chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 70 years old female patient. The patient was vaccinated with ZOSTAVAX (lot# was unknown) in 2006 or in 2007 (exact date unspecified) and then developed shingles about 2 or 3 years later (exact date of shingles unspecified). The patient visit office for medical attention and got unspecified antiviral medication and pain medication to treat the adverse event. The outcome of shingles was reported as recovered/resolved. The pharmacist did not administer the ZOSTAVAX to the patient in 2006 or 2007 and the name of the site the vaccine was administered at in 2006 or 2007 was unspecified. Additional information is not expected.
14OCT92 approx 11PM woke up having difficulty breathing; noticed red rash on neck p/2nd episode of SOB; worked 15OCT92; rash worsened took DPH & applied Hydrocortisone cream; late 15OCT92 PM to ER w/severe red raised rash, difficulty breath
Sore arm: started several hours after the injection and was pretty mild, was very sore the next morning, almost gone if not completely gone by the following morning. No treatment  Slight chills and shakiness the night of the vaccine (which was at noon), gone by morning. No treatment
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: dry mouth-Mild, Additional Details: 5 minutes after recieving vaccine, patients put head in hands during observation period. when I went out to check on her she said she was very weak, and was starting to slide off the her chair, moved pt to the ground, where she stated she was getting chills, covered her with white coat, she remained coherent, added her mouth was dry, was told to take deep breath the entire time, and stated she was not having any difficulty breathing, EMS arrived, she did not go to Hosp.
marked non tender erythematous, swelling 3x4" over the infected site lt deltoid;
chronic hives; dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 013L20A and 025J20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Patient reported that it was more than 1 month prior to the Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient experienced URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID F) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Chronic urticaria, at a dose of since the start of chronic hives. At the time of the report, URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia) had not resolved.            No medical history was reported.  Patient reported birth control as concomitant medication.  Patient stated that the adverse reaction had stayed the same. However, it was probably due to the medications she was taking to treat her symptoms. Patient stated that she was getting better at managing her condition. Patient felt that if not treated herself properly, condition would worsen. Patient had been seeing a Dermatologist monthly since FEB 2022, and her primary care physician twice (JAN 2022 and FEB 2022) for her condition.  Patient reported acupuncture as a treatment.   This case was linked to MOD-2022-537821 (Patient Link).
The patient was seemed OK after I gave her the shot.  She came in with her mother who was in the vaccination room with her while I gave the shot. I told them to stay in the store at least 15 to 30 minutes after receiving the first dose.  They walked out the vaccination room and I returned to the dispensing area. The mother immediately came up to the pharmacy dispensing window to ask for an ice pack because her daughter passed out on the floor and hit her head. I got the ice pack and went to the patient to see if she was OK.  She was lying down on her back. The mother took the ice pack and rested it under the patients head. I checked her pupils and checked her pulse. Those vitals were normal. I asked the patient if she could tell me her name and what day of the week this was. She answered correctly. I took her temperature on her forehead and it was elevated to 100.4 - I re-checked her temperature again in 3 minutes and it was 99.  The patient was able to get up to a chair a few minutes later, and then they left after 15 minutes and the patient seemed OK.
Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient; Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.   Reporter had stated that the 4 doses 1 vial, vaccines were past their beyond use date of 26JAN2022 in the refrigerator and the vial did not undergone any temperature excursions and the vial was initially stored in the refrigerator was 27DEC2021.  Patient received her both doses in her left arm shoulder deltoid muscle and did not complain of any other Adverse events. No treatment information was reported.   This case was linked to MOD-2022-468655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up contains no new information.
Patient received dose of undiluted vaccine. Patient had no adverse effects while in observation. Patient was informed, verbalized understanding of error and was educated on potential adverse effects . Patient was instructed to call PCP if any symptoms that occur after vaccination.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored PROQUAD, lot # L004005, expiry date 05-AUG-2016; L006388, expiry date 25-AUG-2016; K003817 expiry date 14-SEP-2015 (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
about an hour after receiving the vaccine, felt a "prickly" feeling on his penis. noticed his foreskin was swollen. no pain on urination. was instructed by his urologist to wash the area and apply hydrocortisone and to be seen by the physician saw his pcp dr. the following day. now experienceing itching, redness on face and lips. progressed to ear and chin. Dr prescribed a 7 day course of prednisone and recommended cold compress.  6pm same day, rash progressed to entire face and had an injection site reaction.  reported to pharmacy on 8/3/20. states symptoms are getting better, but still not well. still experiencing itching, swelling, and irritation.
Patient was complaining about shoulder pain that has not gone away since receiving her 1st dose in April.
Fever, chills, severe body aches, fatigue. Random sharp pains. Pain at site of injection. Onset 6-8 hours after dose.  Mostly resolved after 30 hours. Soreness remained several days after.
