chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On 16-SEP-2015, 17-SEP-2015, 18-SEP-2015 and 08-OCT-2015, the patients were vaccinated with doses of improperly stored GARDASIL (Lot #K010215, expiry date: 05-MAY-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Pt developed a rash and was seen by a doctor in a children's clinic. Mom reported allergic reaction to Varicella #2 dose. Doctor's notes indicated Rx. Phone call on 7/30/01; child is fine.
This spontaneous report was received from an office manager and refers to multiple unspecified patients of an unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M019707, expiration date 25-OCT-2017, lot # M017514, expiration date 07-NOV-2017 or lot # reported as M006111, expiration date 18-NOV-2017 (dose was not reported). The administered doses of vaccine were exposed to the temperature of 30 degrees Fahrenheit for 11 hours. No adverse effects were reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse, via a company representative, referring to a 14 year old female patient. The patient's medical history and concurrent conditions were not reported. On approximately 05-OCT-2016 (reported as "about 2 weeks ago"), the patient was vaccinated with GARDASIL 9 injection, for prophylaxis (strength, dose number, route of administration, lot # and expiration date were unknown). Concomitant therapies were not reported. On approximately the same date (reported as "about 2 weeks ago"), the patient fainted and then had a seizure like reaction after receiving GARDASIL 9. The patient was in the physician office at the time of the events and received medical attention. No product quality complaint was involved. At the time of reporting, the outcome of the seizure and the syncope was unknown. The causality assessment between the seizure and the syncope with GARDASIL 9 was not provided. Upon internal review, the seizure was determined to be medically significant event. Follow up information has been received from the Medical Assistant (previously reported as a "nurse") on 13-DEC-2016, concerning the 12 year old (previously reported as a "14") female patient. The patient had not eaten at all day and was nervous. The patient had not intake recent alcohol, large amounts of coffee or energy boosting supplements, she had not sleep deprivation or was exposed to flashes of light. On 14-OCT-2014 at 15:10 (previously reported as a "05-OCT-2016"), the patient was vaccinated with GARDASIL 9 dose 1 in the left deltoid for prophylaxis (lot number reported as "M018644") and with VAQTA dose 2 in the right deltoid for prophylaxis (lot number "L023232") (route and expiration date were not reported). There were no concomitant medications. On 14-OCT-2014, after the vaccination, the patient got pale head, dropped and started convulsing while eye rolled to the back of the head. The same episode happened about 20 minutes later. The duration of the seizures was 20 seconds. On the same date, the patient recovered from the adverse events. The causality assessment between the seizure and the syncope with GARDASIL 9 and VAQTA was not provided. Additional information is not expected as all follow up information was received. Sender's Comments: MERCK 1610USA010870: Mfr number.
Went to ER and was diagnosed with Arterial Fibrillation.  First time event.
extreme joint pain & It's been over 6 weeks and I still have it & joint pain is getting unbearable; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (extreme joint pain & It's been over 6 weeks and I still have it & joint pain is getting unbearable) in a male patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (extreme joint pain & It's been over 6 weeks and I still have it & joint pain is getting unbearable). At the time of the report, ARTHRALGIA (extreme joint pain & It's been over 6 weeks and I still have it & joint pain is getting unbearable) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
flu like symptoms as she had for the first dose. Presented today with redness, swelling extending down arm to elbow area. Blotchy and patient reported itching as well. Recommended her to be evaluated at urgent care
dizzy; achy; her eyes began to ache; she felt feverish but she did not have a fever; she just felt lousy; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and exp date not reported), via an unspecified route of administration on 20Jan2021 11:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt fine right after receiving it at approximately 11:00 am. On 21Jan2021, the next day around 11:30 am, she began to feel dizzy and achy and her eyes began to ache. On an unspecified date in Jan2021, she felt feverish, but she did not have a fever and she just felt lousy. The patient states on an unspecified date (Friday) she felt better but still a little dizzy and achy. Patient was instructed to call the number listed on the FactSheet to report her experience. She would like to know if her symptoms were normal and would like to know what she should do about her symptoms. She asked if she should receive the second dose of the vaccine. She was scheduled to receive second dose on 10Feb2021. She just wanted to call so that her symptoms can go on record for what people are experiencing after receiving the Pfizer COVID vaccine. Caller states the fact that everyone gets the same dosage no matter their size was amazing to her. She had been bragging to her neighbors and others how the first dose of the vaccine was a piece a cake and then she started to experience side effects 24 hours after receiving the vaccine. The outcome of events was unknown.  Information on the lot/ batch number has been requested.
