chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RARE SKIN REACTION; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUN-2021, the subject experienced rare skin reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rare skin reaction. This report was non-serious.
Roughly three hours after getting the shot I was very cold and developed a fever of 102.8. I vomited that night. I took an ibuprofen to help reduce the fever then slept. For the next six days I had an on again and off again low grade fever and was nauseas most of the time. Sometime during those 6 days I developed intermitted tingling in my left hand, primarily by index finger. This continues to today happening roughly once a day.  On rare occasion my right had will do the same thing but that is far less often. I never had tingling in either hand prior to my vaccine. I also developed heartburn occurring roughly 1-2 times a day. Prior to the vaccine I rarely (1-2 times a year) had heartburn and I have not changed anything about my diet or lifestyle since my vaccine. Occasionally my head feels "foggy" as well and this began sometime after the vaccine but I can't recall exactly when it started. It's not a headache, more of a slight lightheaded, dull feeling. I had none of these symptoms with any regularity until I was administered the vaccine.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of GARDASIL, lot# M043731, expiry date 22-JUN-2019, via intramuscular route (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
"Warmth" in arm after pneumonia shot.  Denies edema, redness, fever.
Dtap #4 given IM right upper thigh and Polio #3 given IM right lower thigh on 11-29-05. On 11-30-05 parents reported right leg was red and swollen. No improvement through course of day with conservative tx parents took to ER 11-30-05 pm and followed up at office 12-12-05.
Information has been received from a physician concerning a 15 year old female patient who was vaccinated with the first dose of GARDASIL IM, 0.5ML on 31-MAY-2008 (lot#: 659441/1446U), the second dose IM, 0.5ML on 26-JAN-2009. After the second dose, the patient developed seizures twice. Concomitant therapy included meningococcal vaccine (manufacturer unknown) and Hep A vaccine (manufacturer unknown). The patient had sought unspecified medical attention. No further information is available at the time of reporting. Upon internal review, Seizures were determined to be an other important medical event. Additional information has been requested.  7/21/09 Medical records received DOS 5/31/08 to 6/27/09. Assessment: Seizures. Parents of patient report several ER visits for seizures.
This spontaneous report as received from a physician refers to an immunocompromised male patient in his 60s. In approximately 2012, reported as two years ago, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. The physician reported that on approximately 30-MAR-2014 (10 days ago), the patient was diagnosed at an unspecified urgent care facility with shingles of the shoulder. The patient was prescribed an unspecified antiviral medication and was recovering. Additional information has been requested.
Headache, Arthralgia, Fever, PAIN/SWELLING BILAT HANDS, MALAISE, POUNDING HEADACHE, PAIN/SWELLING INJECTION SITE, FEVER 101.4
flu-like symptoms; felt very cold; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-038496, MOD-2021-029671, MOD-2021-038923, MOD-2021-038934 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: No specific follow-up information recorded. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021. The most recent information was received on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING COLD (felt very cold) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-038496, MOD-2021-029671, MOD-2021-038923, MOD-2021-038934 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-038496:Reporter's friend MOD-2021-029671:Reporter's first injection MOD-2021-038923:Reporter's second injection MOD-2021-038934:Reporter's husband
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of RECOMBIVAX HB (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. Follow up information as received from the medical assistant refers to a 12 months old patient. The patient was vaccinated IM with improperly stored VAQTA (lot # 672470/1697AA, Exp. Date: 22-SEP-2014) at right thigh on 17-SEP-2012. Concomitant medications administered on the same day included M-M-R II (lot # reported as 0233AE, Exp. Date: 24-JAN-2014, intramuscularly at left thigh), VARIVAX (Merck) (lot # reported as H007702, Exp. Date: 30-MAR-2014, subcutaneously at left thigh). This is one of several reports received from the same source. Additional information has been requested. Additional information has been requested.
