chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with incontinence, acid reflux, diabetes, high blood pressure and gastroesophageal reflux disease (GERD). The patient had drug reactions/allergies with penicillin. On 12-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX for shingles prevention (lot#, expiry date, route, dose and strength not reported. The patient presented with shingles the following day, on 13-SEP-2012. The patient stated that the evening of 13-SEP-2012 she experienced tingling on her neck and itchiness around her neck, head and eyes. She also experienced unspecified pain. The patient visited an unspecified emergency room on 13-SEP-2012. The patient was not admitted to the hospital. The patient was diagnosed with shingles on 13-SEP-2012. She was prescribed VALCYCLOVIR by a physician, to treat the shingles. The patient was fully recovered on an unspecified date. Additional information has been requested.
crying & uncomfortable for 9 hrs then fine; rt leg has local sterile abscess @ site of inject on 5APR93;
Swelling (R) arm and axilla. (R) axilla swelling, no red, no adenopathy. BENADRYL OTC.
pt exp high fever, chills, extreme, h/a, nausea, vomit & severe aching all over; pt unable to keep down med for fever & pain; seen by MD who stated pt had poss serum sickness due to vax; t103.6;
14 year old vaccinated with Moderna vaccine.  Moderna is not approved for <18 years of age.  Clinic lead notified of error and will review critical age restrictions on vaccine brands per EUA approvals.
Information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 was vaccinated IM in deltoid with a second dose of Gardasil. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later bumps appeared on the same arm. She was given over the counter ibuprofen (Motrin) for pain. The reporter reported that patient experienced mild pain at the injection site after getting her first dose of Gardasil. The patient has not recovered. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a health professional concerning her 17 year old daughter who on 25-MAY-2007 at 03:30 PM was vaccinated IM in left deltoid with a second dose of GARDASIL lot #657621/0387U. On 25-MAY-2007 the patient experienced pain next to the injection site after vaccination and her arm started to swell. Two days later bumps appeared on the same arm. She was given over the counter MOTRIN for pain. The reporter reported that patient experienced mild pain at the injection site after getting her first dose of GARDASIL. In follow up information it was reported that on 25-MAY-2007, at 06:30 PM patient had "hard painful lump adjacent to injection site with multiple raised smaller non painful bumps down and around the same arm". It was reported that on 01-JUN-2007 patient recovered. Additional information is not expected.
Mild flu-like symptoms.  Fatigue, Headache, fever, body ache.  Onset a day after shot, lasted 4-5 days.
Patient developed itchy rash on face about 2 hours after MMR vaccine. Subsequently became generalized without edema or respiratory symptoms. Patient was seen at local ER at 11:55 pm and improved after Benadryl and Decadron treatment.
not normally, but I did get a rash after the first covid vaccine; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 01:30 PM (at the age of 53-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gallbladder removed, depression as I take an antidepressant, menopause (Patient did not have a menstrual period in nearly 10 years). The patient took many vitamins, minerals (unspecified) received in two weeks. No other vaccine received in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On an unspecified date, the patient experienced not normally, but I did get a rash after the first Covid vaccine. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant (who was also the administrator) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M015931, expiration date 30-MAR-2018 (therapy type, dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccines experienced the temperature excursion of more than 8 but less than 25 degrees Celsius for 1 hour and 18 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007587:
(L) deltoid with erythema & mild induration. Diffuse papular rash.
This case was reported by a healthcare professional and described the occurrence of cellulitis in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject's medical history included asthma. Previous and/or concurrent vaccination included Hib (non-gsk); Merck; unknown given on 19 June 2009. On 19 June 2009, the subject received 1st dose of KINRIX (.5 ml, unknown left thigh). On 21 June 2009, 2 days after vaccination with KINRIX, the subject experienced cellulitis. The subject went to the emergency room and was given an antibiotic and PRELONE. The subject was not hospitalized overnight. This case was assessed as medically serious by GSK. The subject was treated with Antibiotic unknown and PRELONE. On 24 June 2009, the event was resolved. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Patient reported reaction to pharmacy on 1/14/16. She had redness and swelling down her left arm and hand.
No side effects reported; An expired Merck Sterile Diluent was reconstituted with VARIVAX and administered to a patient; An expired Merck Sterile Diluent was reconstituted with VARIVAX and administered to a patient; This spontaneous report was received from a registered nurse referring to a 56-year-old patient of unspecified gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.  On 22-JUN-2022, the patient was administered a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis, which was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) (lot number S024549 has been verified to be valid, expiration date reported and established as 29-MAY-2022) (expired product administered, product reconstitution quality issue).   No side effects were reported (no adverse event). The reporter confirmed that the expired sterile diluent (MERCK STERILE DILUENT) had no temperature excursions.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2207USA000565:
Second pediatric dose administered  prior to completing  at least 17 days post first dose,   first administered november 17. 2021. No adverse reaction.
