chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Neck pain, Pain in extremity
Clinical narrative: Booster; pain in the left arm neck and shoulder; pain in the left arm neck and shoulder; pain in the left arm neck and shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male 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: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain in the left arm neck and shoulder".  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Product use issue, Rash pruritic
Clinical narrative: pruritis and rash small raised red beneath breasts under arms stomach and upper chest; pruritis and rash small raised red beneath breasts under arms stomach and upper chest; Booster; other vaccine same date product=Flu; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 13:45 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 03Nov2021 (Batch/Lot number: unknown) as single for immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "HDL" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; TELMISARTAN; ROSUVASTATIN; PANTOPRAZOLE. Past drug history included: Dermabond, reaction(s): "Known Allergies: Dermabond". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Same facility has information, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 11Jan2021, when the patient was 64 years old, for COVID-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Same facility has information, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 21Dec2020, when the patient was 64 years old, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 03Nov2021, outcome "unknown", described as "other vaccine same date product=Flu"; ERYTHEMA (non-serious), RASH PRURITIC (non-serious) all with onset 05Nov2021, outcome "recovering" and all described as "pruritis and rash small raised red beneath breasts under arms stomach and upper chest". Therapeutic measures were taken as a result of erythema, rash pruritic.  Additional information: The patient was treated with steroid ointment for pruritis and rash small raised red beneath breasts under arms stomach and upper chest. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Lf arm still pain after 3 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Lf arm still pain after 3 weeks".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen lymph nodes/ She notices it under right side of jaw; no sore throat but I can feel it ache; the first shot made my immune system weak; 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 female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "hypothyroidism" (ongoing); "gluten allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen lymph nodes/ She notices it under right side of jaw"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "no sore throat but I can feel it ache"; IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "the first shot made my immune system weak".  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Irritability
Clinical narrative: cough; felt miserable and grouchy; felt miserable and grouchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US254562.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 64 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 (Dose-1), for Covid-19 immunization. The following information was reported: COUGH (non-serious) with onset Nov2021, outcome "not recovered", described as "cough"; FEELING ABNORMAL (non-serious), IRRITABILITY (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "felt miserable and grouchy".  Additional information: Patient had cough, felt miserable and grouchy for the past 3 days since he got his 2nd COVID vaccine on 02Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Pain
Clinical narrative: upper body inflammation; pain; 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 male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: Bnt162b2 (Dose: 01), for Covid-19 immunization.  The following information was reported: INFLAMMATION (non-serious) with onset 04Apr2021, outcome "recovered" (2021), described as "upper body inflammation"; PAIN (non-serious) with onset 04Apr2021, outcome "recovered" (2021), described as "pain".  Additional information: Patient received 2nd dose of Covid vaccine on 27Mar . 8 days later he started experiencing upper body inflammation and pain and that lasted a couple of weeks. He is wondering if there have been any other reported incidents of this from the Covid vaccine. Relayed RA information and transferred. Faxed due to long hold times.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: is having some stomach pain; I am having some discomfort in my stomach and I am taking Prilosec; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "is having some stomach pain"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "I am having some discomfort in my stomach and I am taking Prilosec". Therapeutic measures were taken as a result of abdominal pain upper, abdominal discomfort.  Additional information: Caller is due to get her booster dose and she is taking Prilosec and is having some stomach pain, wants to know if she can get the booster. She is asking if it's safe to get the Covid-19 vaccine booster while also taking Prilosec but she did state that she is already on the medication for 5 days. So, while after her first and second dose of the Covid-19 Vaccine. Consumer stated, I already had the original shot the last one was 28Apr. So, I am a candidate for the booster but at this moment I am having some discomfort in my stomach and I am taking Prilosec and I am wondering if it's safe to be the booster.  Follow-up (PRD 09Nov2021/SRD 10Nov2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself included: Updated information: Clinical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (15Dec2021)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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: After dose 1 and dose 2 I had a fever and body soreness; After dose 1 and dose 2 I had a fever and body soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 10:00 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and administered in arm left, administration date 02Feb2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Allergy to Shrimp. The Patient experienced PAIN (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "After dose 1 and dose 2 I had a fever and body soreness". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea
