chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; Slight fever; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 13:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included dermatomyositis (autoimmune disorder). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown) received at 53 years of age, via an unspecified route of administration on the left arm, on 29Dec2020 09:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 28Jan2021 at 10:00, the patient experienced severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough, severe headache, all lasting several days; and slight fever which lasted for 1 day. The adverse events resulted to physician office visit. The patient underwent lab tests and procedures which included rapid test (nasal swab) on 31Jan2021 with negative result and nasal swab on 01Feb2021 with unknown result (pending). The patient recovered from slight fever on 29Jan2021a at 10:00; and was recovering from severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough and severe headache.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 30-JAN-2009, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JAN-2015, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This is a spontaneous report from a Contactable other HCP. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date in Mar2021 (age at vaccination: 57-years) as dose number unknown, single for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis since 11Jan2021. Co-suspect drug included ongoing Xeljanz XR 11 mg, daily, oral, taken since 11Jan2021, for rheumatoid arthritis. Concomitant medications were not reported. Patient reported she had been off of xeljanz xr during the time of receiving the pfizer covid 19 vaccine at the end of Mar2021, and when diagnosed with covid 19 end of Jun2021. Patient reported during the time she was without xeljanz xr she had pain but, when she had covid she didn't notice any pain. No exact dates, further details provided, and md is aware. The patient underwent lab test which included SARS-CoV-2 antibody test, with positive results on an unspecified date in Jun2021 (diagnosed with covid 19 end of June). The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, COVID-19 and suspect drug BNT162B2 cannot be excluded.
Itching; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Deltoid Right (reported as right shoulder muscle) on 13Feb2021 at noon (at the age of 84-year-old) as dose 1, single and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6200 and expiry date not reported), via an unspecified route of administration, administered in Deltoid Right (reported as right shoulder muscle) on 06Mar2021 at noon (at the age of 84-year-old) as dose 2, single, both for COVID-19 immunisation. Patient had no medical history and no family medical history. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). Patient had no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. On 22Feb2021, the patient started itching like crazy and she had to go to her primary care, and they gave her a steroid shot, but it had no effect. They gave her a Prednisone 6 pack and it helped. The patient went to the doctor on 05Mar2021 because she was still itching from the first shot. The patient was due for the second COVID shot on 06Mar2021, and she did not want to go through it again, but the doctor insisted to get it, they said it was better than COVID and a ventilator, so she did it. The patient was still itching when she had the second shot on 06Mar2021. It got better because she was on the oral steroid. The patient got the same reaction 10 days later again and the itch got much worse. It had been on her upper torso neck, chest, and arms and she renewed the steroid pack Methylprednisolone tablet, so she has had 2 packs, 6 days worth. It was reported that, she was still suffering with the itching and she did not want to take anymore Prednisone because she doesn't like putting chemicals in her body, but she doesn't know if this triggered an allergy or something in her body or what. But she has never experienced this in her life, and she attributes it to the Pfizer shot. The outcome of the event was not recovered.  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-2021366684 Same reporter/drug/event, different patients.
Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.  Treatment information was not provided.
Sought treatment on 5/16/22 after experiencing 2 nights of severe sore throat w/ coughing and cold/respiratory flu symptoms.  Tested positive for COVID in clinic. Not necessarily an adverse reaction to the vaccine, but a failure of the vaccine to protect against infection.
Information has been received from an adult female certified medical assistant who on an unknown date was vaccinated with a dose of PNEUMOVAX (Lot #660717/0224X). Subsequently, she experienced a shoulder joint pain. At the time of reporting the patient was recovering. The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up the medical assistant reported that she was vaccinated on 15-Oct-2008. In October 2008, then she experienced a sore achy arm with limited range of motion. Subsequently she recovered from the sore achy arm with limited range of motion. She shoulder still ached. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patient's hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports provided by the same source. Additional information has been requested.
Itching and a rash; Itching and a rash; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot Number: FA6780, Expiry Date: unknown) via an unspecified route of administration on arm left on 04Jul2021 16:15 (age at vaccination: 49 years) as dose 1, single for COVID-19 immunization. Vaccination Facility Type was reported as  pharmacy. The patient medical history (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to Adverse events was reported as none. Patient concomitant medications were not reported. 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) was reported as none, first dose. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) If applicable, any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. No adverse events following prior vaccinations. On Jul2021, the patient experienced itching and a rash, since she took the shot and wondered if there is anything to take to stop the itching. Noticed this last week, she thinks it was on a Monday, she thought it was something she was eating, but it is still going on, so she knows it is not something she was eating. Time the Vaccination Was Given was reported as between 16:00 and 16:30. The Relevant Tests was reported as none. The clinical outcome of the events was not resolved.
