chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inspiratory capacity decreased, Painful respiration, Productive cough
Clinical narrative: Diminished capacity to draw a full breath; Mild discomfort with deep breathing; Productive cough; This is a spontaneous report from a contactable other healthcare professional, the patient. This 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose 1, single dose via intramuscular route of administration in the right arm on 06Jan2021 at 09:45 AM (at the age of 24 years-old) for COVID-19 vaccination. Relevant medical history included attention deficit disorder and allergy to non steroidal anti-inflammatory drugs .  Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYNASE). The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021 at 06:00 AM, the patient had diminished capacity to drawa full breath that started 12 days after vaccine date and has persisted. mild discomfort with deep breathing, productive cough. Laboratory tests included negative COVID polymerase chain reaction (PCR) tests (nasal swab) on 19Jan2021 and on an unknown date. The clinical outcome of diminished capacity to draw a full breath, mild discomfort with deep breathing and productive cough was not recovered. There was no treatment received for the events.  It was also reported that since the vaccination, the patient had been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: pulled a muscle in her back/ strained her back; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on Tuesday 19Jan2021, at 66-year-old. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. She stated that on 20Jan2021, Wednesday, she pulled a muscle in her back. She had strained her back and it had nothing to do with the vaccine. On Thursday, 21Jan2021, she went to the doctor and received a ketorolac tromethamine (TORADOL) injection and a triamcinolone acetonide (KENALOG) (steroid) injection to help with her back. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Lymphadenopathy, Paraesthesia, Peripheral swelling
Clinical narrative: swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm tingling to fingers; very uncomfortable; Right armpit discomfort; This is a spontaneous report from a contactable healthcare professional (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), intramuscular in the right arm on 20Jan2021 at 10:00 (at the age of 48-years-old) as a single dose for Covid-19 immunization. Medical history included central nervous system disorder (CIS) from an unknown date. The patient did not have any allergies to medications, food or other products. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140) on 30Dec2020 in the right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 18:00, the patient experienced right armpit discomfort. On 22Jan2021 the patient experienced swollen armpit lymph nodes and upper right arm leaving the right arm tingling to fingers and very uncomfortable. Therapeutic measures were not given for the events. The clinical outcome of the events axillary pain, lymphadenopathy, peripheral swelling, paresthesia and discomfort was not recovered. It was reported that since the vaccination (dose 1), the patient had been tested for COVID-19 via a PCR nasal swab on 19Jan2021 with a negative result.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: swollen armpit lymph nodes and upper right arm; swollen armpit lymph nodes and upper right arm; arm tingling to fingers; very uncomfortable; Right armpit discomfort; This is a spontaneous report from a contactable healthcare professional (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), intramuscular in the right arm on 20Jan2021 at 10:00 (at the age of 48-years-old) as a single dose for Covid-19 immunization. Medical history included central nervous system disorder (CIS) from an unknown date. The patient did not have any allergies to medications, food or other products. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140) on 30Dec2020 in the right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021 at 18:00, the patient experienced right armpit discomfort. On 22Jan2021 the patient experienced swollen armpit lymph nodes and upper right arm leaving the right arm tingling to fingers and very uncomfortable. Therapeutic measures were not given for the events. The clinical outcome of the events axillary pain, lymphadenopathy, peripheral swelling, paresthesia and discomfort was not recovered. It was reported that since the vaccination (dose 1), the patient had been tested for COVID-19 via a PCR nasal swab on 19Jan2021 with a negative result.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Limb discomfort, Pain
Clinical narrative: Severe body aches; headache; heavy feeling injection arm unable to lift it; cough; exhaustion; This is a spontaneous report from a contactable nurse (the patient).  A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1284), via an unspecified route of administration in the left arm on 03Jan2021 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunization. Medical history included Crohn's disease and migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: azathioprine sodium (IMURAN), propranolol, and sertraline hydrochloride (ZOLOFT).  The patient previously took and had allergies to infliximab (REMICADE) and morphine. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 04Jan2021 07:00, the patient experienced severe body aches, headache, heavy feeling injection arm unable to lift it, cough, and exhaustion. The patient did not receive any treatment for these events. The clinical outcome severe body aches, headache, heavy feeling injection arm unable to lift it, cough, and exhaustion was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Paraesthesia, Psoriasis
