chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a patient (no demographics were provided) of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiry date unknown). No concomitant medication was reported. On an unknown date (also reported as six months after vaccination), the patient developed shingles. No further event information was provided. There was no product quality complaint. Outcome of the reported event was unknown. Causality of the reported event was unknown for ZOSTAVAX. This case is related to 1405USA005041 (Same Reporter Link). Additional information has been requested.
A small muscle discomfort an x-ray showed degree of difficulty with one of the muscles and PT was prescribed.
temp 37.1C; blood pressure 135/75; right part of the neck stiff; cannot open mouth big; headache was worse, especially when turning the head; This is a spontaneous report from a contactable consumer reported for himself.   A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982) on 20Jan2021 at 13:00 at single dose in left arm for covid-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. Concomitant medication included febuxostat (FEBUXOSTAT), benazepril hydrochloride/hydrochlorothiazide (BENAZEPRIL/HCTZ), finasteride and tamsulosin. On 21Jan2021 in the evening at 20:00 (reported as second day after vaccine) the patient experienced right part of the neck stiff and cannot open mouth big; on 22Jan2021 (reported as the third day after vaccine) headache was worse, especially when turning the head (headache started on an unspecified date in Jan2021); on 23Jan2021, 24Jan2021 and 25Jan2021 kept having headache, neck was still stiff; on 25Jan2021  temp was 37.1C and blood pressure 135/75. Events required office/clinic visit. The events were all non serious. It was unknown if treatment was given; the final outcome of all the events was not recovered.
As I was waiting my 15 minutes sitting, at my 15 minute mark, I felt burning/ tingling starting at my feet working it?s way up my body. My body felt like it was one fire / tingling / burning. I was very dizzy and weak.  The nurse checked my heart rate and blood pressure. All normal. We agreed to have myself checked out in the ER and they took me over by wheel chair.  Once in the Er they checked my sugar level and vitals. My heart rate and BP were slighted elevated. They kept me under observation for a few hours. I been sick all weekend with headache, Diarrhea, higher than normal pulse and tiredness. I have to follow up with an allergist and my PCP.
This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
suffered slurred speech and right arm weakness / diagnosed with an acute stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-FEB-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as recommended for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, lot #, expiration date were not provided). On an unknown date, reported as shortly after receiving suspected vaccine the patient suffered slurred speech and right arm weakness. Subsequently, she was diagnosed with an acute stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not presented prior to using suspected vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. Causality assessment between the event and the suspect vaccine was considered related, by the reporter.   Upon internal review, the event of stroke was considered to be medically significant. Acute stroke was considered to be disabling.
February 23 woke up in the middle of the night with sudden left peripheral vision loss. Developed severe eye pain and light sensitivity, pain with eye movement one week later. Saw ophthalmology, referred to neuroopthamology.  Has increased eye pressure in left eye and brimodine drops started. Having scotoma-like vision changes in left eye along with intermittent eye pain and jaw pain. Pain and vision changed lasted 3.5 months before resolving. Eye pressure elevation resolved. Also saw retina specialist and PCP. Had MRI, CTA, US all performed to find underlying cause. No cause was found. Assumption is inflammatory response of some sort, cannot explain Visio loss, vision change, eye a s jaw pin, and increased eye pressure.
I was fine immediately after the vaccine until the night of the 25th and my throat started to hurt. I started drinking liquids because it felt dry. And then the 26th, I woke up and my throat was killing me and it was hurting so bad. I ran to the mirror to see if I could see if my tonsils were infected. They weren't infected but throat was flaming red and swollen. They took a strep test. It wasn't strep. He gave me a prescription for amoxicillin and I didn't take it since I wanted the booster to do it's job. I started gargling three times a day with salt water. By Saturday, 28th, I couldn't talk at all and it hurt so bad to swallow. I started taking ibuprofen for the pain. 29th, the swelling went down a little bit but it still hurt to swallow and I couldn't talk still. I thought it was Laryngitis. Thirtieth - on Monday - when I woke up in the morning, I could swallow with no problem except it felt like something was still there and I went to the mirror and I saw that there was a pocket of pus - a little one. I kept gargling with salt water all day on Monday. On Tuesday it was all gone. Today, I still have a raspy throat but as of yesterday swelling and redness is gone, etc. I am tired, though.
about 10 minutes after vaccination, the patient reported tingling in the arms, feeling light headed, brief syncope, patient self recovered without intervention but was given water and watched for further reaction until EMS arrived. Patient ultimately walked out of the store with EMS and I (the pharmacist) am unaware of what happened to the patient.
J18.9 - Pneumonia, unspecified organism ALTERED MENTAL STATUS VOMITING
Rec'd flu shot 10/20/15. Next day began with itching and hives. Went to ER for treatment. Had some swelling of lips. No SOB or dyspnea. No known triggers except receiving flu shot. Pt treated with hydroxyzine and MEDROL dose pack. No previous reaction to flu shots. No allergy to eggs. It was pt's first time receiving High Dose Flu shot.
Approximately two weeks post vax, the pt developed less than 40 generalized vesicular rash.
Headache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 002A21A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after second dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included cholesterol pill.   This case was linked to MOD-2021-388603 (Patient Link).
This spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses (32 doses in total) of VARIVAX injection, lot # L035127 with expiry date 14-SEP-2017 (2 doses) and lot # M035142 with expiry date 03-AUG-2018 (30 doses) (exact dose, route of administration and anatomical location were not specified) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the administered doses of VARIVAX underwent a temperature excursion under 6 Fahrenheit degrees to 14 Fahrenheit degrees for 14 hours. It was reported that there were previous temperature excursions: between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 1 hour and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 6 hours. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing report per requirements.
