored Program via a non-contactable consumer (patient's mother) reported for patient (reporter's son).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that her son got sick from the 1st vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: got cold feet; This is a spontaneous report from Pfizer-sponsored program and 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 and Expiry date: Unknown), dose 1 via an unspecified route of administration on 12Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose 12Jan2021 and on an unspecified the patient experienced got cold feet. The patient had missed second dose scheduled for 02Feb2021.The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: From bottom of my knees all down its swollen; This is a spontaneous report received from a contactable consumer (patient).  A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number  EW0202 and expiration date: not reported), via an unspecified route of administration, on Left arm on 09Jun2021 between 08:30 - 09:00  (at the age of 47-year-old), as 1ST DOSE, SINGLE DOSE, for covid-19 immunization in the emergency room in the clinic.  Medical history included diabetes mellitus. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient stated that from bottom of her knees all down its swollen on 09Jun2021  at 05:48 (as reported).The patient would like to know long will this last. The  Patient didn't take any treatment however it was also reported that all she had was some grapefruit juice, and Kool-Aid and had some rice. The outcome of the event is unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Insomnia
Clinical narrative: Very deep coughs; Have trouble sleeping at night; This is a spontaneous report from a Pfizer-sponsored patient support program COVAX US Support and a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very deep coughs and have trouble sleeping at night on an unspecified date. It was reported that caller received the vaccine 3 weeks ago and his wife a month and a half ago. They both were experiencing very deep coughs and have trouble sleeping at night. The outcome for all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021680675 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Cough, Insomnia
Clinical narrative: Very deep coughs; trouble sleeping at night; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported for a female patient (reporter's wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced very deep coughs and had trouble sleeping at night. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021680667 Same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Pruritus, Varicella virus test
Clinical narrative: 14 days post 2nd dose of Pfizer mRNA vaccine itchiness; 38 days shoulder triceps area shingles breakout.; 17 days pain; This is a spontaneous report from a contactable physician via a sales representative.   A 65-year-old male patient received second dose of bnt162, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as second dose single dose for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing treated with valacyclovir and gabapentin. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose single dose for covid-19 immunisation. The patient experienced 14 days post 2nd dose of Pfizer mrna vaccine itchiness, 38 days shoulder triceps area shingles breakout and 17 days pain. Included in medical journal letter accepted in May. The patient underwent lab tests and procedures which included varicella virus test: positive on unspecified date. Therapeutic measures were taken valacyclovir, gabapentin, as a result of the events itchiness and shingles and no treatment received for pain. The outcome of the events was reported as recovered.  Information about lot/batch number is requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Pain in extremity
Clinical narrative: Mild pain in left arm; This is a spontaneous report from a non-contactable consumer or other non hcp. This consumer (patient) reported for herself that 51-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 as unknown, single dose for covid-19 immunisation. Medical history included pain in lower abdomen and diarrhoea during the time of infection. The patient's concomitant medications were not reported. The patient previously took xeljanz XR (11MG). The patient reported mild pain in left arm after receiving COVID vaccine yesterday (07Jun2021). The patient underwent lab tests and procedures which included colonoscopy: bcteria in her colon on Mar2021 (she was on antibiotics for bacteria in her colon found after a colonoscopy). The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: it feels like there is nick there in my veins, it is burning; having a burning sensation; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (solution for injection, Batch/Lot No: EN0178), via an unspecified route of administration on unspecified date at unknown dose number, single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that patient was not having a very good reaction, it felt like there was nick there in veins, it was burning (was having a burning sensation) and it was not all the time, it was just off and on an unspecified date. The patient stated considering going to an ER or urgent care right now and spoke with Pharmacist and was checking the dosage. Patient was told by the technician who gave the vaccine that it was 3 ml and then Pharmacist said that it was 0.3ml, the standard dose and then the lady that answered the phone said patient was given 0.3 ml. The outcome of the event was unknown.  Follow-up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis
Clinical narrative: Bad cold or a sinus infection; Bad cold or a sinus infection; This is a spontaneous report via Pfizer sponsored program. A non-contactable consumer (patient) reported a female patient of an unspecified age received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection), via an unspecified route on 22May2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient experienced bad cold or a sinus infection. Patient is due to get her second dose on Saturday 12Jun2021 and she would like to know if it is okay for her to take the second dose on Saturday. The clinical outcome of the bad cold or a sinus infection were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea, Vomiting
