chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Pain in extremity
Clinical narrative: heat sensation in my right arm from my wrist to my elbow; sore arm; unusual feeling; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9264, expiry date not reported), via an unspecified route of administration, administered in right arm on 01Feb2021 05:15 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. Medical history included primary adrenal insufficiency from an unknown date and unknown if ongoing, and hypothyroidism from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and of the report. Concomitant medications included hydrocortisone, fludrocortisone, levothyroxine sodium, vitamin c [ascorbic acid], colecalciferol (VITAMIN D), calcium citrate, cetirizine hydrochloride (ZYRTEC), and fish oil, all taken for an unspecified indication, start and stop date were not reported. The patient previously took cefatrizine propyleneglycolate (CEFTIN) and cefaclor (CECLOR), and experienced known allergies to them.  The patient had no other vaccine in four weeks. On 03Feb2021 at 11:30 AM, the patient had heat sensation in right arm from wrist to elbow, and a sore arm and no other symptoms with either dose 1 or 2, except with dose 1, at day 3. It was on and off for 4 days. It was an unusual feeling since 03Feb2021 at 11:30 AM, but patient didn't require pain meds. The patient did not require any treatments in response to the events. The patient had no covid prior vaccination and was not tested for covid post vaccination. It was mentioned that the patient had the second dose of BNT162B2 (lot EL6202) on 23Feb2021 as covid 19 immunisation administered in the right arm. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 17Feb2021 (at the age of 74 years old) (Lot Number: EL9266; Expiration Date: 31May2021) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. The patient received no treatment for the event. The patient informed that she was just trying to reschedule her appointment for her second dose. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: she has taken her second shot and her arm has red to it where she got her shot; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration, in the arm, on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she has taken her second shot and her arm has red to it where she got her shot on an unspecified date. She clarified the product was Pfizer. She also inquired what to put on it if it gets worse as it was just a little red. She also stated that she will just call her doctor and ask her doctor what they put on it. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: My legs are swollen all way up to my hip; They are twice as big as they should be; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Feb2021 01:00 (Lot Number: EM9809) (at the age of 81 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included high blood pressure and cholesterol. Concomitant medications included simvastatin (10 mg strength), taken an unspecified indication, and hydrochlorothiazide;triamterene (TRIAMTERENE HCTZ, 25mg/5mg strength), taken for hypertension. The patient previously received the 1st dose of a COVID-19 Vaccine (MANUFACTURER UNKNOWN) for COVID-19 immunisation. The patient experienced "my legs are swollen all way up to my hip; they are twice as big as they should be" on 26Feb2021. When the patient came home at around 3 or 3:30, the patient went to the bathroom. When the patient pulled down her pants, the patient noticed that her legs were super swollen but doesn't hurt. The patient was not taking anything for the events and was keeping her legs elevated up over the heart, hoping that the swelling would go down. The patient has not undergone any lab tests as she canceled all her appointments with the doctor due to the virus. The patient has not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Neck pain, Pain
Clinical narrative: achy; tired; achy in her shoulders, neck and arms and back; achy in her shoulders, neck and arms and back; achy in her shoulders, neck and arms and back; shooting pains in her calf and feet; regular sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in the left arm on 04Feb2021, at 09:00 (at the age of 78 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing arthritis (being treated for her shoulder and right arm), high blood pressure, low thyroid, high cholesterol (under control), and factor 5. The patient reported that both of her parents died of cancer. Concomitant medications included high blood pressure medicine (taking for about 3 years), thyroid medicine (has been taking it many years), and cholesterol medicine (taking half of it, has been taking it for about a year). It was reported that the patient did not receive any other vaccines within four weeks prior to vaccination. The patient previously received shingles and flu shot on an unspecified date for immunisation with no side effects. The patient reported that she has had different symptoms from what other people have said. On 04Feb2021, the patient experienced regular sore arm. At 21:00, she experienced achy, tired, achy in her shoulders, neck and arms and back, and shooting pains in her calf and feet. The clinical course was as follows: On 04Feb2021, the patient has had the regular sore arm, tired which was normal. At 21:00, the patient took a paracetamol (TYLENOL) because of the aching in her arm shoulders and back. She said that she normally uses a heating pad because she has arthritis. The patient said that an hour after that she had shooting pains in her calf and feet she thought it was electrical shocks from heating pad, it lasted for about 2.5 hours. She used the heating pad for back. The patient said she was achy in her shoulders, neck and arms and back. The patient was unable to clarify if she has recovered completely or recovered with lasting effects, she said its better but she was still really tired. The patient stated that she got the vaccine at 9:00 and all of the symptoms started at 9pm on 04Feb2021, except for the sore arm, which started earlier. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: achy; tired; achy in her shoulders, neck and arms and back; achy in her shoulders, neck and arms and back; achy in her shoulders, neck and arms and back; shooting pains in her calf and feet; regular sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in the left arm on 04Feb2021, at 09:00 (at the age of 78 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing arthritis (being treated for her shoulder and right arm), high blood pressure, low thyroid, high cholesterol (under control), and factor 5. The patient reported that both of her parents died of cancer. Concomitant medications included high blood pressure medicine (taking for about 3 years), thyroid medicine (has been taking it many years), and cholesterol medicine (taking half of it, has been taking it for about a year). It was reported that the patient did not receive any other vaccines within four weeks prior to vaccination. The patient previously received shingles and flu shot on an unspecified date for immunisation with no side effects. The patient reported that she has had different symptoms from what other people have said. On 04Feb2021, the patient experienced regular sore arm. At 21:00, she experienced achy, tired, achy in her shoulders, neck and arms and back, and shooting pains in her calf and feet. The clinical course was as follows: On 04Feb2021, the patient has had the regular sore arm, tired which was normal. At 21:00, the patient took a paracetamol (TYLENOL) because of the aching in her arm shoulders and back. She said that she normally uses a heating pad because she has arthritis. The patient said that an hour after that she had shooting pains in her calf and feet she thought it was electrical shocks from heating pad, it lasted for about 2.5 hours. She used the heating pad for back. The patient said she was achy in her shoulders, neck and arms and back. The patient was unable to clarify if she has recovered completely or recovered with lasting effects, she said its better but she was still really tired. The patient stated that she got the vaccine at 9:00 and all of the symptoms started at 9pm on 04Feb2021, except for the sore arm, which started earlier. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: not feeling well; very sick right now; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well and very sick right now. The reporter was asking if the patient can take Tylenol or is there anything else to help her feel better. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Vomiting
Clinical narrative: vomiting / She has vomited five times since then; Chills; Really sick; Started feeling tired; This is a spontaneous report from two contactable consumers (patient included). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EM9809; Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:30 as dose 2, single for COVID-19 immunisation. The patient was okay for about four hours after receiving the second Pfizer shot and then experienced started feeling tired and went to bed on 25Feb2021. The patient woke up at about 12:00 AM, 26Feb2021 and experienced vomiting, she has vomited five times since then. The patient was experiencing vomiting and chills, was very tired and was really sick (reported that she doesn't known what to do) on 26Feb2021. The reporter wanted to know if this was normal. The outcome of the events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: A lot more fatigued; Ringing in his right ear; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Feb2021 (at the age of 41 years old) (Lot Number: EN6201) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Jan2021 (at the age of 41 years old) for COVID-19 immunisation and experienced pain, redness, swelling, itching, and rash. On an unspecified date, the patient experienced a lot more fatigued and ringing in his right ear. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt terrible; This is a spontaneous report from a contactable consumer (patient's cousin). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the second dose of the vaccine and felt terrible. The patient's cousin asked how she can know if the vaccine is working. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Libido decreased
Clinical narrative: significant decrease in libido, as in nearly nonexistent libido; This is a spontaneous report from a contactable pharmacist (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Feb2021, at 17:00 (Lot Number: EN6198; at the age of 28 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient took Chinese herbs from acupuncturist within two weeks of vaccination. He did not receive any other vaccines within four weeks prior to vaccination. The patient previously received the first dose of BNT162B2, administered in the left arm on 24Jan2021, at 13:15 (Lot Number: EL9262; at the age of 28 years old) for COVID-19 immunisation. On 22Feb2021, the patient experienced noticeably significant decrease in libido, as in nearly nonexistent libido. Began day after dose 2 of vaccine was administered. Noticed 48 hours after receiving vaccine. Has not reversed in 96+ hours. The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient has not recovered from the event.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233930 same reporter, same suspect product, similar event
