chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (reporting himself). This 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ep6955), via an unspecified route of administration in left arm on 17Apr2021 at 09:30 (age at the time of vaccination was 17 years) as a single dose for COVID-19 immunization. The patient had no known medical history. The patient previously took penicillin, ibuprofen, amoxicillin and experienced drug allergy. The patient's concomitant medication included calcium, colecalciferol (CALCIUM +D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination with in 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ep6955), via an unspecified route of administration in left arm on 27Mar2021 at 09:00 as a single dose for COVID-19 immunization. On 17Apr2021, the patient experienced swollen lymph nodes in left arm pit. The patient received 1 aleve pill (naproxen) as treatment for the event. The outcome of the event was resolving.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Body temperature, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: Woke up with low grade fever; Headache; felt achy and sore and injection site very sore by this point.; very tired and achy/sore; My sugar numbers were 10-20 points higher than usual for every meal (breakfast is always the exact same food, lunch is very similar food).; Sore arm at injection site started 12 hours after injection; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (patient). A 36-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EP6955 and expiration date was not reported), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 at 09:30 as dose 2, single (at the age of 36-year-old) for COVID-19 immunization. Medical history included gestational diabetes during this twin pregnancy and did not have known allergies. The patient was 28 weeks pregnant and due date was on 04Jul2021. Concomitant medications included insulin human injection, isophane (HUMULIN 30/70); minerals NOS, vitamins NOS (PRENATAL VITAMINS); folic acid and docusate sodium (COLACE), all concomitant medications taken for an unspecified indication. The patient did not have COVID prior vaccination. 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. The patient was pregnant at the time of vaccination. The patient previously took first dose of BNT162B2 (lot number: EP6955, pregnant at time of vaccination) on 25Mar2021 at 13:15 administered in left arm (at the age of 36-year-old) for COVID-19 immunization. The clinical course of the events was reported as: on 16Apr2021, the patient woke up with low grade fever and headache (100.6F) at 2:30, took 1 Extra strength Tylenol. She felt achy and sore and injection site very sore by this point. Sore arm at injection site started 12 hours after injection. She woke up at 5:30, very tired and achy/sore. Low grade fever again around 11:30 on 16Apr2021. Took another extra strength Tylenol. General very tired for the rest of the day. By 6pm she was feeling less fatigue. She had gestational diabetes and manage by diet and exercise except for night time fasting which was controlled by 20 units at night of Humulin insulin injection. Her sugar numbers were 10-20 points higher than usual for every meal (breakfast is always the exact same food, lunch was very similar food). On 17Apr2021, she woke up with no more side effects. The patient was not COVID tested post vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with Tylenol for the events low grade fever and headache and did not receive treatment for the other events. The reporter assessed the events as non-serious. The outcome of the event "Vaccine exposure during pregnancy" was unknown and patient recovered from all other events on 17Apr2021.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Woke up with low grade fever; Headache; felt achy and sore and injection site very sore by this point.; very tired and achy/sore; My sugar numbers were 10-20 points higher than usual for every meal (breakfast is always the exact same food, lunch is very similar food).; Sore arm at injection site started 12 hours after injection; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (patient). A 36-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EP6955 and expiration date was not reported), dose 2 via an unspecified route of administration, administered in arm left on 15Apr2021 at 09:30 as dose 2, single (at the age of 36-year-old) for COVID-19 immunization. Medical history included gestational diabetes during this twin pregnancy and did not have known allergies. The patient was 28 weeks pregnant and due date was on 04Jul2021. Concomitant medications included insulin human injection, isophane (HUMULIN 30/70); minerals NOS, vitamins NOS (PRENATAL VITAMINS); folic acid and docusate sodium (COLACE), all concomitant medications taken for an unspecified indication. The patient did not have COVID prior vaccination. 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. The patient was pregnant at the time of vaccination. The patient previously took first dose of BNT162B2 (lot number: EP6955, pregnant at time of vaccination) on 25Mar2021 at 13:15 administered in left arm (at the age of 36-year-old) for COVID-19 immunization. The clinical course of the events was reported as: on 16Apr2021, the patient woke up with low grade fever and headache (100.6F) at 2:30, took 1 Extra strength Tylenol. She felt achy and sore and injection site very sore by this point. Sore arm at injection site started 12 hours after injection. She woke up at 5:30, very tired and achy/sore. Low grade fever again around 11:30 on 16Apr2021. Took another extra strength Tylenol. General very tired for the rest of the day. By 6pm she was feeling less fatigue. She had gestational diabetes and manage by diet and exercise except for night time fasting which was controlled by 20 units at night of Humulin insulin injection. Her sugar numbers were 10-20 points higher than usual for every meal (breakfast is always the exact same food, lunch was very similar food). On 17Apr2021, she woke up with no more side effects. The patient was not COVID tested post vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with Tylenol for the events low grade fever and headache and did not receive treatment for the other events. The reporter assessed the events as non-serious. The outcome of the event "Vaccine exposure during pregnancy" was unknown and patient recovered from all other events on 17Apr2021.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Loss of consciousness
