chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurred vision; Feeling dizzy; Hadn't eaten since a few hours; Nausea; This spontaneous case was received on 09-Oct-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-03268) and concerned a female patient of unknown age.   The patient's concurrent conditions included uric acid and hypertension. The patient's concomitant medications included potassium, omeprazole, unspecified vitamin D, allopurinol and amlodipine, all used for unreported indications.    On 04-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was 279813, expiry date: 30-Jun-2021.   On the same day, some hours after receiving Fluad Quadrivalent, the patient started feeling dizzy, had nausea and blurred vision. She also had to stop doing her shopping because of her symptoms and she hadn't eaten since a few hours. The patient did not receive any treatment for the events.   At the time of initial reporting on 09-Oct-2020, the patient was recovering from the events, as she started feeling better.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Vision blurred, dizziness, decreased appetite and nausea were associated with the use of the suspect product - Fluad Quadrivalent. The events occurred on the same day, some hours after receiving the product making chronology suggestive. The patient's concurrent conditions included uric acid and hypertension while concomitant medications included potassium, omeprazole, unspecified vitamin D, allopurinol and amlodipine, all used for unreported indications. Causality is assessed as unlikely related for nausea and not related for all other events due to reported confounders - hypertension, reported nausea and provided confouners. (unlikely related defaults to related for reporting purposes); Sender's Comments: Vision blurred, dizziness, decreased appetite and nausea were associated with the use of the suspect product - Fluad Quadrivalent. The events occurred on the same day, some hours after receiving the product making chronology suggestive. The patient's concurrent conditions included uric acid and hypertension while concomitant medications included potassium, omeprazole, unspecified vitamin D, allopurinol and amlodipine, all used for unreported indications. Causality is assessed as unlikely related for nausea and not related for all other events due to reported confounders - hypertension, reported nausea and provided confouners. (unlikely related defaults to related for reporting purposes)
Pt received 3rd dose of Engerix B  Jul90. 2 days later developed hives around the mouth, condition resolved /win 3 to 4 days.
Child had high fever (104) for 1 day and lower fever the following day. On the second day of fever the child developed a rash all over face and body that resembles measles (small red dots approx 250 of them). Day three the fever is gone but rash is still present. Child has had no appetite for 3 days.
Appears as chicken pox  on neck / posterior chest, groins and armpits; This case was reported by a nurse via call center representative and described the occurrence of chickenpox in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2020, the patient received the 1st dose of Shingrix. On 12th June 2020, 2 days after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was recovered/resolved.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 2 days later broke out with what appears to look like chicken pox.  It disappeared after 10 days and at the time of reporting had returned. The patient experienced, chicken pox like first time on neck. This time generalized on anterior and posterior chest, groins and armpits. The reporter was unable to provide any vaccine details of lot and expiration. The reporter did not consent to follow up.
Pt presents to ER for chest pain, palpitations and dizziness. Pt pre-syncopal and diaphoretic in triage and immediately bedded. pt connected to tele monitor, EKG performed and pt was found to have a STEMI heart attack. Pt reports symptoms started 2 days ago and got progressively worse. Pt reports he was in good physical conditon, and the only thing that changed was a Moderna injection #1 on 9/24/21. Pt was taken to   Dr , Cardiologist to perform cardiac cath.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar reports for 2 patients. This is the second of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, (batch number requested) via an unspecified route of administration in the arm on an unspecified date at single dose for routine vaccination and influenza vaccine via an unspecified route of administration on the arm on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with flu vaccine with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the same arm with an inch apart. Then the patient called back and stated that it hurts. The patient also stated that the arms were swollen and got a lump in 2017 (the reporter thought these events happened between Sep2017 and Nov2017). The patient recovered from the events on 2017. The following information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017527179 same reporter drug event different patients.
Patient called the pharmacy 10/8 AM and reported the following: The day that the vaccine was given, 10/4, she developed severe pain, swelling, and redness at the injection site that extended all the way to her left wrist.  She was unable to move her arm. She also experienced shortness of breath.  Over the next 4 days, the redness, swelling, and pain gradually waned but the shortness of breath worsened to where she was having extreme difficulty breathing.  I told her this is uncommon though likely a severe allergic reaction to the vaccine.  I encouraged her to contact her PCP and go to an urgent care.  Later than PM, a rep from the PCP office called the pharmacy to inform us that the pt was having a terrible rxt and was going to the ED for care.
On 9/7/01 between 1:15 to 1:30, patient was observed having grand mal seizure after getting off the tricycle at preschool. Patient does not remember getting off tricycle and starting to walk. She fell foward, hitting her forehead as a result of the seizure.
12 year old received 5-11 year old Pfizer dose (0.2 ml) instead of adult Pfizer (0.3 ml)
Pt has had pain and numbness in left arm into fingers ever since he received the flu shot in Oct. 2014.