Clinical narrative: Booster; it made her nauseous all night and she is still nauseous; 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 85 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 09Nov2021, outcome "not recovered", described as "it made her nauseous all night and she is still nauseous". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Urticaria
Clinical narrative: difficulty in breathing; breakout in hives; could not swallow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 38 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "severe gluten allergy" (unspecified if ongoing), notes: Caller said that she has a severe gluten allergy. The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "difficulty in breathing"; URTICARIA (non-serious), outcome "unknown", described as "breakout in hives"; DYSPHAGIA (non-serious), outcome "unknown", described as "could not swallow".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: She gets a burning tongue where it feels like it is on fire; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TONGUE DISCOMFORT (non-serious), outcome "unknown", described as "She gets a burning tongue where it feels like it is on fire".  Additional information: After receiving both primary vaccination series, patient experienced a burning tongue after she ate Salmon. She described the feeling as fire on her tongue. When she eats salmon she gets a burning tongue where it feels like it is on fire. That happened with both doses of the vaccine. It was reported that patient wants to get booster dose. patient queried for does the booster dose have the same ingredients as the others she got. and further queried for is it a full dose or half dose  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Fast heartbeat after second shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (vaccine: 1st dose, Date: 19Oct2021, NDC/expiration: unknown, Lot: unknown, Site: right arm), administration date: 19Oct2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Fast heartbeat after second shot.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient is on several medications but does not feel it is relevant to the report. investigation Assessment: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Dec2021): Follow-up activities closed. Batch/lot number not available
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea
Clinical narrative: Nausea; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 56 year-old female patient received bnt162b2 (COMIRNATY) (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: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tremor
Clinical narrative: his arm got numb; shaking; 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 53 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date Feb2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: Feb2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "his arm got numb"; TREMOR (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "shaking".  Additional Context: Warm transfer (name) with Pfizer states the caller is a patient, caller states he was 52 at time of the administration of Pfizer Covid vaccines, when he got his vaccines reports arm got numb and started shaking, also heard that some people who had numbness got nerve damage. Clarifies that it happened after the second shot took all day to recover, right arm, completely recovered. States that he had spoken to people who know people that have had permanent nerve damage after the vaccines. No further information provided. Recovered completely, states he is unsure of the exact date he got the vaccine, states it happened all in about 10 minutes immediately after the second dose. Caller states the first dose didn't do anything, just had issues after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depressed mood
Clinical narrative: felt down; had no energy at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 70 years 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: DEPRESSED MOOD (non-serious) with onset May2021, outcome "unknown", described as "felt down"; ASTHENIA (non-serious) with onset May2021, outcome "unknown", described as "had no energy at all".  Additional information: She is supposed to be getting the booster Pfizer COVID Vaccine this month but she is having eye surgery for cataract and replacing the lens at the end of November. Then she will have the other eye done the first week in December. She is going to be on antibiotics and steroids. Is there any interaction between these medications and the vaccine? She is hesitant. Caller clarified the medications she is asking about. Caller states she will be on Prolensa for two weeks, Prednisolone for the whole month for both eyes, and Moxifloxacin for 9 days. She starts Moxifloxacin 2 days before the surgery and then takes it for one week later. A friend that was on a steroid and has only one eye got her thinking about being on the steroids and COVID. Caller clarified that the friend that had only one eye and was on steroids had nothing to do with the vaccine, but it just got her thinking. All this is unknown and things change. She is worried about it. If they say she has to wait two or three months she will. Pfizer COVID Vaccine: caller states she doesn't have vaccination card to provide NDC, lot, and expiry. The card is locked up with her passport. Therapy start date:  she got the first one in the first part of May2021. Caller clarified that she has not started the medications Prolensa, Prednisolone, or Moxifloxacin. She will start Moxifloxacin two days before surgery. No further details provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling hot, Headache, Malaise, Oropharyngeal discomfort
