chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bruise at the injection site; giver intravascularly by accident; Experienced immediate pain/pain/sharp stabbing pain; Bleeding; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding), PYREXIA (Fever), VACCINATION SITE BRUISING (Bruise at the injection site) and INCORRECT DOSE ADMINISTERED (giver intravascularly by accident) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding), PYREXIA (Fever) and INCORRECT DOSE ADMINISTERED (giver intravascularly by accident).   On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site). The patient was treated with ACETAMINOPHEN for Drug side effect, at an unspecified dose and frequency and IBUPROFEN for Drug side effect, at an unspecified dose and frequency.   On 25-Jan-2021, INCORRECT DOSE ADMINISTERED (giver intravascularly by accident) had resolved. On 28-Jan-2021, VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 102 f (High) Patient had fever of 102 F on the night when vaccinated.   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.   Patient's treatment included ice packs. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: New events added, accordingly outcome of the events updated. Treatment drug details added.
Symptoms started 06/05/2022. I tested positive on 06/04/2022. Doctor prescribed Paxlovid to take for 5 days. Symptoms disappeared within 48 hours of starting Paxlovid. I still have low energy to this day but otherwise feel normal.
Mother brought child in for Immunization on 9/15/04. Stated had fever of T102 after Dtap and Prevnar on 8/17/04
Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later
Moderna COVID-19 Vaccine EUA  12/28- vaccinated, felt like I was punched in the arm, headache 8 hours later 12/29-very bad pain at injection site and weakness in that arm, intense headache throughout the entire day, body aches especially in knees and back, exhaustion, mild nausea 12/30- pain and weakness at injection site, mild headache, mild joint pain, throat felt scratchy, mild itchy rash on waist (red/pink with some bumps, golf ball sized) 12/31- pain and weakness at injection site, mild head and joint aches 1/1- 1/5 head ache 1/5 - 1/7 itchy, puffy, red rash at injection site, tennis ball sized, hot to touch, puffiness feels firm
DID NOT FEEL GOOD FOR 3 DAYS; ARM WAS REALLY TIRED; This spontaneous report received from a patient concerned a 61 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced did not feel good for 3 days, and arm was really tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good for 3 days, and the outcome of arm was really tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20211154414.
Redness at vaccine site on 4/16/21.  Redness started spreading on 4/18/21, with pruritic rash across chest.  Today developed rash extending onto neck, tightness in throat, and mild swelling of the lips.
Shooting pain from heart, headache, labored breathing, body aches, chills started the night of the shot and lasted the next day. Felt somewhat better by day 3.
On the first day, my arm was sore and I was a little tired. I had some abdominal pains on the day after the vaccine with diarrhea. After 24 hours of that pain, I could get up and move around. About a week I felt better.
bursitis of the left elbow; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (bursitis of the left elbow) in a 24-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for Cold.     Concurrent medical conditions included Type I diabetes mellitus.    On 16-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 18-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BURSITIS (bursitis of the left elbow). The patient was treated with IBUPROFEN (ADVIL 12) for Swelling and Inflammation, at an unspecified dose and frequency. At the time of the report, BURSITIS (bursitis of the left elbow) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medications were not reported. The Left shoulder was the site of vaccine administration. The patient had Bursitis symptoms as swelling, and inflammation. It was unknown if the patient experienced any additional symptoms/events. The cold presses on the inflicted site.
Developed Shingles within few weeks of vaccination / Suspected vaccination failure; Developed Shingles within few weeks of vaccination; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Developed Shingles within few weeks of vaccination / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Developed Shingles within few weeks of vaccination). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's related via interactive digital media. The reporter reported that the patient got the shingles vaccine and developed shingles within a few weeks.  The reporter stated that the vaccine did nothing. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2023AMR067517, reported by same reporter. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067517:Same Reporter
Moderna Dose 3-  11/05/2021. 01/07/2022 was not feeling good. Look for COVID-19 test location 01/09/2022- COVID-19 tested positive. 01/10/2022 positive for COVID-19 omicron, asthma breathing was an issue, went to Urgent care, they did diagnose for COVID-19 Omicron. Went to hospital, difficulty breathing, quarantine for 12 days, tired very easily all condition. Went to Pulmonologist. 02/17/2022 Prednisone for a week and 95-98% better. Check temp and x-ray, diagnosed and provided directive to stay home quarantine and drink lots of liquids.
