chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1 and Batch number as EL9265) on 28-Jan-2021; for Product used for unknown indication: Pfizer (Dose 2 and Batch number as EL9265) on 18-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. A pharmacist, the vaccine coordinator in their health care facility reported that they inadvertently administered expired dose of the Moderna COVID-19 vaccine. Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient received 1st booster dose on 01-Mar-2022 and not reported adverse reaction to the HCP's knowledge. No treatment medications were provided by the reporter.
4JUN92 woke up @ 7AM  sitting in chair slumped onto floor shallow resp, pale, gagging sounds, rigid eyes open to whole unresponsive x 8 mins ER hosp; blood drawn; WBC up, t99.9; ER
Case number PHEH2014US019556 is an initial spontaneous report from the health care professional on 25 Sep 2014. This report refers to a 47-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly on 14 Sep 2014. On 15 Sep 2014, he had fever. On 16 sep 2014, he experienced injection site reactions which were mentioned as itchy, warm to touch, arm swollen and redness. He also had diarrhea. He went to doctor on the same date and went to pharmacy to report. On 17 Sep 2014, he went to emergency room. On an unknown date, the patient recovered from the events. The seriousness and causality of the events were not reported.
Patient presented hives on her torso, back and hips.  It decreased in severity until evening, when it spread to her shoulders, arms, legs, torso, back, and chin.  She spent all night crying and complained of stomach pains.  The hives left at 8:20 on 11/20/09.  She now has a cough, a runny nose, is tired, and cried during her nap.
Pt presented 2/13 for ppd placement; had mild diffuse redness at site. Evaluated by a provider, thought to be a mild allergic reaction.  Staff checked lot # and expiration date documented - it didn't match with tubersol, but did with Fluzone.  Pt informed of error, no adverse events expected, verbalized understanding.
Expiration date was checked on Moderna website and was labeled with an expiration date of 11/01/2021. It was unknown that this date was for frozen storage rather than refrigerated storage. Expiration date should have been labeled as 10/03/2021. Vaccine was used on 10/29/2021 to vaccinate the employee and was expired
I received my second dose of the Moderna Covid vaccine on Thursday and was incredibly sick by 2am Friday which lasted through Saturday until 2pm. My symptoms were to be expected: nausea, body aches, fever, headache, stomach cramps. The biggest issue that was not expected is my milk supply has drastically decreased to where today baby isn?t able to get any milk and screaming when I put him to breastfeed. I?m trying to pump all day long and not producing any. I was overproducing 20-25oz a day  by catching in haakaa, not even pumping. I had a seamless breastfeeding journey so far and he?s gaining rapidly and was eating 4oz+ a feed. He was born 10/18/21 so he?s 3 months old. I?m not having to give him the frozen milk since I?m not producing any. Nothing else has changed, I?m still in maternity leave, eating healthy and drinking tons of fluids.
Pt had vax on 6/11/99. On 6/13/99, had swollen wrists & became fussy. On 6/19/99, had ataxia. On 6/20/99, developed pin-point rash on face, arms & legs persisting still on 6/25/99, but now with a fever. Dr. considered pt's experiences to be  60 day follow-up provided a corrected Manufacturer number.
chill, fever (102F), cough, body ach, pain in injection site, loss of taste
inflammatory burning sensation, throughout her whole body and into the back of her head; Slept for about an hour that night; Throat and neck were burning; Sore arm; Reaction was painful; Headache; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), PAIN IN EXTREMITY (Sore arm) and RASH (Reaction was painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), PAIN IN EXTREMITY (Sore arm), RASH (Reaction was painful), HEADACHE (Headache) and ARTHRALGIA (Joint ache). On 05-Mar-2021, BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), RASH (Reaction was painful) and ARTHRALGIA (Joint ache) had resolved. On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
EUA Pfizer-BioNtech vaccine reaction Patient complained 10 min after vaccine of shortness of breath. she was visibly shaking , she was speaking normally but difficulty breathing.
Developed fever x3 days with onset of rash on the 3rd day. Has erythematous papules that started on the forehead and spread downward. Few of the red bumps have clear fluid or white fluid.
