chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin discolouration, Urticaria
Clinical narrative: she developed a large red circle on the right inner leg. It was sore to the touch.; she developed a large red circle on the right inner leg. It was sore to the touch.; hives on both wrist; turned into black and blue look and she did not recall banging at all; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a 75-year-old female patient (wife) received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration on 05Feb2021 between 11:15 and 11:20 and first dose on 14Jan2021 (Lot number: EL8982) both as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed just one hive on her right inner wrist area couple hours after the first vaccine which stayed for 3 to 4 hours and then dissipated. On 05Feb2021, several hours after the second dose vaccination, the patient developed hives on both wrist area more than one. The patient applied cream on it and it dissipated right after. On 06Feb2021, the patient developed a large red circle on the right inner leg. It was sore to the touch and it lessened over a three day period. It turned into a black and blue look. Treatment received for event hives was cream. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: received Coronavirus vaccine and then 2 days later got shingles; This is a spontaneous report from a contactable consumer. A 91-year-old female patient that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunization. The patient's medical history and patient's concomitant medications were not reported. Reporter said that this patient is like his mom, her son was his best friend and her son died in 1986 in a car accident and he takes care of this woman. The patient received coronavirus vaccine and then 2 days later got shingles on an unspecified date in Jan2021. Outcome of the event was unknown.  Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm to lay on; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL3248; Expiration Date: not reported) administered in Arm Right on 19Jan2021 12:00 (at the age of 24-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing hypersensitivity, ongoing, Chronic dermatitis ongoing, flu (Had flu shot unknown date, maybe 6-8 months ago). Concomitant medication(s) included dupilumab (DUPIXENT) taken for dermatitis (Injects self every 2 weeks), loratadine (LORATADINE) taken for hypersensitivity. The patient experienced sore arm to lay on (pain in extremity) on 19Jan2021 with outcome of recovered on an unspecified date 2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing, requiring oxygen relief, a week after receiving vaccine to present.; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation; Solution for injection, Lot Number: EL8982) via an unspecified route of administration in the right arm on 01Feb2021 at 10:30 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included chronic obstructive pulmonary disease and heart history. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Post the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient's concomitant medications were not reported. On 08Feb2021, a week after receiving vaccine the patient experienced difficulty breathing. Treatment for the event was oxygen relief. The outcome of the event was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: 2 weeks after first injection sore neck and shoulder; 2 weeks after first injection sore neck and shoulder.; soreness in upper body; Minor arm soreness at time of injection; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E13249, Expiry date: unknown) via an unknown route of administration, administered in left arm on 15Jan2021 13:30 pm (age at vaccination was 68 years) at a single dose for covid-19 immunisation. Medical history included high BP and CIDP in 2006. There were no known allergies. Concomitant medication included amlodipine besylate (AMLODIPINE BESYLATE), atorvastatin (ATORVASTATIN) and losartan (LOSARTAN). The patient experienced minor arm soreness at time of injection. 2 weeks after first injection sore neck and shoulder. Neck so bad had to sleep upright in chair for several days. Was not consistent all time. 3 weeks after first injection, neck pain was better but overall soreness in upper body. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269, Expiry date: unknown) via an unknown route of administration, administered in left arm on 05Feb2021 07:30 am (age at vaccination was 68 years) at a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The outcome of all the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in injection site, left arm; This is a spontaneous report from a contactable consumer (patient). Follow-up (18Mar2021) received from same reporter was processed together with initial information.    A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, expiry date: not reported), via an unspecified route of administration, administered in arm left on 22Feb2021 14:30 (at the age of 43years, not pregnant) as single dose for covid-19 immunisation at workplace clinic. No other vaccine and other medications in four weeks. No COVID prior vaccination and no COVID test post vaccination done. Medical history (other): none and no known allergies. There were no concomitant medications. On 22Feb2021 20:00, the patient experienced pain in injection site, left arm. Event was not treated. The outcome of the event recovered.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; This is a spontaneous report from a contactable consumer (Caregiver). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for covid-19 immunisation. Caregiver calling about client who received second dose of Pfizer covid vaccine on 22Feb2021. Client experienced chills and fatigue during the night on 22Feb2021. Caregiver asked how long symptoms usually last. The outcome of the events was unknown.  Information about the lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nerve compression, Pain, Pain in extremity
