chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recipient vaccinated post expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Recipient vaccinated post expiry) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Recipient vaccinated post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Recipient vaccinated post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
01/30/2023 I felt a sore throat coming on with fever, congestion and coughing. I tested positive for COVID-19 . Reached to my physician and was prescribed a course of Paxlovid. I felt better 2 days later.   03/11/2023 I woke up with a sore throat, low grade fever, nauseasness, head and chest congestion. I tested positive for COVID-19 again. I contacted my Husbands physician and was prescribed another course of Paxlovid.  I also wanted to mention that I also have Rosacea on my back which has never happened to me.
Received MMR vaccine and Hepatitis B vaccine at 1:45 PM. Brought in to ER at 10:48 PM in full cardiac arrest. Apparently had witnessed seizure prior to arrest.
Back started itching, noticed huge red spot warm to the touch, hives. Neck and face become blotchy looking.  Called NP, took 50mg of diphenhydramine.  The hives and rash subsided by the end of the day on December 24th.
Employee received vaccine 11/8/13 - had localized symptoms/ache - pain/decreased range to motion in left deltoid area. Did not report until 10/31/13. Took ALEVE for a few days - pain and range of motion improved. 75% better now. Did have previous left shoulder stiffness as reported by employee 11/15/13.
63yo male who received his flu shot on October 4 at an oustide facility.  On October 15 (six days prior to hospital admission), he started noticing weakness in his toes bilaterally which gradually progressed up to his legs, hips and arms. Patient was unable to crawl or ambulate. Symptoms associated with numbness and tingling to both feet and hands, diplopia and some dysarthia are consistent with demyelinating polyneuropathy (Guillain Barre Syndrome).  Patient admitted to Hospital.  Labs showed elevated protein and patient underwent plasmapheresis for 5 days. Patient is still hospitalized and degree of permenant disability or recovery status is unknown.  1/15/08 Reviewed hospital & rehab medical records which reveal patient experienced numbness & weakness in bilateral toes 6 days prior to admit which gradually progressed up legs to the point where he could only crawl, could not lift legs or arms, had double vision.  Also had congestion, SOB, cough, asthma, wheezing.  Neuro exam was areflexic, muscle weakness shoulders down, decreased sensation in glove & stocking distribution.  Admitted to intensive care 10/21-11/6/2007.  Neuro, Pulm, ST/OT/PT consults done.  LP done.  Tx w/plasmapheresis x 5 days via right femoral Quinton cath w/only slight improvement.  Transferred to inpatient rehab from 11/6-12/20/2007.  Improved to be able to ambulate w/rolling walker for short distances w/assist.  D/C to home for outpatient PT/OT, neuro & pcp f/u. FINAL DX: Guillain Barre syndrome, quadriparesis, HTN, COPD, asthma, UTI. Per 60 day follow up: Currently undergoing physical therapy, left hospital with residual effects from GUILLAIN BARRE.
Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022; Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine beyond use date on 01-Apr-2022, vial was stored in the refrigerator on 04-Apr-2022 and administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vaccine beyond use date was reported as 01-Apr-2022.  On 04-Apr-2022 vial was initially stored in refrigerator.  No temperature excursion occurred.  Treatment details was not reported by the reporter.
Administered 12/29/10. Rash, swelling in arm started. 3rd day (12/31) worse when touched such as putting on clothes. - Itchy back of Rt upper arm.
Patient stated she experienced, "Dizzy, Nausea, and warm sensation", and was found to have an elevated blood pressure. Treated and monitored in Emergency Room.
Ring around injection site (medium red color) & pink around the ring. Last night (5/8/11) a little painful.
