chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed joint and muscle pain about 4 hours after receiving the vaccine (Prevnar 13). The pain was described as a 6/10 by patient. The pain started to decrease by the time the patient went to sleep that night. The patient was lethargic, and her arm was hot and red in the shot area for a few days after getting the shot.
Redness from injection site halfway down arm. told pharmacy 11/21/20 told pt to seek md attention
As a result of the accidental intradermal tentanus instead of PPD, I had to go back to the doctor's office.  I was put on Prednisone and a steroid cream because of the redness and infammation.  I suffered shooting pain into my pinkie and ring finger and tingling in my hand, I believe as a result to how low the shot was givin.  The "skin test" was administered two inches above my wrist.  It is my belief that this should be somewhat farther from my wrist.  When I went back to receive my actual test the other arm was brushed aside and no one really wanted to look at it.  Whne I asked what had happened they simply said, "Oh she just grabbed the wrong thing."
Information has been received from a physician who is the spouse of a 72 year old female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included low dose corticosteroids (unspecified). The patient developed fever over 105 F, swelling of arm and redness on both upper and lower arm, vomiting, diarrhea, disturbances of consciousness and was hospitalized for 6 days and treated with antibiotics (therapy unspecified) and released. The discharge diagnosis was cellulitis. No additional information provided at this time. Additional information has been requested.  Follow up on 07/17/2003: "Follow up information received from a physician indicated that within 12 hours of vaccination, on approximately 04/22/2003, the patient developed a fever, swelling of the entire arm, redness at the injection site, nausea, vomiting, and diarrhea.  The patient was hospitalized 2 days after receiving the vaccination.  Her white cells were elevated and her blood cultures were negative.  An ultrasound of the patient's arm showed no abscess formation, only normal muscle.  The physician indicated that she was unsure if the patient had cellulitis or a reaction to the vaccination.  The patient reported to the physician that she had a history of similar reactions to many vaccines as a child.  The patient was treated with Ampicillin sodium (+) sulbactam sodium (UNASYN(ampicillin sodium(+)) and IV fluids while hospitalized.  She was sent home on amoxicillin (+) clavulantate potassium (AUGMENTIN).  The physician reported that the patient had recovered completely.  Additional information has been requested."
This spontaneous report was received from a 67 years old male patient. The patient was vaccinated with ZOSTAVAX (Lot, route and dose not provided) on 12-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 14-DEC-2012 in the morning, the patient felt warm, and the area under the injection site was red, and painful. The patient stated that he felt a little sick. No treatment information was reported. The outcome of the event was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Vomiting, periods more cramping, bleeding and irregular. Fever, chills. No seizures.
IPOL instead of TUBERSOL 0.1 ml intradermally with no adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 22 years old female patient who had ipol instead of tubersol 0.1 ml intradermally with no adverse event while receiving vaccine ipv (vero) (Ipol).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix).  On an unknown date, the patient received a dose of suspect ipv (vero) with at a dose of 0.1 ml with lot V1A121M via intradermal route in right arm for prophylactic vaccination.  On an unknown date the patient had ipol instead of tubersol 0.1 ml intradermally with no adverse event (Wrong product administered) (unknown latency) following the administration of ipv (vero).  Action taken: not applicable.  Outcome: unknown  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 guidelines. 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.
As soon as the vaccine was injected my arm hurt through my neck to the back of my shoulder blade. I was immediately feeling woozy and dizzy. I sat for 20 minutes and took a Tylenol. I left the site and about 30 minutes later I was feeling extremely tired, and out of breath. Talking was difficult and taking too much energy, my shortness of breath was alarming. It went away within 4 hours.  2 days later I was feeling fine, and was sitting having a coffee. Out of nowhere I had a rapid heartbeat and started feeling woozy and light headed again. I didn't have as much shortness of breath but it felt like if I were to try and do anything it would exhaust me. I took Tylenol again and things calmed down in about 2-3 hours.
Joint Pains,.  Extreme in Shoulder that had irreparable rotator cuff repair.  Hips .  headaches  neck pains
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 9/7/2022 -- RECURRENCE OF SAME SYMPTOMS
shingles; rash; open lesions; wheeping lesions; scabs; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date unknown) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Shingrix. On 11th August 2019, 2 days after receiving Shingrix, the patient experienced shingles, rash, skin lesion and secretion discharge. In August 2019, the patient experienced scab. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, rash, skin lesion, secretion discharge and scab were recovering/resolving.   It was unknown if the reporter considered the shingles, rash, skin lesion, secretion discharge and scab to be related to Shingrix.  Additional case details were provided as follows: The reporter noted that, the patient was in another country prior to his 1st dose. She was not aware of any previous shingles cases or if he had received the other zoster vaccine on the market in the past. The patient returned to the pharmacy with report of rash and shingles, 2 days after receiving vaccine. The patient had went on vacation in the state but developed a open, weeping lesions between his eye brows. The patient was seen at an urgent care and physician diagnosed him with shingles and prescribed valacyclovir. The area was now dry, scabs appeared and the patient was getting better. The reporter noted that, the area was not indicative of a shingles area but the appearance did mimic shingles. It was unknown if he would receive the 2nd dose. The prescribing information with post marketing data was shared and offered to the reporter. She also wanted to know 1st dose efficacy, if 2nd dose should be received by this patient and use with valacyclovir.