Clinical narrative: felt like was going to pass out; became very cold; This is a spontaneous report from a contactable consumer or other non-health care professional. This consumer reporting for a female patient for a different event under the same suspect product for four patients. This is four of four reports. A female 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 14Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Apr2021The patient experienced became very cold and felt like was going to pass out. She had to lay down after 10 minutes and EMT's were called, not sure of end result or any other information except she didn't eat today. The outcome of event was unknown.  Information about lot/Batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: blood bleed in his right eye; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0164), dose 2 via an unspecified route of administration on 19Apr2021 at 11:30 (57 years age at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection,  Lot#ER8732), dose 1 via an unspecified route of administration in Left arm on 29Mar2021 (57 year age at the time of vaccination) for COVID-19 immunisation. On 20Apr2021 at 09:30, this morning, consumer has a blood bleed in his eye and consumer did not see anything online that indicates a connection, is there a connection? Consumer stated consumer took a shower and when consumer got out of shower, consumer noticed it. Consumer took Eye Drops on a normal basis; Moisturizing Eye Drops. Consumer also mentioned his daughter roommate(s) sister had to go to the emergency as she developed shingles and other issues related to the vaccine. The shingles started in the eye. The outcome of event was not resolved.  Follow-up (26May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This is a spontaneous report from a Pfizer COVAX  from a contactable consumer (husband of the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on 31Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, the patient was diagnosed with COVID-19 on 01Apr2021, but then she was tested negative of the virus. The patient was scheduled for the 2nd shot on 23Apr2021. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested Covid-19 Positive 4 days after her first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported. A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient already had the first dose of the Pfizer Covid-19 vaccine and was tested Covid-19 Positive 4 days after her first dose and now she still feels sick. Caller wants to know if when she's fully recovered on the 30Apr2021 which is her second dose due date, is it still safe to get her second dose. The relevant lab tests included test : COVID-19 test, result: positive 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: M
Vaccine: COVID19
Symptoms: Renal disorder, SARS-CoV-2 antibody test
Clinical narrative: Kidney Disease; This is a spontaneous report from a Pfizer sponsored program  via contactable consumer or other non hcp (Patients wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient experienced kidney disease on an unspecified date.The Pfizer Covid 19 Vaccine about a month ago thinking they were fully vaccinated but has no antibodies. The patient underwent lab tests and procedures which included that sars-cov-2 antibody test: no. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Feeling abnormal, Hypoaesthesia, Nausea, Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia was triggered; some TN pain; Trigeminal neuralgia was triggered; face numbness on the left side (TN side) for 6 days; brain fog; nausea; This is a spontaneous report received from COVAES. A contactable consumer (patient) reported a non-pregnant 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: not reported and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on 16Apr2021 at 16:45 (at the age of 44 years old) as dose 1, single for COVID-19 immunization. Patient's medical history included trigeminal neuralgia (TN) (left side of brain), unruptured brain aneurysm (right side of brain), anemia, and asthma. The patient was reported to have allergies to penicillin, contrast dye, latex, paprika, white wine, and vodka. Concomitant medications included carbamazepine, montelukast sodium (SINGULAR), fluticasone propionate (FLOVENT), fluticasone propionate (FLONASE) and GNC Vit (as reported). The patient previously took erythromycin for an unspecified indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since vaccination. On 17Apr2021, the patient stated that her TN was triggered and experienced face numbness on the left side (TN side) for 6 days, brain fog, some TN pain, and nausea. The patient did not receive treatment for the reported events. The events resulted to a visit to the doctor's office. The events were assessed as non-serious, did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient recovered from face numbness on the left side (TN side) was on 23Apr2021 while the outcome of the other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: son tested positive for COVID-19 on Tuesday, they are asymptomatic; This is a spontaneous report from a contactable consumer (parent) via Medical Information Team. A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 08Apr2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Apr2021, the patient tested positive for COVID-19 and patient was asymptomatic. Their second dose was scheduled on 29Apr2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on 20Apr2021. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19; This is a spontaneous report received from a contactable consumer reported for a male patient via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 02Apr2021 at an unspecified dose as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021 finished quarantine on 18Apr2021. It was reported that she and her husband got their first dose last 02Apr2021 and scheduled to have their 2nd dose today 23Apr2021. Mentioned that both of them tested positive last 08Apr2021. Asked if they can still get the 2nd dose today or not. Also mentioned she finished quarantine last 18Apr2021 and her husband finished his quarantine yesterday. The patient experienced positive covid-19 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: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposure to Covid-19; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced exposure to covid-19 on an unspecified date in 2021. Caller reported that a repairman, the patient, came to her house to service her washer and dryer. Caller reported that the patient stated that he had the Covid-19 vaccine and was down for a week with symptoms. Outcome of the event was unknown.  Follow-up (28Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the conformation below mentioned. This report included that:  Query: Can you please provide the ID as it was not provided in the narrative of the master case. Caller was warm transferred. Response: After reviewing the call recording, it is noted that the transfer agent did not provide her ID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Aches and pains Redness pain at injection site Tired/fatigued Nausea Headache
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Aches and pains Redness pain at injection site Tired/fatigued Nausea Headache
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Upper respiratory tract infection
Clinical narrative: sick; upper respiratory infection; This is a spontaneous report received from Pfizer-sponsored program COVAX US Support. An unspecified age female consumer (patient) received Bnt162b2 (BNT162B2; Formulation: Solution for injection), dose 1 via unknown route of administration, administered in unspecified location 26Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. It was reported that caller, received her 1st dose on March 26 and 2nd dose should be on April 16. Caller did not go on her scheduled 2nd dose schedule because she's very sick. Caller said not from the vaccine, it's from her upper respiratory infection. Caller is asking if she can get the 2nd dose in more than 21 days or should she start all over again. The outcome of event was "unknown". Medical Information were any medical questions addressed by this program forwarded/referred to Medical Information?: Yes No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: First dose of vaccine 13Apr2021 and tested positive for Covid 16Apr2021; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) via Pfizer Sponsored Program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 on 16Apr2021 and was still testing positive at the time of report. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Apr2021, sars-cov-2 test: still positive on an unspecified date in 2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19 virus; This is a spontaneous report from a contactable consumer (patient's daughter-in-law). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0162) via an unspecified route of administration, administered in Arm Right on 17Apr2021 17:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Apr2021. The reporter has a question about her mother-in-law. Her mother-in-law received her first dose of the Covid 19 vaccine on 17Apr2021 but then tested positive for the Covid 19 virus about 10 days ago. Her mother-in-law's second Covid 19 vaccine is scheduled for Saturday, 08May2021. She was asking if her mother-in-law can get her second dose or if she needs to wait. The patient had the Covid 19 virus test on 21Apr2021 at an urgent care. She reports that some people say if her mother-in-law has had the Covid 19 virus she'll have worse symptoms with the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive for covid also; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that her daughter and she got the first dose of the Pfizer covid 19 vaccine three weeks ago. She stated that three days after getting the shot, her daughter tested positive for covid. She also tested positive for covid. She asked if they do not have symptoms and whether they were able to get the second shot. She had no symptoms and completed isolation. She also stated that she did not consider this an AE, stating that she just got exposed to a relative. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: her daughter tested positive for covid; This is a spontaneous report from a non-contactable consumer (patient's mother). A female patient (daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller stated that she and her daughter got the first dose of the Pfizer covid 19 vaccine three weeks ago. Caller stated that three days after getting the shot, her daughter tested positive for covid on Apr2021. Caller stated she tested positive for covid also. Caller asked if they do not have symptoms were they able to get the second shot. Caller stated she has no symptoms and completed isolation. Caller stated she did not consider this an AE, stating that she just got exposed to a relative. The patient underwent lab tests and procedures which included covid test: positive on Apr2021. The outcome of event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 69-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient started getting rash on "tuesday" so the patient went to doctor and got shingles from it now. Patient was not aware that you could get shingles by talking the Pfizer vaccine. Now patient has an appointment to take the 2nd dose 28th of this month, now the doctor said to call back evidently some time in last 7-10 days, so said to call back on 10th but if the rash does not completely go away so should the patient take the second dose or should wait a little longer to let the body recover. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 19May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 19May2021. Two days later (21May2021) and since then, he has presented dizziness. This dizziness produces a feeling of instability. He has used medications for the dizziness. At times, the symptoms improve but always return. He wanted to know if he should receive the second dose of COVID-19. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: Developer rash at injection sites; small itch and rash/ small bumps develop on her face and arms/ itchy/ diagnosed with pityriasis rosea; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 17:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included known penicillin allergies. No other medical history. The patient previously received first dose of BNT162B2 in left arm on 07Apr2021 17:00 PM. The patient was not pregnant. No other vaccine in four weeks and other medications in two weeks. The patient's concomitant medications were not reported. Developer rash at injection sites on 20May2021 20:00. First started as small itch and rash that wouldn't go away. Almost 3 weeks after getting the final shot (around 20May2021), she saw small bumps develop on her face and arms. The rash at the injection site also seemed to spread. Took antihistamines (24May2021) but would not go away. She went to first doctor and they gave her antibiotics (doxycycline on 25May2021). Did not like the effects that it had on her body so she went to another doctor who gave her steroids (26May2021) Took that for 6 days and bumps on face got considerably worse. They were always itchy but never hurt or looked pus filled. She went to another doctor who gave her a fungal cream (02Jun2021) to put on them and also a recommendation to the dermatologist. She went to dermatologist (04Jun2021) and they diagnosed with pityriasis rosea and gave her acyclovir. This rash was only on her face and along her shoulders where she got the vaccines to her forearms. Still very itchy at the moment. The patient underwent lab tests included COVID-19 Nasal Swab PCR test negative on 25May2021. The event resulted in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment included 1-doxycycline,2-steroids,3- ketoconazol,4-acyclovir and Anti-histamine. No covid prior vaccination. The outcome of events was recovering. Seriousness was reported as non-serious as not resulted in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating or congenital anomaly or birth defect.  Information about lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen bottom lip (left side only); This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jun2021 16:30 (Batch/Lot Number: EW0178) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient received first dose of vaccine BNT162B2 on 14May2021 (at 15 years) for COVID-19 immunization (product=COVID 19, brand=Pfizer, lot number=EW0182, administration time=16:00 PM, dose number=1, vaccine location=Left arm). Concomitant medications included tretinoin (ALTRENO) taken for an unspecified indication, start and stop date were not reported. On 05Jun2021 21:45, the patient experienced swollen bottom lip (left side only). Therapeutic measures were taken as a result of swollen bottom lip (left side only) AE treatment: Benadryl (after call to dr). The outcome of the event was unknown. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  Batch/lot number already provided
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypersensitivity, Migraine
Clinical narrative: experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; allergies; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 02Apr2021 at 18:30 (Batch/Lot Number: ER8730) (at the age of 28-years-old) as second dose, single for COVID-19 immunisation. Medical history neuro-cardiogenic syncope and birth control. Patient has no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) taken for an unspecified indication, start and stop date were not reported and unspecified medication for birth control. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6207) on 12Mar2021 at 18:30 (at the age of 28-years-old) in the right arm for COVID-19 immunization. Patient reported that shortly after receiving second dose, on 06Apr2021, she experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped. Patient stated that this may or may not be a result of the vaccine, but the timing is far too coincidental for her to not report this. Patient had seen her doctor multiple times and no conclusive explanation/diagnoses has been given. Due to the headaches, they had tried antihistamines and decongestants to rule out allergies. Patient tried Motrin and Tylenol with no positive results. Patient also tried natural sleeping aids but none of the symptoms have gotten better. Patient even saw an ophthalmologist to ensure it was not vision related. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events as non-serious. Outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped; allergies; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 02Apr2021 at 18:30 (Batch/Lot Number: ER8730) (at the age of 28-years-old) as second dose, single for COVID-19 immunisation. Medical history neuro-cardiogenic syncope and birth control. Patient has no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) taken for an unspecified indication, start and stop date were not reported and unspecified medication for birth control. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6207) on 12Mar2021 at 18:30 (at the age of 28-years-old) in the right arm for COVID-19 immunization. Patient reported that shortly after receiving second dose, on 06Apr2021, she experienced extreme fatigue, vertigo, dizziness, headaches, and migraines and these symptoms have not stopped. Patient stated that this may or may not be a result of the vaccine, but the timing is far too coincidental for her to not report this. Patient had seen her doctor multiple times and no conclusive explanation/diagnoses has been given. Due to the headaches, they had tried antihistamines and decongestants to rule out allergies. Patient tried Motrin and Tylenol with no positive results. Patient also tried natural sleeping aids but none of the symptoms have gotten better. Patient even saw an ophthalmologist to ensure it was not vision related. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events as non-serious. Outcome of the events was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Jaw clicking, Myalgia, Pulpitis dental
Clinical narrative: I got  the severe inflammation in the root canal of my tooth #18; One of my muscles on the front RIGHT side of my neck was in pain when lightly squeezed.; I got a chomping sound from my Left jaw joint area each time I open my mouth.; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 11:15 (Lot Number: EW0161)  (at age of 49-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included known allergies tequila. 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. Other medications in two weeks: Digest basic Ennzyme dietary supplement. The patient reported "1. I got  the severe inflammation in the root canal of my tooth #18 (same left side where the vaccine was injected) 3 days after the vaccine injection. The root canals in that tooth have been filled 2.5 years before with no problems afterwards. The inflammation was so severe that I had to arrange an emergency visit to my dentist with consecutive visit of the endodontix specialist for the retreatment. 2. One of my muscles on the front RIGHT side of my neck was in pain when lightly squeezed. The symmetrical muscle on the left side of my neck was normal. This effect was gone after one week. 3. I got a chomping sound from my Left jaw joint area each time I open my mouth. This effect persists.". The onset date of the events reported as 19Mar2021. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of event 'severe inflammation in the root canal' was  recovering, of  'One of my muscles on the front RIGHT side of my neck was in pain ' was resolved in May2021, of 'got a chomping sound from my Left jaw joint area each time I open my mouth' was not resolved. This case was reported as non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Choking sensation, Dizziness, Dyskinesia, Fatigue
Clinical narrative: insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown.   Information on lot number/batch number was requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Investigation, Suffocation feeling
Clinical narrative: insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown.   Information on lot number/batch number was requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray, Chest pain, Computerised tomogram, Depression
Clinical narrative: Headache; Extreme body fatigue; Muscle aches; Had difficulty sitting up or lying down unless lying on a hard floor; Felt like I was going to pass out; Heart palpitations; Two panic attacks; Chest pains/Felt like heart attack; Shortness of breath/Felt like heart attack; Increased severe anxiety; Depression; This is a spontaneous report from a contactable Healthcare Professional. A non-pregnant 51-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 29Mar2021 10:15, at 51 years of age, (Batch/Lot Number: ER8733) as single dose, for COVID-19 immunization. Medical history included hyperthyroidism, allergy to shrimp, menopause and allergy to IV dye, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot Number: EN6206) on 08Mar2021 10:00 AM, at 51 years of age, administered in left arm. Concomitant medications included levothyroxine 25 mcg, progesterone and estradiol, all taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine in the previous 4 weeks. She wasn't diagnosed with COVID-19 before vaccination. The patient reported that on 29Mar2021, after the second dose she had severe headache; extreme body fatigue; muscle aches; and had difficulty sitting up or lying down unless lying on a hard floor for the first 3-4 days after vaccine. For 3 weeks she continued to have severe continual headache; extreme body fatigue where if she tried to exercise or simply walk dog or go up flight of stairs she felt like she was going to pass out; she also had heart palpitations and two panic attacks, all of these symptoms lasted 3 weeks after vaccine. She went to the emergency room twice: once for headache and chest pains (as she felt like heart attack); second time it was for shortness of breath, again she felt like heart attack, she had to call for an ambulance. All these instances increased severe anxiety and panic and interfered with her work and daily functioning until 24Apr2021. She then began to feel herself again. However, she was still experiencing anxiety, depression, and panic at times. The patient underwent lab tests and procedures on an unknown date in 2021, which included CT scan, chest X-ray and EKG, with unknown results. The patient was tested for COVID-19 via nasal swab on 23Apr2021, which was negative. The patient was treated with headache medication. The events headache, extreme body fatigue, muscle aches, had difficulty sitting up or lying down unless lying on a hard floor, felt like i was going to pass out, heart palpitations, chest pains and shortness of breath recovered with sequelae on an unknown date, whereas the events two panic attacks, increased severe anxiety and depression had not resolved yet at the time of the report.