chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: I have a large red spot at the injection site that is hot to the touch and very firm; The spot is only slightly raised but very painful; a large red spot at the injection site that is hot to the touch; The day after the shot, it was about the size of a quarter. The day after that it was a bit larger than a half dollar. Since 3 days after the shot, it has been about the size of a baseball.; 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: GW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 18:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones, migraines, sulfa (sulfonamide allergy) and adhesive (adhesive tape allergy). The patient previously received bupropion hydrochloride (WELLBUTRIN) on an unknown date and for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alprazolam (XANAX), trazodone (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), duloxetine hydrochloride (CYMBALTA) and gabapentin (MANUFACTURER UNKNOWN); all started on unknown dates and for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 19:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00 the patient experienced a large red spot at the injection site that was hot to the touch and was very firm. The day after the shot, it was about the size of a quarter. And again, the day after that it was a bit larger than a half dollar. 3 days after the shot, it has been about the size of a baseball. The spot is only slightly raised but very painful. It was reported that it looks very similar to like a COVID arm on online. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a large red spot at the injection site that is hot to the touch and very firm and spot is only slightly raised but very painful were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Transient lingual papillitis
Clinical narrative: Transient lingual papillates; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the left arm on 15Jan2021 at 09:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Jan2021, the patient experienced transient lingual papillates that had been ongoing since January after the first dose. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event transient lingual papillates was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: Skin disorder; Very itchy neck only on the sides and front; Rash on the inside of my right elbow; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The medical history included type 2 diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 20, simvastatin (MANUFACTURER UNKNOWN) 20 and metformin (MANUFACTURER UNKNOWN) 1000 two times a day from unknown dates and for unspecified indications. On an unknown date in Mar2021, the patient experienced skin disorder, very itchy neck only on the sides and front, also rash on the inside of the right elbow. The patient received treatment for the reported events which included unspecified cream on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events skin disorder, very itchy neck only on the sides and front, rash on the inside of right elbow was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 59-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives in succession over all and various parts of the body. One hive at a time which itches briefly and then fades away. Followed by another hive in another part of the body which itches and then fades away. Followed by another..... and repeats.; Hives in succession over all and various parts of the body. One hive at a time which itches briefly and then fades away. Followed by another hive in another part of the body which itches and then fades away. Followed by another..... and repeats.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis. The patient was not sure of known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination  included sertraline (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and multivitamin; all from unknown date for unknown indication. The patient previously took first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 69-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 18Apr2021 at 18:00, the patient experienced hives in succession over all and various parts of the body. One hive at a time which itched briefly and then faded away. Followed by another hive in another part of the body which itched and then faded away. Followed by another..... and repeated. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events hives in succession over all and various parts of the body; one hive at a time which itched briefly and then faded away; followed by another hive in another part of the body which itched and then faded away; followed by another..... and repeated was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Swelling face
Clinical narrative: Swollen face; neck lymph nodes; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient 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 06Apr2021 at 11:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any other medications in two weeks. The patient previously received morphine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 12Apr2021, the patient experienced swollen face, neck lymph nodes and headache. The events resulted in emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen face, neck lymphnodes and headache were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Petechiae
Clinical narrative: straight line of tiny dots on my upper left arm, diagnosed it as petechiae by doctor. Given the location and shape of it; After getting the shot, noticed a super sore arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 12:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. The patient received tetanus vaccine toxoid, diphtheria vaccine toxoid, pertussis vaccine acellular (TDAP) on 30Mar2021 for immunisation within four weeks prior to the vaccination. On 17Apr2021, after getting the shot, the patient only noticed a super sore arm, but she was expecting this. On 18Apr2021 at 18:45, over 24 hours later on Sunday evening, the patient noticed a straight line of tiny dots on upper left arm before she went to took a shower. The patient was alarmed as she had no idea where this would have come from and why it was happened. The patient saw a doctor on Monday afternoon and was diagnosed it as petechiae. Given the location and shape of it, doctor was confused as how it could have happened and mentioned that, having just received the COVID vaccine could have caused this and also mentioned it could be nothing or something serious, just to wait it out and see if goes away or gets worse. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm, tiny dots on upper left arm which was diagnosed as petechiae was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Headache, Nausea, Vomiting
