chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Head pounding  My entire body muscles felt like I had been beat up. Blankets were difficult move  stretching/ spasms were strong and long. Took two pain killers  my low back felt so bad I wasn?t sure if I could walk to bed. Rough night  still have a bad headache  low back ~ hips hurts to bend over.
Patient complains of swollen and painful arm - stated that immunizer "hit a nerve". She stated she was unable to work for the 3 days after. Patient went to the walk in clinic 5 days after immunization and was prescribed cyclobenzaprine.
Organ Failure following Second Shot - otherwise healthy person - Kidneys showed failure on 5/3/2021 at an ER visit- Blood Pressure became elevated- Kidneys have been failing since second shot
Pt. was administered 0.3ml of undiluted Pediatric formulation instead of the adult version.  No adverse effects reported to date.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 03-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations is because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. on 19-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
patient reports arm soreness, and red to the touch at site of injection.  Symptoms began 8 days after injection
Patient received Varivax and Boostrix.  Approximately 7-8 minutes patient fainted (? seizure).  Hit head on floor, confused, vision changes.  Sent to ER for evaluation via ambulance.
PRURITIS AND BUMPS BEGINNING UNDER ARM AND ON FOREHEAD LATER SPREADING TO THE BACK OF THE NECK. PRURITIS IN ONGOING AS OF TODAY. PRURITIS BEGAN DAY AFTER IMMUNIZATION.
jittery, crying, pale, intermittent lethargy (t103.8), breath holding vs apnea (lasting 10sec); occurring 2 1/2hrs p/vax; observation in hosp overnoc on monitor
Patient who is 15 years old received moderna vaccine that is only indicated for 18 years and older. I spoke to patient's mother  and explained the problem then  inquired how she was doing. Her mother assured me that she did not experience any adverse reactions from vaccine and is feeling well. I did tell mom that she will not be given second shot. .
Hives and rash beginning under arms and in groin, advancing to back, chest, arms, legs and face over 12 hours.  Took Zyrtec for 4 days, which slowly reduced rash and hives until gone.  Checked with primary care doctor by telephone on morning after event first occurred.  He concurred in continuing to take Zyrtec.
Patient didn't feel well after 1st dose. After second dose, on Friday she was throwing up in bed. Saturday she was hallucinating and then slept for 5 hours. When she woke up she was unresponsive. The hospice nurse feels it was a stroke.
Pain, burning and itching at injection site rash, swelling at site and adjacent to site.
Redness/bruising - large area (within 1 day of shot) extending down arm
pt was sick prior to shots but no fever that day;pt lost all speech he had prior to shots, ignored attention toward him-was in own world-like confused;this happened the next day;low grade fever also;dx autistic like sx; sx improving
significant itching at the injection site; redness from elbow to below my shoulder; looked like a hematoma; soreness; redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (significant itching at the injection site), ERYTHEMA (redness from elbow to below my shoulder) and HAEMATOMA (looked like a hematoma) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (significant itching at the injection site), ERYTHEMA (redness from elbow to below my shoulder) and HAEMATOMA (looked like a hematoma). The patient was treated with BENZOCAINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (significant itching at the injection site), ERYTHEMA (redness from elbow to below my shoulder) and HAEMATOMA (looked like a hematoma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient received primary series booster of covid 19 pfizer vaccine on 3/1/22 at 2:30 PM.  First dose was administered on 8/26/21.  It was discovered on 3/2/22 that the dose given on 3/1 had expired on 2/28/22 at 8:50 PM.    Our vaccine coordinator contacted pfizer to determine viability of vaccine to learn there is no current data to support this incident.  The pfizer recommendation was to follow CDC recommendation and have patient receive another vaccine immediately.  Patient was notified, she does not want to receive another dose, as she currently having side effects of site pain, muscle aches, fatigue.
Patient received second dose pfizer. Within 25 minutes patient started to clear throat, cough, and complained of throat dryness.
The local immunization registry called and informed us that the patient received 5 doses of the vaccine.  The database didn't show any vaccines for the patient.
