chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he tested positive for Covid-19 infection last 11Jun2021; This is a spontaneous report from non-contactable consumer (patient) and sponsored program via information team. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 05Jun2021 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were none. On 11Jun2021, patient tested positive for Covid-19 infection. Patient haven't been hospitalized ever since getting the vaccine. Patient stated he was scheduled for his second dose of vaccine on 26Jun2021. Patient stated that he believes he may have had Covid when he got his first dose of vaccine. The patient underwent lab tests and procedures which included COVID-19 SARS-CoV-2 test: positive on 11Jun2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: my daughter had the Pfizer vaccine and didn't have any problems with the first dose but was kind of out of it and felt back the next day but it wasn't too bad.; This is a spontaneous report from non-contactable consumer (Patient's mother). This Non-contactable consumer reported for her daughter (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient didn't have any problems with the first dose but was kind of out of it and felt back the next day, but it wasn't too bad. The outcome of the event was reported as unknown.  No follow-up attempts are Possible. No Further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fall, Feeling drunk
Clinical narrative: She feels dizzy and has been vomiting; She had no strength to walk; She falls down, she can't stand up, she can't stand on her foot,; She falls down, she can't stand up, she can't stand on her foot,; She has headaches, her head is spinning,; She has headaches, her head is spinning,; She feels dizzy and has been vomiting; Her head is spinning, "like a drunk person"; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via Medical information team.  A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route on 12Jun2021 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient's medical history included diabetes. The patient's concomitant medications were not reported. On Saturday (12Jun2021), the patient was vaccinated and was fine till Wednesday (16Jun2021). On 17Jan2021 at 04:00, the patient started having symptoms when she attempted to reach the bathroom  she experienced no strength to walk, she falls down, she can't stand up, she can't stand on her foot, she has headaches, her head was spinning like a drunk person, she feels dizzy and has been vomiting. The outcome of the events was unknown.  Information on Lot/Batch number was requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo, Vomiting
Clinical narrative: She feels dizzy and has been vomiting; She had no strength to walk; She falls down, she can't stand up, she can't stand on her foot,; She falls down, she can't stand up, she can't stand on her foot,; She has headaches, her head is spinning,; She has headaches, her head is spinning,; She feels dizzy and has been vomiting; Her head is spinning, "like a drunk person"; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via Medical information team.  A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route on 12Jun2021 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient's medical history included diabetes. The patient's concomitant medications were not reported. On Saturday (12Jun2021), the patient was vaccinated and was fine till Wednesday (16Jun2021). On 17Jan2021 at 04:00, the patient started having symptoms when she attempted to reach the bathroom  she experienced no strength to walk, she falls down, she can't stand up, she can't stand on her foot, she has headaches, her head was spinning like a drunk person, she feels dizzy and has been vomiting. The outcome of the events was unknown.  Information on Lot/Batch number was requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headaches and dizziness have gotten worse; headaches and dizziness have gotten worse; This is a spontaneous report from a contactable consumer (patient herself).  A 74-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0182, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 11Jun2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure (for about 15 years), diabetes (called it diabetes and pre-diabetes, for about 4 years) and pre-diabetes (about 4 years), anxiety (for about 15 years), pacemaker (inserted 2 years ago) and sinus problems (for 5-6 years). Patient had chronic headache dizziness. Patient had no family medical history relevant to adverse event. Concomitant medications included metformin hydrochloride for diabetes; amlodipine for high blood pressure (been on medication for years); losartan for high blood pressure (been on medication for years); hydrochlorothiazide, as water pill for an unspecified indication (been on medication for years); lorazepam (been on and off this medication for 15 years); vitamin D. Patient received no other vaccinations within four weeks prior vaccinations (within 4 weeks). On 11Jun2021, patient had taken the dose. On an unspecified date Jun2021, patient stated that it seems like she had been a little dizzy and had headaches all week and stated that since receiving the vaccine, her headaches and dizziness had gotten worse. Patient stated she had a sinus problem, so she was not concerned. Patient normally takes one paracetamol (Tylenol), and it will go away. Patient noticed it more this morning (17Jun2021) when she took her walk and stated that she gets like that sometimes because she takes other medications; this time though it feels like it was lingering longer. Patient stated she had been getting them every day. On 17Jun20201, around 05:30 she took a lorazepam, and it went away, and she went back to sleep until around 12:30 when it started again. When it started again, she took a paracetamol (Tylenol). Patient was concerned about headache today (17Jun2021). No relevant tests were performed. Patient had no emergency room and physician office. Patient stated that she had had this problem with headaches and dizziness before the vaccine and now that she was looking at the side effects, she thought it might be something she needed to report. Patient asked if this was something to be concerned about and should she go to the doctor or emergency room for her symptoms. Patient was notified to consult with healthcare professional or seek emergent medical attention if needed. Patient has an appointment on 21Jun2021 (Monday) with her neurologist. The outcome of both the events was unknown.    Follow-up (17Jun2021): This is a follow-up spontaneous report from a contactable consumer (patient).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Loss of personal independence in daily activities, Migraine, Nausea
