chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine -injection #1 on March 1st. March 10 began with symptoms of cardiac irregularity-heart rate- 105(I am an RN) and took my extra doses of cardizem and atenolol and tried to "break it" as it felt like a.fib.waited a few days- Contacted my endocrinologist I believe about 3/15- and also the cardiologist - my irregularity was persistent and did not change   and also just the rate became slower- 60/min. still very irregular- on 3/23- I was sent for an entire endocrinology workup as I have a adrenal adenomas- all was fine- cardiologist had cardiac monitor applied - worn for 10 days- showed severe arrhythmia- and the  nuclear stress test that was followed also highly irregular.Cardiologist changed my meds- d/c cardizem add atenolol and started me on eplerenone and bisoprolol which caused me to have diarrhea so I stopped them and went back to cardizem and atenolol.Received my secon vaccine on the 29th- symptoms continued thru July -middle of.
DuRIng the 15-min wait post vaccination Patient feels nauseaus, sweating, pale & fainting. Got his oxygen level, it's 99, pulse 60, B/P 86 over 47. He was lucid but weak. He answers our questions. observe him for another 15mins. until EMS came per family's request EMS got same BP result 86/47. As peR mom. Her son is alway afraid of needles/vaccines. Patient left Pharmacy walking.
HYPOXIA Narrative: Patient received dose one of COVID vaccine and at the time was COVID negative (documented shortly before and after the vaccine). COVID test turned positive 14 days after first injection. He then received his second vaccine 4 days after positive test. 12 days after the second vaccine he was admitted to our facility and is currently in critical condition in the ICU with COVID pneumonia. It is unclear what role, if any the second vaccination had related to critical condition.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 51-year-old male patient who received SHINGRIX. On 7th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site reaction and nerve pain. In April 2018, the outcome of the injection site reaction and nerve pain were recovered/resolved. The reporter considered the injection site reaction and nerve pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist did not have lot number and expiration date. The reporting pharmacist was not aware of any medical intervention taken, and was not aware of any medical or mediation history of patient. The reporter stated that a patient experienced severe nerve pain in the injection site after receiving SHINGRIX in his right arm. The reporting pharmacist stated that symptoms began 24 hours after injection, and took 5 to 7 days to resolve. The reporting pharmacist consented to being contacted if safety had more questions.
Hives on face for and  occasional hot flashes for 2 days, fever blister on  lip.   Benadryl stopped the hives.
This spontaneous report was received from a nurse refers to a patient of unknown age. No relevant medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot not reported). No concomitant medication was reported. On an unknown date, the patient received the first dose of GARDASIL on January of 2012 and the second dose of GARDASIL on an unknown date in January 2013 and was in office on 16-JAN-2014 for his third dose. Additional information has been requested.
01/21/2022 Friday the night next day 01/22/2022, not able to get out of bed low grade fever 101.8 highest and severe body arches and joint pain, did not notice the dizziness 01/24/2022 Monday, unable to move without extreme nausea, migraine and motion sickness of vertigo. Tele-visit on Tuesday and was given directive of if not better to come to the office. On Friday 01/28/2022, went to doctor office as symptoms was not improving. Prescribed medication that current is not working and contact the doctor on 01/31/2022 and new prescriptions was prescribed and supposed to pick up new medication today. Diagnosed with vertigo and extreme enhanced migraines. Was prescribed exercised for inter ear issue and  the motion system is proving to be difficult in the exercise process. Swollen lymph node under left arm side of vaccination and that occurred with vaccination 1 and two as well 101.8 temp.
This spontaneous report was received from a physician via a company representative refers to a 63-year-old female patient. Current conditions included chronic bronchitis/asthma, GERD (Gastro oesophageal reflux disease), hypothyroidism, fibromyalgia and allergy to sulfa drugs. On 22-MAY-2013 the patient was vaccinated with a dose of 0.5 milliliter (ml) (reported as standard dose) PNEUMOVAX23 (lot# H017759, expiration date 04-JUL-2014), subcutaneously (reported as standard route) in the arm. Concomitant medications included unspecified medications for chronic bronchitis/asthma, GERD (Gastro oesophageal reflux disease), hypothyroidism and fibromyalgia. On 22-MAY-2013, the patient experienced extreme swelling and pain the evening after receiving her vaccination with PNEUMOVAX23. During her office visit the patient presented with swelling that was 8 inches across the injection site and 4 inches along the length of the arm. ROCEPHIN was given as a treatment. The outcome of the event was reported as recovering/resolving. It was unspecified whether lab diagnostic studies were performed. Causality was not reported. Additional information has been requested.