Clinical narrative: pins and needles in the feet, toes, bottom of the feet; it's just uncomfortable and the bottom of my feet; My wife says it can be Psoriasis; This is a spontaneous report from a contactable consumer (patient). A 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination, the patient park the car and all of a sudden he started to get like pins and needles they used to call in old days in his feet, in his toes. Last time he had this something like this years ago, he sat in the car too long. So, he loosen up his snickers and all and sat there, everything else was all right, a lady came over 15 minutes later and she said okay they can go. So the patient said he got some pins and needles in his feet, before he said the lady said "huh, are you having trouble breathing or anything", the patient said no he felt fine. So let they go home, and then the patient went home it's at night when he was laying down he didn't get much reaction and all. So he went up to the doctor she looked at up a few things and opened few things and the patient didn't think the doctor really had an answer for it. It was scheduled to go Monday again for the second it was still there. The patient didn't know it was probably kind of nerve reaction and all and his wife said it could be psoriasis, he never had this, it was not aggravating it's only when he walked he forgot he even had it . It's just uncomfortable and the bottom of his feet. He never had any reaction to any shot whether it was shingles or pneumonia, flu shots or whatever. The outcome of events was unknown.    Information on the batch number/lot number  has been requested
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine.  Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Pyrexia
Clinical narrative: fever; "stopped up" difficult to breathe with mask; "stopped up" difficult to breathe with mask; This is a spontaneous report from a contactable Other HCP reporting for self. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a fever and is "stopped up" difficult to breathe with mask. Outcome of events was unknown. Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; fatigue; back pain; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient age at vaccination was 50 years old. The patient medical history and concomitant medications were not reported.  Patient experienced fatigue and back pain. Patient also experienced shortness of breath and used salbutamol (ALBUTEROL). Stated she used the "machine you put the stuff in". Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave the vaccine; This is a spontaneous report from a contactable Nurse (self). A 65-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 (at 65 years of age), as single dose for COVID-19 immunisation.  Medical history was lung disease, scar tissue in lungs and Sarcoidosis. Concomitant medication was not reported. After reading the documents she realized the second dose should be scheduled 21 days after first dose. Her schedule for the second dose is 28 days after the first dose. The patient experienced "Yesterday evening (22Jan2021) when I raised my arms up there was soreness (3-4 times in an hour or 2-hour period) where they gave the vaccine."  Outcome of event "When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave the vaccine" was unknown.    The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: sore neck; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On 22Jan2021, an hour after receiving vaccination the patient experienced sore neck, just on the right side. The soreness was still there. The clinical outcome of the event sore neck was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue
Clinical narrative: caller coughing, clearing her throat; shortness of breath; feeling extremely tired; This is a spontaneous report from a contactable consumer via the Medical Information Team. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing throat discomfort. The patient's concomitant medications were not reported. It was reported that the patient was experiencing symptoms of feeling extremely tired and shortness of breath; both on 23Jan2021. It was also reported that the patient was coughing. The outcome of the event shortness of breath was not recovered, recovering for tired while unknown for coughing.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Heart rate increased
Clinical narrative: metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient).  A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization.  Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Muscle fatigue
Clinical narrative: sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Musculoskeletal stiffness, Terminal insomnia, Vaccination site pain