Clinical narrative: Doctor thinks its continuous migraines but theyre not 100% sure; unable to work; Continuous nausea; Light headedness; Weak; This is a spontaneous report from a Pfizer sponsored program from patient and patient's mother. A contactable 35-year-old female consumer (patient) reported herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 06May2021, as 2nd dose, single for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as 1st dose, single for COVID-19 immunization and had no reaction. On an unknown date the patient's mother reported that her daughter was unable to work. On 16May2021 the patient experienced side effects, she was really weak and had continuous nausea and lightheadedness. The doctors thought it was continuous migraines, but they were not sure. The patient had spoken to 4 different clinicians around the area and the clinicians stated that people had weird immunological things. The patient was calling to see how long this reaction would last and to report the symptoms.   Information on the lot/batch number had been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient's Grandmother).  A 17-years-old adolescent female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left Arm on 17Jun2021 as 1st Dose, Single for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. After the first dose of Covid vaccine, the patient experienced headache ever since. Headache was reported as worsened. She wants to know if her granddaughter can take anything for her headache and if that would be safe. The outcome for the events was not recovered/not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: rosacea rash; This is a spontaneous report from a contactable consumer. This pharmacist reported for a 13-year-old female consumer(patient).   A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST dose, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the reporter stated that the patient received the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and 3 days later developed rosacea rash that she still has, and HCP recommended that the patient does not get the 2nd dose by HCP. HCP was asking how effective was the first dose. A total of 514 took part in the study (age 19 to 77 years). The first dose of the vaccine was immunogenic in 92% of the participants 21 days after administration. The IgG levels elicited by the vaccination in individuals with previous evidence of COVID-19 infection were at least one order of magnitude higher than those with no evidence of previous infection. Outcome of the event was reported as unknown.   Follow-up attempts are needed. Further information is expected.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Paralysis, SARS-CoV-2 test
Clinical narrative: Guillian Barre-was totally paralyzed; Guillian Barre-was totally paralyzed; This is a spontaneous report from a contactable consumer (patient). An 80-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809) at the age of 79-years, via an unspecified route of administration, administered in left arm on 09Feb2021 at 12:00 at single dose for COVID-19 immunisation; second dose of other vaccine (unspecified, lot number: ENG205) at the age of 79-years, via an unspecified route of administration in left arm on 09Feb2021 for immunization. Medical history included esophagus cancer. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks were none. On 31May2021 at 12:00, the patient experienced Guillian Barre-was totally paralyzed. The events were reported as life threatening illness (immediate risk of death from the event). The patient received oxygen and medicines as treatment. On 03May2021, COVID-19 virus test (nasal swab) was negative. Outcome of the events was unknown.   Follow-up actions are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia
Clinical narrative: Numbness on the left side of her body; Its hard for her to walk; I don't have balance; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 05Jun2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, the patient experienced numbness on the left side of her body, its hard for her to walk and don't have balance. Response received as Offered to give caller a website address to access the Fact Sheet for Recipients however she never stated if she wanted it or not. Stated the PI for the vaccine does not contain any information about numbness going down the side of the body as a side effect. Outcome for the case was unknown.  Information on the lot/ batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Had no pain in his knees/Caller stated he has had knee pain for 4 or 5 years/The next day after receiving the covid vaccine, he woke up at 5:00AM, and he had no pain in his knees; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injecton; Batch/Lot Number: EW1078), via an unspecified route of administration, administered in left arm on 27May2021 at 18:00 PM (at the age of 64-years-old), as single dose, and received second dose via an unspecified route of administration, administered in left arm on 17Jun2021, (Batch/Lot Number: EW0180) as single dose for COVID-19 immunisation. Patient stated that he was taking Pfizer vaccine as he figured he waited long enough to get it, and everyone else was still alive. Medical history included chronic knee pain from 4 or 5 years. Patient was healthy except for his knees. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that his chronic knee pain was so much that it was hard for him to stand up, and it hurts him to walk. Patient reported that after receiving the first dose of the covid vaccine on 27May2021 (he thinks it was Thursday), the next day, on 28May2021, he woke up at 5:00AM, and he had no pain in his knees, that lasted for nine days. The patient received the second dose of the covid vaccine a while before reporting and was hoping that it might do the same thing tomorrow. He does not take nothing. He was amazed. He went on the computer to see what the ingredients were, and he saw that there are lipids. But it does not say what they are or what they do. He also saw that there is a bunch of salts, and sucrose in the covid vaccine. He asked his pharmacist about it, and she gave him a printout. There was no information in the printout. He was hoping that there was something in there. His knee pain has been like this for 4 or 5 years. Patient was asking if Pfizer has heard of this happening to anyone else and if have there been anything reported being positive for back, hips and knees. The patient had the beneficial effect of vaccine (no pain in his knees) till 06Jun2021 that lasted for 9 days.  Information about lot/batch number is available. Follow-up attempts are needed.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Migraine, Pain, Pyrexia
Clinical narrative: My fever was at 101; I felt achy; I had rash on my neck and body; It was a terrible headache; It was a terrible headache. I don't usually get migraines; I have burning skin all over; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number unknown) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had a side effect after the first dose of the vaccine. On an unspecified date, the patient had a fever for 5 days, and the fever was at 101. Patient felt achy and stuff after. Patient had rash on neck and body. Two nights after, patient couldn't see cause of the headache. It was a terrible headache. Patient didn't usually get migraines. Patient had burning skin all over and had been taking baths to calm it down. Event fever resolved while outcome of the other events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: My fever was at 101; I felt achy; I had rash on my neck and body; It was a terrible headache; It was a terrible headache. I don't usually get migraines; I have burning skin all over; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number unknown) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had a side effect after the first dose of the vaccine. On an unspecified date, the patient had a fever for 5 days, and the fever was at 101. Patient felt achy and stuff after. Patient had rash on neck and body. Two nights after, patient couldn't see cause of the headache. It was a terrible headache. Patient didn't usually get migraines. Patient had burning skin all over and had been taking baths to calm it down. Event fever resolved while outcome of the other events was unknown.  Information on Lot/Batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration (at the age of 37-years-old) on 16Jun2021 as second dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she received the second dose of the Pfizer COVID 19 vaccine yesterday and she was having a headache today (17Jun2021). She would like to know if it is okay to take headache medications in this case. Response: Spoke from attached document regarding the use of OTC NSAIDs or Antipyretic medication use after receiving the vaccine and having side effects. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16Jun2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache on Jun2021. Patient mentioned that not a huge reaction; just looking for something to take the edge off. The outcome of the event was unknown.  Information regarding the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: some swelling on his arm; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on the second week in May2021 as unknown single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient stated he sustained some swelling on his arm and he infused twice after to treat the swelling. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: First dose: She felt tired; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history included cancer survivor and very bad digestive issues. Concomitant medications were not reported. On an unspecified date, after the first dose of the covid vaccine, she felt tired. She got the first dose of the covid vaccine, she thought that it was a low dose. She was going to feel out the first dose of the covid vaccine. But nothing really traumatic. It was not so bad. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: daughter might have also gotten the vaccine injected in fatty part of her arm because the same person administered it; The daughter is experiencing the same arm soreness as her mother/her arm is extremely sore/sore arm; This is a spontaneous report from a contactable consumer. This female consumer reported for her daughter. This is report two of three. This is a clone report for the first daughter. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0172, Expiration Date was not reported), via an unspecified route of administration, administered in arm on 09Jun2021 (at the age of 17-year-old) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On an unspecified date the daughter experienced the same arm soreness as her mother. Her arm was killing her. It was reported that, she might have also gotten the vaccine injected in fatty part of her arm because the same person administered it. Reporter's daughters both had the first dose and they had sore arms but she didn't see them get the shot and she doesn't think this happened to them. it hurt for a week. They were both sleeping and can't get information from them. Reporter also stated that if she touched it, she thinks her daughter would complain. Adds both our arms are killing us and it looks like this daughter got the vaccine injected from that same tech at pharmacy. She has not had anything happen yet, except that her arm is extremely sore which it was not the first time. The outcome of the event the daughter is experiencing the same arm soreness as her mother/her arm is extremely sore/sore arm was not resolved and unknown for the other event.  Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: severe inflammation throughout the body; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date patient experienced severe inflammation throughout the body after taking the vaccine. There was no seriousness of Life Threatening, Intervention/Medically Important, Disabling/Incapacitating, Congenital Anomaly/Birth Defect, Hospitalization Required, Death, Hospitalization Prolonged, Other for the reported event severe inflammation throughout the body with BNT162B2. Outcome of event was unknown.  Product Complaint: There is no product complaint associated with this case.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: 2 weeks after 1st dose-pain in both big toes lasting 5-7days; 2 weeks after 1st dose-pain in both big toes lasting 5-7days ending with dark purple color under both big toe nails.; This is a spontaneous report from a contactable consumer(patient). A 72-years-old elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in Left Arm on 12Mar2021 at 19:00 as 1st Dose, Single for COVID-19 immunization.The patient's medical history was reported as none. The patient's Concomitant medications included vitamins nos (VITAMINS NOS) taken for an unspecified indication.The patient did not suffer from covid prior vaccination. The patient did not perform covid tested post vaccination.In Apr2021,2 weeks after 1st dose-pain in both big toes lasting 5-7days ending with dark purple color under both big toe nails. No treatment was received for the events occurred. The outcome for the events was recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site swelling
Clinical narrative: Headache; tennis ball sized lump on her right arm at injection site; This is a spontaneous report from a contactable consumer (patient's mother). This report is 2 of 3.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration at right arm on 16Jun2021 as single dose for COVID-19 immunisation. The patient's medical history included seizure which started when patient was of 18 months (they were so bad that caller had to learn how to do a tracheotomy and she had to learn triage). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) on an unspecified date for COVID-19 immunisation and experienced headache. The patient's mother reported that she experienced headache, a tennis ball sized lump on her right arm at injection site on 16Jun2021. The outcome of headache was not recovered and a tennis ball sized lump on her right arm at injection site was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site mass
Clinical narrative: Second vaccine gave her tennis ball sized lump on her right arm at injection site; Headache; This is a spontaneous report from a contactable consumer (patient mother). This is report 2 of 3. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 16Jun2021 13:30 as 2nd dose, single for covid-19 immunization. The patient medical history included head seizure. They were so bad that caller had to learn how to do a tracheotomy and she had to learn triage. Her daughter started these at 18 months Concomitant medications were not reported.  The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization on an unspecified date and experienced headache. It was reported that, on 16Jun2021, second vaccine gave her tennis ball sized lump on her right arm at injection site and headache. she got her second vaccine and it looked like half a tennis ball on her arm from what the picture she sent her mother; clarified second vaccine gave her tennis ball sized lump on her right arm at injection site and had headache with second vaccine too, still had headache. The outcome of the event headache was not resolved and unknown for event second vaccine gave her tennis ball sized lump on her right arm at injection site.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye swelling, Hypersensitivity
Clinical narrative: eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen; eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen; eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen. Reporter reported that she never wanted to see (Patient name) again because the ladies eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen and she kept wiping it the whole time she was handing her paperwork. (Patient name) volunteers in another town to give Covid vaccines; She was the one who was so upset that no ones getting the Covid vaccine. (Patient name) got her Covid Vaccine like the first month you could get them; and she was so gung-ho on it that if caller said her right arm fell off (Patient name) would just offer to give it to her in her left. Caller did not think the eye had anything to do with Covid. The idea that someone would be wiping their eye while; it was she did not not blame her; they should have had someone else do the paperwork; they should have had (Patient name) wipe her eye first, then put on her gloves and then gave the shot. The outcome of events was unknown.   Information about lot batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's mother) received from a Pfizer sponsored program COVAX US support.   A 15-years-old female patient (second daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0168, expiration date unknown) via an unspecified route of administration on 24May2021 as 1st dose, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0217, expiration date unknown) via an unspecified route of administration on 15Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history and concomitant medications was none. On an unspecified date, the patient experienced sore arm. The mother of the patient reported that her second daughter received the first dose of the vaccine on 24May2021 and the second dose on 15Jun2021 and stated that she had a sore arm. The outcome of the event was unknown.  