Achy right after the shot, then extreme skin sensitivity in his torso. Pt has had shingles twice before and this felt like having shingles. No rash. Felt feverish, but pt did not take his temperature. Muscle and joint aches. Symptoms lasted 5 days and then resolved. Pt did not use any treatment and did not visit the doctor's office fore this. Pt also felt sensitive to temperature, expecially heat.
I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness.; I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness.; This is a spontaneous report from a contactable Nurse (patient). A 56-years-old non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 18Jan2021 (Batch/Lot Number: EJ1686) as single dose for covid-19 immunisation. Medical history included Graves Disease, supraventricular tachycardia and vertigo from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) verapamil and piroxicam (MAXIDENE) via unspecified route of administration, unspecified date, dose, unit, frequency and indication. The patient previously took first dose (56-years) BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE,) on30Dec2020 at10:00AM administered in right arm and doxycycline and experienced allergies. The reporter stated that I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness on 20Jan2021. The patient did not received prior and covid tested post vaccination. Therapeutic measures were taken as a result of I'm now 23 days post my 2nd Pfizer Covid19 injection and I still have neck discomfort and soreness and included treatment with inflammatory and heat applications. The outcome of the events was reported as Not recovered.
Immediately after receiving flu vaccine, Hib, Prevnar, Pediarix (Ibuprofen 50mg) developed body wide hives, no wheezing, no stridor. (had received Hib/Previnar/Pediarix & Ibuprofen @ 4 mo. no problems).
COVID-19; COVID-19; Dose Number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 15:00 as dose 5 (booster), single (Lot number: FK9895) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Dose Number: 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (16Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 24-NOV-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
1 of 3 pts vaxed from the same lots of Tetramune/OPV who exp an adverse event;pt vaxed 2SEP94;later that evening began screaming in a high-pitched tone for several hrs;screaming contd on & off for several days;4SEP ER visit-exam nl;
FLUBLOK was given to a 15-year-old patient, no AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from pharmacist.  This case involves a 15 years old patient (gender unknown) who was given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unspecified date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency) and it was reported that the if the patient should be administered the FLUZONE after receiving FLUBLOK.   No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Narrative: Pt received the first Moderna COVID-19 vaccine and when he went to receive his second dose, he was told he had to consult with his PCP because he experienced a reaction to the vaccine. It was later documented in the chart that he experienced generalized muscle pain and soreness in his body. Unknown if he had taken any medication for pain.
Pt recvd vax & w/in 24 hrs of vax pt was ill; 24JAN hospitalized w/Bronchiolitis; DX RSV-rx'd w/Ribavirin; Pneumonia rx'd w/IV Cefotaxime; sx improving; still has chest congestion;
first dose on 9 June 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The pharmacist reported a patient received the first dose of the Shingrix vaccine and not received 2nd dose. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination
Pt had no reactions or concerns on 04.10.23 after appointment, but was given Tylenol at home due to complaints of mild pain.  Mom noticed red circular patch on left thigh at injection site this morning. Pt was not bothered by red patch (2x2), nor did it cause any pain. Mild itching was reported.
1 day after injection noticed swelling redness, and itching and became tender to touch Lt deltoid area.
This spontaneous report was received from a female consumer of unknown age referring herself. Pertinent medical history or allergies were not reported. On an unknown date (reported as: a while ago) the patient was vaccinated with ZOSTAVAX. Concentration, duration and route of administration were not reported. Concomitant medications were not reported. The patient stated that on an unknown date the patient had ZOSTAVAX and "now" she suffers Fromm neuropathy and was treated with LYRICA. She also said that her elderly father has nerve pain as a result of shingles (he did not received the vaccine) and has taken LYRICA, but it didn't control the nerve pain. The patient's father also took several unspecified creams, but these have not relieved his nerve pain. The outcome of neuropathy was unknown. The reporter did not established any relationship between ZOSTAVAX and neuropathy. Additional information has been requested.
8 x 3 area of erythema with slight edema at the right upper arm.
Arm was sore by the shot area. Had flu shots before and soreness always quickly went away. Arm still sore now over 1 month later. If arm is by side it is mostly OK. Raise arm and it hurts. Muscles very sore sometimes to the point of sharp pain.
Immediately after injection of Varivax, pt's leg became erythematous and swollen without induration but with an area looking like a small wheal "2" posterior inferior to injection site. Ice was applied for 30 min. and 2-3 ml Benadryl was given. After 30 min., leg still swollen and red but wheal had resolved.