Clinical narrative: lower back muscle twitching; At 20Jan2021 04:30 woke up with his left lower back muscle twitching; back and neck stiffness; soreness in left arm (injection arm); This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL8982), via an unspecified route of administration at Arm Left on 19Jan2021 08:45 at the 65 years old at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. At 19Jan2021 13:45 the patient experienced soreness in left arm (injection arm) and took 800 mg Motrin. At 19Jan2021 20:00 developed back and neck stiffness. Took another dose of Motrin. At 20Jan2021 04:30 woke up with his left lower back muscle twitching. He felt back asleep and woke up at 20Jan2021 8:00 will all symptoms resolved. The outcome of the events soreness in left arm, back and neck stiffness, lower back muscle twitching was recovered on 20Jan2021 08:00, the event woke up was recovered on 20Jan2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: My arm I can barely move it, it's really painful; My arm I can barely move it, it's really painful; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 23Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got the first dose on 23Jan2021 and patient arm can barely move it and just wanted to know if she can take Ibuprofen, I mean it was really painful. It was also described as "My arm I can barely move it, it's really painful". The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin burning sensation, Vaccination site pain
Clinical narrative: her left arm is still sore at the injection site; an area about "a quarter of an inch" was burning on the left side of her arm; entire arm felt like it was going to fall off "it was so sore"; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Jan2021  as a single dose in the left arm for COVID-19 immunization. Medical history included a tooth had been bothering her from an unknown date and was ongoing. Concomitant medications were not reported. In Jan2021 (since her first vaccination), the patient experienced her left arm was still sore at the injection site, an area about "a quarter of an inch" was burning on the left side of her arm and on Saturday her entire arm felt like it was going to fall off "it was so sore". The clinical outcome of the events vaccination site pain, skin burning sensation and pain in extremity was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling cold, Nausea
Clinical narrative: bad nausea; diarrhea; chills; feels very cold; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 79, unit: unspecified) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bad nausea, diarrhea, chills and felt very cold on an unspecified date. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on R side of neck; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 (10:00) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines and penicillin allergy. There were no concomitant medications. The patient previously took chlorhexidine gluconate (HIBICLENS), and had drug allergy. The patient was not pregnant at the time of vaccination. On 23Jan2021 (16:00), the patient had swollen lymph node on the right (R) side of the neck. The patient did not receive any treatment for the reported event. The outcome of the event, swollen lymph node on the right side of the neck, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: marginal pain 3 inches below the injection site/arm sore; This is a spontaneous report from a contactable Other Health Professional (patient). A 65-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: FL9263), intramuscularly on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medication included metformin for type 2 diabetes and rosuvastatin for unknown indication. Patient reported marginal pain 3 inches below the injection site as his only side effect. His arm was sore, a little late last night. Maybe later last night (22Jan2021), so maybe 8 hours after the injection. Patient meant the injection was painless. Patient stated, "A little bit. It's not that bad, it's better, it is improved." Treatment included "Ice pack". His second dose was scheduled for 19Feb2021, 4 weeks after the first dose. Patient had COVID-19 test on unknown date and was negative. Outcome of the event was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: the following morning low grade temp; chills; I also had areas of pain in my spine; I also had areas of pain in my spine, lower back; the pain( a dull ache) radiated over to both sides of my kidneys off and on; I was sweaty and fatigued; I was sweaty and fatigued; joint pains; My right Arm was sore at injection site/real bad arm soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 21Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, patient received her 1st vaccine dose and her right arm was sore at injection site. Then the following morning (22Jan2021) she had low grade temp and chills and real bad arm soreness. She also had areas of pain in her spine, lower back and the pain (a dull ache) radiated over to both sides of her kidneys off and on, on 22Jan2021. She took Advil and felt better. That night (22Jan2021) she woke up during the night with the chills really bad and had a low grade temp and she was sweaty and fatigued. Felt ok most of the day yesterday (22Jan2021), some joint pains. She went to sleep last night and woke up because of chills, low grade temp and aching in my spine again. Woke up later last night and she was sweaty. Today, she was doing fine and took some Advil this morning. Patient was nervous about taking the second dose because of the symptoms she was having because she experienced these side effects. She wanted to know if it will be worse with the 2nd shot. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Renal pain, Spinal pain, Vaccination site pain