In January I started complaining to my husband about a noise at night - low hum. I thought it was related to our home (freezer, pipes, gas, etc), but my husband couldn?t here it.  The sound persisted, and I noticed it also when we stayed elsewhere so I then recognized it as tinnitus.   Interestingly, after my husband got his covid vaccine he started to have tinnitus as well, so we began to question if this is a side effect of the vaccine.  It is now May, and my tinnitus persists.
7/15-7/20 19y.o. male with history of depression, anxiety, aggressive behavior, substance abuse, previous suicide attempt who presented to the ED on 7/15 for worsening depression, suicide ideation and polysubstance abuse. He uses tobacco, marijuana and alcohol 3 times per week. He was previously taking Xanax, but stopped about one month ago. He was previously on antidepressants but is no longer taking them.  He tested positive for COVID on 7/4/22. He had nasal congestion for one day, no other symptoms. No chest pain, dyspnea, cough, abd pain, n/v.  In the hospital his COVID precautions were lifted once his quarantine period finished. After this, he was transferred to IP psych in stable condition.
12/1/08 5pm patient states cough, some swelling under tongue and chills. 12/2/08 Patient called office complaining of mouth dry, lips puffy, throat scratchy. No swallowing or breathing difficulty. Injection site without redness or swelling, afebrile.
Small hives the size of a flea bite beginning 2/3/21 and increasing in number every day (about 10 presently). Hives at the bottom of my buttocks on 2/6/21 and 2/7/21.
Narrative:  PATIENT WAS IMMUNIZED IN TIMELY MANNER ON 1/19/21 AND 2/9/21 RESPECTIVELY WITH PFIZER MRNA VACCINE. PATIENT PRESENTED TO ED 11/4 WITH WEAKNESS AND SOB. HE WAS ADMITTED WITH HYPOXIA AND COVID PNEUMONIA. HE WAS TREATED WITH REMDESIVIR AND DEXAMETHASONE. HE WAS LIKELY MORE SUSCEPTABLE TO INFECTION DUE TO MAINTENANCE ADALIMUMAB AND MTX USED TO TREAT RA. PATIENT WAS PROVIDED MULTIPLE FORMS OF 02 SUPPORT--NC, BIPAP, OXYMASK AND WAS ULTIMATELY DEPENDANT ON HF TO SUSTAIN. PATIENT WAS PUT ON COMFORT CARE AND PASSED 11/21/21
High Fever (102 versus normal of 96), high heart rate (135 to 150 for 12 hours at rest including sleeping),  chills, and tiredness.   I went to the emergency room to get it checked out.  Received Toradol for headache, ice pack and IV fluids.   Heart rate reduced to 100 and temperature down to 97.  HR elevated throughout Sunday (80 to 100 at rest)    I was symptom free from AS with Enbrel treatment, but after adverse event severe inflammation in chest and upper left quadrant.  Restarted enbrel use but flair up worse than anything seen throughout 8 week cessation of Enbrel usage.
Fever 104.5, rash on legs and back, vomiting and fussy.
Information has been received on 21-NOV-2016 from an office manager referring to unspecified patients (number of patients, ages and genders are unknown.) The patient's concurrent conditions, medical history and concomitant therapy are unknown. The office manager reported that improperly stored doses of GARDASIL 9 lot number M067764 expiration 30-JAN-2018 and ROTATEQ lot number M019691 expiration 02-NOV-2017, L048857 expiration 15-OCT-2017, and L042215 expiration 02-OCT-2017 doses may have been administered to unspecified patients on unspecified dates. The vaccine doses were exposed to 34 degrees F for 4.5 hours. The vaccine doses were exposed to a previous temperature excursion of 35 degrees F for 279 hours. No adverse effects were reported. No further information was reported. Lot number M067764 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast.) Additional information has been requested.