Clinical narrative: arm soon became sore; Felt weak; Ache; my arm was squeezed/pinched; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not provided) via an unspecified route of administration as a single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose (lot number: EL9261 and expiry date: not provided), via an unspecified route of administration, in Arm Left, on 30Jan2021, 01:15 PM as a single dose for COVID-19 immunization. The patient experienced felt weak, arm soon became sore, ache and my arm was squeezed/pinched. The patient said that, his second dose was as expected. Administered by the same nurse as the first. He was very much felt the needle. It was somewhat painful. His arm soon became sore and was sore for about two days. he felt weak and aching all over like he was getting the flue. he felt fine after one day. At that point he questioned whether he actually got the first injection. At both events he told the nurse my arm is so small that a needle inserted too far would hit the bone. The second injection my arm was squeezed/pinched for the injection, not so on the first. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test
Clinical narrative: Weakness in face; metallic taste in mouth; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 15:45 (Batch/Lot Number: EN6200) as SINGLE DOSE, for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. The patient medical history, no allergies and concomitant medications were not reported. Patient has been tested for COVID, post vaccination. It was reported that, on 22Feb2021 at 16:15, patient experienced weakness in face (muscular weakness) and metallic taste in mouth (taste disorder). The patient underwent lab tests and procedures which included COVID-19 Nasal Swab test unknown on 23Feb2021. The outcome for the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: developed a headache within two hours after the shot, and it lasted for the rest of the day; woke up from severe body aches and shivers/I was in 9/10 pain from body aches; woke up from severe body aches and shivers; I was sweating, feeling like I had a fever; next day I woke up very tired and fatigued and I was unable to leave my bed; My arm at the injection site became very inflamed, swollen and painful; My arm at the injection site became very inflamed, swollen and painful; My arm at the injection site became very inflamed, swollen and painful; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 10:45 (Lot Number: 5318, Expiry date: Unknown) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included heart rate increased, oral surgery. Patient did not have COVID prior vaccination. Concomitant medication(s) included ZYRTEC [CETIRIZINE HYDROCHLORIDE] and metoprolol. The patient previously took first dose of bnt162b2 for COVID-19 immunisation, morphine and experienced hives. There were no other vaccines taken in four weeks. On 17Feb2021 01:00 PM patient experienced headache within two hours after the shot, and it lasted for the rest of the day, woke up from severe body aches and shivers/she was in 9/10 pain from body aches, woke up from severe body aches and shivers, she was sweating, feeling like she had a fever, next day she woke up very tired and fatigued and she was unable to leave my bed and her arm at the injection site became very inflamed, swollen and painful. At 2am, she woke up from severe body aches and shivers, and it did not pass for 2 hours, at which point she took 600 mg Ibuprofen. The pain relievers worked within 20 minutes and she was able to sleep. Body aches lasted Thursday and Friday, and she still feel fatigued to this day. The injection site is not as red anymore and does not hurt, but it is still swollen and feels very hard to the touch almost a week after the shot. The patient underwent lab tests and procedures on 18Feb2021 which included body temperature: 98.5f and pain assessment 9/10. Patient did not test covid post vaccination. Therapeutic measures were taken for the event severe body aches and shivers with 600 mg Ibuprofen. Rest of the events didn't receive treatment. The outcome of all events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
Clinical narrative: developed a headache within two hours after the shot, and it lasted for the rest of the day; woke up from severe body aches and shivers/I was in 9/10 pain from body aches; woke up from severe body aches and shivers; I was sweating, feeling like I had a fever; next day I woke up very tired and fatigued and I was unable to leave my bed; My arm at the injection site became very inflamed, swollen and painful; My arm at the injection site became very inflamed, swollen and painful; My arm at the injection site became very inflamed, swollen and painful; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 10:45 (Lot Number: 5318, Expiry date: Unknown) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included heart rate increased, oral surgery. Patient did not have COVID prior vaccination. Concomitant medication(s) included ZYRTEC [CETIRIZINE HYDROCHLORIDE] and metoprolol. The patient previously took first dose of bnt162b2 for COVID-19 immunisation, morphine and experienced hives. There were no other