Clinical narrative: Nausea; Throwing up; Sick; This is a spontaneous report received from a contactable consumer or other non hcp.   A 33-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0185), via an unspecified route of administration, in Arm Left on 09Jun2021 16:30 (age at vaccination 33years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, throwing up, sick on an unspecified date. The clinical outcome of the event was unknown.  Information on Lot/Batch information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Gait disturbance, Insomnia, Pain
Clinical narrative: leg was burning/ burning sensation on the leg and also on right foot/ veins are burning; The caller has a lot of pain to the point; The caller  cannot even walk; She could not sleep; This is a spontaneous report from a contactable consumer. A 44-years-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0217; expiry date and NDC number were reported as unknown) via an unspecified route of administration on 09Jun2021 in right arm as a single dose for covid-19 immunization. Medical history included ongoing varicose vein which started years ago. The patient's concomitant medications, investigation assessment and other products were not reported. On 09Jun2021 at 17:00 after receiving the first dose Pfizer Covid 19 Vaccine the patient felt like her leg was burning and had a burning sensation in the leg and also on right foot. She had lot of pain to the point where she could not sleep and had to get up. She was not able to walk. She already had the varicose veins before the vaccine but did not had the sensation, she was aware that varicose veins can be dangerous and can give thrombosis. The outcome of the event burning leg was not recovered and for all other events was unknown.  Follow-up attempts are needed. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Discomfort, Disease recurrence, Gait disturbance, Insomnia
Clinical narrative: leg was burning/ burning sensation on the leg and also on right foot/ veins are burning; The caller has a lot of pain to the point; The caller  cannot even walk; She could not sleep; This is a spontaneous report from a contactable consumer. A 44-years-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0217; expiry date and NDC number were reported as unknown) via an unspecified route of administration on 09Jun2021 in right arm as a single dose for covid-19 immunization. Medical history included ongoing varicose vein which started years ago. The patient's concomitant medications, investigation assessment and other products were not reported. On 09Jun2021 at 17:00 after receiving the first dose Pfizer Covid 19 Vaccine the patient felt like her leg was burning and had a burning sensation in the leg and also on right foot. She had lot of pain to the point where she could not sleep and had to get up. She was not able to walk. She already had the varicose veins before the vaccine but did not had the sensation, she was aware that varicose veins can be dangerous and can give thrombosis. The outcome of the event burning leg was not recovered and for all other events was unknown.  Follow-up attempts are needed. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Varicose vein
Clinical narrative: leg was burning/ burning sensation on the leg and also on right foot/ veins are burning; The caller has a lot of pain to the point; The caller  cannot even walk; She could not sleep; This is a spontaneous report from a contactable consumer. A 44-years-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0217; expiry date and NDC number were reported as unknown) via an unspecified route of administration on 09Jun2021 in right arm as a single dose for covid-19 immunization. Medical history included ongoing varicose vein which started years ago. The patient's concomitant medications, investigation assessment and other products were not reported. On 09Jun2021 at 17:00 after receiving the first dose Pfizer Covid 19 Vaccine the patient felt like her leg was burning and had a burning sensation in the leg and also on right foot. She had lot of pain to the point where she could not sleep and had to get up. She was not able to walk. She already had the varicose veins before the vaccine but did not had the sensation, she was aware that varicose veins can be dangerous and can give thrombosis. The outcome of the event burning leg was not recovered and for all other events was unknown.  Follow-up attempts are needed. Further information has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer. A 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164 and Expiration Date not reported) via an unspecified route of administration, administered in Arm Left on May 2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no family medical history relevant to Adverse event. The patient had no history of all previous immunization with the vaccine considered as suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient reported that, he took one shot. The patient took the first shot about 2 weeks ago. The patient reported that in the last day or so he noticed a little lymph node swelling in the left chest area and stated that, it was not bad, it was not something that the patient cannot live with. The patient stated that the swelling came up about 3 days ago and it was just tender when he pressed on it. The patient was due to get his second shot next week. The patient was wondering if he should take it as scheduled or wait a few days for shot. The patient mentioned later should he take it in the right arm this time instead of the left arm. The patient denied medications, medical conditions, labs, testing, or treatments relevant to event. The patient did not visit emergency room and physician office. The outcome of little lymph node swelling in left chest area was not resolved and the outcome of event asking about postponing second dose of the vaccine was unknown. Information on Lot/Batch number was available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Product use issue, Vaccination site pain