Approximately one week subsequent to receiving first dose of Engerix B, the pt experienced the flu like symptoms of achiness, stiff neck and diarrhea. These symptoms resolved after four days. One day after receiving the second dose of Engerix B the pt experienced dizziness, fatigue and flu like symptoms. The next day she experienced a burning sensation in hr feet which lasted two hours. Additionally, she experienced chest pain and shortness of breath which lasted 1/2 hour.   The following day she experienced extreme dizziness and could not think clearly. She felt as if she were in a fog. A doctor visit was required. The pts dizziness was treated with Antivert. Engerix B was discontinued. As of 08/17/2000, the pt continues to feel very tired, dizzy, cannot think clearly and still feels some flu like symptoms (achiness).
No additional AE/ PQC reported at this time; Physician reported PROQUAD (lot T009932 exp 16-SEP-2021) was administered to two patient who are sisters; This spontaneous report as received from a physician, and refers to a 12 month old female patient. No information has been reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 20-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis. Lot number reported as T009932, expiration date: 16-SEP-2021. On an unspecified date, the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) underwent a temperature excursion of -58 Fahrenheit degrees (°F) and 5°F (6.8°F) for 0 hours 30 minutes 0 seconds. No previous excursions were reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2108USA007693:
Pt states she felt "funny" and throat felt "tight". Physician and pharmacy notified, pt medicated with Benadryl and observed for 2 hours at which point she felt fine and was discharged home.
No adverse reaction; Received expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse reaction) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture).    This case contains information for the 3rd of 3 patients described by the reporter. No concomitant medication was reported. It was unknown when the vial was initially stored in the refrigerator. On 08-Aug-2022, the vial was first punctured. It was unknown if the vial stored post puncture was stored in RT/fridge. It was unknown if the vial had undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was unknown. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-627637, US-MODERNATX, INC.-MOD-2022-627651 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627637:case for patient 1 US-MODERNATX, INC.-MOD-2022-627651:case for patient 2
Pt c/o light headedness and nausea almost immediately after the injection. Pallor noted. Pt moved from chair to floor mat, and legs elevated on chair. BP 102/60, HR 76, RR 18, Pulse oxygen 96. Color pinked up. Pt stated he felt better. Tolerated sitting up well. Recheck BP 96/60. After a couple minutes, tolerated standing without distress. Left with parent and sibling In good condition.
herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently 67 or 68-years-old patient (pt.) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 23-OCT-2014, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt. was treated by health care providers (HCP) for herpes zoster. The pt. claimed damages as a result of injuries to itself and economic losses. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Currently 13 weeks pregnant, no complications.  Symptoms: sore arm, aches, headache, fatigue, low fever, chills, sore throat
Multiple seizures, went to ER, lost complete memory for 18 hours, 3 day hospital stay, loss of driving privileges for 90 days, on Keppra for seizures  and on Eliqios for blood clot near the lung.
Student inadvertently received both Tdap and TD vaccines during a travel clinic. He should have received only the Tdap vaccine. The error was discovered 3 days later. Attempts to contact the student have been unsuccessful. He is not reading secure message sent and unable to leave voice message on his phone.
Body temperature is above 103 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Body temperature is above 103 degrees Fahrenheit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Body temperature is above 103 degrees Fahrenheit). At the time of the report, PYREXIA (Body temperature is above 103 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Within 12 hours patient had Redness, swelling and pain at injection site. Her arm became immobile. Within 72 hours, she developed a fever of 100 that lasted over 2 days. Other symptoms include, nausea, cramping, muscle pain, fatigue. Patient described symptoms as flu like symptoms. Patient presented to MD with symptoms. MD was concerned patient may develop cellulitis. After physical exam of injection site as well as surrounding area, MD found no cellulitis. Patient came into the pharmacy today, 5/19/2018 to tell me about symptoms and said she is just now getting back to normal.