No other adverse effects were reported; patient received a dose of PROQUAD by intramuscular route instead of subcutaneous route; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported.  On 20-MAR-2020, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA) (PROQUAD) (lot number S012530 has been verified to be a valid lot number, expiration date reported and validated as 20-OCT-2020) for prophylaxis, via intramuscular instead of subcutaneously (incorrect route of product administration) (concentration, frequency of vaccination scheme and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (indication, concentration, and dose were not reported; lot number and expiry date were unknown to the reporter).   No adverse events were reported.
I had dermatitis. I had a dry and itchy rash on my lower legs, chest, upper body, and upper arms. I went to the doctor, and they prescribed me 3 doses of oral medication. The medication helped and I no longer have this problem.
Fluarix was administrated and person is also PREGNANT.; Fluarix exposed to freezing temperature was administrated; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. The patient was pregnant at the time of vaccination which led to vaccine exposure during pregnancy. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Upset stomach 2 days after vaccinations, followed by diarrhea. Achiness, mild ear pain, and sore throat. Painful welt at site of injection, unknown which arm received which vaccine. Symptoms have resolved.
Patient fainted shortly after vaccination (within 15 minutes) and had low BP.  Patient refused transport to ER and was released to home.
Hives appeared near "tight clothing on body" and "snug fitting" areas. 11/1/00, MD feels it's base preservative in vaccine.
a tingle on her left arm and now she is feeling the same on her right arm as well; little of numbness on her hands and both of her arms; Vaccination site Paresthesia; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (a tingle on her left arm and now she is feeling the same on her right arm as well), HYPOAESTHESIA (little of numbness on her hands and both of her arms) and VACCINATION SITE PARAESTHESIA (Vaccination site Paresthesia) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PARAESTHESIA (a tingle on her left arm and now she is feeling the same on her right arm as well), HYPOAESTHESIA (little of numbness on her hands and both of her arms) and VACCINATION SITE PARAESTHESIA (Vaccination site Paresthesia). At the time of the report, PARAESTHESIA (a tingle on her left arm and now she is feeling the same on her right arm as well), HYPOAESTHESIA (little of numbness on her hands and both of her arms) and VACCINATION SITE PARAESTHESIA (Vaccination site Paresthesia) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information were reported.; 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.
ITCHY EYES; ITCHY NOSE; ITCHY LIPS; SLIGHT NUMB FEELING IN LIPS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to penicillin, allergy to sulpha drugs, and sensitive to blood pressure medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 16:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 08-MAR-2021 16:55, the subject experienced itchy eyes. On 08-MAR-2021 16:55, the subject experienced itchy nose. On 08-MAR-2021 16:55, the subject experienced itchy lips. On 08-MAR-2021 16:55, the subject experienced slight numb feeling in lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy eyes, itchy nose, itchy lips and slight numb feeling in lips was not reported. This report was non-serious.
Patient presented to pharmacy day 3 post vaccination with redness/ rash at injection site.  Reaction was 2 inch "wheal" with darker center.
Somehow a 16 year old was able to slip through the cracks and received a vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Somehow a 16 year old was able to slip through the cracks and received a vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Somehow a 16 year old was able to slip through the cracks and received a vaccine). On 19-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Somehow a 16 year old was able to slip through the cracks and received a vaccine) had resolved.        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.   No concomitant or treatment medications were reported. The patient did not experience any side effects.
About 2 hours after vaccine, patient describes her throat feeling like it was closing, difficulty swallowing.
This case was reported by a physician and described the occurrence of death unspecified in a subject of unspecified age and gender who was vaccinated with Dtap, Manufacturer unspecified, for prophylaxis. On an unspecified date approximately a year before 11/7/06, the subject received a dose of Dtap (dose number and lot number not provided). Approx one month after vaccination with Dtap, the subject died. Report received via manufacturer.
pt recv vax 16NOV95 & 3JAN96 & 19MAR95 lab eval revealed varicella antibody 0.94 which was still negative;
Oth complications following immunization, NEC, subs on 2016-04-20.