Initial unsolicited report received from office staff on 31 October 2017. This case involves a female patient (age was not reported) while administering the dose of ADACEL cuts her finger on an unspecified date. It was reported that she went to push in the plunger the glass rim broke and she cut her finger. She stated that she had not dropped the syringe prior to giving the vaccine. It was a case of syringe issue. Corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
A few days after my booster, I started my menstrual cycle. It had been late, but started just a few days after the booster. I proceeded to have a 3 week long bleeding period followed by daily spotting. I have not started my period again, 2 two weeks early. I have always been regular so this is very out of the ordinary for me and I believe it is linked to my booster.  I have also had bad eczema flare ups during this time.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of VAQTA (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # K019560, expiration date 02-JUN-2017 - 31F or colder (23F) for 67 hours, 32F to 35F for 79 hours, 47F to 77F for 7 hours lot # reported as L0002717, expiration date 02-JUN-2017 - 31F or colder (20F) for 68 hours, 32F to 35F for 71 hours lot # reported as K012547, expiration date 04-JUN-2017 - 32F to 35F for 32 hours lot # K010579, expiration date 12-FEB-2017 - 31F or colder (23F) for 95 hours, 32F to 35F for 63 hours, 47F to 77F for 3 hours lot # reported as K023232, expiration date 25-FEB-2017 - 31F or colder (20F) for 68 hours, 32F to 35F for 88 hours lot # L004743, expiration date 01-JUN-2017 - 31F or colder (20F) for 53 hours, 32F to 35F for 55 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006088: US-009507513-1707USA008730: US-009507513-1707USA008729: US-009507513-1707USA008728:
little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
within 15 minutes, throat felt funny, went home and looked and noticed it was swollen.  Tongue swelled as well and a small rash on arms and stomach was noticed.
Intense pain at injection site & entire upper arm/shoulder down to elbow lasting 4-5 days. Low-grade fever, constant chills, whole body aches, muscle soreness everywhere, extreme fatigue, near-migraine headache, bad diarrhea, nausea, dehydrated?all started night of 1st vaccine & got worse over next couple of days. Then a lupus/RA flare occurred because of that & I was very sick in bed for a week+. Took 2 full weeks to recover. Drs/vaccination providers shouldn?t be telling people to take their immunosuppressant meds on same day of vaccination?I almost ended up in the hospital!
Fever up to 102.6°, chills, body aches, headache, stomach cramps, sore arm at injection site, fatigue, mild asthma like symptoms
Employee reported feeling anxious and heart racing. Lasted approximately 4 hours. No other symptoms.
Shoulder pain; Mild back pain; Stiffness; Neck pain; This is a spontaneous report received from a contactable patient. A 65-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 09:15 AM (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to erythromycin, eggs, fish/seafood, corn and wheat. The Concomitant medications included tacrolimus (MANUFACTURER UNKNOWN), multivitamin, biotin (MANUFACTURER UNKNOWN), lutein (MANUFACTURER UNKNOWN) and cal ((MANUFACTURER UNKNOWN),) since from unknown dates for unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 11:00 AM, within about 3 hours he began experiencing neck, shoulder, and mid back pain and stiffness. Using constant heat/cold measures, on the fourth day (morning submitting report), the pain was finally going down and stiffness was limited to the neck and shoulder region. The patient felt okay approx (32 hrs after injection). The patient did not receive treatment for the event. The clinical outcome of the event back pain, neck pain and shoulder pain was recovering. No follow-up attempts are possible. No further information is expected.
-Localized swelling, redness, itchy to (R) subcutaneous region -(+) tingling (R) arm.
Fever, up to 100.9F, injection site pain, headache,  body aches
Mom reports pt is pale w/an odd cry, floppy; t101 R; last dose APAP was @ 1230PM; family MD notified;
Severe rash- left arm, side of neck, back, stomach, groin area? not especially itchy, but a bit sore. Lasted a couple of days. Crimson red and solid everywhere but on stomach. Stomach was speckled, patchy.
Sudden weakness/dizziness with rapid heartbeat and arythmia ( Per EMT EKG) . Heart rate normalized /Resolved on its own after about 10 minutes with dizziness lingering a little longer
Paralysis of right upper eyelid impaired motility of right eye and eye pain.; Paralysis of right upper eyelid impaired motility of right eye and eye pain.; Paralysis of right upper eyelid impaired motility of right eye and eye pain.; This is a spontaneous report from a contactable physician. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), first dose intramuscular, administered in Arm Right on 09Mar2021, single dose for covid-19 immunisation. Patient had no relevant medical history. Concomitant medicine included an unspecified vitamin. On 10Mar2021, patient experienced, paralysis of right upper eyelid impaired motility of right eye and eye pain. It was unknown if treatment was given for all adverse events. The outcome of the events was unknown. The events was assessed as serious, disability criteria. No other vaccine given in four weeks. No Covid prior vaccination. Not Covid tested post vaccination. No known allergies.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for the reported paralysis of right upper eyelid, impaired motility of right eye, and eye pain 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.
