chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller is a pharmacist asking about the second dose of Comirnaty for her child, who is sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Caller is a pharmacist asking about the second dose of Comirnaty for her child, who is sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The pharmacist wanted to know about the second dose of Comirnaty for her child, who is sick. Her child has was not diagnosed with anything, but she wanted to know if there was information about getting the second dose with a current illness.  Follow-up (20Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness
Clinical narrative: felt dizzy/ Dizziness; Aches across his shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "felt dizzy/ Dizziness"; ARTHRALGIA (non-serious), outcome "recovered", described as "Aches across his shoulders".  Additional Information: Reason for no lot number of Covid-19 Vaccine was Caller unwilling to complete the report. Caller said that about 2 hours after his dose, he felt dizzy and had aches across his shoulders. He said that the dizziness lasted about 15 minutes or less, and the aches were for a hour or 2. He had no reaction to the second dose or the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Head discomfort, Oropharyngeal pain, Pyrexia
Clinical narrative: Low grade fever; Head congestion; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 11:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 03Jan2022 18:00, outcome "not recovered", described as "Low grade fever"; HEAD DISCOMFORT (non-serious) with onset 03Jan2022 18:00, outcome "not recovered", described as "Head congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 03Jan2022 18:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, head discomfort, oropharyngeal pain.  Additional information: Facility type vaccine: Hospital. covid prior vaccination. no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog".  Additional information: Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. I had a patient who experienced brain fog with the adult dose and she had concerned about the possibility of that type of side effect for pediatrics before she makes a decision to vaccinate her child.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: inflammation n my body decreased to the point where I had the best mobility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "I have mixed connective tissue disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "inflammation n my body decreased to the point where I had the best mobility".  Additional information: Patient have mixed connective tissue disease, when got second shot, 2 weeks later the inflammation in body decreased to the point where patient had the best mobility with the lowest pain than had for years. (benefit lasted for almost 8 weeks) 2 weeks ago Patient got the booster, and beginning to see the same response. Patients Doctor is stumped.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: When she first got the vaccine she had a bright red strawberry colored, it was the size of a dime and then got to the size of a quarter at it's largest size; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "recovering", described as "When she first got the vaccine she had a bright red strawberry colored, it was the size of a dime and then got to the size of a quarter at it's largest size".  Additional info: Patient stated, she had a bright red strawberry coloured. When she first got the vaccine it was the size of a dime and then got to the size of a quarter at it's largest size it was like the size of he opening of a cup or a mug, it was getting better now and fading in color.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: have the same shoulder pain that I experienced with the first two vaccine, very similar; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 18Jan2021 (Lot number: FE3594) at the age of 42 years as dose 2, single and administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Verbatim: Type 1 diabetes. The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "have the same shoulder pain that I experienced with the first two vaccine, very similar".  Additional information: Consumer was informed about Pfizer. Consumer was informed about Information department. Consumer was provided with Information department contact information. When probed if patient has received the Pfizer COVID-19 Booster Shot: Consumer stated, "Correct." Consumer stated, "I have the Lot number." Consumer stated, "I would not be surprised. It is definitely noticeable shoulder pain so it lead me to believe that I got something." Laboratory tests were none. Investigation Assessment: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired/ tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired/ tiredness"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program. A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced peripheral swelling (legs swelled-up like before), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Insomnia, Pain in extremity
Clinical narrative: Having pain in arm ever since got Vaccine and she keep going move it; pain is really bad; she cries; missed to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: AMLODIPINE taken for hypertension; LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (First Dose), when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Having pain in arm ever since got Vaccine and she keep going move it; pain is really bad"; CRYING (non-serious), outcome "unknown", described as "she cries"; INSOMNIA (non-serious), outcome "unknown", described as "missed to sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Photophobia, Vision blurred