I had several vials of facial fillers injected in October of 2020. After feeling fluish the first 24 hours those symptoms went away and I began to feel pain and have swelling in my cheeks where the injections were given. At this time I have received no doctor intervention though have take naproxen sodium.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE, SUSPECTED COVID-19, outcome "unknown" and all described as "COVID-19".  Clinical courses: It was unknown if there were other medications in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity htn" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; BENAZEPRIL; TRAMADOL; XANAX; ZOLOFT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (27Jul2022) Positive, notes: We are both Sick and COVID + today 27Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Three days after completion of Plaxovid, symptoms came back. Severe cold symptoms. This happened to the patient and her husband. Patient and her husband were very diligent in taking the medication as prescribed. Patient and her husband are Sick and COVID positive on 27Jul. Other medication in 2weeks: Yes. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she had received the Shingrix vaccine (first dose) in January 2020. Due to covid 19, she had not yet received the second vaccine.; 3 worst bouts of shingles/getting 40 blisters of shingles; blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 3 worst bouts of shingles that had in 5 years).   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2020, between 6 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the shingles, blister and social problem were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had 3 worst bouts of shingles. Due to covid 19, she had not yet received the second vaccine.  The reporter felt as if susceptibility was higher than it's been in 5 years and it did not make sense that getting 40 blisters of shingles at the time of reporting when had not anything in 5 years. The reporter consented to follow up.
stomach pain; neck pain; Does the medication give you pain under your armpit for your neck all the way down to your fingertips/my fingertips under my armpits by my boob; Head pain/headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), NECK PAIN (neck pain), MYALGIA (Does the medication give you pain under your armpit for your neck all the way down to your fingertips/my fingertips under my armpits by my boob), HEADACHE (Head pain/headache) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), NECK PAIN (neck pain), MYALGIA (Does the medication give you pain under your armpit for your neck all the way down to your fingertips/my fingertips under my armpits by my boob), HEADACHE (Head pain/headache) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), NECK PAIN (neck pain), MYALGIA (Does the medication give you pain under your armpit for your neck all the way down to your fingertips/my fingertips under my armpits by my boob), HEADACHE (Head pain/headache) and NAUSEA (nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-265761 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received included: updated action taken, added events and updated narrative
Pt received vaccine and within 10 minutes experienced chest pain and nausea. Pt escorted via wheelchair to litter in separate space. Vitals taken at 1100: 120/38, HR 63 and 1114 114/81, HR 65. Pt symptoms resolved with rest.
After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,fast heartbeat,join pain
This spontaneous report was received from a register nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The nurse reported that improperly stored doses of VAQTA lot # M039202 with expiration date of 11-MAR-2018 (dose, frequency and route were not reported) for prophylaxis, were administered to patients from 01-MAY-2017 to 30-MAY-2017. The vaccines were exposed to temperature excursion of 9° Celsius (°C) to 25°C for a time frame of 1 hour 9 minutes because of data logger. The vaccines had a previous temperature excursion of 9°C to 25°C, for a time frame of 7 hours 50 minutes. Nurse stated that no adverse effects had been reported by any patient and that she was unable to provide any additional patient information for patient who had received supported vaccines. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000368: US-009507513-1706USA006156:
Had nausea after eating for about a month after the shot. Also dizziness and joint pain for about a month after the shot. Also got shingles after the initial shot. Refused to 2nd dose due to adverse reaction to 1st dose.
Systemic: claims "loss of hearing, ringing, popping in right ear along with numbness in face-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: pt did not directly contact pharmacy-she filled out survey from a receipt-tried to follow up twice with pt but pt did not call back
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-NOV-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), dose, route and anatomical location not provided. There was no concomitant medication provided. On an unknown date, the (23-valent) PNEUMOVAX had temperature excursion for 1704 hours, the highest recorded temperature was 59.9F (15.5 Celsius). The vaccine status was reported and "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse events were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Stiffness in knees and lower back. Muscle burning and weakness in thighs over 5-6 days  Narrative: Patient reported experiencing joint stiffness particularly in knees and in lower back. Patient also reported having muscle burning and weakness in thighs. It started slowly and had built up over the last 5-6 days. Patient self treated with anti inflammatories, ice, epsom salt baths and lots of water. Unknown if resolved, however on March 23, 2021, patient given second dose of Covid vaccine and monitored for 15 minutes without any reports of adverse effects from the vaccine.
Information has been received from a registered nurse concerning an 87 year old female who in August 2001 was vaccinated with the first dose of Pneumovax 23. On 14-NOV-2006, the patient was vaccinated with the second dose of Pneumovax 23 (Lot# 651399/0486F. On an unspecified date, the patient developed an injection arm erythema which extended to the elbow and also to the axillary and the chest area. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. The registered nurse was requesting a lot check for Pneumovax 23 (Lot #651399/0486F). The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information has been requested.
wrong patient- with no reported adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 7 days old female patient who experienced wrong patient- with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine for Immunisation.  On 29-Mar-2022, the patient received 0.5 ml of 1 dose of suspect HIB (PRP/T) vaccine (batch lot : UJ569AD Expiry date :02-Oct-2022)(unknown :strength and formulation)cycle, series:1 via intramuscular route in the right thigh.  On 29-Mar-2022 (latency :same day)the patient developed a non-serious event of wrong patient- with no reported adverse event (wrong patient received product) following the administration of HIB (PRP/T) vaccine  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Info has been received from an RN concerning a 2 year old pt who in 12/94, was vaccinated with a dose of varicella virus vaccine live. The RN reported that in approximately 11/05, the pt presented to the physician's office with mild breakthrough chickenpox. At the time of this report, the outcome was unknown. No further info is available.
Rash, UrticariaPruritus, Injection site rash, pruritus Narrative:
Approximately 3 weeks after booster, awoke with right-sided hearing loss. This resolved slowly over the next 3 days.
pt recvd vax & exp burning; the burning was reportedly not associated w/insertion of the needle; No further details were provided;
Pt. felt dizzy; sat down; said vision blurry, body was rigid, Hands clammy, Unresponsive, Would not answer questions, He yawned 3 times. Eyes glazed over. EMT arrived. BP 70/52. He threw up. The he came out of it. Started talking.