Fever, chills, nausea, vomiting, headache, lethargy for 1 day
Information has been received from a pharmacist concerning a 60 year old female who was scheduled to receive ZOSTAVAX (Oka/Merck) inadvertently received VARIVAX (Oka/Merck).  The patient was not experiencing any known symptoms.  A product quality complaint was not reported.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Information has been received from a pharmacist concerning a 64 year old male, weight 118.4 kg, who on the morning of 25-FEB-2008 was scheduled to receive ZOSTAVAX (Oka/Merck) but inadvertently received VARIVAX (Oka/Merck) (MSD) subcutaneously.  The patient was not experiencing any known symptoms.  A product quality complaint was not reported.  Additional information is not expected.
Pt stated that once he received the vaccine on Saturday, 11 Sep 2021 at 11:00,  he felt left arm pain and burning sensations throughout his arm.  Later on in the evening, he experienced chills, fever and a severe headache. Pt came to work on Sunday and complained of chest pain and difficulty breathing. Pt was transported to  ER.
This spontaneous report was received from a certified medical assistant and refers to a 6 months old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-APR-2016 at 18:26, the patient was vaccinated with improperly stored dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Sore, red, inflamed arm. Tongue swelling. No difficulty breathing. Began about 24 hours after shot. Left arm.
Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
Pt complained of fever and chills around 5:30pm, no complaints of night sweats of body aches. Pt woke up at 5:30 Tuesday with full body rash. Pt took 50mg of Benadryl, worked throughout the day with barely any complaints. Returned from work and rash worsened. Pt took another 50mg of Benadryl and went to sleep. Woke up Wednesday with same symptoms as previous day at which point he took another 50mg of Benadryl and came to see one of our providers concerning side effects of the immunization.
PAIN IN HANDS TO ELBOW AND LEFT THIGH,"STABBING" FEELING LASTING SECONDS. NO TREATMENT NEEDED. RESOLVES BY IT SELF AFTER SECONDS. NO PARALYSIS. NO NUMBNESS. FAMILY REPORTED PROBLEMS AFTER HPV VACCINE
patient received two expired vaccines with no reported adverse event; Initial information was received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 months old male patient who experienced patient received two expired vaccines with no reported adverse event while receiving vaccines diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] and hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On 04-Apr-2023, the patient received a 4th dose of 0.5ml suspect hib (prp/t) vaccine lot U7260AA expiry date: 30-MAR-2023 via intramuscular route in the left thigh for Immunization. On 04-Apr-2023, the patient received a 4 dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine lot number not reported via intramuscular route in the left thigh for Immunization.  On 04-Apr-2023 the patient developed a non-serious event of patient received two expired vaccines with no reported adverse event (expired product administered) following the administration of hib (prp/t) vaccine and following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) and DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received two expired vaccines with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received two expired vaccines with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax 13NOV94 & had fever 99 to 100 & congested;immed p/vax irritable, cranky & high pitched/inconsolable screaming; sxs on & off;also insomnia;rx APAP;MD visit-Motrin rx;improved;but screaming cont as of 29NOV94
Information has been received from a physician concerning a 52 year old female who was believed to have been vaccinated with a complete series of hep B vaccine recombinant. On 8/15/02, the pt donated blood, and subsequently, was found to be anti-HBs positive, anti-HBc ositive and HBaAg positive. The outcome of the pt's experience was unknown. It was reported that the pt sought unspecified medical attention. Follow-up info has been received from a health professional. The health professional reported that the pt did not have a reaction to hep B vaccine recombinant. The health professional also reported that, according to the physician, the pt had hep B in the past and was now immune. No additional info is expected.
Shingles on right upper back and right chest. Pain and widespread shingles rash. Prescribed Valacyclovir and Gabapentin.
pt recv vax & devel an inj site rxn characterized by redness & swelling, w/pain radiating from site down the arm;pt has recv pneumococcal vax in the past;this is one of ten pt who exp above rxn p/vax;
patient felt dizzy, lightheaded, nauseous after receiving pfizer covid-19 vaccine. I checked her blood pressure, it was normal 127/96; pulse was 87. I gave patient ice pack and she said she was feeling numbness in her left arm and fingers. After 5 minutes she was feeling some chest pain and wanted me to call 911. She said she was feeling anxious and hadn't eaten all day. patient takes weekly methotrexate injections.
Itching and small hives 16 hours after shot. Took 2 Benadryl tablets and put cortisone ointment on hives.