Information has been received from a registered nurse concerning an approximate 77-month-old female who on 17-JUN-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Menstrual period started a week early.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EdD7533) via an unspecified route of administration in the left arm on 27Mar2021 at 09:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient did not have allergies to medications, food, or other products The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206 via an unspecified route of administration in the left arm on 06Mar2021 at 10:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination. On 06Apr2021 at 10:00 the patient experienced menstrual period that started a week early. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event menstrual period started a week early was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt recv vax 1987 & approx 1mo later blood tests showed that hep b was gone;2JUN97 exp chronic diarrhea & was seen by MD;
Erythema, induration, and urticaria at injection site (right arm). Temp was 99. Seen 48 hrs post injection, symptoms occurred 24 hours post injections.
it was a vasovagal response, pt was caught by his sister in the counseling room. Grad intern was giving the shot under rph supervision after he received the shot he stood up and was waiting, then his sister caught him and grad intern made him lie down on the floor with his feet up for a few minutes until it passed while his mother was in the room. The pt stayed in the waiting area for 20 minutes and he was able to walk up on his own and said he was feeling better.
INJECTION SITE WARMTH; NUMBNESS ON THE VACCINATED UPPER RIGHT ARM RADIATING TO THE FINGERS AND HER ARM FELT LIKE IT WAS FALLING ASLEEP; INJECTION SITE REDNESS; FEVER; SWELLING AT INJECTION SITE; CHILLS; WEAKNESS AND FEELING FATIGUED; DIZZINESS; INJECTION SITE LUMP; 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 not reported and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-NOV-2021, the patient experienced dizziness. On 10-NOV-2021, the patient experienced injection site lump. On 10-NOV-2021, the patient experienced chills. On 10-NOV-2021, the patient experienced weakness and feeling fatigued. On 10-NOV-2021, the patient experienced injection site redness. On 10-NOV-2021, the patient experienced fever. On 10-NOV-2021, the patient experienced swelling at injection site. On 20-NOV-2021, the patient experienced injection site warmth. On 20-NOV-2021, the patient experienced numbness on the vaccinated upper right arm radiating to the fingers and her arm felt like it was falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, injection site warmth, weakness and feeling fatigued, injection site redness, and swelling at injection site on NOV-2021, and chills, and fever on 12-NOV-2021, and had not recovered from injection site lump, and numbness on the vaccinated upper right arm radiating to the fingers and her arm felt like it was falling asleep. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of swelling at the injection site in a 2-year-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent medical conditions included penicillin allergy.  Concurrent vaccination included HIB vaccine, (Merck) and VARICELLA Virus vaccine (Merck) both given on 16 June 2008.  There were no concurrent medications.  On 16 June 2008, at 15:00 - 16:00, the subject received 1st dose of PEDIARIX at 0.5 ml in the left thigh.  On 17 June, 2008, 1 day after vaccination with PEDIARIX, the subject developed a swollen, raised area at the injection site that was warm to the touch and caused the subject to walk with a limp.  The subject was seen in the physician's office for these events.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with PEDIARIX.
Patient told us that she has high anxiety with needles. She fainted within a minute of giving the vaccine. I touched her arm with a cold water bottle and she woke up.
headache; flu; This is a spontaneous report from a contactable consumer (reporting for wife).   A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported), vaccination age of 68 years, as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  After vaccination the patient experienced headache and flu (non-serious) on an unspecified date with outcome of unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
At approximately 3:00 pm (5.25 hours post vaccines), experienced lower abdominal cramping, followed by light vaginal spotting (light red in color).  As of the current time (4:15 pm), mild cramping is still present.
Lightheaded and nauseous. Pounding Headache and Chills. Pt stated she was very tired pale and diaphoretic.
Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        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 provided.
pain right arm; swelling at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm, injection site swelling and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received the 1st dose of shingrix in the right arm, approximately 3 to 4 weeks before the time of reporting.  The patient experienced pain in the right arm immediately after injection.  Three days after receiving the vaccine, the patient developed swelling and redness at the injection site.  These symptoms were resolved after 5 to 6 days. The patient did not consent to follow-up. The patient did not provide any additional details.
Chills/fever, temp @100, extreme tiredness.  Fever broke at noon on day 2, 2/8/2021.  Slept most of 24 hours.  Day 3, 2/9/2021, slept 3/4 of the day, up for an hour or so and down for 2 hours.  Day 5, 2/11/2021, returned to usual activities but residual tiredness.