Vaccine was retrieved from pharmacy on the morning of 12/9/2021.  It was mistakenly grabbed from the area of the refrigerator that had been partitioned off for recently expired vaccine that is separate from the active vaccine refrigerator area.  Vaccine was brought to clinic in a temperature-controlled cooler that stored the vaccine at refrigerated temperatures (36F to 46F).  Vaccine was reconstituted and drawn up to administer.  Pharmacist gave vaccine and documented for CDC and Immunization Information Systems data.  It was discovered that vaccine was expired at this time.  Any additional vaccine from expired vials planned to give was postponed and remaining vaccine wasted.  No adverse effects noted post administration.  Called pharmacy who ensured expired vaccine was removed completely to prevent any further errors.  Notified facility administration to notify staff member affected for follow-up.  Followed CDC guidance to contact manufacturer regarding error and gain additional information (Form CS-321629-AS).  Will follow-up with facility and patient tomorrow to make sure there have been no adverse effects/events post administration.
pain and swelling in arms and leg; nausea; fatigue; EPILEPTIC SEIZURES; chills; pain and swelling in arms and leg; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (EPILEPTIC SEIZURES) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disability and Epilepsy. Concomitant products included CARBAMAZEPINE (CARBAMAZEPIN) and PHENOBARBITAL (FENABBOTT) for Convulsion.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPILEPSY (EPILEPTIC SEIZURES) (seriousness criterion medically significant), CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain and swelling in arms and leg). On 28-Mar-2021, EPILEPSY (EPILEPTIC SEIZURES) outcome was unknown. At the time of the report, CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), PAIN IN EXTREMITY (pain and swelling in arms and leg), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment:Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.
Noticed significant increase in hair shedding one week after second dose of Pfizer vaccine. Shedding diagnosed as telogen effluvium and gradually increased. Significantly worse and continuing to lose hair 5 months post vaccine.
weird internal feeling like a big swelling, neck, face and arm have the feeling too.; internal sore in arm; Rash in left arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (weird internal feeling like a big swelling, neck, face and arm have the feeling too.), PAIN IN EXTREMITY (internal sore in arm) and RASH (Rash in left arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced RASH (Rash in left arm). On 05-Aug-2021, the patient experienced SWELLING (weird internal feeling like a big swelling, neck, face and arm have the feeling too.) and PAIN IN EXTREMITY (internal sore in arm). At the time of the report, SWELLING (weird internal feeling like a big swelling, neck, face and arm have the feeling too.) had not resolved and PAIN IN EXTREMITY (internal sore in arm) and RASH (Rash in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No lab data was provided.
This spontaneous report as received from a physician refers to a 56 years old female patient with allergy to penicillin. The patient's medical history included herpes simplex. On 07-JAN-2013 the patient was vaccinated in her left arm with ZOSTAVAX (lot # and route not reported). Concomitant medications included influenza virus vaccine (unspecified) on 07-JAN-2013 in her right arm and VALTREX occasionally for herpes simplex. On 08-JAN-2013 the patient developed a red, hard lump on her left arm at the injection site after receiving ZOSTAVAX. The patient also had developed a bilateral vesicular like rash to her body, arms and legs. The patient took one dose of VALTREX when she first noticed the rash. The patient sought unspecified medical attention by office visit. The outcome of the events was reported as not recovered. Additional information is not expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JAN-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (strength: 0.5ml, lot # K020188, expiration date 22-OCT-2016, route unspecified). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 24 hours with lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 32 hours with the highest recorded temperature of 48 Fahrenheit degree. The total cumulative excursion time of the third time was 168 hours with the highest recorded temperature of 7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R) for the first and the second excursion and Frozen (F) for the third excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia & Fever Narrative:  Employee got the second dose of vaccine 02/02/2021, at 2.45pm employee stated that the reaction started 3.40pm headache body ache chilLS Employee missed work 2/3/21
Information has been received from a physician concerning a brestfed 6 month old male with no other pertinent medical history or drug allergies who on 15-AUG-2007, 12-OCT-2007 and 13-DEC-2007 was vaccinated PO with his first, second and third (lot# 656833/0407U) doses of Rotateq. Concomitant vaccinations administered on 13-DEC-2007 included a dose of Pediarix, a dose of Prevnar and a dose of ActHIB. On 13-DEC-2007 the patient vomited four times after being vaccinated and was not eating." The patient sought unspecified medical attention. On 14-DEC-2007 the "patient had been taken to the hospital  and where he tested positive for intussusception. The patient had 2 air enemas, the second was successful)." Other labs or diagnostic studies were performed but not specified. On 17-DEC-2007 the patient was recovered. It was noted that "around the time of vaccination, the patient was transitioning from breast milk to formula." There was no product quality complaint. Additional information has been requested.  02/14/2008 Vax record received and info updated in database./pc 02/19/2008 MR received for DOS 12/14-15/2007 with D/C DX: Intussusception-ileocolic.  Infant presented to ER with 2 day hx of emesis and 1 episode of bloody, jelly-like stool. Pt dehydrated.  IS reduced on 2nd attempt by air contrast enema. Pt did well post procedure and D/Cd home next day.