First dose: Felt a lot like how I expected the second dose to feel. Chills, low-grade fever, aching muscles and joints, fatigue, mild "covid arm". I also experienced nausea which caused vomiting that put me in the hospital overnight due to dehydration. (This happened the day after I got the vaccine.)  Second dose: Similar symptoms as the first dose but they're much stronger. My fever reached 103F one day after the vaccine, strong chills and aches, headache, mild nausea, bigger "covid arm" reaction (I wish I could attach pics, there's a large area below the injection site that's red, hot to the touch, and the muscle feels hard), very sore joints and glands (esp. armpits). The fatigue and pain keep me from functioning regularly.
I?m a retired physician in generally good health for 85 years. In March 2020 I had a mild case of Covid-19 with no late after effects and in February 2021 twice received mRNA Covid vaccines (Pfizer) without incident. A routine health exam on October 13, 2021 included basic laboratory tests, all of which were normal except for elevated glucose, and I was given a Flu shot. The very next day I had a Covid-19 booster at a local pharmacy ? then things got complicated.  On October 15, 2021 I attended an outdoor event and stood for nearly two hours in 80 degree heat. Feeling faint, I lay down and drank water and that night was surprised to note gross hematuria. I had no history of kidney disorders and only the next day was there moderate left flank pain. A CT urogram revealed a radiolucent 7 mm stone obstructing the mid left ureter. I was hospitalized and when a urologist inserted a ureteral stent to decompress the kidney, the stone was pushed back up into the renal pelvis. Three weeks later ureteroscopy and lithotripsy was performed, the stent then was reinserted for three more weeks. (Follow-up CT urogram performed on 1/3/22?..)   Almost unnoticed amidst all this, a rash had developed behind my left eyebrow, soon followed by small lesions on the temple, forehead and nose. Then there was unilateral neck and scalp tenderness that initially I attributed to cervical arthritis ? until I awoke on December 4 with slightly blurred vision and noted conjunctivitis of the left eye. I realized that the rash corresponded with the dermatome of the ophthalmic division of the trigeminal nerve and only then did I understand that Herpes Zoster (HZ) from long forgotten childhood chickenpox must have become activated. An ophthalmologist confirmed presence of acute iritis and increased intraocular pressure and I was begun on eye drops, including tapering doses of a steroid.. I?d never received a shingles vaccination and it was decided not to begin an antiviral because by now, it probably was several weeks since initial eruption of the rash and scalp tenderness ? too late for benefit. Pain was managed with nonprescription analgesics.
After waiting in the pharmacy for 15-20 min my right arm started itching I broke out in a rash or hives only my right arm . It got better  in about 1 hour of having the vaccine .
Patient describes that she developed hives, facial redness, difficulty breathing, some redness at injection site.
8 days after shot, experiencing small pink-red itchy area around inoculation site. 2 inches X 1 inch. Have not yet spoken with Doctor as of 1-27-2021. No treatment yet.
Itching and rash to the injection site, left deltoid. Down left arm shoulder and chest. After a few minutes patient was stable and sent home after monitoring patient. Benadryl was administered at 12:17pm. Patient advised to take Benadryl prior to 2nd dose.
Information has been received from a healthcare worker concerning a 14 year old female with a history of ankle surgery (May 2006) who on 20-JUL-2007 was vaccinated with the first dose of Gardasil (lot #656051/0244U). On 20-JUL-2007 the patient felt fine before and during the administration of Gardasil, but within 5 minutes of receiving it she experienced seizure-like activity and diaphoresis. The healthcare worker indicated that the patient felt lightheaded and blacked out and then experienced muscle spasms for 2-3 minutes. The patient was shaky initially but recovered completely the same day. Her blood pressure after receiving Gardasil was 94/60 and later that day it was 108/72. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.