Swollen Lymph Nodes, they swell up then go away, then swell up again; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 15:45 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). Family history included: "Hereditary angioedema" (ongoing). Concomitant medication(s) included: BENADRYL taken for hereditary angioedema. Vaccination history included: Flu vaccine, reaction(s): "no adverse reaction"; Pneumonia vaccine, reaction(s): "no adverse reaction". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Swollen Lymph Nodes, they swell up then go away, then swell up again". The event "swollen lymph nodes, they swell up then go away, then swell up again" was evaluated at the physician office visit. Additional Information: The patient was taking Benadryl (unknown strength; pink and white capsule), one in the morning, one at 1500 and two when he goes to bed. The patient was also having hormone shot at clinic every 3-4 months for prostate cancer that he had 16 years ago. The patient has hereditary angioedema and stated that his father also had this condition. It causes fingers to swell, or feet, or hand, or something and he took Benadryl to keep it under control. The patient stated his high blood pressure was under control, every time they check it is normal. On 04Mar2021, the second day after the vaccine, the patient experienced swollen lymph nodes, they swell up a little bit then go away, and they might come back the next day, and they are still doing it. It has not worsened but is persisting. They swell up a bit, go back down, might come up again about halfway. The patient stated right now he can just barely feel them. His doctor told him that the lymph node swelling usually lasts 10-12 days then it is gone.  The patient was concerned because he stated it has been 20 days. He has been to the doctor twice recently; one time was for his physical and the other time was related to his lymph nodes swelling. His doctor recommended that he get the second vaccine but he uncertain if he should get the second vaccine. The patient has no history of all previous immunizations and has no additional vaccines administered on same date of the COVID-19 Vaccine. The patient has no prior vaccinations within 4 weeks and has no adverse events following prior vaccinations. The patient got his Flu and Pneumonia vaccines every year and every time they are due with no adverse reactions. The patient has no family medical history relevant to the adverse events. No relevant tests were done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2011US02399 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. He was given only the CYW-135 liquid component MENVEO (batch number: 090901) intramuscularly on 18 Jul 2011. On the same day he was also vaccinated with BOOSTRIX (manufacturer and batch number: unknown) intramuscularly and varicella vaccine (manufacturer and batch number: unknown) subcutaneously. No other adverse reaction was reported.
right hand could not grasp objects, muscle weakness right hand, lightheadedness, flush face, chest, left arm, high blood pressure 204/96, heart rate 101
discomfort; misery; This case was reported by a consumer via call center representative and described the occurrence of discomfort in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced discomfort and feeling miserable. On an unknown date, the outcome of the discomfort and feeling miserable were unknown.   It was unknown if the reporter considered the discomfort and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that, people were suffering a great deal of discomfort and misery and to hold on before having injection. No further information was provided. This case has been linked with case US2019100249, reported by the same reporter.
mom called 24APR95 stating pt has whelps all over trunk & face; instructed to take to clinic; pt given DPH; pt taken to ER 25APR95 for difficulty breathing;
Fever ranging from 99.9-100.3 beginning 25.5 hours post-vaccination and lasting approximately 8 hours.  Moderate body aches and fatigue during period of fever, but none before or after. Mild swelling and tenderness with palpation at injection site beginning ~4 hours post-injection and lasting ~48 hours. Mild swelling and moderate pain in left axillary region beginning 5 days post-vaccine.
See attached info 02/22/07-records received adn reviewed for DOS 10/26-11/10/06 DC DX: new onset seizure disorder possible hypoxic encephalopathy possible encephalitis pancreatitis developmental regression visual cortical impairment Hospital course:experienced right sided seizure lasting approximately 45-60 minutes with possibly hypoxia during that time. Subsequent seizure on 10/30/06 required intubation and extubated on 11/3/06.   11/4/06 developed persistent right gaze and right tracking and hypertonic symptoms. Multiple myoclonic jerks were noted.  Continued to have diffuse truncal hypotonia. Persistent left ankle hypertonic extension. Per 60 day follow up: Still with global developmental delay. Can get lot # from her PCP. I took care of her during her rehab admission.
Arm swell up, hot to touch are went numb and tingly one week after vaccination.   Period is has not come for this month at all currently 13 days late
Afib 16 hour the day after shot two. Additional testing showed pericarditis and heart enlargement not previously noted
Migratory skin rash, diarrhea, soreness @ inj. site, headache, back pain, myalgia.
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,