Patient received J&J vaccine on 8/11/21 and 12/22/21. Unsure of details.  Patient positive for COVID 5/28/22. Admitted 6/13 for stroke-like symptoms. No covid symptoms. DIscharged on 6/15/22
Acute Coronary Syndrome- Chest pain, unable to catch breath while playing Ice Hockey EMS performed a EKG on-site to confirm Heart Attack and transported to Hospital Once at Hospital the staff ran another EKG confirmed I was having a Heart Attack(told afterward I had 100% blockage of the "Widowmaker")
Pentacel has been administered to a 5 years old boy in place of Dtap Ipv combination, no AE; Pentacel has been administered to a 5 years old boy, no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 5-years-old male patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (dose, batch number, epiry date, route and site were unknown for both vaccines) in place of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV [DTAP IPV] combination (wrong product administered and product administered to patient of inappropriate age), as prophylactic vaccination.  Medical history, concomitant therapy, medical treatments, vaccinations and family history were not provided.  This was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
a lot of abnormal bleeding with cuts; shaving her legs cutting her knee and the cut bled for over a day; receiving a paper cut on her finger and it bleed for a couple of hours; something looked like a mole on her arm that is more of a bunch of blood vessels that burst; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a lot of abnormal bleeding with cuts, shaving her legs cutting her knee and the cut bled for over a day, receiving a paper cut on her finger and it bleed for a couple of hours and something looked like a mole on her arm that is more of a bunch of blood vessels that burst. The outcome of the events shaving her legs cutting her knee and the cut bled for over a day, receiving a paper cut on her finger and it bleed for a couple of hours was recovered on an unspecified date in 2021 and rest of the events was unknow.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
My thoughts and memory became cloudy. I couldn't fully remember what was said to me not long before that and I couldn't think straight.
Started coughing heavily and very weak - Unable to stand up on her own and could barely walk 5 ft without stopping to catch breath.  Administered her inhaler (only taken when having asthma issue due to allergy or exercise) and measured Sp)2 which was at 87 Took my mother to the ED and she was diagnosed with Bacterial Pneumonia - Was tested for Covid-19 which was negative Antibotic Azithromycin was prescribed at ED
I had pain in armpit in same arm as injection for a couple of days. The pain intensified ALOT! On 3rd day pain and swelling of arm pit and pain, selling and redness of injection sight was extreme! I had missed my allergy medication that morning. Later that night I took allergy medication (Allegra) and two maximum strength Tylenol and within a few hours the pain was lessening and by morning pain and swelling were down. There remain minimal swelling, itching, and pain, all of which I can deal with.
Became sore very soon after injections, increasing over the next 3-4 days.  Went to the doctor, he x-rayed it and there were no findings.  She read her paperwork recently and realized she needed to report it.
left ear tinnitus, extreme sore throat, extreme sinus congestion in ears and nose.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB (Lot # L025738 expiration date: 14-AUG-2017) (route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34.2 degrees F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Started 3 hrs p/injection; non-stop crying >= 3 hrs; rt leg became very swollen; stopped crying p/1.5 hr of admit to hosp; put topical unj. on leg & gave more Tylenol; slept thru noc;
Nausia , head aches , body pain, fatigue.  On the 7th day the pain worsened and became severe nerve pain in all the areas of previous nerve damage. I have had 6 spinal surgeries. I know where my injuries are and the normal pain I have increased to an almost unmanageable level.
Information has been received from a nurse practitioner via field representative referring to her son, a 1 year old (reported as 12 months and 1 week) patient. Sometime between 27-NOV-2014 and 25-DEC-2014 the patient was vaccinated with a dose of M-M-R II (one time, route, lot# and dose were unknown). Other suspect therapies included a dose of varicella virus vaccine (manufacturer unknown) (route, lot# and dose were unknown) and a dose of hepatitis A vaccine (manufacturer unknown) (route, lot# and dose were unknown) both of which were vaccinated simultaneously. Concomitant therapies included Hib conj vaccine (unspecified carrier) and PREVNAR 13 vaccinated on the same day. The patient also received amoxicillin along with these vaccines. The patient developed erythema multiforme all over his body immediately following administration of these products. The patient also could not eat. 4 days from the date of vaccination, the doctor prescribed an unknown dosage of unspecified steroids for the patient. There were no lab diagnostics studies performed. After one week of being on this treatment, the patient was fully recovered. The reporter considered that the patient was significant disability as he could not eat. Additional information has been requested.