bruising occurred shortly after about 4 inches in diameter, still has bruising 2 weeks after; arm still sore after 2 weeks
SX-1/24/10 Headache, dizziness, vomiting and loss of vision-Hospital admission 1/25/10-Hospitalized x 1 wk-1/26/10 DX with Rt occipital lobe infarct. Back to work part-time-continues to c/o dizziness and some visual field loss.
Panic attack; Anxiety attack; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (Panic attack) and ANXIETY (Anxiety attack) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PANIC ATTACK (Panic attack) and ANXIETY (Anxiety attack). At the time of the report, PANIC ATTACK (Panic attack) and ANXIETY (Anxiety attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatments were not reported.
tested positive with Covid-19; tested positive with Covid-19; extreme diarrhea; high fever; sore throat; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "diabetes" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "atrial fibrillation" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "monoclonal antibody infusion", start date: 17Jun2022, stop date: 17Jun2022, notes: (Name withheld) received a monoclonal antibody infusion on 17Jun. Concomitant medication(s) included: COUMADIN; INSULIN. The following information was reported: COUGH (hospitalization) with onset 17Jul2022, outcome "unknown"; DIARRHOEA (hospitalization) with onset 17Jul2022, outcome "unknown", described as "extreme diarrhea"; PYREXIA (hospitalization) with onset 17Jul2022, outcome "unknown", described as "high fever"; OROPHARYNGEAL PAIN (hospitalization) with onset 17Jul2022, outcome "unknown", described as "sore throat"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "tested positive with Covid-19". The patient was hospitalized for drug ineffective, covid-19, diarrhoea, pyrexia, oropharyngeal pain, cough (start date: 18Jul2022). The patient underwent the following laboratory tests and procedures: Pyrexia: (17Jul2022) high, notes: (Name withheld) tested positive for Covid-19 on 17Jul. His symptoms included extreme diarrhea, sore throat, cough, and high fever; SARS-CoV-2 test: (17Jul2022) Positive, notes: tested positive for Covid-19 on 17Jul.  Clinical course:(Name withheld) tested positive for Covid-19 on 17Jul. His symptoms included extreme diarrhea, sore throat, cough, and high fever. (Name withheld) also received four Pfizer Covid-19 vaccination shots. (Name withheld) DOB is (DOB withheld). He is 6'1 and approximately 360 pounds. (Name withheld) received a monoclonal antibody infusion on 17Jun, and was hospitalized on 18Jul. (Name withheld) has CKD, diabetes, atrial fibrillation, He is also on Coumadin, insulin shots, and numerous other co-morbid medications. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200026265 same reporter/product/event, different patient;
I reacted by my arm swelling up, getting really red and hard, Dr said it also attacked my immune system which triggered shingles. ER Dr said that.
Hard red knot appeared immediately at the injection site. Later in the day, the knot became hot. After a couple of days, a red rash about 6 inches in diameter appeared around the injection site. The rash is splotchy and bumpy. It is also hot. The rash continued to get larger. On the 6th day, I took a Benadryl tablet before going to bed. This morning (one week after the injection) the rash is not as hot and the knot seems slightly smaller. There is still swelling.
No adverse reaction. Patient stated she felt no symptoms at the time. Advised to monitor self for symptoms and call clinic if needed.
no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant. The patient was a one year old male. On 27-NOV-2018, he was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1811USA011976: US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012374:
development of HPV18-positive glottic larynx cancer in a 31-year-old without sexual exposure
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. On 16-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
5-6 hours after I got the 1st shot, I felt a pulling sensation on the inside of my legs, just under the knee area. Because I have a history of varicose veins, the sensation of rubber bands pulling felt familiar to me. It felt like there was pulling/constriction/swelling deep in my legs in that area. This sensation was felt intermittently every day for 3 weeks. Then, over the next couple weeks, the intensity and frequency faded. At about week 5 it stopped completely.  Additionally, since I got the shot, it feels more difficult to get a full deep breath. Now, 6 weeks later, I still notice it, especially when doing exercise. Additionally, exactly one week after the shot, I got "covid arm." My right arm, where I got the
Patient seen 11/24/17 with 8 day h/o fever (TMax 103), sore throat, rash which worsened; thrombocytopenia; Patient seen again 11/28/17 for worsening morbilliform rash; fever resolved; some joint pain on elbows and feet without obvious edema; Patient seen again 11/30/17, no change in rash.