Clinical narrative: Throwing up,; bone aches; nausea; headache; stomach craming; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Apr2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient previously had penicillin for unknown indication on unknown date and experienced penicillin allergy. The patient had received other medication within two weeks of vaccination which included her regular prescriptions for unknown indication on unknown date. 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 19Apr2021 at 09:00, the patient experienced throwing up, bone aches, nausea, headache, stomach craming. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events throwing up, bone aches, nausea, headache, stomach craming was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Around 12 hours after dose injection started to experience shaking; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male 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 19Apr2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methylphenidate hydrochloride (RITALIN) and bupropion (MANUFACTURER UNKNOWN), from an unknown date for unknown indication and unknown if ongoing. 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 29Mar2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021 at 21:00, around 12 hours after dose injection, the patient experienced shaking. The episode only lasted about 15-30 minutes. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of shaking was recovered on 19Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram, Magnetic resonance imaging, Muscle twitching, Oromandibular dystonia
Clinical narrative: Oromandibular dystonia; twitching of left side of face; difficulty speaking; This is a spontaneous report from a contactable consumer (patient) received via regulatory agency.   A 21-year-old non-pregnant female patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 12:30 (Batch/Lot number was not reported) (at the age of 21-year-old) as single dose for COVID-19 immunisation.  Medical history was none. There were no concomitant medications. No known allergies.  The patient has not experienced COVID-19 prior vaccination, the patient has not tested positive since vaccination. On 09Apr2021 at 23:00, the patient experienced twitching of left side of face, difficulty speaking within 24-36 hours after initial injection, dx oromandibular dystonia. The events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unspecified date, the patient underwent lab tests and procedures which included computerized tomogram (CT): unknown result, magnetic resonance imaging (MRI): unknown result.  Therapeutic measures were taken as a result of the events and included CT, MRI, labs, neurology, speech, medication (as reported). The patient outcome of the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Bowel movement irregularity, Fatigue, Headache
Clinical narrative: severe vomiting; abdomen pain / severe intestinal pain; fatigue; swollen lymph nodes; headache; joint/muscle soreness; joint/muscle soreness; disrupted bowel movements; This is a spontaneous report from a contactable consumer (patient).  This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 at 14:15, at the age of 43 years, at single dose, in left arm, for COVID-19 immunisation. Medical history included unspecified auto immune disorder, Hashimoto disease, allergy to minocycline hydrochloride (SOLODYN) and emergency surgery. The patient did not have COVID prior vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN) and polycarbophil calcium (FIBER), HRT and prob. No other vaccine was administered in 4 weeks. The patient had typical symptoms listed that started on 2nd day post shot, on an unspecified date in Mar2021: fatigue, swollen lymph nodes, headache, joint/muscle soreness, etc. Then a week after, on 09Apr2021 at 04:00, she had severe vomiting and abdomen pain. She went to ER with pain and no physical cause (it was only the second time he had ever been to an ER, first resulted in an emergency surgery so this was very unusual for me). Dr said perhaps food poisoning or a virus but she had not been out of house except for vaccine shot and ate same as husband that did not got sick at all (and they were in close proximity so likely not a virus). She had never had this issue before. She experienced 2.5 days vomiting even with nausea medicine and severe intestinal pain and disrupted bowel movements for 4-5 days. The events resulted in Emergency room/department or urgent care. Treatment included pain, anti-spasm and anti-nausea injections + IV. The events resolved on an unspecified date in 2021. COVID was not tested post vaccination.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Vomiting
Clinical narrative: severe vomiting; abdomen pain / severe intestinal pain; fatigue; swollen lymph nodes; headache; joint/muscle soreness; joint/muscle soreness; disrupted bowel movements; This is a spontaneous report from a contactable consumer (patient).  This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 at 14:15, at the age of 43 years, at single dose, in left arm, for COVID-19 immunisation. Medical history included unspecified auto immune disorder, Hashimoto disease, allergy to minocycline hydrochloride (SOLODYN) and emergency surgery. The patient did not have COVID prior vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN) and polycarbophil calcium (FIBER), HRT and prob. No other vaccine was administered in 4 weeks. The patient had typical symptoms listed that started on 2nd day post shot, on an unspecified date in Mar2021: fatigue, swollen lymph nodes, headache, joint/muscle soreness, etc. Then a week after, on 09Apr2021 at 04:00, she had severe vomiting and abdomen pain. She went to ER with pain and no physical cause (it was only the second time he had ever been to an ER, first resulted in an emergency surgery so this was very unusual for me). Dr said perhaps food poisoning or a virus but she had not been out of house except for vaccine shot and ate same as husband that did not got sick at all (and they were in close proximity so likely not a virus). She had never had this issue before. She experienced 2.5 days vomiting even with nausea medicine and severe intestinal pain and disrupted bowel movements for 4-5 days. The events resulted in Emergency room/department or urgent care. Treatment included pain, anti-spasm and anti-nausea injections + IV. The events resolved on an unspecified date in 2021. COVID was not tested post vaccination.