Next day 100.5 fever sleeped almost all day, 2 days 103.5 fever, threw up and a  trip to emergency room sleep all day and was prescribed Zofran ODT 4mg oral tablet for nausea. 3rd day fever reduced but broke out in a rash back of neck and his back and face.
headache, low grade fever, weakness, chills, dry mouth, stuffy nose, sore arm.  crummy feeling. tired.
Hand got tingly right away then went away after a minute. As I was leaving the site my face got tingly from my eyes down to my chin about 12-15 minutes after the injection  and then went numb for about 20-30 minutes. The following day I was very tired and felt slightly nauseous for most of the day. After about 30 hours after the vaccine I was feeling better.
The pt developed fever and extreme irritability for two days and beginning two hours after vaccine administration. He also developed increased nasal congestion, poor nursing.
Patient took VIVOTIF dose #1 on 11/30 and dose #2 on 12/2. Patient woke up Tues 12/3 and noticed a non-raised, non-itchy red/blotchy rash on her abdomen. It has not worsened or spread as of 12/5.
Period started 2 days after the second vaccine dose. This period ended up being a week early and extremely light and short. My periods have been light and short ever since. My periods run like clock work and are usually medium to heavy in flow. I am now dealing with a yeast infection, with blood spotting right after my shortened period. None of this is normal to me.
When he stands up the dizziness worsens,dizziness; His left leg or balance is affected; he is scared to be left alone,He was afraid; having trouble getting to the bathroom; he is totally blind; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown), via an unspecified route of administration on 20Sep2021 morning at 10:05 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Sep2021, the caller was on the line with his caregiver as the patient was legally blind. About 20 minutes after patient received the shot, he experienced dizziness. The Pharmacist advised them that this is natural and can happen after the shot. The caregiver also read it on the information sheet that was provided to the caller prior to the vaccination. It continues now and patient was afraid to be left alone. When he stands up the dizziness worsens, he was totally blind, and he was having trouble using the bathroom. He was fine sitting up and does not complain of nausea, he was drinking coffee at this time. He was afraid because he cannot get around as he usually does. They spoke with someone the first time they called and reported his experience. The caregiver added it was his left side that was affected and now she understood that this could be an allergic reaction because of how soon it happened after he got the shot. Caller stated the patient had a bad reaction to the first Pfizer Covid vaccine received today. His left leg or balance was affected and he was scared to be left alone. He was having trouble getting to the bathroom and that is not cool. Outcome of event was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 07-APR-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 20 degrees Fahrenheit (F) (-6.666666667 Celsius) for a total of 2316 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare student refers to a patient of unknown age. It was reported the patient received 4 doses of PNEUMOVAX 23 (Injection, lot #, dose, route and duration were unspecified) or unspecified dates within a one year period of time. No adverse symptoms reported. Additional information has been requested.
October 30, 2016 trembling inside, Saturday, November 12 2016 Fever 103.8, head spinning, rash on elbows, hair falling out, diarrhea, eyes and face swelling. With Family Practice November 15, 2016. Place on TAMIFLU. Hives appear on face and neck. Stop taking TAMIFLU. Head spinning sick November asthma, December kidney, diarrhea and rash and hives worsen. January can't go without (hives) infection (attack pituitary). I have been so sick and traumatized that bipolar gene has surfaced. Please help I keep getting this is over my pay grade.
At 9.45PM on 2/26/2021 ( Day of Vaccination 2nd Dose) before brushing my teeth. I gargled cold water. Immediately I had burning sensation on the upper jaw inside the mouth as if I had drank real hot drink. It felt like the skin on the upper jaw is going to peel off. Then I brushed my teeth and took my tablets. After swallowing I got burning sensation in my Stomach. Both feelings subsided after some time may be half hour.
Chills, fever as high as 102, body aches, head ache lasting one full day after shot.  March 27 and 28 running 99 degrees and very tired.  Arm that shot was given in was sore during this time also.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt really sick after each shot) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt really sick after each shot). At the time of the report, MALAISE (felt really sick after each shot) had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-599999 (Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-599999: Master case.
INFLAMMATION FOR DAYS; ANXIETY OF WONDERING IF THE SHOT WOULD KILL; NOT A GOOD FEELING; FEVER; This spontaneous report received from a patient 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: Unknown, Expiry: Unknown) 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 an unspecified date, the patient experienced inflammation for days, anxiety of wondering if the shot would kill, fever, and not a good feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, inflammation for days, anxiety of wondering if the shot would kill and not a good feeling was not reported. This report was non-serious.
Parents brought back to PH - stated just noted this AM lg red area on lt upper arm approx 4cm in size - encouraged to go to doctor to have checked.
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 54-year-old male patient received BNT162b2 (BNT162B2), on 25Dec2020 at 11:00 as dose 1, single (Lot number: EL0140), in left arm, on 19Jan2021 at 16:00 as dose 2, single (Lot number: FJ1686), in left arm and on 31Jan2022 at 16:00 as dose 3 (booster), single (Lot number: 059H21A) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Aug2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) negative, notes: Tested negative; (07Jan2023) positive, notes: Tested positive immediately with 2 covid tests; (07Jan2023) positive, notes: Tested positive immediately with 2 covid tests; (29Dec2022) positive, notes: Tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks: Yes. The patient received Antiviral drug Paxlovid from 29Dec2022 to 02Jan2023 for the treatment of COVID-19. Other medical history: Pacemaker implanted 03Jun2022. Not on medication.
Chills, myalgias, weight loss, started <24 hours after vax and weakness persisted > 2 weeks.
Sore arm: 1-4 days after vacccination Headache: 1 day after vaccination Lower back pain: 1-3 days after vaccination Palpitations: 2-3 days after vaccination (could be anxiety or WPW, not related to vaccine)  COVID arm (itchy, swelling, redness, warm): occurred 1 week after vaccination
This spontaneous report was received from a physician via company representatives from a support services director concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were not provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10Pk-0.5mL SD-PFS LLokwTip) lot number K010466, expiration date of 23-MAR-2016 (route of administration was not reported). The vaccine had two temperature excursions: one for 24 hours and another one for 32 hours. The lowest recorded temperature for the first excursion was 34 degrees Fahrenheit (1.111 Celsius) and the highest recorded temperature for the second excursion was 48 degrees Fahrenheit (8.888 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills - 6 hours Fever - 8 hours  High heart rate (sleeping average 83, wake average 103 when normal is in 60s) - 20 hours  Headache - 4 hours
Pt had swelling, heat and redness of arm vaccinated from elbow to shoulder. Dx began 4 days post vaccine - seen private MD - Pt states PMD advised was reaction to pertussis portion of Tdap. gave Pt "steroid" and advised pt to avoid pertussis containing vaccines in future.
lump around injection site; redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE MASS (lump around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site). At the time of the report, VACCINATION SITE MASS (lump around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included applying ice packs topically.
I had an outbreak of shingles or herpes zoster on my right hand.; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry date was not reported) dose 1 via an unspecified route of administration at Arm Right on 23Jun2021 11:00 (at the age of 57-years-old) as a single dose, for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, depression from an unknown date and unknown if ongoing Verbatim: ADHD. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL), citalopram taken for an unspecified indication, start and stop date were not reported. patient had no Known allergies. 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 01Jul2021 04:00 the patient experienced outbreak of shingles or herpes zoster on her right hand. with outcome of recovering. No treatment was given for the event. Outcome of the event was recovering.
Mother reported child developed rash all over body, no fever no N/V, no swelling. Took child 8/24/04 to MD, given Benadryl every 12 hours and Lidamente cream per MA at DR.
This pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, an unkonwn time after receiving BOOSTRIX, the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. A BOOSTRIX vaccine that was stored below 32 degrees F was administered to a pregnant patient. RN had no further information. She will call back with more info on the patient. All that was given was recorded.
Day 1: Intense itchy scalp and back and arms. Day 2: Welts of hives all over body. Severe dermatographia. Day 3: Hives and severe joint pain all over body especially legs. Severe dermatographia. Day 4 - 13: Less hives; severe dermatographia with daily combination of cetirizine 10mg and Vitamin D 1,000IU. Day 14 - present day 25: Itchy skin with occasional hives, tends to worsen at end of 24 hour cetirizine mark. Severe dermatographia. Itchier skin on menstruation cycle even with cetirizine.