Abnormal vaginal spotting Shortness of breath  Chest Tightness Irregular heartbeat
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX intramuscularly instead of subcutaneously, which had a lot # of M038350 (expiration date was not provided), for prophylaxis.  No adverse experiences were reported. Additional information has been requested.
Pain in arm, generalized muscle aches, nerve ending tingling especially head and neck, lethargy, nausea & vomiting, chills, headache.
No adverse event; One of my nurses gave a dose to a patient 6 hrs and 36 minutes post vial puncture; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of my nurses gave a dose to a patient 6 hrs and 36 minutes post vial puncture) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pancreatic cancer and COPD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUSPIRONE, CLONIDINE, APIXABAN (ELIQUIS), FLUTICASONE and ALPRAZOLAM for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of my nurses gave a dose to a patient 6 hrs and 36 minutes post vial puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 25-Mar-2021, EXPIRED PRODUCT ADMINISTERED (One of my nurses gave a dose to a patient 6 hrs and 36 minutes post vial puncture) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04-jun-2021 contains non significant information.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 006B21A)  with no associated AEs.
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12-OCT-2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30-JUN-17, intramuscularly, on an unspecified date (over the past month). Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date (over the past month), following the vaccination, the patient had localized redness and warmth at injection site,"3 days". It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Axillary pain with both shots and throat irritation causing and annoying cough after the second injection
3 days after receiving tetanus shot- Had severe pain & aching (deep) in right upper arm - It has been 4 months & although the pain is less, is still very much present
No adverse event; Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant information provided. Patient had not reported any adverse events after the vaccine was administered. No treatment information provided.
The patient who received the vaccine was not eligible to receive the vaccine under the pharmacy's protocol or standing order.  EUA for Moderna's Covid-19 Vaccine is for 18 years old and up.  This is a patient who was 17 years old at the time of administration.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 27Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. COVID 19 Treatment with Paxlovid from 02Mar2023 to 08Mar2023, lot number: GF6436   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Daily since vax: Migraines Lack of appetite Constant bloating Extreme weight gain  Fatigue   Menstrual cycle now extremely heavy  Diagnosed as exaggerated immune response to vax
Developed shingles (herpes zoster) on face and in left eye appx 3 days after vaccine.  Was treated with 2 courses of Valtrex.
She had severe congestion which started to build up as the days progressed, we didn't notice until a few days later and her eyes were not doing well either, she has a dry eye condition and it got worse after the vaccine. The under parts of her eyes started getting bigger and she started taking BENADRYL and it did not help, and then she started taking CLARITIN and that helped a bit with the eyes but the congestion is still the same and has actually gotten worse since that vaccine.
Since I have asthma; Since I have asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "History of Bronchitis" (unspecified if ongoing); "colds" (unspecified if ongoing), notes: Often develop bronchitis. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 15Jan2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 06Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 28Sep2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown, Site and route of injection: Upper arm, Intramuscular), administration date: 15Apr2022, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), DISEASE RECURRENCE (non-serious) all with onset 2022, outcome "unknown" and all described as "Since I have asthma". Therapeutic measures were taken as a result of asthma, disease recurrence.  Additional information: Patient had booster on 21Sep2022 in AM. By evening started to feel a sore throat and cough begin. On morning of 22Sep2022 definitely felt sick, took rapid COVID test which came in mail from Government. She tested positive, her husband did not, very bad cough, some throat, fever 100-101. Since she had asthma, she called her doctor, had televisit (word not legible). MD prescribed anti COVID medication for 5 days and special cough medication benzoate. After completion of anti COVID pills, she tested negative, then her husband developed symptoms and tested positive positive 08Oct or 09Oct. She started feeling sick again, some throat and lots of sneezing, no cough. Next day she tested positive again. Felt like a very bad cold, no fever, just took COVID/flu medication-over the counter.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202201198008 same patient, different vaccine dose/AE.
22 JUL 2022: congestion, cough; 24 JUL 2022: high fever, fatigue, no appetite or thirst, congestion, mucousy cough, gagging/vomitting, admitted to ER for rapid breathing, treated with Motrin, Tylenol, Zofran; 25 JUL 2022: high fever, fatigue, no appetite or thirst, congestion, mucousy cough, Motrin, Tylenol, Zofran; 26 JUL 2022: high fever, fatigue, no appetite or thirst, congestion, mucousy cough, Motrin, Tylenol, Zofran; 27 JUL 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, Zofran; 28 JUL 2022: fatigue, no appetite or thirst, mucousy cough, Motrin, Tylenol, vomitting; 29 JUL 2022: mucousy cough, Motrin, Tylenol; 30 JUL 2022: mucousy cough, Motrin, Tylenol; 31 JUL 2022: mucousy cough; 01 AUG 2022: mucousy cough
heart palpitations, rapid and variable HR on and off for 3 days starting on day 5 after vaccine. Feeling of discomfort/fatigue in chest. HR as high as 168 at rest.. HR tracked on smart watch.  Did also have general body aches, headache without fever on day 2-3 after vaccine. No Symptoms day 4.
Pt called states she had a localized reaction, whole upper arm turned bright red and skin was hot. Lasted a few days. Itching. Pt fine now.
I went to a gathering and two days after I started to feel very tired. I felt like I was cold and shivery. I got a runny nose and then a cough. Each day the cough got worse. On the third day I had GI problems and then I lost my sense of taste and smell on the fifth day. I went to get tested and it was Positive for Covid-19.  I was having difficulty breathing and once I started to cough it would get out of control and I couldn't catch my breath. I was prescribed an Albuterol inhaler, Benzonatate 100mg 3X daily, Montelukast 10mg at night. The medications seemed to help.  It has been three weeks and my breathing is much better. My sense of smell returned but my sense of taste is coming back gradually.  I was very tired and I could not sleep during the worst of my symptoms.