Clinical narrative: 14 years patient received BNT162b2  vaccine; Second Dose: pain under arm around arm pit area; left arm, same one she received the shot in; Second Dose: Left Arm Injection Site Pain; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a 14-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Batch/Lot Number: EW0196; Expiration Date: Sep2021) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187, Expiration date: Aug2021), via an unspecified route of administration in the left arm on 17May2021 for COVID-19 immunization and expereinced left arm injection site pain. 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 prior to the vaccination. No investigation assessment was provided. Caller stated the patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time. Caller stated it lasted about 2 days after her first injection, so 17May2021, 18May2021, and 19May2021. Caller stated this time with the second dose, the injection site pain was less than the first time, but now she has pain under her arm at the arm pit area. Caller stated after the second dose the injection site pain was just that day, so just one day, it wasnot bad. Pain under arm around arm pit area; left arm, same one she received the shot in. Therapeutic measures were taken as a result of second dose: pain under arm around arm pit area; left arm, same one she received the shot in and second dose and left arm injection site pain with Advil. The outcome of the event second dose: left arm injection site pain was recovered on 07Jun2021; event second dose: pain under arm around arm pit area; left arm, same one she received the shot in was not recovered and unknown for other event.   Lot/batch no. detail are available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time; This is a spontaneous report from a Pfizer sponsored program  support. A contactable consumer (patient's mother) reported for a 14-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0187 and expiry date: Aug2021, patient was 14-years old at the time of vaccination), via an unspecified route of administration in Arm Left on 17May2021 as a single dose for COVID-19 immunisation. The patient's medical history and family medical history reported as None. The patient's concomitant medications were not reported. Patient took Pfizer covid vaccine to hopefully not get Covid, no other product and history was reported. On 17May2021, the patient experienced patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time. This report related to a study or programme. Reporter seriousness for First Dose experienced Left Arm Injection Site Pain was unspecified. Patient received treatment with Advil for the event. Reporter reported on behalf of her daughter, who is 14 years old and was scheduled to get her second dose, then states, no she got her second dose of the Pfizer Covid Vaccine on 07Jun2021, and she is complaining of pain under her arm around the arm pit area and wants to know if that is okay or if that is an adverse reaction? Reported that the patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time which lasted about 2 days after her first injection, from 17May2021 to 19May2021, but this time with the second dose, the injection site pain is less than the first time, but now she has pain under her arm at the arm pit area, after the second dose the injection site pain was just that day, so just one day, it wasn't bad. Second dose was received on 07Jun2021, LOT: EW0196, Expiration: Sep2021, also provides the Saline Lot Number for the First Dose of the Covid Vaccine: Saline Lot Number: 21099DK Expiration: 22Sep2021. Vaccine was not administered at Military Facility. Patient not visit emergency Room and physician Office for event. Patient had no prior Vaccinations (within 4 weeks) and not AE(s) following prior vaccinations. The outcome of event was recovered on 19May2021.  Information on lot/batch number was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diaphragmalgia, Dyspnoea, Illness, Pleurisy
Clinical narrative: Patient now has gotten pleurisy. Reporter describes pleurisy as meaning patient is now having a tough time breathing deeply, and patient has pain in her diaphragm area; Patient now has gotten pleurisy. Reporter describes pleurisy as meaning patient is now having a tough time breathing deeply, and patient has pain in her diaphragm area; Patient now has gotten pleurisy. Reporter describes pleurisy as meaning patient is now having a tough time breathing deeply, and patient has pain in her diaphragm area; Patient had the covid vaccine on Sunday afternoon. Patient has been feeling very ill since; Reported as worsened; This is a spontaneous report from a contactable consumer (patient's father) (primary care physician). A 25-year-old female patient (reporter's daughter) received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered to her right arm on 06Jun2021 14:30 (Lot number: EW0182, NDC number/Expiry date: Unknown) as single dose for COVID-19 immunization. The patient was taking Pfizer Covid vaccine as required to take it for college. The patient's medical history included ongoing bouts of diarrhea (had bouts of diarrhea prior to receiving the Covid vaccine). Patient had been having bouts of diarrhea. Reporter stated that patient has been having bouts of diarrhea prior to receiving the Covid vaccine. Age at the time of vaccination: 25-year-old. Concomitant medications were not reported. On 09Jun2021, patient now had gotten pleurisy. Reporter described pleurisy as meaning patient was having a tough time breathing deeply, and patient had pain in her diaphragm area. It was reported as worsened. Reporter was calling about the first dose of the Pfizer Covid vaccine. Reporter's daughter was the patient. Patient had the Covid vaccine on Sunday afternoon. Patient had been feeling very ill since. Patient had gotten pleurisy. Reporter provided spelling for pleurisy. Reporter describes pleurisy as meaning patient was having a tough time breathing deeply, and patient has pain in her diaphragm area. Began yesterday morning, Wednesday, 09Jun2021. Reporter was asking had Pfizer seen pleurisy as a side effect after the Covid vaccine. Reporter already took patient to the emergency room once before. The emergency room gave patient Maalox. Reporter had been trying to take patient to see her doctor, but reporter was having a hard time getting an appointment for patient. Outcome of the event reported as worsened was unknown, whereas other events was not recovered.