vaccines taken in four weeks. On 17Feb2021 01:00 PM patient experienced headache within two hours after the shot, and it lasted for the rest of the day, woke up from severe body aches and shivers/she was in 9/10 pain from body aches, woke up from severe body aches and shivers, she was sweating, feeling like she had a fever, next day she woke up very tired and fatigued and she was unable to leave my bed and her arm at the injection site became very inflamed, swollen and painful. At 2am, she woke up from severe body aches and shivers, and it did not pass for 2 hours, at which point she took 600 mg Ibuprofen. The pain relievers worked within 20 minutes and she was able to sleep. Body aches lasted Thursday and Friday, and she still feel fatigued to this day. The injection site is not as red anymore and does not hurt, but it is still swollen and feels very hard to the touch almost a week after the shot. The patient underwent lab tests and procedures on 18Feb2021 which included body temperature: 98.5f and pain assessment 9/10. Patient did not test covid post vaccination. Therapeutic measures were taken for the event severe body aches and shivers with 600 mg Ibuprofen. Rest of the events didn't receive treatment. The outcome of all events was recovering.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Paraesthesia oral, Swollen tongue
Clinical narrative: Swelling of tongue; Shortness of breath; Chest tightness; Tingling lips; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (patient) reported that the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EL9264) on an unspecified date via an unspecified route of administration in right arm and for covid-19 immunization. The patient medical history included breast cancer and concomitant medication was not reported. The patient took blood work in the emergency room (further not clarified). On an unspecified date the patient had swelling of the tongue, then back shortness of breath, chest tightness and tingling in my lips. The patient also reported that she did not being admitted, she had been to the emergency room throughout night, they gave me medicine in the emergency room two shots of epinephrine and one shot of Benadryl and then they gave two things, they did the blood work and then they gave me something similar to Pepcid for the reflux but it was not Pepcid. The outcome for the events were unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; fever; chills; muscle soreness; weakness; This is a spontaneous report from a contactable nurse (patient) response for herself in HCP letter sent. A 52-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9261, Expiry date: May2021) via intramuscular route in right arm on 26Jan2021 at 11:30 as single dose for covid-19 immunization. Family medical history included all 4 household family members positive covid 18Dec2020 to 20Dec2020. The patients ,medical history included positive covid test. Historical vaccine included dose 1 of BNT162B2 (COMIRNATY) vaccine. On 26Jan2021 at 22:00 (approximately 11 hours after vaccination), the patient experienced headache, fever, chills, muscle soreness, weakness. The patient did not receive any treatment for the events. The adverse events did not require a visit to emergency room or physicians office. The clinical outcome of the events headache, fever, chills, muscle soreness, weakness was recovered. The patient reported that there was a causal relationship between the events and the suspect.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Headache, Pain
Clinical narrative: headache; Pimple on right breast; achiness; This is a spontaneous report from a contactable consumer (patient herself).  A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm on 04Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021, at about 4PM, then that night in the evening the patient had a couple reactions from the first dose. The patient stated that she was achy and had a headache. The patient stated that her achiness was not bad at all, and she had gone through much worse and stated that achiness lasted for just one evening. The patient was not sure whether she had last effects of it or if she was just old. The patient also stated that she experienced her headache prior to the first dose and she actually has a light headache almost everyday. On 16Feb2021, the patient had a sort of broke out, like there was a pimple on the breast. The patient stated that it is just one pimple and it has the size of a nickel.  The patient stated that the pimple was on her right breast and she put some salve on it. She was scheduled to take the second shot on 25Feb2021 but she couldnot get through it and was supposed to get it next week. The patient wanted to know whether she was late in getting the second shot. The outcome of the events was resolved achiness, while the patient had not recovered from the events of for headache and pimple on right breast.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Tingling; Headache; This is a spontaneous report from a contactable consumer reporting for husband (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL9265), intramuscularly in left arm on 07Feb2021 (at the age of 66-years-old) as single dose for covid-19 immunization. Patients medical history included prostate cancer treated with unspecified medication on an unknown date (diagnosed about a year ago in Jan or Feb) and is cancer free now. Concomitant medications were not reported. On an unknown date in Feb2021, the patient experienced tingling and headache. The reporter stated that her husband was specific where his tingling was but did say that he had tingling after the shot. The reporter stated that she does not know when her husband started experiencing the tingling after his vaccination and said that she does not know if he was still experiencing the tingling. She said that he may have noticed the tingling the next day or the day after. The patient was treated with Ibuprofen for the event headache. The outcome of the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Weight