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick after the second dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got really sick after the second dose 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. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021215875 Same reporter/drug diffrent patient
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: vomiting; sicker than a dog; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. She previously received the first dose on unspecified date for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient took the second dose and she was in a hospital vomiting. She's sicker than a dog. Outcome of events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 99.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Confusional state, Electrocardiogram, Visual impairment
Clinical narrative: serious vision problem; the biggest problem is complete feeling of confusion, which is not normal for him at all. It has been 8 days, and it's not much better.  He had  a CT scan; This is a spontaneous report from a contactable consumer or other non hcp. A 99-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 13:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history was none. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not have any allergies. Concomitant medication(s) included potassium (POTASSIUM) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On 25Feb2021, at 02:00, the patient experienced serious vision problem (visual impairment) and the biggest problem is complete feeling of confusion, which is not normal for him at all. it has been 8 days, and it's not much better. he had a ct scan (confusional state). The patient had a CT scan which was normal, but he does not know where anything is and is totally disoriented. He was told this would pass in a week's time, but it hasn't. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result, computerised tomogram: normal, electrocardiogram: unknown result. Therapeutic measures were taken as a result of serious vision problem (visual impairment) and the biggest problem is complete feeling of confusion, which is not normal for him at all. it has been 8 days, and it's not much better. The clinical outcome for the events was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Vaccination site discomfort
Clinical narrative: just minor discomfort at the injection site; Queasy; Headache; Malaise; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Feb2021, at the age of 70-years-old, (Lot Number: EL9266) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose 1 of BNT162B2, lot number: EN5318. On 25Feb2021, the patient experienced queasy, headache, and malaise. The patient had minor discomfort at the injection site on an unspecified date. The outcome of the event minor discomfort at the injection site was unknown; while the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise
Clinical narrative: has not been feeling well; has been laying around with no energy; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date, at the age of 68-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient stated that she had the first Pfizer shot has not been feeling well, that she has been laying around with had no energy. The patient wanted to know if she can get the Johnson shot, if it is okay to switch or if she has to get the second Pfizer shot. Stated that she has an appointment for her second shot next week. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a sponsored program. A non-contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified, the patient experienced arm soreness. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold; Headaches; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunisation. Medical history included tested positive for covid from 08Jan2021. Concomitant medications were not reported. The patient had his first shot yesterday 25Feb2021. He tested positive for covid last 08Jan2021 and today, 26Feb2021, he had a cold, headaches, and he felt like he had Covid. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia, Fatigue, Influenza like illness, Pain, Urine analysis
Clinical narrative: strange pink or dark tinge urine; Normal Fatigue; Aches; flu like symptoms; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received unknown dose number of BNT162B2 (Covid 19 vaccine), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced the normal fatigue, aches, flu like symptoms for 2 or 3 days. She had strange pink or dark tinge urine. After week, had urine test, all was normal. Events took place after use of product. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Gastrointestinal discomfort; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202, Expiration Date: Jun2021), via an unspecified route of administration, on 26Feb2021 (at the age of 88 years), as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was administered the second dose of Pfizer COVID-19 vaccine on 26Feb2021. Starting today, 01Mar2021 around 11:30 (about 70 hours after the patient was administered the vaccine), she had onset of gastrointestinal discomfort. The patient's daughter asked if there have been any late adverse events reported like gastrointestinal discomfort with the vaccine. Gastrointestinal discomfort was described as being generalized, abdominal discomfort with no nausea and no diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes under arm are super swollen and painful; Lymph nodes under arm are super swollen and