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: Swelling of bottom lip; Swelling of hands and fingers; This is a spontaneous report from contactable consumer (patient's father). A 12-year-old female patient received first shot of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration, administered to her left arm on 24May201 (Batch/lot number: EW0179, NDC/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She had no prior vaccinations (within 4 weeks). On an unspecified date in May2021 (reported as a couple weeks ago), the patient experienced swelling of hands and fingers, and swelling of bottom lip on 10Jun2021 (noticed this morning). It was reported that, the patient took BNT162B2 so she would not contract COVID-19 virus. Began a couple weeks ago. Had no swelling in hands or fingers as of today. Stopped might be a week ago. Clarified both hands and all of her fingers were swollen. Recovered completely; was a volleyball player and had not complained of pain or anything. The reported wanted to know, what he can do, does patient need to go see a doctor or the emergency room, will it go away and how should it be treated. The patient did not go to emergency room and physician office. Outcome of the event morning swelling in her bottom lip was unknown, whereas swelling of hands and fingers was recovered on an unspecified date in Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; headache; This is a spontaneous report from a contactable female consumer (patient, she is a therapist) reported for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12May2021 at 10:00 (at the age of 61 years old), as 1st dose, single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date (she takes thyroid medicine and has been taking it for over 10 years). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported. The patient previously took dupixent for rash (She states her last dose was the 1st week of May2021). The patient experienced tired, headache on 12May2021. The reporter stated, she got her 1st dose 12May2021 and had side effects of massive headache and very tired that started the same day in the evening. The outcome of the events were unknown.   Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Hypersensitivity, Lip swelling, Peripheral swelling
Clinical narrative: Experienced an allergic reaction after getting the second dose of the Pfizer BioNtech COVID-19 vaccine; Chest pain; Dizziness; Rashes/rash is better in some places and has went away and then the rash comes back in other places; Lips are swelling; Hands are swelling; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient's mother) or other non hcp. A 17-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0177, Pfizer NTEC), via an unspecified route of administration on 06Jun2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot: ER8736) on 16May2020 (at the age of 17-yesr-old) via an unspecified route of administration for COVID-19 immunisation. On unknown date, the patient experienced an allergic reaction after getting the second dose of the Pfizer BioNtech COVID-19 vaccine. Mother stated that the son started experiencing chest pain, dizziness, and as of yesterday he has been experiencing rashes, but after taking Benadryl the rash healed, and now his lips and hands are swelling. Mother clarified that her son's rash has not healed completely from the Benadryl, but it has made the rash better in some places it has went away and then the rash comes back in other places, like it is moving around. Caller clarified that the reason she was calling was to find out if this reaction to the vaccine was normal or if her son should be seen. The caller stated that she could not tell if it was the letter R or D but she thinks that it was the letter R. Caller requested a transfer for Medical Information, so limited information was able to be obtained for the report. No further details were obtained or provided for the report. Therapeutic measures were taken as Benadryl for rash. The outcome of the events was reported as unknown.  Description of Product Complaint: Caller reporting an AE on the Pfizer BioNTech COVID-19 Vaccine. She mentioned her son had a rash and used Benadryl. Her son's rash has not healed completely from the Benadryl, but it has made the rash better in some places it has went away and then the rash comes back in other places, like it was moving around.  No further information obtained, due to caller requesting MI transfer.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Experienced an allergic reaction after getting the second dose of the Pfizer BioNtech COVID-19 vaccine; Chest pain; Dizziness; Rashes/rash is better in some places and has went away and then the rash comes back in other places; Lips are swelling; Hands are swelling; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient's mother) or other non hcp. A 17-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0177, Pfizer NTEC), via an unspecified route of administration on 06Jun2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot: ER8736) on 16May2020 (at the age of 17-yesr-old) via an unspecified route of administration for COVID-19 immunisation. On unknown date, the patient experienced an allergic reaction after getting the second dose of the Pfizer BioNtech COVID-19 vaccine. Mother stated that the son started experiencing chest pain, dizziness, and as of yesterday he has been experiencing rashes, but after taking Benadryl the rash healed, and now his lips and hands are swelling. Mother clarified that her son's rash has not healed completely from the Benadryl, but it has made the rash better in some places it has went away and then the rash comes back in other places, like it is moving around. Caller clarified that the reason she was calling was to find out if this reaction to the vaccine was normal or if her son should be seen. The caller stated that she could not tell if it was the letter R or D but she thinks that it was the letter R. Caller requested a transfer for Medical Information, so limited information was able to be obtained for the report. No further details were obtained or provided for the report. Therapeutic measures were taken as Benadryl for rash. The outcome of the events was reported as unknown.  Description of Product Complaint: Caller reporting an AE on the Pfizer BioNTech COVID-19 Vaccine. She mentioned her son had a rash and used Benadryl. Her son's rash has not healed completely from the Benadryl, but it has made the rash better in some places it has went away and then the rash comes back in other places, like it was moving around.  No further information obtained, due to caller requesting MI transfer.