Information has been received from a physician concerning a 9 month old male who in October 2009, was vaccinated with a first dose of ROTATEQ (oral, lot # 664345/1056Y), the second dose (oral, lot # 664592/1057Y) in January 2010 and the third dose (oral, lot # 665273/0204Z) on 09-JUN-2010. No adverse effects were reported. Follow up information received from physician concerning a 9 month old male with no illness at time of vaccination, who on 09-JUN-2010 at a.m. was vaccinated with a third dose of ROTATEQ (oral, lot # 665273/0204Z). It was reported that the wrong dose was administered in spite of the patient being 9 months already. Previous dose was administered 5 months earlier. The patient did not have an adverse effect, and there was no adverse effects following prior vaccination. No further information is available.
- Same day with numbness, headache, dizziness, fever and 2 days after
Sore right arm shortly after the shot. Arm is still slightly sore as of completing this form. Lost of appetite, chills, sweating, and mild fever starting 12 hours after the shot. Took Ibuprofen shortly after the symptoms showed up. Symptoms lasted for 7 hours.
syringe issue; when reconstituting ACTHIB the needle popped off the syringe and about 1/4 of the diluent spilled from the syringe onto the counter; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 month old male patient who had received a 0.5 mL dose HIB (PRP/T) VACCINE [ACT-HIB] whose needle popped off the syringe while reconstituting and about 1/4 of the diluent spilled from the syringe onto the counter and syringe issue,(lot UJ347ABA and expiry date 30-july-2021) and received via intramuscular route in the right thigh for prophylactic vaccination on 15-Feb-2021(underdose and syringe issue).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and WATER FOR INJECTION (STERILE WATER FOR INJ.).  Caller stated that when they drew the vaccine up, they used the package diluent and when they administered the vaccine, the needle popped off and not all of the vaccine was administered because part of it spilled out.   this case associated with syringe issue.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Severe pain during periods eversince the second dose. The cramps are very strong each cycle, and I am not able to function properly due to the pain during the period cycle. This has never happened to me in the past.
27 YOF seen after Pfizer vaccination.  Previously had a COVID positive tests JUN2020 & 29NOV2020, with negative results in between.  During June illness, PT was asymptomatic, during November illness, PT sts she had similar symptoms to those she began to experience after the first dose of the vaccine, including: dizziness, body aches, fever (unk temp) chills, and tightness in chest upon exertion.  After vaccine, PT sts she had the same symptoms as during the November illness but also had mild dizziness upon exertion, though gait steady when walking and no issues driving or navigating stairs as per PT, she also began to get blurriness of vision.  Within 24 hours all symptoms have resolved.
This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
Approximately 1 1/2 hours after patient received FLUVIRIN he broke out in hives. I told mom to give him BENADRYL and keep an eye on him. Take to ER if trouble breathing. BENADRYL helped and hives were gone within a few hours.
A few minutes after the shot, patient told her mom she didn't feel well and fainted into her mother's arms.  She was put on the floor and she was conscious at that time.  We put a blanket under her head.  I took her BP and it was 111/67.  After 5 minutes she wanted to sit up and she sat in a chair and passed out again.  911 was called at that point.  We had her on the floor after that until the paramedics arrived.  They retook her bp and it was 111/63.  They checked her vitals and decided to take her to the ambulance just to give more privacy and have their equipment more readily available.
Chest tightness and pain, shortness of breath, Constant pain  with spasm that radiated to the back, lightheaded
Vaccinated on Friday AM.  Typical fever chills of vaccine about 10 hours later.  Pt was taking NSAIDS, and symptoms continued Sat and Sun getting worse Sunday Night.  Woke up Monday AM with severe CP 8/10. Came to ER.  Found to have Trop HS of 222, EKG changes with diffuse ST elevation, and preserved EF.    diagnosis of perimyocarditis and actively recovering.  Treated with anti inflammatory medications.
9 days after the shot was given a red ring showed up around the area I was vaccinated.
received 3rd full dose; chills; fatigue/he stated he is "almost back to par", but still is experiencing fatigue; feeling achy; sore right arm/ some soreness still in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received 3rd full dose), CHILLS (chills), FATIGUE (fatigue/he stated he is "almost back to par", but still is experiencing fatigue), MYALGIA (feeling achy) and VACCINATION SITE PAIN (sore right arm/ some soreness still in the right arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to sulfa) and Penicillin allergy. Concomitant products included LOSARTAN, ATORVASTATIN and HYDROCHLOROTHIAZIDE (HCTZ) for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 3rd full dose) and VACCINATION SITE PAIN (sore right arm/ some soreness still in the right arm). 05-Nov-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue/he stated he is "almost back to par", but still is experiencing fatigue) and MYALGIA (feeling achy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Nov-2021, ACCIDENTAL OVERDOSE (received 3rd full dose) had resolved. At the time of the report, CHILLS (chills) and MYALGIA (feeling achy) was resolving and FATIGUE (fatigue/he stated he is "almost back to par", but still is experiencing fatigue) and VACCINATION SITE PAIN (sore right arm/ some soreness still in the right arm) had not resolved.            He stated events got worse on 06-Nov-2021.