painful; Headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198, Expiration Date: Jun2021), via an unspecified route of administration in left arm, on 27Feb2021 at 11:00 (at the age of 43 years), as dose 2, 0.3 mL, single, for COVID-19 immunization. The patient's medical history included asthma (diagnosed around 5 years old) and polycystic ovarian syndrome (PCOS; diagnosed at 23); both were ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EN9581) on 06Feb2021 (at the age of 43 years) for COVID-19 immunization (right arm). The patient was calling about the COVID-19 vaccine and reported that she had the vaccine second dose and her lymph nodes under arm are super swollen and painful since 28Feb2021. The patient also has a pretty bad headache that started coming on the afternoon one day before reporting (28Feb2021) and has gotten worse at the day of reporting. The conditions worsened at the day of reporting. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oedema peripheral, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling under her arm, it is like a sack of fluid; Little bit of burning under her left arm; Injection site painful; Swelling of injection site; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6203, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 26Feb2021 at 14:30 (at the age of 57 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included leukemia (treated in 2003 with chemotherapy) and asthma from 1990 (diagnosed as an adult). The patient's concomitant medication included salbutamol (ALBUTEROL) for asthma. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient just got first Pfizer vaccine on Friday, 26Feb2021. On 26Feb2021, the patient experienced swelling of injection site. Today (01Mar2021), the patient was noticing she has some swelling under her arm, it is like a sack of fluid and a little bit of burning under her left arm. The injection site is a little swollen but not as painful today (01Mar2021). The patient asks if she should be concerned. The patient had not recovered from the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea 4-5 hours post vaccine; arm pain next day; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Mar2021 at 02:00 (at the age of 72 years old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation in the pharmacy. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the event and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID-19 prior to vaccination. On 03Mar2021, the patient experienced nausea 4-5 hours post vaccine and arm pain next day (04Mar2021). No treatment was received for the events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Migraine, Nausea, Pyrexia
Clinical narrative: Severe swelling at injection site; fever; nausea; vomiting; migraine; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), autism spectrum disorder, attention deficit hyperactivity disorder (ADHD) and allergies to penicillin and latex. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), sertraline hydrochloride (ZOLOFT), clonidine (MANUFACTURER UNKNOWN) and ethinylestradiol, norethisterone (NECON 35); all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 23-year-old) as a single dose for COVID-19 immunization, previously received Sulfur on unknown date and experienced allergy. 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. On 04Apr2021, at 00:00 the patient experienced Severe swelling at injection site, fever, nausea, vomiting, migraine, fatigue and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event Severe swelling at injection site, fever, nausea, vomiting, migraine, fatigue and swollen lymph nodes was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter information (MD captured as suffix), Patient Email address updated, Concomitant medication (ADDERALL updated to ADDERALL XR, NECON updated to NECON 35), updated narrative ("ADHD" updated to "attention deficit hyperactivity disorder (ADHD)", "as a single dose for COVID-19 immunisation and Sulfur on unknown date and experienced allergy" updated to "as a single dose for COVID-19 immunisation, previously received Sulfur on unknown date and experienced allergy").
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Severe swelling at injection site; fever; nausea; vomiting; migraine; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), autism spectrum disorder, attention deficit hyperactivity disorder (ADHD) and allergies to penicillin and latex. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), sertraline hydrochloride (ZOLOFT), clonidine (MANUFACTURER UNKNOWN) and ethinylestradiol, norethisterone (NECON 35); all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 23-year-old) as a single dose for COVID-19 immunization, previously received Sulfur on unknown date and experienced allergy. 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. On 04Apr2021, at 00:00 the patient experienced Severe swelling at injection site, fever, nausea, vomiting, migraine, fatigue and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event Severe swelling at injection site, fever, nausea, vomiting, migraine, fatigue and swollen lymph nodes was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter information (MD captured as suffix), Patient Email address updated, Concomitant medication (ADDERALL updated to ADDERALL XR, NECON updated to NECON 35), updated narrative ("ADHD" updated to "attention deficit hyperactivity disorder (ADHD)", "as a single dose for COVID-19 immunisation and Sulfur on unknown date and experienced allergy" updated to "as a single dose for COVID-19 immunisation, previously received Sulfur on unknown date and experienced allergy").