This is a spontaneous report received from a consumer or other non-HCP (patient), via a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Jan 8, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed myalgia/muscle soreness, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Initial information was received from a health care professional on 16 September 2008. A four month old female patient with no reported past medical history developed a rash four days post vaccination after she received a second left thigh injection ACTHIB lot number UF492A (sanofi pasteur SA lot number B0067), DAPTACEL (lot number C2956BA), a second left arm injection of IPOL (lot number A0491-4), a second right thigh injection of PREVNAR (manufacturer Wyeth, lot number WC4527H), and an oral second dose of ROTATEG (lot number 0407Y) on 05 September 2008. On 09 September 2008 the patient developed a "red and raised" rash on her chest, arms, and legs. She did not have a fever or any other symptoms. The patient recovery status was unknown at the time of the report. This case is linked to case number 2008-02907.
Days 1-3 Moderate right arm pain; Days 1-2 Moderate chills; Days 2-5 low grade fever- Mine normally runs 97.6 and my temperature was consistently 99-99.8; Day 3-4 Bright, red, patchy non-raised rash on both hands (mainly the fingers) with slight swelling and what felt like a bump on two spots on separate fingers; Day 7-today's date- Lump developed on my chest, just under my collar bone. A virtual appointment was had today (1/15) with my Dr and she wants me to come in for an office visit (which is scheduled for Tuesday 1/19). My temperature was taken after the appointment and it is 99.3. My blood pressure was also unusually high today (159/109 HR 81 and 150/92 HR 76).
Headache  Diarrhea  Flushed/feverish (no fever)
This spontaneous report was received from a certified medical assistant and referred to a male patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. It was reported that the patient received 2 doses of ZOSTAVAX (lot #, expiration date, strength, dose, frequency and route of administration were not reported) vial 19400 (plaque-forming units (PFU). He received a first dose on 09-NOV-2012 and a second dose on 29-APR-2015. No adverse symptoms were reported. Additional information has been requested.
2nd dose not given in recommended time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Fever papular rash - feet, legs, trunk, arms. Crying (suspect it was from Hep A because no reaction to prior 3 HIB doses).
Experienced all side effects listed on CDC website, more than moderate, with the exception of joint pain. What scared me most was shooting, jabbing eye pain for four days after the injection that was NOT listed on the CDC website.
fever; chills; body ache; nasal congestion; nausea; Headache; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and hypercholesterolemia. Concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unspecified date in 2021 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 03:30, the patient experienced fever, chills, body aches, nasal congestion, nausea and headache. The patient reported that it was more severe than expected and was only confined to bed. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, nasal congestion, nausea and headache lasted for 12 hours before subsiding and was recovered on 16Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient received incorrect vaccine at vaccine clinic. Patient was scheduled to received a covid vaccine, but received a flu vaccine. Patient had already received his flu vaccine a month prior on 10/12.; received extra dose
Patient reported feeling flush,  numbness in her face, shaky, weak and "foggy"
Pain at site of injection that radiated to entire arm-fingers to shoulder-no rash, flush, hyperemia.
Mom said next day child had fever, chills, body ache, swelling, and soreness of vaccine site. Seen in office on 3/15/10. Had fever 103, redness and swelling injection site. KEFLEX 250mg q 8 x 1 wk given - MOTRIN PRN.
mild shingles; lesion(s) on torso; pain in area; 1st dose on 11/12/18, 2nd dose on 6/24/19.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2018).   On 24th June 2019, the patient received the 2nd dose of Shingrix. On 24th June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles, skin lesion and pain. On an unknown date, the outcome of the shingles, skin lesion, pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles, skin lesion and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The patient received both the doses of Shingrix. The patient presented with mild shingles, lesion(s) on torso, pain in area on 27th Sep-2022. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Fever with maculopapular rash.  Likely not related to vaccines, but diagnosis unclear.  Coarse and appearance consistent with measles or rubella.
Administered vaccine which had been exposed to a low temp of 31.3F. No adverse event reported by patient.  Contacted Pfizer: Vaccine can be exposed to less than 23f for over 7 days. My vaccine was exposed to temps between 31.3 an 32f for a cumulative exposure of less than 8 hours.
After receiving my second shot, I have been experiencing adverse effects. The week after receiving the second shot I was experiencing vertigo/light headedness everyday day, multiple times a day. I still experience these symptoms. I?m a 27 year olds, in great shape, eat healthy, don?t have any pre-existing medical conditions, and I don?t do any drugs.
Patient describes a rash that started at the site of the immunization and goes down the arm. Patient states it started a week after the immunization. Patient has not received medical care and refused to show the rash to the pharmacist.