Rash and hives to left and right arms, neck, back, trunk, and inner thighs. Swelling in face and then had trouble breathing. Went to ER, received steroids and put in hospital (1) day observation.
no side effects other than a sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: no side effects other than a sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient via interactive digital media. The reporter reported that the patient got the RSV vaccine as soon as it was available, no side effects other than a sore arm. Follow up was not possible as no contact details were available. This case was linked with case US2023AMR132094, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR132094:same reporter, different patient
In July of 2022, I started noticing some neck stiffness on both sides of my neck and then I noticed my shoulder hurt. I went to the doctor for it and they did X-ray and said nothing was wrong. I also had some pain in my right arm, so I went to the doctor and had some blood work done and it came back positive for signs of Rheumatoid Arthritis. After that blood test, they sent me to a rheumatologist that confirmed I had Rheumatoid Arthritis. I went back in September of 2022 to start treatment and the doctor had me take Prednisone and Methotrexate.  Then during the Fall, we increased the Methotrexate and decreased the Prednisone. I still wasn't getting enough relief and couldn't use my hands. I began a study in January of 2023 and am now taking Olumiant one pill twice a day which is a jak inhibitor along with Methotrexate.
Patient came in for vaccine and told me she was nervous, but received the shot without issue. Patient was asked to stay for a few minutes before leaving. After 10 minutes, patient came to register counter to receive and sign paperwork. While ringing out, patient got extremely pale, her eyes rolled back and she collapsed onto the counter and then fell to the floor. By the time I got around the counter to her, she had already come-to and, with the help of a friend, was getting ready to leave despite my insistence that she stay for more time.
Pt. reported itching and swelling in ankles and top of feet within 2 hrs of injection. It progressed to her wrists, knees and elbows. On Sat 9/19 she started using BENADRYL, but hives became more generalized on Sun to cover area's of her trunk, scalp and ears. She also reported chest tightness for several hrs on Sun. Dr called. CLARITIN and low dose corticosteroids prescribed.
Sore arm and pain ran through my neck and into the left shoulder. I was achy like I had an autoimmune flare. Lasted over two weeks.
24hrs p/adm of DPT developed inability to walk, ataxia & tremors w/also cont crying;
The patient received the Pfizer vaccine on 2/8/21 and 3/1/21, so was fully vaccinated when they tested positive for COVID-19 on 8/25/21.
Per telephone report from CNP of ER, pt presented to ER today with fever 104 degrees f. Patient was given 650mg Tylenol 7/11/18 at 8:37am. Out come unknown at this time.
Zoster (Shingrix) is given SQ which is incorrect route. Vaccine should have been given IM. Patient is contacted and informed of incorrect route and instructed to inform us if she has any adverse reactions such as high fever or localized swelling.
After dose 1 and dose 2 I had a fever and body soreness; After dose 1 and dose 2 I had a fever and body soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 10:00 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and administered in arm left, administration date 02Feb2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Allergy to Shrimp. The Patient experienced PAIN (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "After dose 1 and dose 2 I had a fever and body soreness". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complained of itching and welps on trunk and face friday evening. She called her PMD and he told her to take Benadryl and phone pt today.  She stated her face turned is still broke out.  Pt given a low dose of Prednisone by PMD.  Pt recovering now. Still has some on face and chest.
Patient received influenza and pneumovax vaccinations on 10/1/08 in the clinic. Patient reported that on 10/2/08, he had new onset of head congestion, nasal congestion, headache with facial tenderness, feeling hot, generalized body aches, chest congestion with frequent cough of yellow secretions. Patient was seen to rule out pneumonia and dehydration due to fever and nausea and vomiting. Patient was treated with antibiotics, promethazine, acetaminophen and recovered. Symptoms: Fever, Wheeze, dehydration, nausea, vomiting.
This spontaneous report as received from a registered nurse refers to a patient of an unknown gender and age. No information regarding the patient's medical history and concurrent conditions was provided. On an unspecified day in February 2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On 23-NOV-2015, the patient was inadvertently administered a second dose of ZOSTAVAX lot # K020802, expiration date: 31-JAN-2016 (dose and route of administration were not reported). The patient's concomitant medications were not reported. There was no adverse effect reported. Product quality was not involved. Additional information has been requested.
started with very sore arm muscle, felt achy and woke up every hour all night, felt hot and dizzy and had diarrhea on waking, passed out and woke up in a cold sweat at 6:30am, continued to have fever for an hour and gradually started feeling better as the day is wearing on.
This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Pediarix (previous 3 doses were administered on an unknown date). On 4th January 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The nurse administered Pediarix for 4th time to the patient, which resulted in receiving an extra dose of Hep B and early dose of IPV to the patient, which led to extra dose administered. The reporter consented to follow up.