Patient had erythematous, blanching facial rash.  Macular papular extended from face, to chest, abdomen & back.  Prescribed Benadryl and follow-up in 3 days.
On about April 5/6 2021 I had dislocated my rib in which I was placed in ICU at my work to recover. During that time I began to fell pain in my right leg calf area.  When I was released I still had pain and it gradually got worse in which then I went back and it was discovered that my right calf was 1 inch larger then then my left & a ultrasound was conducted in which a blood clot was discovered. Approximately 2 weeks after discovering the blood clot I was sent to have testing and visuals done and was notified I had DVT and PE. I received treatment receiving medication for approximately 6-7 months. A few months following behind the conclusion of my treatment  I found out I  yet again had received another blood clot in my right leg. I had no signs of discomfort with this blood clot but was sent to the ER for verification due to signs of PE and DVT again at a OBGYN appointment.
Injection site was initially sore for two days and then pain became minimal. Today I awoke to find my injection site raised, bumpy, hot to the touch, and very itchy. Today is day 8 following my injection.
started vomiting the next day. We weren't concerned because this was expected and she recovered within two days. She improved the next day but became sick again the day after and every day since. We are now at day 19 and she is still nauseated every day. She vomits periodically about every second or third day. She vomited profusely today on day 19.  I am reporting this because the symptoms shouldn't last this long.
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 72 years old male patient with chronic lymphocytic leukaemia. He received 2 courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 5. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 3. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Literature report:  Sender's Comments:  US-009507513-2103USA003406:
On 1/7/21 client received second dose of Pfizer COVID vaccine (lot # EL 32249) and 16 hours later experienced "palpitations" and a heart rate of 180-200.  With MD approval the client received a Moderna booster on 12/30/21.  Unknown if she experienced side effects because client left against advice to stay for observation period.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient is autistic. Did not respond well to process of administering the vaccine (jumped away and tried to push me away with his other arm despite efforts to calm him). Vaccine was administered, but will likely be more sore due to how he responded to administration. Patient seemed fine and actually not even in pain at time of leaving 30 minutes after the vaccine was given.
Information has been received from a female consumer who reported that she received GARDASIL (dosing dates and lot number not reported). The patient reported that she has "medical problems due to the vacation [sic]." Additional information has been requested.
3:15 pm -> while examining patient she went from sitting to laying down position, cleared eyes, rolled back, twitched entire body x 2 x 30 sec then recovered with sweating + +, completely awake. BP 110/80 HR 120/m.
From initial information received on 05/23/03 from a physician regarding an adverse event occurring in the USA, it was reported that a six-month old male pt received ActHIB, Lot # UA839AA, Tripedia, Lot # U0856BA, and Prevnar, Lot # 492-393 (manufactured by Wyeth), on 05/16/03 at 11:00AM.  Routes and sites of administration were not reported.  Later that day, the pt started crying and continued until 11:00 PM that night.  On 05/17/03, the pt's mother called the physician.  Tylenol was recommended. The crying had stopped.  On 05/19/03, the mother called the physician to say that the baby seemed tired, but was doing much better.  The pt reportedly recovered from these events.  The reporter of this case is the same reporter of case 2003-01026.
no additional AE/no additional information provided; VARlVAX and MMR II that underwent multiple temperature; This spontaneous report has been received from a medical assistant referring to a 4-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 06-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# T020652, expiration date was reported and validated as 16-JUN-2022; strength, dose, and route were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) (lot# S035352, expiration date was reported and validated as 05-NOV-2021; strength, dose, and route were not reported) for prophylaxis. Both vaccines were improperly stored under multiple temperature excursions (product storage error), which were at -14.03 degree Celsius for 1 hour 15 min, at -14.9 degree Celsius for 9 min, at -10.3 degree Celsius for 1 hour, at -6.3 degree Celsius for 2 hours. The temperature excursion was detected by a data logger. There were previous temperature excursions at -14.03 degree Celsius for 1 hour 15 min and at -14.9 degree Celsius for 9 min. No additional adverse event or additional information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA003554: US-009507513-2105USA003472:
Patient reports having numb fingers that progressively got better (started with whole fingers, than just about 1/2 and then just the finger tips). Patient states this lasted for about a week and is no longer experiencing adverse event.
Patient states initially muscle soreness and mild flu-like symptons and slightly red and hot on evening after administered.  Within next few weeks and currently the arm is sore and achy and hurts with certain movements.  Has had previous hand and forearm nerve issue in same arm but did not feel this way "higher up" until received vaccine.