The vaccine caused me to develop  Persistent Postural Perceptual Dizziness.  For almost a year, I have suffered from severe dizziness.  I began vomiting approximately ten days after my vaccine.  I also developed diarrhea.  Just in the last eight weeks the vomiting is better.  My dizziness and diarrhea have persisted.  I have had numerous tests.  I recently had a MRI and a CT Scan to see if I had a tumor or a stroke.  The tests were negative.  It is the second Pfizer vaccine that made me very ill.  I have suffered for almost a year.
Missed her second dose Moderna vaccine appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second dose Moderna vaccine appointment) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose Moderna vaccine appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her second dose Moderna vaccine appointment) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received, included reporter address was updated.
another swelling 5 inch long and 3 inch width, just below the site; swelling like a bump 2inch diameter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (another swelling 5 inch long and 3 inch width, just below the site) and VACCINATION SITE SWELLING (swelling like a bump 2inch diameter at the injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (another swelling 5 inch long and 3 inch width, just below the site) and VACCINATION SITE SWELLING (swelling like a bump 2inch diameter at the injection site). At the time of the report, PERIPHERAL SWELLING (another swelling 5 inch long and 3 inch width, just below the site) and VACCINATION SITE SWELLING (swelling like a bump 2inch diameter at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Could not make a whole 20 minutes walk; she felt tired; Consistent cough; This is a spontaneous report from a contactable consumer (patient' son). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The reporter stated the patient was an active 77-year-old with no medical history and after having the first dose, the patient told him that she could not make a whole 20-minute walk as she used to; further reporting she could for 10 minutes as she felt tired. The patient also presented a consistent cough, reported as not bad. The reporter wanted to consult if there were any reports of these side effects. The patient received her second dose of BNT162B2 on 31Mar2021. The clinical outcomes of could not make a whole 20-minute walk, consistent cough and she felt tired were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Nausea all the day; Tiredness; chills evening; severe heartburn; High Blood Pressure; vertigo when got out of Bed; Joint pain in shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A 69-year-old female non pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 19Feb2021 17:00 (age at vaccination 69-year-old, Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hepatitis C (recovered), cholelithiasis from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol, menaquinone-7 (VITAMIN D3 K2) and ubidecarenone (COQ 10) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. It was reported that facility type vaccine was hospital and no other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. On 19Feb2021, the patient experienced joint pain in shoulder above the injection (adverse event Day1). Next morning she had vertigo when got out of bed on 20Feb2021. On 21Feb2021 (Day 3) she had high blood pressure. On 22Feb2021 (Day 4), she had vertigo in morning /high blood pressure and severe heartburn in evening. On 23Feb2021 (Day 5), she had nausea all day and tiredness and chills evening. It was reported that on day 6, she had tiredness and some chills. Patient not received treatment. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
got injected expired Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00692200) and transmitted to Sanofi on 21-Jul-2021.  This case involve a 31-year-old female patient who was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of got injected expired adacel (Expired product administered).   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 05-Jan-2021.  The estimated due date is 12-Oct-2021.  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [prefilled syringes, lot U6273AA and expiry: 24-Apr-2021] via an intramuscular route in the left deltoid for prophylactic vaccination (Fetus prevention of whooping cough).  It was reported that, "The patient was given the Adacel because she is 28 weeks pregnant to protect the fetus against Whooping cough". The expired box of Adacel, but is believed that one of the expired Adacel prefilled syringes got accidentally put in a new Adacel box.  It was as actual medication error due to expired product administered (latency: on the same day)  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was unknown for the event got injected expired adacel.  Additionally, at time of reporting, the pregnancy is still ongoing.  At the time of report, 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 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.
PHONED BY MOTHER-FEW RED SPOTS ON ARMS & LEGS THAT FRIDAY, HAD SEEN MORE OVER THE WEEKEND ESPECIALLY ON THE THIGHS (MORE CLUSTERED & THICKER & WARMER TO TOUCH, A FEW TIMES CHILD HAD SCRATCHED BUT MOTHER USED CORTISONE CREAM. TODAY, 10/14/2013, APPEARS TO BE LESS RED, HAS NOT SCRATCHED AS MUCH, LOOKS LIKE HEALED. MOTHER DID NOT GO TO PEDIATRICIAN.
48 hours - sweats, painful chills, body ache, headache, fluctuating 100-105 fever