Clinical narrative: blurred vision; irritation; initial light sensitivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; EYE IRRITATION (non-serious), outcome "unknown", described as "irritation"; PHOTOPHOBIA (non-serious), outcome "unknown", described as "initial light sensitivity".  Additional information: Company Info Customer Verbatim: Hi- Is there a place to report adverse reactions to covid vaccine. Since getting my first dose I have been experiencing issues with my eyes, blurred vision, irritation, initial light sensitivity. Have there been other reports of this? Kindly advise.  Follow-up (17Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain got worse; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "joint pain got worse".  Additional information: patient reported xeljanz was placed on hold on 29Oct21 for 6 weeks per md due to getting the covid vaccine and wanted her to be off xeljanz for that period. joint pain got worse due to missed doses, stated "she will never do that again". no infections or illnesses reported. patient told she would have md at appointment that day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had a headache, dizziness, fatigue and head discomfort (pressure in his head), with outcome of unknown. Additional information: Patient inquired as to how to stop all of these side effects. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tinnitus
Clinical narrative: fingers and toes numb; fingers and toes numb; ringing/humming in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "fingers and toes numb"; TINNITUS (non-serious), outcome "unknown", described as "ringing/humming in ears".  Additional information: The patient received the 2nd shot of Pfizer COVID vaccine on 27Dec2021 and reports that it made her nose run and was ongoing, ears were still humming and ringing, numbness in fingers remains and now she developed lump on her pinky finger, a lump on her left foot (toe), lump on right side of her stomach. Stated she felts 'these pains' and started rubbing it and was a lump. Also reports having had diarrhea and an ongoing raspy voice. Stated she knows it was from the vaccine. Stated she went to her HCP but her HCP doesn't know what to do. Asking for recommendations on how to get rid of humming and ringing noise in ears and the lumps on her body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Vaccination site irritation, Vaccination site pain, Vomiting
Clinical narrative: soreness and irritation around the injection site; soreness and irritation around the injection site; Diarrhea; Vomiting; shortness of breath; Wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE IRRITATION (non-serious), outcome "not recovered" and all described as "soreness and irritation around the injection site"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 07Jan2022, outcome "unknown", described as "Vomiting"; DYSPNOEA (non-serious) with onset 07Jan2022, outcome "unknown", described as "shortness of breath"; WHEEZING (non-serious) with onset 07Jan2022, outcome "unknown", described as "Wheezing".  Additional Information: The Patient stated that she had the booster on Wednesday and since then she was experiencing soreness and irritation around the injection site. She was also experiencing diarrhea, today she experienced vomiting, shortness of breath, and wheezing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: soreness and irritation around the injection site; soreness and irritation around the injection site; Diarrhea; Vomiting; shortness of breath; Wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE IRRITATION (non-serious), outcome "not recovered" and all described as "soreness and irritation around the injection site"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 07Jan2022, outcome "unknown", described as "Vomiting"; DYSPNOEA (non-serious) with onset 07Jan2022, outcome "unknown", described as "shortness of breath"; WHEEZING (non-serious) with onset 07Jan2022, outcome "unknown", described as "Wheezing".  Additional Information: The Patient stated that she had the booster on Wednesday and since then she was experiencing soreness and irritation around the injection site. She was also experiencing diarrhea, today she experienced vomiting, shortness of breath, and wheezing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: experiencing  tingling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "experiencing tingling".  Additional information:Caller: Concern is a pharmacist and she had a patient, after receiving her third dose of the vaccine, she's experiencing tingling specially with her foot. No color cap provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menopause, Menstrual disorder
Clinical narrative: I got the vaccine and went into menopause; I too have experienced menstruation changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENOPAUSE (non-serious), outcome "unknown", described as "I got the vaccine and went into menopause"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "I too have experienced menstruation changes".  Additional information: Patient reported she was not a conspiracy nut. She know that this is being studied right now in a scientific way, but she also know that it's not being taken seriously by some people in the scientific Community. But she want it on record that she too have experienced menstruation changes. She got the vaccine and went into menopause. She discounted this at first, as 45 is the youngest age that it is "normal" to experience menopause.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I had a slight headcold after the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "I had a slight headcold after the 1st dose". Therapeutic measures were taken as a result of nasopharyngitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Full blood count normal, Therapeutic response unexpected
Clinical narrative: It appears that each time I received the COVID vaccine my rate of blood dropped to near normal.; It appears that each time I received the COVID vaccine my rate of blood dropped to near normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "polycythemia vera" (unspecified if ongoing), notes: I have polycythemia vera which causes me to generate large quantities of, red blood cells. The patient's concomitant medications were not reported. The following information was reported: FULL BLOOD COUNT NORMAL (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "It appears that each time I received the COVID vaccine my rate of blood dropped to near normal.". The patient underwent the following laboratory tests and procedures: blood test: near normal, notes: my rate of blood dropped to near normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, SARS-CoV-2 test