Chills- was occasional, not associated with any fevers. Happened multiple times a day until 12/27/2020 in AM then subsided.
As of 8/11/21 - date of disease investigation the case reported onset of symptoms on 8/5/21 which included chills, runny nose, headache and cough. Case reports also being a previous positive Covid19 case - released from isolation the first week of December 2020.
Patient described odd sensation on tongue. Felt some tingling on tongue. No swelling or other ill effects.
Information has been received from a registered nurse concerning a 20 year old female with hypothyroidism who on 10-SEP-2007 was vaccinated with a third dose of GARDASIL (Lot # 658558/1061U). Concomitant therapy included SYNTHROID, ORTHO-NOVUM, tetracycline. On approximately 10-SEP-2007 the patient developed egg-sized lump at injection site with redness and itchiness. The patient's mother called the office on 11-SEP-2007 to report the egg-sized lump at injection with redness and itchiness. It was recommended for the patient to take BENADRYL and TYLENOL. The patient's outcome was unknown. Additional information has been requested.
Very bad sore throat Sunday night and all day Monday. Moved into bronchial tubes on Tuesday, no more sore throat. Continued Tuesday and Wednesday (now) have slight fever (99 under armpit).  FYI, The vaccine was both seasonal and H1N1. I am a healthy male, have had flu shots many times without reaction, rarely have significant cold or flu symptoms, and am not aware that I was exposed by somebody else.
after they pulled out the syringe some blood dripped down the patient's arm; patient was concern they did not get the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (after they pulled out the syringe some blood dripped down the patient's arm) and INCORRECT DOSE ADMINISTERED (patient was concern they did not get the full dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (after they pulled out the syringe some blood dripped down the patient's arm) and INCORRECT DOSE ADMINISTERED (patient was concern they did not get the full dose). On 26-Feb-2021, VACCINATION SITE HAEMORRHAGE (after they pulled out the syringe some blood dripped down the patient's arm) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient was concern they did not get the full dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications for the event was not provided.  No treatment information provided
2/22/23 my feet started to tingle. This continued at night then began happening in the day. Happens mainly at night but does not bother me when I walk. I started drinking tonic water and it helped my night time leg cramps. I already had an appointment with my doctor on 3/15/23 for bloodwork. He suggested that I use chelated magnesium and calcium for my feet. Last week I had a sharp pain in my feet, and I took a TYLENOL. I will have a follow up in the next few weeks.
Swelling/ redness 4X3 cm diam. L deltoid at site of injection. No systemic rx.
15 minutes after injection, itching in throat,  anterior chest and neck. hive formation over itchy areas, transported to ED and given epi, Benedryl and Solumedrol.  Throat swelling sensation gone after epi and within 30 min to 1 hour the itching gone.  Sent home with epi-pen and Prednisone
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse (R.N.) and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No primary quality complaint was involved. Follow-up information from a health professional indication that the that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Pt recv vax on 8/11/98; on 8/17/98 pt exp red, swollen area on R upper A; tenderness at the site; pt to M.D., tx=Keflex.  8/19/98 pt imp
Rash under right arm (hives?); This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 16:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced rash under right arm (hives?). The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event rash under right arm (hives?) was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented today for her second COVID-19 vaccination. Before processing her dose, she expressed concerns over a reaction she had to her first dose.  After her first dose, she had nausea/vomiting and generalized hives and presented to the ER. Her treatment included IV benadryl followed by oral benadryl ATC until her hives subsided. She was hesitant to receive her second dose, but we encouraged her to go ahead and that we were prepared with benadryl if she needed it again and asked that she wait an extended 30 minutes post vaccination. Patient received her vaccine at 3:15pm and sat down. After about 10 minutes she started getting hot and nauseous.  She did vomit twice but said she was feeling better than she did after her first dose.  However, at 3:30 she started feeling itchy and could feel hives forming. I gave her 25mg of benadryl and we sat her by a fan.  at 3:48 she was still feeling a little itchy so I gave her another dose of 25mg of benadryl.  At 4:00 she insisted she was "feeling ok and wanted to go home because her daughter was there to pick her up and she was just so embarrassed about her reaction".  I allowed her to leave because this was how she presented after her first vaccine and was treated with benadryl. I instructed her to continue taking benadryl 25mg ATC until her hives subside. She expressed understanding and was walked her to the back door where her daughter was waiting for her.