Clinical narrative: Feeling hot; Headaches; Stomach; Throat; General malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: FEELING HOT (non-serious), outcome "unknown", described as "Feeling hot"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "Throat"; MALAISE (non-serious), outcome "unknown", described as "General malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up 15Dec2021): Follow-up activities closed. Batch/lot number not available
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Inflammation, Muscular weakness, Pain in extremity
Clinical narrative: Inflammation starting yesterday in his hands; Hands feel weak; hands feel weak and hurt; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "pneumonia" (unspecified if ongoing), notes: hospitalized for one day (27Sep2021); "hospitalized", start date: 27Sep2021, stop date: 27Sep2021, notes: for pneumonia. The patient's concomitant medications were not reported. Past drug history included: Xeljanz xr, start date: Sep2020, for Rheumatoid Arthritis, notes: Strength: 11Mg, Manufacturer: Pfizer, Dose 11mg once daily. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; INFLAMMATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "Inflammation starting yesterday in his hands"; MUSCULAR WEAKNESS (non-serious) with onset 09Nov2021, outcome "unknown", described as "Hands feel weak"; PAIN IN EXTREMITY (non-serious) with onset 09Nov2021, outcome "unknown", described as "hands feel weak and hurt".  Additional information: The patient reported, he reported starting back on xeljanz for about a week, and then was back on hold with his xeljanz because his md instructed him to hold his xeljanz for 15 days after his covid booster, he was on day 10 withholding his xeljanz.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Hasn't felt good since the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: Flu vaccine (She mentions her husband gets the flu shot every year). The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Hasn't felt good since the vaccine".  Additional information: The caller (patient wife) mentions her husband and is eligible for his third dose, but the withheld is not giving Pfizer. The withheld is only giving Moderna and Johnson&Johnson. She was told they are not to mix vaccines, so she did not know what to do about her husband. Her husband cannot even get the Pfizer vaccine from his own caregivers. The caller states she did not know if she should get him the third shot or what. She knows they said not to mix vaccines. Her husband said he had not felt good since he took the first two shots, but they have seen anything like they did with her. She did not know what to do.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood test, Endoscopy, Eye pain
Clinical narrative: heart racing; GI/ Stomach problems; muscle tremors; weakness; pain in her eyes; head feeling foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (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: PALPITATIONS (non-serious) with onset Nov2021, outcome "not recovered", described as "heart racing"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "not recovered", described as "GI/ Stomach problems"; TREMOR (non-serious) with onset Nov2021, outcome "not recovered", described as "muscle tremors"; ASTHENIA (non-serious) with onset Nov2021, outcome "not recovered", described as "weakness"; EYE PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "pain in her eyes"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "not recovered", described as "head feeling foggy". The events "heart racing", "gi/ stomach problems", "muscle tremors", "weakness", "pain in her eyes" and "head feeling foggy" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 10nov2021, adverse event was Forwarded and withheld, reporter provided verification of contact address on 09Nov2021. on 09Nov2021 reporter wife received 1 Pfizer vaccine shot, She was having ongoing issue -heart racing, GI/stomach problems, muscle tremors and weakness, pain in her eyes, head feeling foggy, and more. She is very scared these symptoms have been caused by the vaccine. She has been to the cardiologist (2x), GI Dr (endoscopy), been to ER 3x, tons of bloodwork. All normal. We are not anti-vax and this was not political. do not know where to turn and looking for help.  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, Palpitations, Tremor