Clinical narrative: the following morning low grade temp; chills; I also had areas of pain in my spine; I also had areas of pain in my spine, lower back; the pain( a dull ache) radiated over to both sides of my kidneys off and on; I was sweaty and fatigued; I was sweaty and fatigued; joint pains; My right Arm was sore at injection site/real bad arm soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 21Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, patient received her 1st vaccine dose and her right arm was sore at injection site. Then the following morning (22Jan2021) she had low grade temp and chills and real bad arm soreness. She also had areas of pain in her spine, lower back and the pain (a dull ache) radiated over to both sides of her kidneys off and on, on 22Jan2021. She took Advil and felt better. That night (22Jan2021) she woke up during the night with the chills really bad and had a low grade temp and she was sweaty and fatigued. Felt ok most of the day yesterday (22Jan2021), some joint pains. She went to sleep last night and woke up because of chills, low grade temp and aching in my spine again. Woke up later last night and she was sweaty. Today, she was doing fine and took some Advil this morning. Patient was nervous about taking the second dose because of the symptoms she was having because she experienced these side effects. She wanted to know if it will be worse with the 2nd shot. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Inappropriate schedule of product administration, Malaise
Clinical narrative: Injection site pain; headache; muscle pain; Joint pain; chills; fever (100.9-103.6); feeling very unwell.; first dose was given on 04Jan2021 and the second was on 21Jan2021; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: GL3302, expiration date was not reported), via an unspecified route of administration on 21Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included vilazodone hydrochloride (VIIBRYD), quetiapine, and mirtazapine (MIRTAZEPINE TEVA). She was not pregnant. She had no known allergies. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: EJ1685) on 04Jan2021 in the left arm when the patient was 31-years old for COVID-19 immunization. The patient had no any other vaccine in four weeks prior covid vaccine. The patient had no covid prior vaccination. She was not tested for covid post vaccination. The patient experienced injection site pain, headache, muscle pain, joint pain, chills, fever (100.9- 103.6), and feeling very unwell, all on 21Jan2021 10:00 PM with outcome of recovered on an unknown date in 2021. It was reported that the first dose was given on 04Jan2021 and the second was on 21Jan2021. No treatment received for the events.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; headache; muscle pain; Joint pain; chills; fever (100.9-103.6); feeling very unwell.; first dose was given on 04Jan2021 and the second was on 21Jan2021; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: GL3302, expiration date was not reported), via an unspecified route of administration on 21Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included vilazodone hydrochloride (VIIBRYD), quetiapine, and mirtazapine (MIRTAZEPINE TEVA). She was not pregnant. She had no known allergies. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: EJ1685) on 04Jan2021 in the left arm when the patient was 31-years old for COVID-19 immunization. The patient had no any other vaccine in four weeks prior covid vaccine. The patient had no covid prior vaccination. She was not tested for covid post vaccination. The patient experienced injection site pain, headache, muscle pain, joint pain, chills, fever (100.9- 103.6), and feeling very unwell, all on 21Jan2021 10:00 PM with outcome of recovered on an unknown date in 2021. It was reported that the first dose was given on 04Jan2021 and the second was on 21Jan2021. No treatment received for the events.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain
Clinical narrative: Pain; knee swelling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, and knee swelling after getting the first dose of the vaccine on an unspecified date. Outcome of the events was unknown.  Information about Lot/ Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: skin disease; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (wife) reported that the husband (male) patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  It was reported that yesterday (in Jan2021), her husband was prescribed with cefalexin (KEFLEX) for a skin disease not in relation to the vaccine for 4 times a day for 5 days straight. The wife asked it would be ok to take cefalexin on top of the COVID 19 vaccine. Outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch cannot be obtained.; Sender's Comments: The event skin disease is likely intercurrent and is unrelated to suspect drug BNT162B2.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Polymerase chain reaction, Pyrexia