Clinical narrative: she had terrible pain and it was in her right arm where they gave the shot; where they gave the shot was red; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263), via an unspecified route of administration, in right arm, on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included allergic to shellfish, like crabs, cancer of 21 years. There were no concomitant medications. On Her and her husband both got it and she thought maybe she had a pulled a muscle and her husband said it might be the shot because where they gave the shot was red and then a couple days later the shoulder and the arm hurt, she had terrible pain and it was in her right arm where they gave the shot. She is supposed to go 03Mar2021 to get the second shot. She says it is a pain in her shoulder and it goes down her arm. She first noticed it about 3 days ago (13Feb2021) and it comes and goes. She did have shot in that arm and she can see the faint color of it, it was red in that one spot. She has been taking Tylenol and putting a heating pad on it but it doesn't do much, it helps for a while then it comes back. There was a red spot right after she got home from getting it, it was a little red. She could see it. It lasted a couple days later and she can still see it faint, where she got the shot but it is not really bright. The redness was a dime size where they gave the shot. it may have been a little wider, it is hard to tell. Description of Product Complaint: Patient reporting her experience after having the first dose of the Pfizer COVID 19 vaccine. She has had pain in her right shoulder and going down her arm. She has red spot where they gave the injection about a dime size in diameter. She has been taking Tylenol and putting a heating pad on it but it doesn't do much, it helps for a while then it comes back. Lab test included weight is between 145-147 lbs. The outcome of event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201550 Same reporter, different patients/ events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 11Feb2021 15:00 (batch/lot number: EL9262; expiration date: 31May2021) as a single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously had BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 21Jan2021 15:00 (batch/lot number: EL9261; expiration date: Apr2021) as a single dose for covid-19 immunization. On 14Feb2021, at 03:00, the patient experienced vomiting, after the second Dose on 11Feb2021 at 3PM, the reaction vomiting happened on the 3rd day being sunday morning. She woke up at 3AM vomiting and continued to vomit. She could not keep anything down for 24 hours. She didn't know if it had to do with the vaccine, when it passed she actually saw it online. She never had vomiting like that in her life. She could not even hold down ice cubes or water. She has learned that was better to have something in the stomach to throw up, then nothing and so she would eat a cracker. Caller clarified that the vomiting started at 3AM on 14Feb2021 going into the early hours of 15Feb2021. She was able to eat breakfast on the 15Feb2021 Monday. She initially provided her weight at 130, but then stated to put 135, she knows she was not that heavy but would rather be on the heavy side. On 15Feb2021 Monday, she was iffy and only had toast, tea, anything that stayed up and would keep it from upsetting the stomach. She had no other vaccines on the same day or 4 weeks prior. She did not have any ER visit. She did not visit her doctors office but only called them. She has no relevant family medical history that she would like to provide. Caller also complained about the Pfizer reporting website online, she tried on Monday because there were 36 people ahead of her, the online forms ask so many questions, they need to simplify it, it was asking for information like addresses and thing that she did not have, and it would not let her skip it or move on without plugging in the information. Caller again stated that the online report does not allow to skip questions. She even tried to auto fill information, but it did not work. Caller has no reference number from the online reporting. She did not complete it. The outcome of the event vomiting was recovered on 15Feb2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at injection site; This is a spontaneous report from a contactable consumer. A 69-Year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EM9810 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 08Feb2021 at 12:15 (at the age of 69-years-old) as a single dose for covid-19 immunisation. Patient had allergy to penicillin and various rifampicin (MYCIN) antibiotics that cause itching. Patient's medical history included osteoporosis and osteoarthritis. Patient concomitant medications included injection for allergy and calcium tablet. Patient had received other vaccine in four weeks. Patient received other medications in two weeks as injection for allergy and calcium tablet. Patient has not been Covid prior vaccination. Patient had not tested Covid post vaccination. On 10Feb2021 (after 3 days), patient experienced itching at injection site. The outcome of event was recovered on 13Feb2021 (after 3 days).