Initial report received on 28 Oct 2005 from a health care professional. A 43 year old female patient a medical history on no known allergies and denies medical conditions, felt as if "her chest was expanding" 3 hours following the influenza vaccine (Fluzone SV '2005-'2006) administration on 24 Oct 2005. The next day she woke up with a head ache and sore throat. On 28 Oct 2005, headache has been resolved but the sore throat became worse. The patient was complained of lymph node tenderness and she was not recovered at the time of the report. Follow up information received on 13/Feb/2006 from a health care provider. Per the reporter, there is no additional information at this time.
She developed redness, swelling, induration, heat, and itching. The swelling measured about 4x3 inches. She was given Tylenol and Benadryl. The swelling increased from 8/10 to 8/11. It lingered for 4-5 days.
Received #2 Varicella 6-27-07. Presents to clinic 7-12-07 c/o blisters under (R) arm/axilla x one week.
Received vaccines 11 AM 11/24. Late evening c/o sore arm. 11/25 fever 102.5, knee and hip pain, body aches. Arm warm to touch and still painful. TX with ADVIL and ALEVE. 11/26 sx continue, arm red. Went to ER at 8:30A Dx cellulitis tx with doxy and TYLENOL. Fever 102. 11/27 sx continue, went to PCP - changed Rx to Z-PAK. 11/28 redness worse adm to hospital tx with IV clindamycin. Discharged 11/29 after 4 txs., continue with oral clindamycin. Sxs resolving. 12/1 PCP appt for lump at injection site.
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
Received 2nd dose of Pfizer, had been given 1st dose of Moderna
Dizziness, Headache, Myalgia, Chills, Right arm soreness Narrative:
Slight temperature, swelling and hives 1 hour after 1st injection. Benadryl was given. Hives--hands and feet, swelling; eye's swollen close 10/04/02.
arm beneath site of inject became very red, swollen & tender, approx 2" above elbow (26 mm x 41 mm);
Red bumps underside of fingers of both hands that were itchy. Noticed the symptoms the night of 9/18/2009 - Flu vaccine was administered 9/17/09
Osteoporosis; Sick with covid booster shot; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOPOROSIS (Osteoporosis) and ILLNESS (Sick with covid booster shot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ILLNESS (Sick with covid booster shot). On an unknown date, the patient experienced OSTEOPOROSIS (Osteoporosis). At the time of the report, OSTEOPOROSIS (Osteoporosis) was resolving and ILLNESS (Sick with covid booster shot) outcome was unknown.            IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a 66 year old female consumer refers to herself with chronic adult acne. The patient had no known drug allergies. On 24-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported, dose 0.65 ml, subcutaneously) in an unspecified pharmacy. Concomitant therapies included RETIN-A GEL. The patient stated that the vaccine was reconstituted and sat for 50 minutes at room temperature before she received ZOSTAVAX. The patient had been experiencing "bad diarrhea" today, 25-NOV-2014. The patient had not sought medical attention. No treatment was given for the event. At the time of reporting, the patient had not recovered. Additional information has been requested.
pt recvd vax late AM; around 7-8PM swelling around lt knee; fever of 102.6 even p/APAP & cont crying per child;
Redness, Itching, bruising all over the body. Give Steroids and Benadryl Feeling much better today
Patient came into vaccine clinic accompanied by grandmother( legal Guardian) and the uncle. Age given by uncle was 12. patient was vaccinated without incident. Patients grandmother verified age of 11. Grandmother was informed of vaccination given based on verbal age verification given by uncle per vaccinator. Patient was obseved for 30min. observation period with no  reactions noted. Patient discharged into grandmothers care and notified to seek medical attention if necessary.
The patient was given the wrong vaccine for her age group. She received the moderna booster of .25 mL. The patient was to receive the Pfizer booster. The patient had no signs or symptoms after receiving the Moderna booster.
General body aches - first dose; Sore throat - first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EK5730, Expiration Date: Mar2021) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (Apr2021), described as "Sore throat - first dose"; PAIN (non-serious) with onset 31Mar2021, outcome "recovered" (01Apr2021), described as "General body aches - first dose". The event "sore throat - first dose" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient was not visited physician office for AE. The patient's reaction started with a sore throat and aches following the first dose of the Covid-19 vaccine. Sore throat started about 30 minutes after her first dose of the Covid-19 vaccine. The sore throat went away in 36 hours. When she went to the emergency room, she got 2 bags of fluids and was sent home. The emergency room staff instructed her to stay hydrated and hang out at home.  No follow-up attempts are possible. No further information is expected.
Pain in the arm above elbow area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm above elbow area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the arm above elbow area). At the time of the report, VACCINATION SITE PAIN (Pain in the arm above elbow area) outcome was unknown.            Pain killer was taken as a treatment medication. Concomitant medication included Heart medication, Diabetic medication.