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, headaches, vomiting, diarrhea, body aches; Headache; Vomiting; Diarrhea; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00(at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was 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 COVID vaccine. On 07Apr2021 at 08:00, the patient experienced fever, headaches, vomiting, diarrhea and body aches. The patient did not receive any treatment for the events. The clinical outcome of the event fever, headaches, vomiting, diarrhea and body aches were recovering.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient email address added and updated narrative ("The patient did not receive any medication within two weeks of vaccination" deleted and Final sentence updated to "No follow-up attempts are possible. No further information is expected").
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Pain, Pyrexia
Clinical narrative: Fever; Whole body aches; Head is splitting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: Ew0150) via an unspecified route of administration in the arm left on 06Apr2021 at 15:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient did not receive any medication within two weeks of vaccination. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EM6950 ) via unspecified route of administration on 13Mar2021 at 10:00 as a single dose for COVID-19 immunisation. On 07Apr2021 at 02:00, the patient felt head was splitting, fever, chills, whole body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the events occurred. The clinical outcome of the events head was splitting, fever, chills, whole body aches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: RMH (Age and units added for Historical Vaccine), Suspect drug detail (Vaccination Facility Country added), event detail (event coding updated for event Head is splitting).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Limb injury, Retching, Tremor
Clinical narrative: Uncontrollable shaking for about 30-45 minutes; Dry Heaves (vomiting, but nothing coming out); Freezing; Hands and feet hurt; Massive Headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 50-years-old), as dose 2, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omega-3-acid ethyl ester (LOVAZA), simvastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8750) via an unspecified route of administration in the left arm on an unknown date as dose 1, single for COVID-19 immunisation. On 21Apr2021 at 02:00, the patient experienced uncontrollable shaking for about 30-45 minutes. The patient had dry heaves (vomiting, but nothing coming out), freezing and when finally warmed up, hands and feet hurt and massive headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events uncontrollable shaking for about 30-45 minutes was resolved on 21Apr2021 and dry heaves (vomiting, but nothing coming out), freezing, hands and feet hurt and massive headache was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine facility information added
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: 102.6 temp; Fatigue; Swollen glands; Slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included omeprazole (PRILOSEC), biotin (MANUFACTURER UNKNOWN), loratadine (CLARITIN) all from an unknown date for an unspecified indication, birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. 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. On 04May2021 at 00:00 the patient experienced 102.6 temp, fatigue, swollen glands, slight nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events 102.6 temp, fatigue, swollen glands, slight nausea was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data (units for Body temperature "Units: {DF}" removed), event detail (Treatment received updated as No for all events), updated narrative ("The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events." added).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever  (101.7 F).; chills; This is a spontaneous report from a contactable pharmacist. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 30Apr2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medications received within two weeks of vaccination was not available. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 09Apr2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. 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. On 30Apr2021, the patient underwent body temperature check and the result was 101.7 F. On 30Apr2021, the patient experienced fever (101.7 F) and chills. The fever continued the next day. The fever and chill occurred again the following night. Therapeutic measures were taken as a result of fever and chills and included treatment with ibuprofen (MANUFACTURER UNKNOWN) from an unknown date. The clinical outcome of the events of  fever and chills was recovered on an unknown date. The patient had "Not reported" allergies to medications, food, or other products. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data (new date added, unit added, result update to "unknown result on 30Apr2021, 101.7 F on 01May2021"), updated narrative ("The patient had "Not reported" allergies to medications, food, or other products. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care" added and events recovery date (May2021) removed).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Fever 100.4; chills; muscle aches; nausea; tired; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old-non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04May2021 at 11:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and gluten sensitivity. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021, the patient underwent PCR test and the result was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. On 05May2021, the patient underwent temperature check and the result was 100.4 with unspecified units. On 05May2021 at 00:00, the patient experienced fever 100.4, chills, muscle aches, nausea and tiredness. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events of fever, chills, muscle aches, nausea and tiredness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data (result updated for Body temperature as 100.4), Event details (Treatment received selected as No for all events), updated narrative (The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events).