After second injection severe pain began in left lower quad of abd, then to left back, thinking it was sciatica, multiple epidural injections and ablations with little to no relief. Pain continues,disability to walk, run or move. Limited ROM to Left leg,  After injection severe pain down side of Left leg, then into hip, then crept into calf with redness swelling that became so bad, I sought treatment in Er hospital. Pain with "extensive DVT" Left leg" from left retroperitoneal edema in left pelvis, left iliac vein, external iliac vein and femoral. DVT left popiteal, femoral, common femoral and iliac veins related to COVID vaccine. High grade occlusion.  5 days in ICU, stent and IVC filter, Eliquis, IVC filter removal 2/10/23
OFF LABEL USE WITHOUT ADVERSE EVENT; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced off label use without adverse event. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of the off label use without adverse event and expired vaccine administered was not reported. This report was non-serious.
30 MINUTES AFTER RECEIVING MODERNA VACCINE PT EXPERIENCED SWELLIN OF LIPS AND " TIGHT FELING " IN THROAT. TAKEN TO PROCEDURE ROOM. 911 CALLED. EPINEPHERIN 0.3 MG GIVEN IM . DR. CAME IN TO SEE PT. BENADRYL 50MG GIVEN PO. FIRE RESCUE ARRIVED AND ASSUMED CARE OF PT.  CALLED PATIENT AT4PM SHE WAS RELEASED FROM HOSPITAL AND HOME DOING GOOD.
Information has been received from a 62 year old consumer with penicillin allergy and chronic obstructive pulmonary disease (COPD) reporting on himself who on approximately 18-MAY-2012 (reported as "6 weeks ago"), was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included AVODART, vitamin D (unspecified), gabapentin, ibuprofen, montelukast sodium (MSD), tamsulosin hydrochloride, fiber (unspecified), pantoprazole, ABILIFY, SPIRIVA, ADVAIR, trazodone HCl, pravastatin Na, "morandine", "spotipozon", "zopavin" and MINOCIN. It was reported that the patient received ZOSTAVAX (Merck) vaccine and went to see his dentist and had a tooth pulled the following day. On 21-JUN-2012, as a result of the medications given by the dentist the consumer had a rash he believed was Schaumburg purpura, the patient was experiencing a rash at the site of injection. The patient did not seek the medical attention. There was no treatment given for AE. At the time of the report the patient's outcome was unknown. Additional information is not expected.
The vaccinating pharmacist inadvertently mixed the Pfizer Covid-19 Pediatric vaccine with sterile water for injection instead of 0.9% sodium chloride. The patient was then administered the vaccine. The patient's parents report the patient had a black and blue mark at the injection site and it was more painful than the primary series.
has weird reaction; left leg is sore like arm and can't move; The left side of her body is sore; really sweaty; hand is super hot and can't move it; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (has weird reaction), PAIN IN EXTREMITY (left leg is sore like arm and can't move), PAIN (The left side of her body is sore), HYPERHIDROSIS (really sweaty) and FEELING HOT (hand is super hot and can't move it) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included AMOXICILLIN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced FEELING ABNORMAL (has weird reaction), PAIN IN EXTREMITY (left leg is sore like arm and can't move), PAIN (The left side of her body is sore), HYPERHIDROSIS (really sweaty) and FEELING HOT (hand is super hot and can't move it). At the time of the report, FEELING ABNORMAL (has weird reaction), PAIN IN EXTREMITY (left leg is sore like arm and can't move), PAIN (The left side of her body is sore), HYPERHIDROSIS (really sweaty) and FEELING HOT (hand is super hot and can't move it) outcome was unknown.      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 included ibuprofen 800mg and Tylenol 1000mg.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded