chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave Expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave Expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 55 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2022 as dose 3 (booster), single (Lot number: FK9894) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Oct2021 as dose 2 (booster), single (Lot number: 939905) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Apr2021 as dose 1, single (Lot number: 1808978) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Feb2023, outcome "recovered" (03Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2023) Positive; (02Mar2023) Negative; (03Mar2023) Negative; (07Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Treatment of COVID-19 from 26Feb2023 to 03Mar2023. She first tested positive on 26Feb2023, first tested negative on 02Mar2023, tested negative on 03Mar2023 and again tested negative on 07Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300103182 Same reporter/patient, different drug/event.;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 1:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 1:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.43.  Concomitant products were not provided.  On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021.  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.
soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2hrs.  severe pain in all joints and never seen before crippling arthritis within 4 days.   numbness in my hands, severe neck, back, elbow and wrist joint pain.  sores and infections all over my legs after 5 days.  migraines.  blood pressure and severe glucose spikes without substantial change in diet.  now no feeling in hands other than ice-cold fingers that never warm and constant pain.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial (expiration date February 2015, lot#, dose and route of administration were not provided). It was not specified by the reporter if the patient seek any medical attention. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
PAIN IN THE GASTRO INTESTINAL AREA, HEADACHE, FATIGUE.
I had drainage out of my sinus, headache, body ache, fatigue, a lot of coughing, my chest was locked up like when you have bronchitis, a sore throat. I did a home test that came back negative. Three weeks later I went to the doctor because I could not get rid of what I had. I was tested for COVID-19, Influenza A and B, both tests came back negative. They have me a steroid shot and an antibiotic to combat whatever seemed to be lingering and not wanting to go away. I was advised to take my ZYRTEC every day to help my sinuses not stay inflamed. It took almost four weeks for me to start feeling better.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX lot # L000454 expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
SOMETHING POPPED IN HEAD; SICK AS DOG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-OCT-2021, the patient experienced something popped in head. On 17-OCT-2021, the patient experienced sick as dog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the something popped in head and sick as dog was not reported. This report was non-serious.
Partial bottom lip swelling late Wednesday (4/7/21) evening. Took benadryl and went to bed. Woke up with bottom lip normal but top lip swollen to three times its size. Warm to the touch and felt numb/tingly. It went away that evening, but persisted for at least ten hours.
Had no side effects whatsoever for many hours. Felt completely fine until about 7:30 pm, while I was making my plate of dinner. Felt lightheaded, dizzy, and hot. I began to black out, so I sat down, which helped for a few moments to subside lightheadedness. I was still feeling hot, so I walked a few feet to my back door and sat down on the steps outside to cool off. Within minutes, my vision blurred completely, I saw stars, and completely blacked out. My mother, who was nearby, heard me fall on the steps. She said my eyes rolled back, my body was completely limp, I was not breathing but rather making gurgling noises from my throat. She propped my head up, which allowed me to breathe properly, and I came to.   If my mother had not been nearby, I am convinced I would be dead right now. I saw the light, saw the other side, saw my relatives. I have had a near death experience once before, and this was exactly like that.
11/27/21 presents to ED for "shortness of breath, cough, congestion, diarrhea, myalgias". PMHx of "COPD".
Fever until 9/4/2010, ED visit on 9/5/2010 inconsolable crying and writhing in pain. Tests came back normal except for small amt of redness in her ear. I notified the physicians office but they did not think this was a reaction.
Experienced left arm going numb and sharp itching feeling under the skin. The numbness went to my chest, and then up my neck and into my left eye. I couldn't feel the left side of my body and it started getting really weak. My heart beat got very very weak. And I collapsed. I stopped caring about everything.  I've had Tia before, and this felt very similar however, it wasn't nearly as painful. But I just couldn't move. The pulse in my left jugular was incredibly weak.
Began experiencing ocular migraines ever since receiving the first vaccine and continuing on after receiving the second.  Having them anywhere from 2-3 times per week lasting 20-30 minutes each. Have a history of migraine headaches with aura as a teen.
Pt recvd vax & exp welts on wrist (3 to 4" below TB tine site); next morning 24MAR arm was fine; also had low grade temp (99.4), irritability & pain @ DTP site; welts form head to toe;
Patient became dizzy, nauseous and sweaty immediately after receiving immunization.  Patient did not lose consciousness and did not require an Epipen. Patient was monitored closely for 30 minutes by pharmacy staff and by store manager after developing symptoms. Patient was picked up by her spouse. By the time she left her color had returned and she was no longer dizzy.  She was able to walk and no longer required assistance by the time she left.
patient was administrated the right vaccine for his age , MenQuadfi , NOT Men B -4C Bexsero ,  but the data entry was incorrect
Achy joints, migraines, dizziness, severe fatigue, weakness, nausea, sensitivity to light, unable to get out of bed.
Started getting very tired the evening of the vaccination (day 1), the next day (day 2) extreme fatigue, chills, headache and muscle ache, stomach ache through the day and that night. Felt much better the morning of day 3 with some residual stomach ache.
Initial unsolicited report received from a physician on 24 October 2016. This case involves an 80-years-old of male patient who was vaccinated with first dose of FLUZONE HD (lot number: UI636AA, expiry date: 27 Mar 2017, route of administration and dose were not reported) in left deltoid on 05 October 2016. The illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The concomitant medications were not reported. On 07 October 2016, two days following the vaccination, the patient developed pain at the injection site, even when lifting the arm (patient can't lay on left side) and neurological or bursa damage. The patient required ER/doctor visit. The lab test was reported as none. Corrective treatment was reported as ibuprofen. Patient was not recovered from the events. List of the documents held by sender: none.
10/5/18 Pt. had office visit for upcoming surgery- Influenza and Pneumococcal 23 given 10/6/18- Pt. to ER for SOB, arm red swollen and fever. 10/8/18- Pt. OV for re-eval of reaction.
From telephone contact received at manufacturer on 6/19/02, it was reported that a male, born on 12/22/02, received Tripedia vaccine. Patient developed a 10cm local reaction with redness and swelling.
Urticaria, no breathing difficulty. Patient was given STERIPRED DS 6 day dose pack.
He thought it was an onset of heart attack; Severe muscle spasms size of walnut knot by the shoulder and injection site; Back pain; couldn't breath and feels like squeezing; extreme pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (He thought it was an onset of heart attack), MUSCLE SPASMS (Severe muscle spasms size of walnut knot by the shoulder and injection site), BACK PAIN (Back pain), DYSPNEA (couldn't breath and feels like squeezing) and PAIN (extreme pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer and Diabetes.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (He thought it was an onset of heart attack), MUSCLE SPASMS (Severe muscle spasms size of walnut knot by the shoulder and injection site), BACK PAIN (Back pain), DYSPNEA (couldn't breath and feels like squeezing), PAIN (extreme pain) and FATIGUE (tired). At the time of the report, MYOCARDIAL INFARCTION (He thought it was an onset of heart attack), MUSCLE SPASMS (Severe muscle spasms size of walnut knot by the shoulder and injection site), BACK PAIN (Back pain), DYSPNEA (couldn't breath and feels like squeezing), PAIN (extreme pain) and FATIGUE (tired) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: follow up received
pt recv vax  reported a high sensation where felt a rush of energy w/in 1-2 hr p/vax which lasted 2hr
About 5 minute after patient received her 1st dose of Pfizer, patient got dizzy and she is not sure if she blacked out but when I got to her she was learning against her companion that she was with, clinical symptoms were clammy skin and dizzy. I asked her if she felt itchy and throat feels tight she said no. I treated the episode as syncope and patient recovered after a few minutes. Stayed to monitor in the pharmacy for about 30 minutes. Gatorade was provided.
woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in October 2020, Took 400 mg ibuprofen PTA.
This case was reported by a physician and described the occurrence of injection site pain in an adult subject of unspecified gender who was vaccinated with DTP vaccine (GlaxoSmithKline). In September 2009 the subject received unspecified dose of DTP vaccine (unknown). On 29 September 2009, 8 days after vaccination with DTP vaccine,  the subject experienced injection site pain. The reporting physician was calling about an employee of his, who received a Tdap vaccine 9 days ago and developed slight pain at the injection site 8 days later. He did not know which brand of vaccine the subject received. At the time of reporting the event was unresolved. Follow up information was received on 19 October 2009 from the reporting physician. The physician reported that her PCP office recommended her to apply heat to the area and the swelling/redness was gone after two days. The initial reaction was noted only on post vaccine day eight and may not have been GlaxoSmithKline's product. The subject declined to provide information required to complete the adverse event report form. The physician reported that he was not the subject's primary care physician.
Immediately after the injection - fever within 24 hours, chills, achy, fatigue. Fever for 4 day and  fatigue and achy/joint pain lasted for at least a couple weeks.  On February 11/12, 2021 started with double vision, progressively getting worse and constant starting on 2/17.  Sought medical treatment on 2/18 with emergent MRI ordered and completed on 2/18.  MRI results showed swelling/inflammation in the brain, specifically on the left side.  Treatment thus far has been antiviral medication, seeing specialists - Ophthalmologist and Neurologist on 2/24 and 2/25 respectively. Further treatment is ongoing but will include ongoing lab work, IVIG infusions starting 3/1 for 3 consecutive days, repeat MRI, potential LP and Quarantine for a minimum of 30 days following the first IVIG treatment.  Neurologist diagnosis is ADEM at this time.
This case was received from a health professional on 10 July 2007. An 18-year-old female patient with a history of bee sting allergy had received a right deltoid intramuscular injection of MENACTRA (lot number U2228AA) and a left deltoid intramuscular injection of GARDASIL (0522U) on 04 July 2007. Immediately after receiving the vaccines, the patient became dizzy. She also reported soreness at the injection site. The events subsequently recovered.
pt recvd flu vax & exp immed lt arm pain which radiated to the neck & shoulders & lightheadedness;
pain in arm pit on outside of left arm where shot was, raised large red bump, itchy, hot to the touch, sore
I started feeling unwell on the 18th.  I was aching more than usual, and felt fatigued and weak.  By Tuesday, 9/22/09, I was suffering from severe pain and some weakness in the left arm, in the muscle where the vaccine was injected, and the injection site was surrounded by a red circle which was increasing in size.  The injection site itched badly, but when I touched it, it felt like a severe bruise.  Muscle aches continued to worsen, especially in the left hand and arm.  The feeling of fatigue worsened, and my heart was beating hard (not fast - just hard).  I felt dizzy and clumsy, and my left hand and forearm got tingly - a pins and needles sensation.  By 1:30 on 9/22/09, my right hand tingled as well.  By 2:00 p.m. on 9/22/09, I left work and went to the ER.  I was told it was probably a vaccine allergy and that I would be fine.  By the evening of 9/22/09 (around 6:00), hives started popping up all over my body and itched like mad.  Topical anti-itch creams, lotions, sprays, and powders had no effect.  Benadryl had no effect - even at a high dosage.  The hives were on my arms, legs, trunk, hands, feet, palms, and in my external woman parts.  I had some in my ears, and they were also on my neck, chest, breasts, back, pretty much every skin surface of my body.  It was the worst case of hives I've had in my life; there were countless hives grouped close together - I was blanketed with them.  They were slightly larger than the hives I usually get, but not big enough to be called giant hives.  The very worst of it was centered around the injection site, which was red-purple and itched like crazy, although it hurt to touch it.  By 9/23/09, I was on high-dose prednisone, which also had no effect.  The hives finally started to lessen by the morning of 9/25/09 and continued to fade slowly.  The itching continued, but not as bad.  It took until 9/29/09 for the hives to go away, although the scabs I had from scratching the hives off (mostly in my sleep) continued to itch until they healed.  By then I was feeling really sick, and I was tentatively diagnosed with H1N1 flu, which may be unrelated.  I think I was exposed to the flu in the clinic on the day I got the regular flu vaccine (9/15/09).  I had a fever for 12 days and was very sick, but I didn't qualify for government-funded H1N1 testing, so I decided to forego the formal test.  It's hard to say exactly where the allergic reaction ended and the H1N1 flu began, or if the onset of the flu had something to do with the reaction.  I can say with certainty, though, that the vaccine was the initial cause of the allergic reaction, especially since it started at the vaccination site.  The ER doctor told me he's seen a lot more allergic reactions to this year's flu vaccine, incidentally.
Multiple <10mm reddened lesions on neck and face (shaving region) consistent with autoinoculation. No pus, or other erythema consistent with cellulitis.
Pt began developing pain in and around her teeth. All her teeth have began falling out and crumbling.
syncope, multiple episodes of LOC, lethargic, nauseated, Complaints of chest pain right after her COVID shot. wheezing and mild headache
Lethargy, fatigue, "flu-like" symptoms headache, temperature > 102 F, rash over upper body, swelling and pain at injection site of Pneumovax.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild
Rt upper buttocks warm & red but non-tender; poss delayed local rxn or mild cellulitis from inject; consider drug allergy to pneumovac;
I feel terrible today. "I have 3 fingers on each hand will not bend  and there is some numbness/Fingers are stiffening up; can't bed them; both hands; I feel terrible today/It is scaring her.; I am disabled and I can't walk; I just don't want to go to sleep tonight and not wake up; her fingers are stiffening up; she can't bend them they get stuck; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 73 years), dose 1 via an unspecified route of administration on 29Apr2021 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient reported, she received her 1st Pfizer vaccine dose yesterday. She felt terrible today. She had 3 fingers on each hand would not bend and there was some numbness. These symptoms started a couple of hours after the vaccine dose. States she was disabled and can't walk. She just don't want to go to sleep tonight and not wake up. Says her fingers are stiffening up; she can't bend them they get stuck. States they get stuck like as if she was pointing. It is happening on bother her hands. States she has no idea what it is. It is scaring her. All the events occurred on 29Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.