chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 7th August 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This reporter is in risk management department at the reporting pharmacy. The patient received the vaccine in the right arm. The reporter's daughter told him that she called GSK to report and no one called her back. The reporter also said he sent a letter to GSK. It was sent certified mail. The reporter was given the fax number to fax the letter he had originally sent. He had also reported this to VAERS.
ipol stored at 134.70F for 6 minutes, with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 10 years old female patient who reported that ipol stored at 134.70f for 6 minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine; influenza vaccine INACT SPLIT 4V (QUADRIVALENT influenza vaccine); and HPV VACCINE.  On 28-Mar-2023, the patient received a unknown dose of suspect ipv (VERO) (Suspension for injection) (lot V1B901M, Expiry date: 02-JUN-2024) (with unknown strength) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of ipol stored at 134.70f for 6 minutes, with no reported adverse event (product storage error) (unknown latency) following the administration of ipv (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (Ipol) was not applicable.  At time of reporting, the outcome was Unknown for the event ipol stored at 134.70f for 6 minutes, with no reported adverse event.  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 the 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.
Chills, headache, body ache, fever.  Prescribed Tamiflu.
Fever, body aches, extreme chills, nausea, fatigue.  >16 hrs
As described by MOC- Child developed low-grade fever and "felt bad" the evening following immunizations. The following morning (1/20/11)child began developing "a couple" lesions described as beginning like "small, red pimple-like blisters, and starting to turn into welts" on his bottom and back. All are small in size except one on his back which is approximately the size of a silver dollar. Child has not been complaining of itching, pain, or SOB.
Migraines and insomnia, soreness at the injection site, still ongoing at this time of reporting
On day of vaccinations felt normal soreness and tiredness. On 12/20/19 had hives.
The dose was given on 1/10/2022 and the do not use beyond date was 1/6/2022.  The vaccine expiration date was 03/30/2022
Had sudden ?eye? stroke. Neurologist at hospital could not rule out this being an adverse affect from vaccine since there were no underlying health issues or past history of any health issues. Lost 25% vision in right eye due to sudden stroke.
no additional AE was reported; The patient received the third dose inadvertently on 6/18/2021.; This spontaneous report was received from a nurse referring to a 15 years old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 31-JUL-2017, the patient was vaccinated with the initial dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter; strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. 25-JUL-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter; strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.          On 18-JUN-2021, the patient was vaccinated inadvertently with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter; strength, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered). Agent entered quantity filed as 1 for the additional dose only. No additional adverse event (AE) was reported (no adverse event). No product quality complaint (PQC) was reported.
On 2/6/2021, beginning at around 6 p.m., I started experiencing a very severe headache. The headache became progressively worse between 6 p.m. and around 2 a.m. that night. It was one of the worst headaches I have ever experienced. The headache felt like "pressure" around my head - it was not concentrated in a single spot. It seemed to be slightly worse when lying down. I was alarmed at the strength of the headache, and how long the headache lasted. I considered going to the hospital but decided not to. I took two Advil, which did not resolve the headache, but did make it slightly less terrible. I was able to get some sleep, and when I woke up the next morning, I still had a headache (albeit not quite as bad). As of today, 2/10/2021, I still have a slight headache--I have had a headache every single day since 2/6/2021. My current headache is not nearly as bad as the headache on 2/6/2021, but it's still a headache. I experienced the other vaccine symptoms that others have reported (fever, chills, sweating, significant pain at the injection site, etc.), but I was surprised to experience one of the worst and longest-lasting headaches of my life. I am concerned about taking the next dose in a few weeks.
Within a couple of hours of second Pfizer shot I experienced symptoms of Atrial Fib and sought treatment at the local healthcare facility.   After 13 hours of treatment my heart ?coveted ? and was released for the hospital. I received meds and tests to make the conversation happen
PT REPORTS TO PHARMACY 8 DAYS AFTER INJECTION STATING THAT HER ARM IS STILL SORE AND HAS LIMITED ROM IN THE INJECTION ARM (LEFT). SHE SHOWS THAT SHE CAN ONLY LIFT HER ARM ~45 DEGREES AWAY FROM HER BODY. REPORTS THAT IN THE DAYS FOLLOWING THE INJECTION, THE INJECTION SITE WAS ERYTHEMATOUS AND SWOLLEN. THE PAIN HAS NOW RADIATED DOWN HER ARM TO HER FOREARM. SHE HAS USED IBUPROFEN 400MG BID UP TO THIS POINT TO CONTROL THE PAIN. I INFORMED HER SHE COULD DOSE THIS AT 600 MG BID OR 400 MG TID IF NEEDED, BUT THAT SHE NEEDS TO HAVE THE ARM INSPECTED BUT HER PCP OR URGENT CARE DUE TO THE LIMITED ROM.