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headaches; Fevers; Chills; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021, the patient experienced headaches, fevers, chills and loss of appetite. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab for COVID-19 virus test on 03Apr2021 and 15Apr2021 and tested negative for both. The clinical outcome of the events headaches, fevers, chills and loss of appetite were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient 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 15Apr2021 at 10:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 15Apr2021, the patient experienced muscle spasms at the injection site each day, it came and went but they occur several times each day and multiple spasms per event. The patient did not receive any treatment for the reported event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle spasms at the injection site were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Muscular weakness
Clinical narrative: Feeling lightheaded; Weak all over, especially on legs; Weak all over, especially on legs; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included "pre-diabet", high blood pressure and high cholesterol. The patient was allergic to shellfish. Concomitant medications were not reported. The patient previously received the first dose 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. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Apr2021 at 15:15, the patient was feeling lightheaded, felt weak all over, especially on legs. No therapeutic measures were taken as the result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling lightheaded and weak all over, especially on legs were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient had no known allergies to medications, food, or other products (reported as NKA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the 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 on an unknown date as a single dose for COVID-19 immunisation. On 19Apr2021 at 18:00, the patient experienced sore arm. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Nausea
Clinical narrative: Slight nausea; Arm pain/soreness; Raised red blotch on shot arm; Pins and needles sensation in shot arm; Chills; Sore joints (knees and right hip); Sharp pain at the base of skull on right side behind the ear; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, low blood pressure, pelvic floor dysfunction, pudendal neuralgia and sulfonamide allergy from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took hydrocodone (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and diclofenac sodium (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included paracetamol (TYLENOL), diazepam (VALIUM), cannabis sativa (MARIJUANA), and unspecified multivitamins; 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. On 18Apr2021 the patient experienced slight nausea, arm pain/soreness, raised red blotch on shot arm, pins and needles sensation in shot arm, chills, sore joints (knees and right hip), sharp pain at the base of skull on right side behind the ear and fatigue. The events did not result in doctor or other healthcare professional office/clinic, 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 reported events. The clinical outcome of the events slight nausea, arm pain/soreness, raised red blotch on shot arm, pins and needles sensation in shot arm, chills, sore joints (knees and right hip), sharp pain at the base of skull on right side behind the ear and fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Slight nausea; Arm pain/soreness; Raised red blotch on shot arm; Pins and needles sensation in shot arm; Chills; Sore joints (knees and right hip); Sharp pain at the base of skull on right side behind the ear; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, low blood pressure, pelvic floor dysfunction, pudendal neuralgia and sulfonamide allergy from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took hydrocodone (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and diclofenac sodium (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included paracetamol (TYLENOL), diazepam (VALIUM), cannabis sativa (MARIJUANA), and unspecified multivitamins; 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. On 18Apr2021 the patient experienced slight nausea, arm pain/soreness, raised red blotch on shot arm, pins and needles sensation in shot arm, chills, sore joints (knees and right hip), sharp pain at the base of skull on right side behind the ear and fatigue. The events did not result in doctor or other healthcare professional office/clinic, 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 reported events. The clinical outcome of the events slight nausea, arm pain/soreness, raised red blotch on shot arm, pins and needles sensation in shot arm, chills, sore joints (knees and right hip), sharp pain at the base of skull on right side behind the ear and fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: Swelling and moderate pain under left arm.; Swelling and moderate pain under left arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male 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 15Apr2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) for unknown indication from an unknown date and unknown if ongoing. 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 25Mar2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00, the patient experienced swelling and moderate pain under left arm, which was going on since five days (at the time of reporting). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling and moderate pain under left arm were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: I was walking on a trail and suddenly felt faint began to lose balance.; I was walking on a trail and suddenly felt faint began to lose balance/ I staggered a few steps but was unable to steady myself; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient 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 17Apr2021 at 13:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs (Sulfonamide allergy). Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) all for unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 16:00, the patient was walking on a trail and suddenly felt faint and began to lose balance. The patient staggered a few steps but was unable to steady himself, so stooped down to the ground and sat down for several minutes to recover. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events suddenly felt faint, began to lose balance and staggered a few steps but was unable to steady were recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea
Clinical narrative: Muscle pain; Fatigue/Tiredness; Some nauseous; Joints pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient 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 05Apr2021 at 08:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hepatic steatosis and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included telmisartan (MANUFACTURER UNKNOWN), tadalafil (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 00:00, the patient experienced muscle pain, fatigue, some nauseous, joints pain and tiredness, all the symptoms had continued for 14 days after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, fatigue, some nauseous, joints pain and tiredness were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Loud ringing in both ears; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 31Mar2021 at 10:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to 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 31Mar2021 at 10:15, after second dose of vaccination, the patient experienced loud ringing in both ears which was ongoing. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event loud ringing in both ears was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Felt exhausted and tired; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient 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 09Apr2021 at 10:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and hyoscyamine (MANUFACTURER UNKNOWN); for an unknown indication since an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:30, 24 hours after shot, the patient experienced mild injection site soreness. On 10Apr2021 at 22:30, 36 hours after shot, the patient felt exhausted and tired. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness and felt exhausted and tired was recovered on 12Apr2021, 72 hours after shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland in left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG), insulin degludec (TRESIBA), metformin (MANUFACTURER UNKNOWN), semaglutide (OZEMPIC) and Statin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. On 19Apr2021 at 00:00, the patient experienced swollen gland in left side of neck. Therapeutic measures were not taken as a result of the event. The event 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. The clinical outcome of the event swollen gland in left side of neck was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Sleep disorder
Clinical narrative: I started to get minor heartburn; I was then woke up 4 times each night with major heart burn.; Last night I was awaked 1 time.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 at 14:30 (at the age of 40-year-old) as a single dose. Medical history included depression and penicillin allergy. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, one day later in the evening, the patient experienced minor heartburn. The patient woke up 4 times each night with major heart burn. The patient felt that the only way to sleep without having it was to sleep sitting up. That night the patient was awakened once and took turns for it which helped the patient. The patient also reported that if it would not had been for a weekend she would have gone to her doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events minor heartburn, major heart burn and disturbed sleep was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Achenbach syndrome, Condition aggravated, Nodule, Skin mass
Clinical narrative: Symptoms continued and worsened following the second vaccination.; Achenbach Syndrome; painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally; painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally; This is a spontaneous report from a contactable physician. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) in the right arm on 21Mar2021 at 14:00 (at the age of 65-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) in the right arm on 12Apr2021 at 15:00 (at the age of 66-years-old); both as a single dose for COVID-19 immunisation. Medical history included smoldering multiple myeloma, hyperlipidemia, hypertension, hepatitis c ((treated and cleared in 2019), sickle cell trait, stroke and arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem hydrochloride (CARTIA XT), clopidogrel bisulfate (PLAVIX), docusate sodium (COLACE), ferrous sulfate (MANUFACTURER UNKNOWN), rosuvastatin calcium (CRESTOR) and unspecified multivitamins; all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) for unspecified indication from unknown date and experienced drug allergy. On 25Mar2021, about 4 to 5 days after first vaccination, patient developed painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally. The patient saw a hand specialist and was diagnosed with Achenbach Syndrome. The symptoms continued and worsened following the second vaccination. The patient never had similar symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful dark subcutaneous nodules on the palmar surface of her fingers bilaterally, Achenbach Syndrome, symptoms continued and worsened was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vertigo, Vertigo positional
Clinical narrative: Intense positional vertigo; Fatigue; Mild vertigo, overnight intense h/a, intense vertigo; Overnight intense headache/headache; This is a spontaneous report from a contactable physician, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 13Apr2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to seaweed and cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 23Mar2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient previously took tramadol (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 21:30, evening day 3, the patient experienced mild vertigo, overnight intense headache and intense vertigo Saturday (17Apr2021)- intense positional vertigo with h/a and fatigue lasted 36hours. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event vertigo, intense positional vertigo with headache and fatigue were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.