chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next morning he woke up with arm  hurting him (he couldn't lift it). He felt a little warm - had a low grade fever -99.something. He had a headache all day. He was very sluggish, tired. He did online school that day. He took a nap and laid down on the couch in between classes. He was really tired. I was giving him Tylenol every four hours. The first time he felt a little better, The second time, it didn't work. I called the doctor for advice and he told me to give him Children's Motrin. That seemed to do better. I gave that to him once that day.  The next morning, he felt better. I gave him a Motrin anyway  because he had a light headache. He did say he felt some heart racing. And he was a little tired. He called me from school around 11:30 am and he said that his heart has been racing through the whole morning - he was gym and said  he couldn't run or anything but his heart was racing. I told him to go to t he school nurse - he had a pulse of 120. I met him there and I called the pediatrician and he saw him at 03:00. His pulse was high but not as high as before. He had rested in between. My son did see a cardiologist in June 2020- they put him on a heart monitor and she couldn't find anything at that time. At the regular doctor on the 19th, the doctor checked breathing and heart but did not have the materials at that location to do an EKG but said with the lowered heart rate just to watch and if it goes up again to go to Cardiologist we saw in June 2020. He rested some more and it went away on it's own. After that he was fine and no other issues. In fact, the next day he felt better and was running around and had energy and felt great.
Covid-arm - large red rash on arm at injection site that appeared a little over a week after the vaccine was administered; rash worsened (got larger and more red) over a day or two, stayed consistent at about the size of an orange, then vanished suddenly within a few hours
Menactra liquid was accidentally mixed with Proquad powder before administration to a patien/ No AE; Proquad powder given instead of Adacel/No AE; Initial and additional information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse via physician via other health care professional via Regulatory Authority (Reference number- 00495489).  This case involves a 11 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] liquid dose: 0.5 ml, lot number: U6787AA, expiry date: 08-NOV-2021 via unknown route in the right arm on 26-Feb-2021 for prophylactic vaccination which was accidentally mixed with MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD] powder before administration (product preparation issue) given instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included Human papillomavirus (HPV) VACCINE for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique and wrong vaccine administered (latency same day).  Potential product technical complaint (PTC): No. Description: Nurse reports that MENACTRA was accidentally mixed with another vaccine before administration. Nurse reports that today, a medical assistant (MA) was supposed to administer Menactra and Proquad vaccines to an 11 year-old male. When preparing the vaccines, the MA did not reconstitute the Proquad correctly, instead mixing the Menactra liquid with the Proquad powder. Reporter relationship: health care professional (HCP). Product used.  Therapy ongoing: Unknown. Related to company product: Not reported. Nurse has called back to correct previously reported information. Nurse had reported that patient was supposed to receive HPV, Menactra and Proquad vaccines. After going back through the records, he realized that the doctor's order was actually for HPV, Menactra and Adacel. After administering the Proquad diluted with Menactra, the Adacel was not given.  At the time of reporting 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 holders 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.
8-01-2008 Patient was outside felt left arm itchy feeling, scratched arm and noticed quarter size redness and swelling where vaccine was given. 8-2-2008 Redness was larger used anti-itch cream. 8-4-2008 Redness was about baseball size around (per patient)and raised. Patient saw family physician per my recommendation. Patient called back and said the Nurse Practitioner that she saw said it was a normal reaction to the vaccine to use ice and cortisone cream!
AFTER RECEIVING VACCINE SHE COMPLAINED ABOUT BEING LIGHTHEADED. ON SITE EMS RESPONDED, VITALS BELOW. SHE SAID SHE WAS BREAST FEEDING, BUT TODAY WAS HER LAST DAY OF BREAST FEEDING. SHE WAS MONITORED FOR 30 MINUTES AND RELEASED TO HOME
Are painful, warm to touch 1/2 hr after shot given, took ibuprofen.
very aggressive immune response; was like a little spot of poison ivy; tingly sensation; rash at the injection site; injection site was a little itchy; It was raised and was the size of a 50 cent piece; injection site was red; Has a little fever; very tired; not really much soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (was like a little spot of poison ivy), VACCINATION COMPLICATION (very aggressive immune response), PAIN IN EXTREMITY (not really much soreness in the arm), PARAESTHESIA (tingly sensation) and VACCINATION SITE RASH (rash at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (not really much soreness in the arm), PYREXIA (Has a little fever) and FATIGUE (very tired). On 30-Sep-2021, the patient experienced VACCINATION SITE REACTION (was like a little spot of poison ivy), PARAESTHESIA (tingly sensation), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (injection site was a little itchy), VACCINATION SITE SWELLING (It was raised and was the size of a 50 cent piece) and VACCINATION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION COMPLICATION (very aggressive immune response). The patient was treated with ARNICA MONTANA (topical) for Adverse event, at an unspecified dose and frequency. On 05-Oct-2021, VACCINATION SITE ERYTHEMA (injection site was red) had resolved. At the time of the report, VACCINATION SITE REACTION (was like a little spot of poison ivy), VACCINATION COMPLICATION (very aggressive immune response), PAIN IN EXTREMITY (not really much soreness in the arm), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (injection site was a little itchy), VACCINATION SITE SWELLING (It was raised and was the size of a 50 cent piece), PYREXIA (Has a little fever) and FATIGUE (very tired) outcome was unknown and PARAESTHESIA (tingly sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Treatment included Arnica cream and other lotions which made the adverse events worse. Ice helped in relieving the symptoms.