Clinical narrative: not feeling well; Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "Sick"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that has gotten sick (believe in the past week). He has gotten a Covid test, but we have not heard a result. - I am not sure what the resolution of "not feeling well" was, but I know the relative is high risk and that he must be well enough to see her without fret of getting her sick. I do not know the at-risk relative's vaccination status. They are elderly, female, likely white, and I think might have diabetes and has had trouble having discipline managing it (would need to confirm part about diabetes). If I learn vaccination status, will submit an AE report. She recently "is not doing well". I believe (withheld) is not in isolation - have not gotten direct report, but is likely feeling better. Believe (withheld), likely (withheld).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Neuralgia
Clinical narrative: I'm getting a lot of back pain/mild back and nerve pain; I'm getting a lot of back pain/mild back and nerve pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6955) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), NEURALGIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "I'm getting a lot of back pain/mild back and nerve pain". The event "i'm getting a lot of back pain/mild back and nerve pain" and "i'm getting a lot of back pain/mild back and nerve pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, neuralgia.  Additional information: The patient had a question about after his shot symptoms. The patient took his two doses. After his first covid shot on 12Mar2021, he experienced mild back and nerve pain. He was interested to see if this was happening to other people or not, he did not know if this was a Pfizer thing. He was not admitted to the hospital due to events. No emergency room visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: hard to hear; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "hard to hear".  Additional information: She already got the two doses of Pfizer Covid-19 vaccine and then apart from the first and second dose it's more than 21 days and she mentioned about having health problems after taking the two doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: first dose: pain on the side of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 11:00 (Lot number: EN6200) at the age of 27 years as dose 1, single for covid-19 immunisation. Family history included: "Fibromyalgia", start date: 2020 (ongoing), notes: Diagnosed with mid year of 2020. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "first dose: pain on the side of injection".  Additional information: The Reporter was a consumer reporting unusual side effects after receiving the booster dose Adult Pfizer Covid 19 Vaccine. The caller had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects. The booster dose Adult Pfizer Covid 19 Vaccine was unusual side effect. The caller did not call to report, wanted to let play out. Caller provides lot: FF2593 for Adult Pfizer Covid 19 Vaccine booster dose and describes at batch number. The Reporter had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects: The caller clarifies the caller had pain on the side of injection after receiving both first and second dose Adult Pfizer Covid 19 Vaccine that lasted for a day or two for both first and second dose Adult Pfizer Covid 19 Vaccine. First dose: pain on the side of injection: Agent asks caller if pain at injection site recovered completely or with lasting effects and caller replies, the pain began 7 or 8 hours after receiving first dose and was a slow onset. First and second dose was pain on the side of injection: The pain went away after a day or two for both the first and second dose Adult Pfizer Covid 19 Vaccine.  Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6200 and ER2613 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200 and lot ER2613, fill lot EN5332 and EP8678, and the formulated drug product lot EN5321 and lot EP8565. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My whole family except my 12 years has gotten the pfizer and we had no problems just a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My whole family except my 12 years has gotten the pfizer and we had no problems just a sore arm".  Additional information: We need to know if these 2 reports are in fact for different patients as one is 34yo female vs. the other one is 58yo female, but both sharing the same username. In some live chats, we pull members from a larger community that participates in many different studies. Since those members aren't a part of our Pfizer community, they are assigned a generic username and given a generic password. These are two different patients.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200077886 Same reporter/drug/AE, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the first COVID vaccine, she just had pain in her arm, and she had to hold her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: EW0153) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "After the first COVID vaccine, she just had pain in her arm, and she had to hold her arm".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Palpitations
Clinical narrative: heart palpitation; EKG abnormal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (153987). The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid 19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitation"; ELECTROCARDIOGRAM ABNORMAL (non-serious), outcome "recovered", described as "EKG abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Need stat troponin levels (Image attached). The patient experienced heart palpitation after getting second dose of the Pfizer vaccine. The patient did an EKG at doctor office a few day ago and it came back abnormal and so the patient went to hospital and got checked and the EKG came back normal.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Mammogram, Poor quality sleep, Smear cervix