Clinical narrative: heart racing; GI/ Stomach problems; muscle tremors; weakness; pain in her eyes; head feeling foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (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: PALPITATIONS (non-serious) with onset Nov2021, outcome "not recovered", described as "heart racing"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "not recovered", described as "GI/ Stomach problems"; TREMOR (non-serious) with onset Nov2021, outcome "not recovered", described as "muscle tremors"; ASTHENIA (non-serious) with onset Nov2021, outcome "not recovered", described as "weakness"; EYE PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "pain in her eyes"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "not recovered", described as "head feeling foggy". The events "heart racing", "gi/ stomach problems", "muscle tremors", "weakness", "pain in her eyes" and "head feeling foggy" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 10nov2021, adverse event was Forwarded and withheld, reporter provided verification of contact address on 09Nov2021. on 09Nov2021 reporter wife received 1 Pfizer vaccine shot, She was having ongoing issue -heart racing, GI/stomach problems, muscle tremors and weakness, pain in her eyes, head feeling foggy, and more. She is very scared these symptoms have been caused by the vaccine. She has been to the cardiologist (2x), GI Dr (endoscopy), been to ER 3x, tons of bloodwork. All normal. We are not anti-vax and this was not political. do not know where to turn and looking for help.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Headache, Malaise, Oropharyngeal pain
Clinical narrative: feeling hot; stomach aches; throat aches; head aches; general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2; Formulation: Solution for Injection) (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 HOT (non-serious), outcome "unknown", described as "feeling hot"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach aches"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "throat aches"; HEADACHE (non-serious), outcome "unknown", described as "head aches"; MALAISE (non-serious), outcome "unknown", described as "general malaise". Action taken for bnt162b2 (BNT162B2) was not applicable.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 10:45 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2021, outcome "unknown", described as "Sore arm"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 10Nov2021, outcome "unknown", described as "Inappropriate age at vaccine administration". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered was hospital or pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Device Date was 11Nov2021. Patient did not have any allergy with drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 24 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 "sore arm".  Additional information: Vaccination Facility Type: Hospital. The patient had no reaction to first dose aside from sore arm. The patient was not taking any other products. Investigation assessment was done. The reporter was not having the vaccination card at the time of the report to provide the date, lot, NDC or expiration dates of both doses. The dose was administered around 1700 or 1800. As per the reporter, the patient had been healthy. There was no history of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. There were no additional vaccines administered on same date of the pfizer suspect. There was no prior vaccinations within 4 weeks. Apart from Covid vaccine no other prior vaccinations done. There was no relevant family medical history and no relevant tests done.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2], No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Influenza virus test, Pain in extremity, SARS-CoV-2 test
Clinical narrative: experienced diarrhea; Vomiting; has not eaten anything but a couple of jelly sandwiches; He said his arm was a little sore; patient had arm soreness and he said his arm is just a little bit tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 16:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "severe seasonal allergies" (unspecified if ongoing), notes: patient does have pretty severe seasonal allergies.; "Cough" (unspecified if ongoing), notes: Patient had a cold probably 3 weeks ago and it lingered and he has a slight cough; "Cold" (unspecified if ongoing), notes: Patient had a cold probably 3 weeks ago and it lingered and he has a slight cough. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 16Nov2021 06:30, outcome "recovering", described as "experienced diarrhea"; VOMITING (non-serious) with onset 16Nov2021 06:30, outcome "recovering", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "has not eaten anything but a couple of jelly sandwiches"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "He said his arm was a little sore"; TENDERNESS (non-serious) with onset Nov2021, outcome "unknown", described as "patient had arm soreness and he said his arm is just a little bit tender". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient underwent investigation assessment. He had no site reaction and did not require emergency room visit, was just in home care and did not go to physician office. The prior vaccinations (within 4 weeks) and family medical history were reported as none.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vomiting