Approx 2 days after receiving vaccine pt states arm swelled up and become difficult to move. Pt was placed on antibx for another reason and swelling, improved. Pt came to clinic 2/9/15. Arm was hot to touch, red and had a 5cm x 4cm indurated area and painful. Pt was evaluated by MD and placed on additional antibiotics. Pt returned 2 days later. Erythema, redness decreased, however indurated area cont 5cm x 4cm. MD aspirated serous fluid. Sent for culture. No additional fluid except blood aspirated. Pt cont to antibiotics.
Same day that I received vaccine, I began having "episodes", that are described as generalized body aches, extreme malaise and feeling feverish (No temp). These episodes continued daily, lasting 2-3 hrs. 1 week after shot new symptoms of severe muscle pains in both deltoids. To include (R) wrist and (R) knee. Joint pains (L) calf pain. Pain so severe in (R) Deltoid that I was unable to lift arm to comb hair. Since I have similar symptoms after taking Flu vaccines, I concluded that my "episodes" were just my body trying to develop antibodies to this vaccine. With the flu vaccine it has taken 2 weeks for symptoms to subside. So, I suffered through December thinking that it's taking me a long time to develop antibodies. In January 2019, I contacted my PCP's office and was essentially told that it could not be the vaccine and did not offer to evaluate me to see what it was.. on Jan 24, 2019, after advise of an old PCP in another state, I made an appointment with the Rheumatology Department at Clinic (saw a nurse practitioner) 1st tentative diagnosis was Polymyalgia Rheumatica - "But markers did not support this." She felt that my muscle pains and recent stressful events suggested this. Meanwhile, I'm still suffering with these daily episodes of as noted above, "feeling feverish, body aches and malaise: - I have had some relief with episodes from Ibuprofen/TYLENOL. Rheumatologist place me on Meloxicam daily to replace the Ibuprofen. As of today, I am free of these horrible "episodes", that I believe were due to the vaccine, but still having some less severe body aches. I'm receiving PT. to help improve ROM due to nonperforming for 2 months. I know that individual reacts differently to meds, but wanted to let you know about my experience and MDs. need to take this seriously, when caring for patients.
This is a spontaneous report from a contactable nurse. A 15-year-old male patient received 1st dose of TRUMENBA, intramuscular in the left deltoid at 0.5 ml single dose on 22Dec2015 and the 2nd dose (Lot: J28923, Exp date 01Jun2016) intramuscular in the right deltoid at 0.5 ml single dose on 26Feb2016. The patient medical history and the patient's concomitant medications were not reported. With both vaccines the patient experienced the fever within 24 hours of receiving the vaccine, for just one day and the belly ache within 24 hours of receiving the vaccine, for 3 days. He has recovered completely from both side effects. The events were assessed as non serious. The nurse was not provided with the information regarding the adverse events by the patient. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information reported from a contactable nurse included: reporter informed regarding the adverse events; reporter further contactability.
This spontaneous report as received from a nurse practitioner via a company representative and refers to a 20 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates in 2010, the patient completed 3 doses of GARDASIL (doses, lots# and expiration dates were not reported). It was reported that on an unknown date in May 2016 (reported as a month ago), the patient forgot they had completed GARDASIL series, and received the first dose of GARDASIL 9 (dose, lot# and expiration date were not reported) inadvertently. There were no adverse effects reported. Additional information has been requested.