Information on the lot/batch was available, Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; This is a spontaneous report from contactable consumer 83-year-old female (patient) reported for herself. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in arm left on an unspecified date as 2nd dose, single for COVID-19 immunization (at the age of 83-year-old). Medical history included ongoing gout, ongoing High blood pressure and ongoing pain. Concomitant medications included allopurinol taken for gout, aspirin (ACETYLSALICYLIC ACID), losartan taken for high blood pressure, felodipine for high blood pressure, diclofenac sodium taken for pain. The patient administered BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration, administered in arm left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On an unspecified date, the patient experienced Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine. The patient stated she wanted to go to the Urgent Care, but it was crowded. She feels stressed out, because she was waiting for her daughter to take her to the hospital. She cannot figure out why she hurts so bad. The patient stated she was a lady who can get around and take care of herself and stated several examples of how she was independent, and she exercises. The patient stated her daughter was going to take her to the hospital, because she feels there was something serious going on that day. Outcome of the events were reported as unknown.   Information about lot/batch number is requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; Had 103 Fever; Headache; Nausea; Body aches; This is a spontaneous report from a contactable consumer (Patient's parent). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0179; expiration date: 31Aug2021) via an unspecified route of administration in right arm on 12Jun2021 (at the age of 15-year-old) for COVID-19 immunization. Patient had no medical history and concomitant medications. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183) in unspecified route of administration in left arm on 22May2021 (at the age of 15-year-old) for COVID-19 immunization and had no reaction. On 13Jun2021, one day after vaccination, the patient had 103 fever, headache, nausea, body aches and on 14Jun2021, two days after vaccination, the patient experienced vomiting. As per the reporter, patient was getting the side effect for 5 days now. She had 103 fever for day and half. She was experiencing severe headache. Now, she was experiencing headache, nausea, vomiting and body aches. Reportedly, It was started when she had the second vaccination, started on Sunday and Monday she had a fever and had experience headache and body aches and then on Tuesday fever went away and she started experiencing headache, nausea and vomiting still going on. Reporter's daughter received the vaccine shot, the second one, last Saturday, she was still experiencing side effects. She was having nausea, headache, body ache, and she had 103 fever for three days. Reporter mentioned that they were trying to find out what treatment should they give her. Outcome of the event 103 fever was resolved on 16Jun2021 and for the event headache, nausea, pain and vomiting were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain
Clinical narrative: Really bad pain in the lymph node area of the armpit and breast area 2 days after the first shot; Really bad pain in the lymph node area of the armpit and breast area 2 days after the first shot; This is a spontaneous report from a contactable consumer (patient reported for herself).  A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0177, expiration date unknown) 1st dose, via an unspecified route of administration administered in Arm Left on 18May2021 17:00 (33-year-old at the time of vaccination) as 1st dose, single for covid-19 immunization. Medical history included ongoing thyroid disorder discovered about 2 years ago from 2019 when she had blood work done and birth control (from at least 10 years). Concomitant medication(s) included levothyroxine 0.1 mg, once daily (100mcg 1 tablet by mouth) taken for thyroid disorder from an unspecified start date (has been on it for about 2 years now) and ethinylestradiol, norgestimate (TRI FEMYNOR) once daily taken for birth control from an unspecified start date (has been on it for at least 10 years) and both were ongoing. On 20May2021, 2 days after the first shot, she had really bad pain in the lymph node area of the armpit and breast area. It was reported that on 18May2021 the patient received first dose of vaccine and two days after that shot on 20May2021 she experienced really bad pain in the lymph node area of the armpit and breast area. She wanted to know if that was side effect. She said she could have sworn that she read that a vaccine could travel to the lymph node. The reporter stated that the pain started 20May2021. It was 2 or 3 days for the soreness to go down. It lasted 3 days. The reporter further confirmed that it was completely resolved. patient had not received any treatment. She also stated that she was getting vaccine because travelling and they have a lot of restrictions and she said she wanted to have kids and that was her main concern. The outcome of the events were resolved on 23May2021.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021728456 Same reporter/ drug, different patient/ AE