Clinical narrative: heaviness in my head; don't can sleep deeply; weird feeling that I have in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 16:00 (Lot number: EW0168) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot/Batch number: EW0161, Time of vaccination: 03:00 PM, Anatomical location: left arm, Dose 1, Single), administration date: 18Apr2021, for COVID-19 Immunization, reaction(s): "feel a kind and strange sensation in my brain/ werid feeling that I have in my head", "heaviness in my head", "forgot things", "can't sleep deeply", "feel horrible", "tremble", "cold", "sweat", "feel pain for all my body", "feel my brain in burn", "fever, high fever", "feeling that I thinking slowest". The following information was reported: HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "heaviness in my head"; POOR QUALITY SLEEP (non-serious), outcome "not recovered", described as "don't can sleep deeply"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "werid feeling that I have in my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There was no prior vaccination.  There was no specific relevant test for thromboembolic events with thrombocytopenia. Since the patient took the first dose, the patient felt a kind and strange sensation in the brain of feeling that the patient was thinking slowest that and normal or usually the patient did and felt that the patient forgot things, can't sleep deeply. The first day vaccination the patient felt horrible, trembled, got cold, sweat, felt pain for all over the body, had fever, high fever and feel the brain is burn, (burning literally) which is with pass of days felt slower than normal. The patient got vaccinated for the patient has a little baby and mom 47 years old; but the patient doesn't want to do more. Now the patient forgets things it's always heavy in the patient's head and still feel occasional burning in the head. The patient doesn't know what to do with that heaviness in the head, can't sleep deeply, that weird feeling that the patient has in head since the patient used these vaccines and that does not go away.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Hyperaemia, Polymerase chain reaction
Clinical narrative: stomach upset; congestion; HA; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EL3247) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details , Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EL3247, Prev dose lot unknown: False, Prev dose administration date: 23Feb2021 , Prev dose dose number: 1), administration date: 23Feb2021, when the patient was 30 years old, for covid 19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "recovering", described as "stomach upset"; HYPERAEMIA (non-serious), outcome "recovering", described as "congestion"; HEADACHE (non-serious), outcome "recovering", described as "HA". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of abdominal discomfort, hyperaemia, headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: sick; flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; INFLUENZA (non-serious), outcome "unknown", described as "flu".  additional Information: reporter called on behalf of his step son who is sick and having a flu right now. They would like to reschedule the appointment of a second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: stopped her period/ Missed menstrual period; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FK5618) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 24Dec2021, outcome "not recovered", described as "stopped her period/ Missed menstrual period".  Additional Information: Reporter daughter got the first dose on 08Dec2021 and second dose on 29Dec2021. Wants to report a reaction- it stopped her period completely. Patient got her first period in Sep2021- patient was very regular and gets it every 28 days. Patient had periods in October and November. The next period should have started on 24Dec2021 however patient still has not started to this day. Patient states, this was very concerning to me. Patient was going to take her to the doctor but know they aren't going to give me any answers? Do you have any information? Patient has read articles reporting girls getting heavier periods. Reporter reports that her daughter has not had a menstrual period since her first dose. Reporter was concerned that her daughter has not gotten her menstrual period since Nov2021. Family Medical History Relevant to AE(s): not provided. No other vaccines were given within 4 weeks. Emergency Room? No. Physician Office? No. Additional Vaccines had not Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Outbreak of Pityriasis Rosea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 16:00 (Lot number: EW0169) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: ER8732, prev dose lot unknown: False, prev dose administration date: 26Mar2021, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 26Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: PITYRIASIS ROSEA (non-serious) with onset 23Apr2021, outcome "not recovered", described as "Outbreak of Pityriasis Rosea". The event "outbreak of pityriasis rosea" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pityriasis rosea. Additional Information: Outbreak of Pityriasis Rosea after 2nd shot and waned slightly before 3rd shot. Facility type vaccine was reported to be Doctor's office or Urgent care. There were no other vaccine administered in four weeks. Patient had other medications in two weeks. Patient had no COVID prior to vaccination and was not tested for COVID post vaccination. There were no allergies reported.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy
Clinical narrative: enlarged lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The Pfizer COVID -19 vaccine been associated with enlarged lymph nodes in patients after administration. It was reported that after receiving the 2nd Pfizer COVID -19 vaccine the patient experienced enlarged lymph node. The physician ordered a biopsy and it came back normal. Patient questioned if they should get the booster and Dr recommended that the patient get the vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.