Patient reported awakening the night of the injection with cold sweats and feeling very fatigued. Ran 100.3 temp for 4 hours and symptoms resolved after 24 hours
Injection was around noon, felt fine until dinnertime At around 5pm I started feeling a little groggy, lack of appetite By 7 pm I was experiencing moderate chills and shakes and tingling fingers and tongue, shakes subsided around 830p 9pm I went to sleep, 11pm woke up disoriented having been tossing and turning, elevated heart rate (approx 120 bpm) and temp (101.5) which lasted until around 12:30 am  Resolved with symptoms of pressure headache until mid morning, made it difficult to sleep  Treatment was ice and water, cold compress, hot shower, then in the morning two tylenol  Day2 only effects seem to be those lingering from the night before (tired from lack of sleep, muscle soreness from shakes)  The main fear was the high heart rate which was only listed in my side effects packet as something to look out for shortly after the injection as sign of an allergy, not something that would come on later
Varicella immunization. Large local reaction. Diffuse macule and papular rash throughout body suggestive of varicella infection.
No additional AEs; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator and referred to a patient of unknown gender and age. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 02-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter subcutaneously (valid lot #U022321 with an expiration date: 15-JUL-2023) for prophylaxis. The vaccine was administered after temperature excursion, temperature 6 Fahrenheit with a time frame of 30 mins (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Three days post vaccine, patient developed a fever. One week post vaccine, the patient had pain and difficulty moving her joints all over. Daily tasks, such as climbing stairs and getting out of bed, were difficult to perform.
Information has been received from a Registered Nurse concerning a 74 year old male consultant with an allergy to penicillin who on 26-Oct-2005 at 11:00 a.m. was vaccinated IM in left deltoid with his first dose of pneumococcal 23v polysaccharide vaccine (lot #651539/6607R). The patient was ill with chronic sinusitis at the time of vaccination. There was no concomitant medication. On the same day, the patient's left arm became sore. On 27-Oct-2005 the patient felt fatigued and developed redness over left arm for 24 hours. On 28-Oct-2005 there was a 22 cm area of redness, warmth, and slight edema which extended medically overlying medial distal arm. Over 50% over anterior lateral aspect of arm. Overlying bilateral anterior flanks there was a confluent erythematous eruption with satellite macules - symmetrical. There was also an associated abdominal rash. The patient required unspecified medical intervention. On 31-Oct-2005, the patient recovered. The reporter felt that the fatigue, warm skin, edema, erythema, pain in extremity and erythematous rash were other important medical events (OMIC). No further information is available.
C/o nausea and diarrhea over the weekend. Appeared at clinic on 7/14/15 with complaints of fever, nausea and feeling weak and going to "pass out" temp 992 b/p 140/90. Refused to go to the local ER or her MD. Pt unable to leave by self. Husband escorted pt home unable to drive.
Had reddened area measured 82x42mm inferior to injection site. Caused numbness and tingling into hand.
Patient complained her heck was tightening up. Checked with patient after gave her Benadryl, she said no difficulty breathing, and no hives. She said her tongue might have swelled up a little bit, but got better.
Two days after vaccine 6" x 4" oval, red, mildly edematous area surrounding injection site. No fever. No fluctuance.
The rash is a bump looks like a welt; got a rash on the arm; rash came back hard; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (The rash is a bump looks like a welt), RASH (got a rash on the arm) and INJECTION SITE URTICARIA (rash came back hard) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced URTICARIA (The rash is a bump looks like a welt), RASH (got a rash on the arm) and INJECTION SITE URTICARIA (rash came back hard). At the time of the report, URTICARIA (The rash is a bump looks like a welt), RASH (got a rash on the arm) and INJECTION SITE URTICARIA (rash came back hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking Thyroid medications concomitantly. No treatment information provided.
7 year old was given Flublok in error with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00327405) and transmitted to Sanofi on 22-Oct-2020.  This case involved a 7 year old patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with the help of prefilled syringes (Lot number and expiry date not reported) via intramuscular route in the shoulder for prophylactic vaccination (product administered to patient of inappropriate age as the patient age was 7 year).  Relevant medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  No other vaccines were administered.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: 1 day).  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.
5 minutes after vaccine administration, client c/o moderate burning pain and edema to LUE,  noted edema and induration approx. 2 inches below vaccination site, extended down arm approx. 4 inches, no bruising, no redness,  client to low fowlers position,  arm elevated, pressure applied to area, coban wrapped around arm, ice pack applied,  no resp. distress, Vital signs stable, A & O x 3, client taken to nearest Hospital by family member, instructed to report Incident to MD
Hives, no resp involvement, no circumoral numb/tingling NAD, VS 97.9, P90, BP 134/83.