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Second dose: Spotted next morning after the second vaccine; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration on 08Jun2021 at 17:30 (at the age of 33-years-old) in left arm, as 2nd dose, single for COVID-19 immunization. Medical history included ongoing thyroid, it was discovered about 2 years ago when she had blood work done. Concomitant medications included levothyroxine taken for thyroiditis from an unspecified start date and ongoing and ethinylestradiol, norgestimate (TRI FEMYNOR) taken for birth control from an unspecified start date and ongoing. The historical vaccine of the patient included first dose of BNT162B2 (BNT162B2; Solution for injection; Lot number: EW0177) via an unspecified route of administration on 18May2021 at 17:00 on left arm, 1st dose, single  for COVID-19 immunization and experienced Really bad pain in the lymph node area of the armpit and breast area 2 days after the first shot. It was mentioned that the patient did not require emergency room and physician office visit. The prior vaccinations (within 4 weeks) and events following prior vaccinations were reported as none. On 09Jun2021, the patient experienced that she spotted the next morning after the second vaccine. Two of her coworkers spotted as well. Caller stated the spotting stopped the same day that it started which was on 09Jun2021, and it stopped later in the evening. The outcome of event recovered on 9Jun2021.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; Rash; This is a spontaneous report from a contactable consumer (reporter's daughter). A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date in Jun2021 as a 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient went for Pfizer vaccine, last, two weeks back and she got the first dose of Pfizer and after 3 or 4 days, she was getting itching and rash on an unspecified date in Jun2021. So, still it was coming out going away even though the vaccine took like a three weeks back. Patient second dose was next Tuesday which was like 22Jun2021, reporter questioned that as still patient was getting rashes, reporter wants to know that if patient could get second dose or hold it on. Reporter seriousness for itching and rash was unspecified. The outcome of all events was not recovered.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Head discomfort, Incomplete course of vaccination
Clinical narrative: his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long.; his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long.; felt heaviness on his head; having a hard time breathing; very dizzy; felt a little weak; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient, reported himself). A male patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, LOT number and expiry dates were not provided), via an unspecified route of administration, on 22Dec2020, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced felt heaviness on his head, having a hard time breathing, very dizzy and felt a little weak. Patient described that about five minutes after he got the first vaccine, he felt a heaviness on his head, and a couple minutes later, they gave him a snack to see if it would help at all, and he was having a hard time breathing at that point. Patient was into the ER and poured water on his back, and he was very dizzy. And then about ten minutes after, he started to feel better, felt a little weak, but starting to feel better. When he was in the ER, they gave him some fluids, and that's what he thinks made him feel better. Patient reported his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long. No further details provided or able to be obtained to complete report. Outcome of the events was unknown.   Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long.; his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long.; felt heaviness on his head; having a hard time breathing; very dizzy; felt a little weak; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient, reported himself). A male patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, LOT number and expiry dates were not provided), via an unspecified route of administration, on 22Dec2020, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced felt heaviness on his head, having a hard time breathing, very dizzy and felt a little weak. Patient described that about five minutes after he got the first vaccine, he felt a heaviness on his head, and a couple minutes later, they gave him a snack to see if it would help at all, and he was having a hard time breathing at that point. Patient was into the ER and poured water on his back, and he was very dizzy. And then about ten minutes after, he started to feel better, felt a little weak, but starting to feel better. When he was in the ER, they gave him some fluids, and that's what he thinks made him feel better. Patient reported his doctor recommended him not getting the second dose, and he did want to know if he should or should not get the second dose, since it's been so long. No further details provided or able to be obtained to complete report. Outcome of the events was unknown.   Information about batch/ lot number has been requested.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: severe headache; vomiting; This is a spontaneous report from a contactable nurse. A nurse reported that a 17-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization as No reaction on previous exposure to drug. The patient experienced severe headache and vomiting on 17Jun2021. The group that this patient came in with is from an under-served community and most likely these kids came from homeless shelters or a community based housing for them. So they got the COVID vaccine to protect them since they live in like a home in a group setting. Reporter would call it a mild to moderate reaction and she thought that they would of been fine without medical intervention. They were able to be okay with just calming down and that type of thing. Reporter seriousness for complaining of severe headache and vomiting was not serious. The outcome of severe headache and vomiting was recovering. The reporter did not think that the COVID vaccine necessarily caused the reactions. She thought that it was anxiety induced symptoms. The primary source reporter considered events were unrelated.  Information on Lot/Batch number was available. Additional information had been requested.