Rash developed - beginning on scalp and then proceeding to arms, legs, torso three weeks after receiving the Varicella shot
0945 AM Pt c/o 0f difficulty breathing and weak arms and legs.  Observed pt's face pale and some abdomen discomfort.
Developed appendicitis approximately 2 weeks after first dose.  Had emergency surgery to remove appendix.
Patient received his first Pfizer shot on 7/12/21 around 4:45pm and was sitting down for observation when after a few minutes fainted and fell off from his chair.  Patient was already alert and had gotten up himself when pharmacy staff came to assist patient.  He said he was fine and did not need further medical care.  Patient mentioned he has not gotten a vaccine in a long time and was probably nervous. He finished the rest of his 15 mins observation time (with mom waiting with him) and was feeling good to go home.
Shot given 10/20/10. On 10/21/10 patient said she laid around for 2 days. She had muscle aches & pains, sneezing, HA, don't know if had fever but clammy & sweaty.
Large oval red rash appeared two days ago, started out about the size of a quarter, now it?s oval shaped and about 3 inches by 2 inches. Moderate itch started 2 days ago even though it had never itched before.   Other side effects that went away after three days were severe dehydration, soreness at injection site, and fatigue, but those all went away a few days after the shot.  Only this growing rash remains.
Patient had a syncopal episode at 2:55pm lasting less than 1 min. Vaccine was taken at 2:30pm. The patient fell on her right side off the chair after approximately 10min. of sitting upright in the chair in the observation area.  The patient responded to both verbal and painful stimuli (shake and shout). EMT  began taking vitals @2:56pm, HR:50, RR: 18, BP: 130/86, SpO2 100%. Pt. was able to answer orientation questions asked by EMT .  Pt. reported right sided pain s/p fall.  Pt.'s skin was pale with redness in areas of impact.  Pain rated @ 3/10, non-radiating, "soreness" quality.  After 12 minutes PPTS was reassessed and EMT took vitals, BP: 118/82, HR: 76, RR:18, SpO2 99% .
Got flu shot 3pm 11/18/08.  8 hrs. later suddently became light headed, heart rate increased from 60 to 90, blood pressure from 125/75 to 200/95.
Received first Moderna COVID19 vaccine 2/11/21 at Pharmacy , and second Moderna COVID19 vaccine 3/9/21 at Pharmacy.  Within an hour of receiving both vaccines I developed a severe headache which felt like my brain was swelling. Both times the headaches lasted for 2 days. Then on 8/11/21 I developed a head cold which seemed like typical head congestion, but I also developed headaches that did not go away after the head congestion cleared up.  The headaches continued and I am still experiencing them currently. The headaches feel like inflammation in my brain and come and go all day and night.
stomach feels gassy; Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), DIARRHOEA (Diarrhea) and FLATULENCE (stomach feels gassy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was not provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and PARACETAMOL (TYLENOL) for Headache, LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever). On 25-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced FLATULENCE (stomach feels gassy). On 25-Apr-2021, PYREXIA (Fever) outcome was unknown. At the time of the report, DIARRHOEA (Diarrhea) and FLATULENCE (stomach feels gassy) outcome was unknown. Not provided          No treatment information was provided. concomitant medications includes Gatorade and water   This case was linked to MOD-2021-114520 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Nonsignificant Followup Appended On 07-May-2021: Nonsignificant Followup Appended On 07-May-2021: AE Contact Information Updated
Presents to the emergency department complaining decreased appetite, diarrhea, shortness of breath, cough, congestion, loss of taste and smell, and back pain, onset 5 days ago; admitted for sepsis w/acute renal failure, COVID-19 virus infection; tx w/remdesivir, abx; O2 not required; dc'd home.
No additional AE reported; Nurse reporting a patient was administered VARIVAX after a temperature excursion.; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U019904, expiration date 24-JUN-2023 (route of administration not reported)  for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 12.4 degrees Farhrenheit (°F) for 20 Minutes. Also, the vaccine had undergone a previous temperature excursion from 6°F to 14°F (11.6°F) for 25 Minutes.
Patient had received the vaccine and moved to the waiting area for the 15 minutes.  He started getting pale, blurring vision, ringing in the ears, and having more pain near the shot. We tried to move him to a chair that had 2 arms on it for his safety. In moving him to that chair he fell to the ground and in his words "he blacked out" for a moment, maybe a couple of seconds. We moved him to laying on his back with his knees bent on the ground. We gave him water, a granola bar, and a wet paper towel for his forehead. Maybe 5 minutes after he fell he tried sitting up and was a little dizzy. After sitting for awhile he was able to stand up. We had him sit in the waiting area for an additional 15 minutes and took his blood pressure which was high 144/84. We had called his dad by this time and his brother came to pick him up. We advised him to drink plenty of water for the rest of the evening and to get a good meal, he thought spaghetti would work. The patient really thought he had a panic attack.