I began experiencing frequent PAC's on Feb 25th, while skiing. It especially bothered me with exertion or trying to fall asleep. (After the first dose of Moderna, on 1/13, I did not notice symptoms but an oximeter reading on 1/27 was unusually slow, indicating the PAC's could have been present then.) A Holter monitor a couple months later showed 9% PAC's and short runs 9f tachycardia. The symptoms gradually improved over the next few months, but recurred briefly after I got my booster on 11/9/21.
Leg cramps, tingling feet  Tinnitus, sound sensitivity, pressure in ears, pain in ears, vision changed
Patient was brought to the local ER via ambulance from another facility with c/o a fall with injury to left hip, also wheezing.  Patient was evaluated and admitted for acute exacerbation of COPD with acute pulmonary edema.
After recieving the second Coivd Vaccine on 4/8/2021, I experienced full body aches, head ache, stomach ache, and a fever of 100.1 within the next 24 hours after the vaccine. The fever broke midday on 4/9/2021 and the body aches, head ache, and stomach ache went away around mid-afternoon on 4/9/2021. Since 4/9/2021 both feet have had a pins and needles sensation and have been numb to the touch. no sign of alleviation from elevating feet or soaking feet. saw primary care doctor on 4/16/2021 where she said I have peripheral neuropathy from vaccine and put me on prednisone and has ordered a nerve conduction study.
Today, she started with sharp pain underneath her rib on the right side(same side as injection site); Patient had sore arm next day after recieving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Today, she started with sharp pain underneath her rib on the right side(same side as injection site)) and PAIN IN EXTREMITY (Patient had sore arm next day after recieving 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included POTASSIUM and VITAMINS NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Patient had sore arm next day after recieving 1st dose). On 08-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Today, she started with sharp pain underneath her rib on the right side(same side as injection site)). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Today, she started with sharp pain underneath her rib on the right side(same side as injection site)) and PAIN IN EXTREMITY (Patient had sore arm next day after recieving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unknown blood pressure medication.   Patient only rested and did not took any treatment medications.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-JUL-2021, Outcome of the updated. Patient stated that she is doing fine now and did not took any medication but only rest.
Redness and swelling and firm on left thigh at site of DTaP injection noticed; increased swelling by arm; pt able to jump around, pain on palpation only.  Mother stated slight hard bump with each vaccine, but not this big.
Swelling, redness with induration, blister around injection site 3.5 cm x 3cm.
TWENTY-FIVE HOURS AFTER ADMINISTRATION NOTED INJECTION SITE RED ITCHY WITH A BUMP UNDER THE SKIN. FIFTY TWO HOURS AFTER ADMINISTRATION VERY ITCHY AND BUMP "BIG" iMPROVED THE NEXT DAY AND RESOLVED THE DAY AFTER THAT.
Parent was offered all four vaccines, declined to have HPV and Bexsero.  A nursing change during the patients visit resulted in a miscommunication to the covering nurse, and all four vaccines were given.
This spontaneous report as received from nurse refers to a 19 year old female patient. Medical history and drug reactions/allergies were not reported. On 28-JUL-2008, the patient was vaccinated with GARDASIL first dose, 0.5 ml, intramuscular for vaccination (lot not reported). On 13-JUL-2010, the patient was vaccinated with GARDASIL second dose, 0.5 ml, intramuscular for vaccination (lot not reported). On 08-AUG-2013, the patient was vaccinated with GARDASIL third dose, 0.5 ml, intramuscular for vaccination (lot not reported). Concomitant medication was not reported. The patient did not seek for medical attention. No adverse effects reported. Additional information has been requested.
On March 28, L arm at vaccination site became red, itchy, inflamed, slightly tender, and hot. Started at about 10:00 am and got slightly larger and redder throughout the day. Area on arm is an oval shape measuring at its largest dimensions about 2 inches by 3 inches. Today, on March 29, L arm remains much the same. No fever.
Pt. was given ADACEL and FLUVIRIN on 10/14/13. On 10/26/13 she developed numbness and tingling. Was admitted to hospital with Guillain Barre syndrome. Tx with steroids, IV globulins.
p/vax pt became preg (LMP: 9/12/99);pt had an elective abortion;