Red, itchy blisters and lower left and right legs. Clobetasol Propionate cream .05 twice a day for 2 weeks. Neosporin antibiotic ointment twice a day for 2 weeks. Scar therapy band-aids applied for 12 hrs. To biopsy sites for next three months.
Itching and redness at injection site. Slight swelling at injection site. Itchy all over body. Headache, fatigue, swollen lymph node.
extended swelling in his arm; arm pain; decreases agility in arm; redness; This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced swelling arm, pain in arm, mobility decreased and erythema. On an unknown date, the outcome of the swelling arm, pain in arm, mobility decreased and erythema were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, mobility decreased and erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in an unknown arm. The patient had pain and decreased agility in arm for 1 week.  Redness and swelling lasted about 5 to 7days.
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. On an unknown date the patients was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). On unspecified dates, that were exposed to temperatures outside the proper storage range. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
I got the COVID-19 booster and the flu vaccine on the same day and I had body aches all night. Then I was okay. Then in 05/2022 I got COVID-19. It wasn't terrible. I had a sore throat for the first three days and then it went away. Then a cough came about the fourth or fifth day. That was also when the congestion came. I did an at home COVID-19 test that was positive so I went to urgent care and they did another test that was positive. By the ninth or tenth day the sore throat and cough went away. I never had a fever or muscle aches that I know of. The thing that was really bothersome was the congestion. Even after my isolation period of 10 days, I still had congestion for a week or two. My voice was very nasally for a while. I believe I got it from a weeding the Sunday before I started having a sore throat. I have had no problem since. It was about a week or two ago that I started feeling normal. Nobody else contracted COVID-19 in my household.
Patient tells pharmacy on 10/14/20 that she does not want the second dose in the series; says she is still having pain in her arm from the vaccine and "can't move it all the way."
I had a significant exacerbation of my neuromuscular MS symptoms despite no subjective symptoms of fever. I did not take my temperature but did not feel feverish. I also had significant exacerbations of routine aches and pains such as chronic orthopedic aches. The pain symptoms began approximately 5 hours after the injection. The neuromuscular symptoms began approximately 14-16 hours after the injection. I took acetaminophen 1000 mg orally in the morning 24 hours after my injection and had improvement in both the pain and neuromuscular symptoms. I continued to take Acetominphen 1000mg q 8h during the day and had complete resolution of both the pain and neuromuscular symptoms with return to baseline health by 48 hours after the injection.
Information has been received from a RN concerning a 7 yr old white female student who on 24May99 was vaccinated SC with the first dose of varicella virus vaccine live. Concomitant vaccinations on that same day included the first SC dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. The RN reported that on 24May05, the pt developed a blistery rash all over body. On 26May05, the pt was seen by a physician, but no lab/diagnostic tests were performed. Subsequently, the pt recovered from the blistery rash. No further information is available.
pt recvd vax & exp crankiness, sleepiness next day; pt was extremly tired; sleepy 48 hrs stil the same; 72 hrs later difficult to wake; did not want to nurse; rash w/hives, paled; purple, eyes swelled shut, purple, yellow colored;
shortness of breath; She had back pain; Coronavirus 224; pain in arm; fever; This is a solicited report (manufacturer control number: 21K-163-4089904-00). A contactable consumer (patient herself) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via intramuscular, on an unspecified date, as dose number unknown, single for COVID-19 immunisation; and, upadacitinib (RINVOQ), via oral, from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose and frequency for moderate to severe rheumatoid arthritis. The patient's medical history included ongoing moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On unspecified date in Sep2021, it was reported that the patient experienced back pain, pain in arm after the COVID-19 vaccine with updacitinib. It was also reported that the patient had been recently hospitalized for shortness of breath. She had fever, and on Sep2021 she had Coronavirus 224. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was unknown. The outcome of the events of shortness of breath, fever and coronavirus 224 was recovering; for the event pain in arm was recovered on unspecified date in 2021, while for the other event was not recovered. The reported causality for the events pain in arm, back pain and coronavirus 224 as per reporter was possible, while for the other events was on reasonable possibility. Opinion was that there is no reasonable possibility that the events of coronavirus 224, back pain and pain in arm after covid vaccine were related to rinvoq (upadacitinib).  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Coronavirus infection, Dyspnoea, Back pain, Pain in extremity, and Pyrexia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On 08/16/2000 the patient experienced a mild case of varicella on the trunk, back, face, legs and arms. The maximum temperature was 100.0F. The patient complained of hip pain on 08/16/2000. Medical attention was sought. On 08/23/2000 the patient recovered. No further information is available.