Clinical narrative: Fever of 101 at around 4:30 Temp did not go under 100.4 until 18Jan2021; severe fatigue; joint pain; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK4176), intramuscular in the left arm on 07JAN2021 at 08:15 as a single dose, for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a Hospital  Past drug allergy includes drug hypersensitivity to Avelox, Naprosyn, and ibuprofen. Relevant medical history includes molds allergy, dust/dander allergy and pollens allergy. Concomitant medication included meloxicam (MOBIC), ethinylestradiol, norgestimate (TRINESSA), phentermine (PHENTERMINE).   No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10JAN2021 at  14:00, the patient experienced severe fatigue, joint pain continued until 13Jan2021. On 12JAN2021 at 16:30, the patient experienced Fever of 101 at around 4:30, Temp did not go under 100.4 until 18Jan2021.  Post vaccination, the patient had been tested for COVID-19.  The patient underwent lab tests which included body temperature: 101 on 12Jan2021 at approximately 4:30pm; (PCR) polymerase chain reaction results negative on 15Jan2021, and Nasal Swab sars-cov-2 test results negative on 15Jan2021. The adverse events resulted in a Physician Office Visit.  Treatment included Tylenol for aches. The clinical outcome of fever and fatigue was recovered on an unspecified date and Joint pain was recovered on 13Jan2021.              .
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever of 101 at around 4:30 Temp did not go under 100.4 until 18Jan2021; severe fatigue; joint pain; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK4176), intramuscular in the left arm on 07JAN2021 at 08:15 as a single dose, for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a Hospital  Past drug allergy includes drug hypersensitivity to Avelox, Naprosyn, and ibuprofen. Relevant medical history includes molds allergy, dust/dander allergy and pollens allergy. Concomitant medication included meloxicam (MOBIC), ethinylestradiol, norgestimate (TRINESSA), phentermine (PHENTERMINE).   No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10JAN2021 at  14:00, the patient experienced severe fatigue, joint pain continued until 13Jan2021. On 12JAN2021 at 16:30, the patient experienced Fever of 101 at around 4:30, Temp did not go under 100.4 until 18Jan2021.  Post vaccination, the patient had been tested for COVID-19.  The patient underwent lab tests which included body temperature: 101 on 12Jan2021 at approximately 4:30pm; (PCR) polymerase chain reaction results negative on 15Jan2021, and Nasal Swab sars-cov-2 test results negative on 15Jan2021. The adverse events resulted in a Physician Office Visit.  Treatment included Tylenol for aches. The clinical outcome of fever and fatigue was recovered on an unspecified date and Joint pain was recovered on 13Jan2021.              .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Cough, Fatigue, Myalgia
Clinical narrative: face looks a little bit  swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling face
Clinical narrative: face looks a little bit  swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Hyperhidrosis, Paraesthesia
Clinical narrative: Very heavy sweats; Entire body tingling started; Body felt hot all over; Body just felt weird and off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 13Jan2021 at 18:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. The patient's concomitant medications included ergocalciferol (VITAMIN D) and ethinylestradiol/ norgestimate (ORTHO TRI-CYCLEN). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 15Jan2021 (day 2; also reported as 08Jan2021), entire body tingling started. On days 3 and 4 (16Jan2021 and 17Jan2021), the patient had very heavy sweats. No fever, just body felt hot all over, and body just felt weird and off in Jan2021. The side effects went away on day 9 (22Jan2021). No treatment was given for the adverse events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 22Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Very heavy sweats; Entire body tingling started; Body felt hot all over; Body just felt weird and off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 13Jan2021 at 18:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. The patient's concomitant medications included ergocalciferol (VITAMIN D) and ethinylestradiol/ norgestimate (ORTHO TRI-CYCLEN). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 15Jan2021 (day 2; also reported as 08Jan2021), entire body tingling started. On days 3 and 4 (16Jan2021 and 17Jan2021), the patient had very heavy sweats. No fever, just body felt hot all over, and body just felt weird and off in Jan2021. The side effects went away on day 9 (22Jan2021). No treatment was given for the adverse events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 22Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.