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: She says it seems like the right hand does not know what the left hand is doing.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot no and expiry date not reported) via an unspecified route of administration on 28Jan2021 for covid-19 immunisation. The patient medical history, concomitant medications and past drug history were not reported. It was reported that caller was calling about Pfizer COVID 19 vaccine. She had her first shot on 28Jan, and she was then scheduled to get second dose on 19Feb which was Friday and the weather forecast predicting heavy snow and ice on Friday and she did not see any way that she was going to be able to get from her house to (Hospital name withheld) for the appointment. What did she need to do? Who did she contact to reschedule that appointment? She said the people contacted her for the appointment. On an unknown date, she said it seems like the right hand did not know what the left hand was doing. She was not calling to report an adverse events or product complaints. She said she would go back and call someone else. She said she did not have anything to say other than this had been a horrible experience, she had been on the phone for an hour and a half and was trying to find out who to contact to change the appointment and no one could help her with it, it was totally unacceptable. The outcome of event was unknown.  Information about lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count, Red blood cell count decreased
Clinical narrative: my red blood cell count was off a little bit; This is a spontaneous report from contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, expiry: not reported), via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation on his right arm (at the age of 68 years). Medical history included blood pressure (Investigation Assessment: Yes). Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); amlodipine; metoprolol succinate (METOPROLOL SUCCINATE ER); olmesartan medoxomil; fluoxetine hydrochloride (PROZAC, 20 mg); oxybutynin chloride (take oxybutynin chloride ER 24 hours). The patient and his wife had their first dose of the Pfizer COVID 19 Vaccine little over three weeks ago and were scheduled to get their second dose on 12th of February (last Friday), which was exactly 3 weeks. On 11-Feb-2021 (Thursday), the patient canceled their second dose appointments (12th appointment for both of us) and was waiting to get another appointment for their second doses through their private insurance company. The patient stated that the lady was very happy that he called in and cancelled, so somebody else could take that spot. But he gave his phone number and said please call me as soon as you get availability for the second dose of the vaccine. That was last Thursday, and no one has called him since then. He called and he was hoping that they would give him a call. The insurance company said always got some opening some place to get your second dose, but he had not heard anything from anybody as of now. They haven't got the second dose yet. His daughter was a nurse and she told him that they only have a 4-day window to receive the second dose of the vaccine in regard to safety so now they were not certain when they should get their second dose and how will it impact the efficacy of the vaccine. They are going to be getting their second doses of vaccine past the 21 days period and it has already been four days after they were supposed to have the shot. The patient stated that he was 172 pounds right now and has lost about 12 pounds (further clarification unknown). On unknown date, his red blood cell count was off a little bit as shown in the lab tests. The outcome of event was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden onset of sleep, Urinary incontinence
Clinical narrative: PATIENT URINATED ON THE GROUND AND FELL ASLEEP ON THE WAITING CHAIR.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: On 3/23 I had maderna, on 4/24 the pharmacy gave me wrong 2nd does. They gave me Pfizer. They made an error. I am concerned because they have not contacted me with follow up info. I don?t know what to do.  Can you help me.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: chills, fatigue, headache, fever, aches and pains, dizzyness , nausea  all day, since the vaccination, all day the following day.... (today)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chills, fatigue, headache, fever, aches and pains, dizzyness , nausea  all day, since the vaccination, all day the following day.... (today)
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone abnormal, Blood test, Chronic obstructive pulmonary disease, Confusional state, Cough
Clinical narrative: After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion.  His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23.  Discharged with recommendations to see hematologist.  Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ).  Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Hairy cell leukaemia, Platelet count decreased
Clinical narrative: After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion.  His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23.  Discharged with recommendations to see hematologist.  Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ).  Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: fever: 101 degrees: started as 99 degrees went up as day went on, nausea: occurred at the thought of eating, dizziness: when I stood up throughout day, general body soreness/tiredness: all day
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever: 101 degrees: started as 99 degrees went up as day went on, nausea: occurred at the thought of eating, dizziness: when I stood up throughout day, general body soreness/tiredness: all day
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Dyspnoea, Rash, Urine analysis
Clinical narrative: Woke up on the morning of 4/18/21  with difficulty taking a deep breathe withourt experiencing pain in my lower right back.  All day I rested and increased my water intake. Applied a heating pad to reduce the pain.  No relief the next day, so after work I went into the urgent care clinic to see what the problem was.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Woke up on the morning of 4/18/21  with difficulty taking a deep breathe withourt experiencing pain in my lower right back.  All day I rested and increased my water intake. Applied a heating pad to reduce the pain.  No relief the next day, so after work I went into the urgent care clinic to see what the problem was.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Woke up with injection site feeling sensitive. Over the course of the day, slight swelling occurred in upper left arm. The area is hot and hard. No rash at this time. The affected area is about the size of a small yogurt lid.  Does not itch unless I touch it. I have iced it several times and it is still hot.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Pain at injection site (4-36 hours following injection) - subsided after 36 hours Dizziness (7 hours following injection) - subsided within a few hours Found lump above my right collarbone, accompanied by muscle pain on right side of neck, beginning 6 days after vaccine and continuing through today - saw primary doctor regarding lump & pain the day after it began (4/16/21) - ordered ultra sound but couldn't schedule until 5/4/21 - as of today, 4/24/21, the muscle pain has intensified and a cord-like structure is prominent at the surface, also with pain, in addition to a headache and fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Swelling
Clinical narrative: Pain at injection site (4-36 hours following injection) - subsided after 36 hours Dizziness (7 hours following injection) - subsided within a few hours Found lump above my right collarbone, accompanied by muscle pain on right side of neck, beginning 6 days after vaccine and continuing through today - saw primary doctor regarding lump & pain the day after it began (4/16/21) - ordered ultra sound but couldn't schedule until 5/4/21 - as of today, 4/24/21, the muscle pain has intensified and a cord-like structure is prominent at the surface, also with pain, in addition to a headache and fatigue
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, C-reactive protein normal, Ear discomfort, Eye pain, Eye pruritus
Clinical narrative: On 4/12/21 I woke up with a painful bump and rash on my left eyebrow. On 4/13/21 I went to the doctor and was misdiagnosed with cellulitis. I began treatment with antibiotics (clindamycin). The rash was unresponsive to the treatment and I started experiencing terrible pain in my face, eye and scalp. There was intense pressure in my eye and pain in my left ear. I started forming blisters on my eyebrow, side of my nose and temple. On 4/16 I woke up with my eye nearly swollen shut. I went to urgent care the same day and was diagnosed with shingles that was affecting my trigeminal nerve. I was prescribed Valtrex antiviral for 7 days, and remained on the antibiotics. I was also given pain medication (oxycodone). I was referred to Optometry to check to make sure the shingles was not affecting my eyeball and to ensure there was no indication of damage to my vision. As of today (4/24/21) my blisters have mostly scabbed over, the swelling has reduced substantially and the pain is far less intense. I still feel like a quarter of my face has a moderate sunburn, have an itchy eye and a bit of pressure in my eye still. My vision was not impacted and I may have some small scars from the blisters.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Herpes simplex test negative, Herpes zoster, Ocular discomfort, Pain of skin
Clinical narrative: On 4/12/21 I woke up with a painful bump and rash on my left eyebrow. On 4/13/21 I went to the doctor and was misdiagnosed with cellulitis. I began treatment with antibiotics (clindamycin). The rash was unresponsive to the treatment and I started experiencing terrible pain in my face, eye and scalp. There was intense pressure in my eye and pain in my left ear. I started forming blisters on my eyebrow, side of my nose and temple. On 4/16 I woke up with my eye nearly swollen shut. I went to urgent care the same day and was diagnosed with shingles that was affecting my trigeminal nerve. I was prescribed Valtrex antiviral for 7 days, and remained on the antibiotics. I was also given pain medication (oxycodone). I was referred to Optometry to check to make sure the shingles was not affecting my eyeball and to ensure there was no indication of damage to my vision. As of today (4/24/21) my blisters have mostly scabbed over, the swelling has reduced substantially and the pain is far less intense. I still feel like a quarter of my face has a moderate sunburn, have an itchy eye and a bit of pressure in my eye still. My vision was not impacted and I may have some small scars from the blisters.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Red blood cell sedimentation rate normal, Swelling, Swelling of eyelid, Trigeminal nerve disorder