Pt completed the J&J Janssen series, with one dose on 3/28/2021.  This dose was received in another state, so no lot number is available.  On 8/2/2021, pt presented to a local hospital ED for a covid test after a close exposure to someone positive.  Mild symptoms at the time, "sore throat, shortness of breath, cough,dizzy/sweaty.".  Returned to the ED on 8/9/2021 and was transferred to our hospital for inpatient care on 8/10/2021.  Required gen med level of care.  "presents with a chief complaint of ongoing diarrhea, nausea, vomiting and followed at the outside facility emergency room to have hypokalemia, orthostatic hypotension symptoms of dizziness and lightheadedness with standing and fever in the setting of Covid positive test."
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:00 as dose 4 (booster), single (Lot number: HRSAGH9694) at the age of 77 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney donor" (unspecified if ongoing), notes: Kidney donor, I took the appropriate Paxlovid dosage. Concomitant medication(s) included: DOXYCYCLINE MONOHYDRATE; FINASTERIDE; DIPHENHYDRAMINE; FLAXSEED OIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. COVID-19 Treatment brand=Pfizer Treatment start date=25Sep2022 and Treatment stop date=01Oct2022.
Had a high fever the next day, went down. But arm is very painful/red and sore. Has tried taking benadryl to help. Redness was brought down a little but still pretty red and sore.  Patient states she has never had a reaction to a vaccine before this.
my arm is still, is that like red, pink, in a radius area, pre large area; and it''s still sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd), for covid-19 immunization; Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "my arm is still, is that like red, pink, in a radius area, pre large area"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "and it''s still sore.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Freezing Cold, achy starting two hours after getting shot the following day continued with extreme feeling of cold and achy tired and was also nauseous. Began to feel better starting at 36 hours after shot all nausea and freezing seemed to clear up around 48 hours. Arm hurt  and still hurts to touch 4 days later
Hep B Adult dose given, not pediatric HB. Irritable during same day.
This spontaneous report has been received from the medical assistant refers to 4 year old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included Diluent Mrk Inj used to reconstitute the VARIVAX was properly stored. On 11-JUL-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (degrees F) to 14 degrees F (also reported as "9F") for a time frame of 10 minutes; and of 15 degrees F to 46 degrees F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Myalgia, Fever, fever of 100.3, swelling and pain of left axilla, fatigue Narrative: NA
Rash all over face on 9/20/2017. Today only rash on bilat cheeks that itches and feels hot. Per Interpreter Pt also states his face is swollen. No other complaints.
Site: Itching at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Dizzy, lighteadedness. Patient begin to fall backwards. scraped hand-Mild, Additional Details: After patient received vaccination, patient felt dizzy, light-headed and started to falling. Patient hit and scratched hand on display. Patient was evaluated by nurse practitioner from clinic and felt fine after sitting down for 10 minutes. No bruising or swelling at injection site, patient was just shaken
a higher dose which was withdrawn straight out without mixing with the sodium chloride 0.9% was given to the patient.  The patient has not experienced side effects so far.  Her primary doctor was informed.
No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself all day/all night; monkey chatter in head; had a flushed face; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EL 9264) as 2nd dose, single for covid-19 immunisation. Medical history included Pervasive Developmental Delay (on the autism spectrum), penicillin allergy, shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported and multivitamins. The patient previously took ceftin and ceclor and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 46-years-old on 04Feb2021 (lot number EL 3302) administered in left arm for covid-19 immunisation and no adverse effect was experienced. It was reported that after Pfizer vaccine #2, the patient immediately had a flushed face on 25Feb2021 which disappeared by the next day. The following week on 04Mar2021, the patient was hostile/angry/and could not turn off her brain; she was whispering to herself all day/all night called it "monkey chatter" in her head. There was no sleep for two weeks straight. The reporter called their gynecologist for bloodwork, thinking it could be hormonal, perimenopause; it was not. They called the psychiatrist and counselor for guidance and was recommended Seroquel, to stop the chatter in her head, and to help her sleep. They visited their family physician, who prescribed the medication, 25 mg for bedtime. The patient is finally becoming more like herself, pleasant, no whispering to herself, no monkey chatter in her head, and able to sleep at night with the support of the Seroquel. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The patient recovered from flushed face on 26Feb2021, and was recovering from the other events.
Red, itchy, burning rash developed around the injection site beginning 7 days after I received the vaccine.  Currently measures approx. 4"x3".