Clinical narrative: experienced diarrhea; Vomiting; has not eaten anything but a couple of jelly sandwiches; He said his arm was a little sore; patient had arm soreness and he said his arm is just a little bit tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 16:30 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "severe seasonal allergies" (unspecified if ongoing), notes: patient does have pretty severe seasonal allergies.; "Cough" (unspecified if ongoing), notes: Patient had a cold probably 3 weeks ago and it lingered and he has a slight cough; "Cold" (unspecified if ongoing), notes: Patient had a cold probably 3 weeks ago and it lingered and he has a slight cough. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 16Nov2021 06:30, outcome "recovering", described as "experienced diarrhea"; VOMITING (non-serious) with onset 16Nov2021 06:30, outcome "recovering", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "has not eaten anything but a couple of jelly sandwiches"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "He said his arm was a little sore"; TENDERNESS (non-serious) with onset Nov2021, outcome "unknown", described as "patient had arm soreness and he said his arm is just a little bit tender". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient underwent investigation assessment. He had no site reaction and did not require emergency room visit, was just in home care and did not go to physician office. The prior vaccinations (within 4 weeks) and family medical history were reported as none.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Investigation, Overdose, Pain in extremity, Product preparation error
Clinical narrative: Booster was administered to a patient without being diluted; Booster was administered to a patient without being diluted; Booster was administered to a patient without being diluted; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Nov2021 15:00 (Lot number: FF2590) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Abnormal Right Mammogram" (unspecified if ongoing), notes: Illness/AE: Abnormal Right Mammogram, Onset date: Unknown; "Thyroid Nodule" (unspecified if ongoing); "History of Severe Depression" (unspecified if ongoing); "ADHD" (ongoing). Concomitant medication(s) included: VYVANSE taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "Booster was administered to a patient without being diluted"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information  Response: Disclaimer noted. Spoke from the attached document under no diluent, resulting in higher than authorized dose. Do not repeat dose Inform the recipient of the potential for local and systemic adverse events. If the administration error resulted in a higher-than-authorized vaccine dose, in general the second dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the second dose, the decision to administer the second dose may be assessed on a case-by-case basis.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (7Dec2021): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to HCP letter sent included that:  Additional Information: First Name, Mailing Address, Patient Initial, Age at Vaccination, Product Coding, Biological Product, Dosage Regimens, Dose Description, Lot Number, Route of Administration, Anatomical Location, Best Doctor/Health Care Professional Information, Vaccine Facility Information, Concomitant Drug, Relevant Med History, Historical Vaccine. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications)
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Breast enlargement, Breast pain, Chest pain, Immunisation, Lymphoedema
Clinical narrative: lymphdemia; enlarged chest/breast with burning and sensitivity; enlarged chest/breast with burning and sensitivity; enlarged chest/breast with burning and sensitivity; Dose Number 3/ 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 10:00 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Right, Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "enlarged chest/breast with burning and sensitivity", "lymphdemia", "enlarged chest/breast with burning and sensitivity", "enlarged chest/breast with burning and sensitivity"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Right, Administration Time: 02:00 PM), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 10:00, outcome "unknown", described as "Dose Number 3/ 3rd shot"; LYMPHOEDEMA (non-serious) with onset 26Nov2021 20:45, outcome "recovering", described as "lymphdemia"; BREAST PAIN (non-serious), BREAST ENLARGEMENT (non-serious), CHEST PAIN (non-serious) all with onset 26Nov2021 20:45, outcome "recovering" and all described as "enlarged chest/breast with burning and sensitivity". The events "lymphdemia", "enlarged chest/breast with burning and sensitivity", "enlarged chest/breast with burning and sensitivity" and "enlarged chest/breast with burning and sensitivity" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of lymphoedema, breast pain, breast enlargement, chest pain.  Additional information: Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. It was reported that 3rd shot resulted in lymphdemia and enlarged chest/breast with burning and sensitivity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: Severe pain in abdomen (resembling appendicitis) during menstruation; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,), administered in arm left, administration date 21Dec2020 09:30 (Lot number: EJ 1685) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Uterine leiomyoma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication included: NORTREL [LEVONORGESTREL]. The following information was reported: ABDOMINAL PAIN (medically significant) with onset 27Dec2020 00:30, outcome "recovered", described as "Severe pain in abdomen (resembling appendicitis) during menstruation". The event "severe pain in abdomen (resembling appendicitis) during menstruation" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; sars-cov-2 test: (28Dec2020) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of abdominal pain which included intravenous pain medication. The patient received her second dose on 11Jan2021 at 09:30 (lot number: EJ 3246) for Covid 19 immunization.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Abdominal pain cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.