Clinical narrative: On 4/12/21 I woke up with a painful bump and rash on my left eyebrow. On 4/13/21 I went to the doctor and was misdiagnosed with cellulitis. I began treatment with antibiotics (clindamycin). The rash was unresponsive to the treatment and I started experiencing terrible pain in my face, eye and scalp. There was intense pressure in my eye and pain in my left ear. I started forming blisters on my eyebrow, side of my nose and temple. On 4/16 I woke up with my eye nearly swollen shut. I went to urgent care the same day and was diagnosed with shingles that was affecting my trigeminal nerve. I was prescribed Valtrex antiviral for 7 days, and remained on the antibiotics. I was also given pain medication (oxycodone). I was referred to Optometry to check to make sure the shingles was not affecting my eyeball and to ensure there was no indication of damage to my vision. As of today (4/24/21) my blisters have mostly scabbed over, the swelling has reduced substantially and the pain is far less intense. I still feel like a quarter of my face has a moderate sunburn, have an itchy eye and a bit of pressure in my eye still. My vision was not impacted and I may have some small scars from the blisters.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Varicella virus test positive
Clinical narrative: On 4/12/21 I woke up with a painful bump and rash on my left eyebrow. On 4/13/21 I went to the doctor and was misdiagnosed with cellulitis. I began treatment with antibiotics (clindamycin). The rash was unresponsive to the treatment and I started experiencing terrible pain in my face, eye and scalp. There was intense pressure in my eye and pain in my left ear. I started forming blisters on my eyebrow, side of my nose and temple. On 4/16 I woke up with my eye nearly swollen shut. I went to urgent care the same day and was diagnosed with shingles that was affecting my trigeminal nerve. I was prescribed Valtrex antiviral for 7 days, and remained on the antibiotics. I was also given pain medication (oxycodone). I was referred to Optometry to check to make sure the shingles was not affecting my eyeball and to ensure there was no indication of damage to my vision. As of today (4/24/21) my blisters have mostly scabbed over, the swelling has reduced substantially and the pain is far less intense. I still feel like a quarter of my face has a moderate sunburn, have an itchy eye and a bit of pressure in my eye still. My vision was not impacted and I may have some small scars from the blisters.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Blood test, Chills, Confusional state
Clinical narrative: Temperature 94.7°F for 14 hours after 2nd dose. Blurred vision. Swollen fingers every morning since 2/19/2021.  March 2021 extremely heavy period causing me to miss a day of normal activity. Low iron levels now anemic.  Night sweats cause  me to wake up, change sheets and pjs every night. Anxiety and mood swings. Confusion and at times I cannot recall words. Temperature remains under 97°F. Chills, aches, joint paint, pale and dry skin despite drinking water. Recently a large hemorrhoid has appeared requiring me to see doctor. My finger and toes are painful and red and it feels as if my vascular system is ?off?.  Hence, the hemorrhoid. I have been out of work for 5 days and cannot stop sleeping.  I have almost gone to the ER just to get peace of mind with what is wrong with me. I get out of breath quickly. I?m starting to feel very frustrated with physical pain and am becoming very weepy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dry skin, Dyspnoea, Erythema, Haemorrhoids
Clinical narrative: Temperature 94.7°F for 14 hours after 2nd dose. Blurred vision. Swollen fingers every morning since 2/19/2021.  March 2021 extremely heavy period causing me to miss a day of normal activity. Low iron levels now anemic.  Night sweats cause  me to wake up, change sheets and pjs every night. Anxiety and mood swings. Confusion and at times I cannot recall words. Temperature remains under 97°F. Chills, aches, joint paint, pale and dry skin despite drinking water. Recently a large hemorrhoid has appeared requiring me to see doctor. My finger and toes are painful and red and it feels as if my vascular system is ?off?.  Hence, the hemorrhoid. I have been out of work for 5 days and cannot stop sleeping.  I have almost gone to the ER just to get peace of mind with what is wrong with me. I get out of breath quickly. I?m starting to feel very frustrated with physical pain and am becoming very weepy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Iron deficiency anaemia, Mood swings, Night sweats, Pain
Clinical narrative: Temperature 94.7°F for 14 hours after 2nd dose. Blurred vision. Swollen fingers every morning since 2/19/2021.  March 2021 extremely heavy period causing me to miss a day of normal activity. Low iron levels now anemic.  Night sweats cause  me to wake up, change sheets and pjs every night. Anxiety and mood swings. Confusion and at times I cannot recall words. Temperature remains under 97°F. Chills, aches, joint paint, pale and dry skin despite drinking water. Recently a large hemorrhoid has appeared requiring me to see doctor. My finger and toes are painful and red and it feels as if my vascular system is ?off?.  Hence, the hemorrhoid. I have been out of work for 5 days and cannot stop sleeping.  I have almost gone to the ER just to get peace of mind with what is wrong with me. I get out of breath quickly. I?m starting to feel very frustrated with physical pain and am becoming very weepy.