Worried and anxious after receiving 1st dose; A Spontaneous report was received from consumer of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and was worried and anxious after receiving first dose.  The patient's medical history and concomitant medication were not reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, after administration of first dose of vaccine, the patient was worried and anxious. Treatment information was not provided.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome of event worried and anxious after receiving first dose was considered unknown at the time of this report.; Reporter's Comments: This case concerns a patient, who experienced a non-serious unexpected event of Anxiety, after receiving mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time.
8-19-21-After child was home from daycare that night he got a fever-T-102.5, resolved some with Tylenol, but had some kind of fever all night but in am was resolved, had blotchiness only when had fever for awhile,  8-20-21-in am was doing well so sent him to Daycare, while at daycare in afternoon got another T-102.7, Tylenol with some relief, blotchiness for 10 min but resolved, was seen in our office at 4:15, T-101.8 but also had ROM & tx with Amoxil, Dad states will get a fever with immunization but not usually that high or last this long, never get that high of fever with OM in past,
Discharge Provider: MD  Primary Care Provider : MD    Admitting Service: Internal Medicine Service Admission Date: 1/5/2023 Discharge Date: 01/08/2023 COVID positive 01/05/2023 PRESENTING PROBLEM:  Hypoxia [R09.02] Chronic obstructive pulmonary disease with (acute) exacerbation (HCC) [J44.1] Acute hypoxemic respiratory failure (HCC) [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE:    79 y.o. female who presented with SOB and generalized weakness/fatigue. Pt. has a PMH of HTN, lymph edema, COPD. Pt. reports for the past two to three days she has had a nonproductive cough, SOB, generalized fatigue/weakness. She had an appointment with her PCP scheduled for today and she was found to be hypoxic in the 80s for which she was then sent to the ED. Pt. has since been sating well on 2L supplemental O2. Labs with elevated D dimer and positive COVID. CT angio thorax consistent with COVID pneumonia, no evidence of PE. Pt. was given solumedrol in the ED.  during the hospitalization received couple of doses of remdesivir and dexamethasone, did not have any more shortness of breath, did not require any more oxygen, doing well discharge home today in stable condition.  Instructions discussed in detail with patient verbalized understanding.
2/9/21 received 1st dose of Pfizer Vaccine. 2/12/21 woke up with full body aches, feeling like feet were freezing (but feet were warm to the touch). No medications, hot showers, etc would relieve the pain. 2/13/21 went to ER, was given morphine to relieve pain, ran CT scan-found no issues, blamed the  vaccine. Freezing in feet was not addressed  2/25 & 2/26 (approx) lost control of legs and fell twice (no injuries). 3/1/21 needed assistance from walker to get around 3/4/21 appointment with neurologist - diagnosed with Guillain Barre Syndrome and admitted to hospital (numb  from toes to chest) In hospital 3/4 - 3/12. Underwent IVIG treatment. 3/13/21 discharged from hospital to continue physical therapy
Swelling, redness, itching at the site of the vaccination - about 4 inch circle pattern.  Lasted about one week.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. The patient had a Family History of shingles. On 12th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th July 2018, 29 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced injection site pain, myalgia upper extremities, pruritus, shoulder pain, neck pain, tenderness, nerve pain and bone pain. The patient was treated with Valacyclovir, Corticosteroid Cream and TYLENOL. On an unknown date, the outcome of the injection site pain and myalgia upper extremities were recovered/resolved and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus was recovering/resolving and the outcome of the shoulder pain, neck pain, tenderness, nerve pain and bone pain were unknown. It was unknown if the reporter considered the injection site pain, shingles, myalgia upper extremities, pruritus, shoulder pain, neck pain, tenderness, nerve pain and bone pain to be related to SHINGRIX. Additional details were reported as follows: The patient received the Shingles vaccine at left arm at around 11:00 AM and she experienced shingles on her right side and lower back quadrant after the vaccination. She was put on Valacyclovir last Thursday. She described it as a mild case of shingles. The patient also reported that she was terribly sore at the injection site compared to previous vaccinations including a tetanus shot that she had received previously. In 2018, less than a month after vaccination, the patient experienced itching. The itching was far worse than the pain from the shingles. She described the soreness as tolerable. The pain followed her muscle in her arm up her shoulder and up her neck. She was in a lot of pain for 3 days. The pain was tender to the touch and some pain followed for about one week afterwards. The pain followed her nerve endings up the neck. The patient explained that the pain radiated from the injection site up to her shoulder which made her shoulder ache in her neck and through her collarbone area. She treated the side effects with corticosteroid cream and TYLENOL. She claimed that her Shingles was resolving but was not fully resolved. She kept her TYLENOL levels up to prevent the pain. She had pain for about 3 days and then it was tender to the touch and some pain followed for about a week or so. The soreness was worse than the pain and she could tell when attempting to lift something. She claimed that the pain was a level 2 out of 10 and it was not anything she could not stand.
Was given the DTaP-IPV component of PENTACEL in error instead of IPOL. No adverse event was seen.
ADMINISTRATION ERROR, ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 21-SEP-2021) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced administration error, administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error, administration of expired vaccine was not reported. This report was non-serious.