chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received an Expired Dose; Initial report received on 12-Sep-2023  A registered nurse reported that a female patient (age, race, and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were reported as unknown.   No concomitant medications at the time of vaccination were reported.  On 11-Sep-2023, the patient received an expired dose of HEPLISAV-B (Lot # 937229, expiration date 03 Sep-2023, NDC # unknown) intramuscularly (injection site not provided). The patient did not report any adverse effects.  No additional information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Pt had two doses of Moderna covid vaccine and received Pfizer as a third booster immunization.
Syncopal episode immediately after vaccine administration. Patient fell to floor, noted to be pale, cool and clammy. Consciousness recovered within 1 minute. Vitals noted to be stable. Patient was able to walk unassisted after resting for 10-15 minutes.
I contracted COVID-19 while traveling on 07/08/2022 with symptoms of cough, runny nose, congestion, headache, fever of 100.5, and fatigue. My temperature dropped to 97.5 through the second half of my illness. It was recommended that I take ibuprofen, guaifenesin to treat my symptoms. My symptoms began to resolve after 5 days of illness. I was experiencing lingering fatigue for 3 weeks. I have fully recovered with no lingering symptoms.
Pt vax @ 915am-gave APAP 10am-About noon @ school appeared ill,vomited,became unconscious,revived,&became unconscious again.Mom took to ER.Appeared to recover.That pm developed T 103 (AX)& began vomiting.Suppositories given.T broke @ 4am.
swelled for about 1 week; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: swelled for about 1 week). The outcome of the swelling was resolved (duration 1 week).   It was unknown if the reporter considered the swelling to be related to Shingrix.     It was unknown if the company considered the swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 17-OCT-2023 The healthcare professional (HCP) stated that he had a patient who were swelled for about 1 week after having received a dose of Shingrix. The reporter did not consent to follow-up.
anomaly or birth defect; anomaly or birth defect; This is a spontaneous report from a contactable other HCP, the parent for mother/baby. This is the baby case. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) transplacental, in the left arm on 09Apr2021 at 10:00 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced unspecified anomaly or birth defect on an unspecified date.  The outcome of the event was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of anomaly or birth defect  due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : -PFIZER INC-2021456443 mother/baby
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by the Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Lower lip is very swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lower lip is very swollen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-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 20-May-2021, the patient experienced LIP SWELLING (Lower lip is very swollen). At the time of the report, LIP SWELLING (Lower lip is very swollen) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Pt is a 33 year old who received AVA #6 SC in rt arm on 3 Nov 07 in preparation for upcoming deployment. The following day, other than slight arm soreness he denied any problems On 5 Nov, day 2, he stated he had swelling from the injection site extending down to mid forearm are. The area was red and warm to touch. He also noticed that he had numbness of his whole rt hand. He denied fever, headaches, muscle ache and joint pain. The following day, 6 Nov, he went to the emergency room in which he was given a steroid shot and sent home on oral prednisone for 5 days. The swelling lasted a total of 3 days. Currently, he denies swelling and stated that the feeling in his has has returned to normal. He denied problems with AVA 1-4 but did note problems with AVA #5 in Jan 07. Per records, this shot was given IM In the left arm. The next day he had a golf ball size of localized swelling that looked like a bruise, was red and warm to touch. He reported that the swelling lasted 1-1.5 wks. He denied headache, fever, muscle or joint pain. He does, however, report that at least monthly he will get a recurrent 'bump' at the injection site that would itch and last for 2 days. He stated that it looks like a mosquito bite. He did seek medical attention but was told it was a bite.
No additional AE's; VAQTA experienced an excursion on 7/31/2021; which was not reported, and one today, 8/6/2021. Per caller, the product was administered to (1) patient today; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 106-AUG-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T033304, expiration date not reported, but upon internal validation established as 22-APR-2022 (administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported.   The vaccine had a temperature excursion of  9.5 Celsius (C), during 1 hour and 15 minutes.It was confirmed that the vaccine had a previous temperature excursion of 13.5 C during 9 hours and 5 minutes. The reported stated that the vaccine experienced an excursion on 31-JUL-2021; which was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
TOOK IBUPROFEN BEFORE GETTING VACCINE AND AROUND 0230 AM WOKE UP WITH CHILLS THAT LASTED UNTIL MORNING AND AS THE DAY WENT ON HAD GENERAL MALAISE/BODY ACHES.
All symptoms began within 30 minutes of vaccination and lasted 24 hours.  Nausea, extreme fatigue: unable to stay awake- slept for 4 hours before waking, rapid heart rate, headache, dizziness ,weakness, severe muscle ache- painful to move.  Severe pain at injection site for 24 hours, has diminished to slightly sensitive to the touch.
Short-term: general weakness and debilitating fatigue, joint pain, even difficulty walking. Long-term: debilitating fatigue - 6 years later after going on an organic vegan diet, my energy levels have returned to about 80% of pre-vaccination levels.
Pain in arm, nausea, headache,  dizzy, fatigue, body aches
Patient received the GARDASIL vaccine and within 5 minutes fainted and had a seizure while in the doctor's office. She was disoriented for about 10 minutes.
pt recv vax 4NOV96 & swelling & redness started 5NOV96-local rxn only;pain, swelling & redness much worse;
1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5 days-nausea, weakness & fatigue - could not eat or smell or even look at food.
pt recv vax & exp noc sweats, insomnia, nausea, vomiting, chills, diaphoresis, shaking, felt cold, was difficult to awaken, lost 8 lb & was anorexic;had choking or diff swallowing;
This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number Y79A5, expiry date unknown) for prophylaxis. On 19th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 19th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced shortness of breath, increased blood pressure, hives and headache. On an unknown date, the outcome of the shortness of breath, increased blood pressure, hives and headache were unknown. It was unknown if the reporter considered the shortness of breath, increased blood pressure, hives and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced some side effects like shortness of breath, headache, elevated blood pressure and hives. The patient was sent to the emergency room. This is 1 of the 12 linked cases, reported by the same reporter.
15 6/12 y/o female developed lower extremity pain progressing to weakness with altered level of consciousness started 10/6/13 11 days after vaccinations. Admitted to PICU on 10/9/13 and required intubation/mechanical ventilation. MRI of head/spine showed multiple areas of inflammation. Treated with high dose steroids and IVIG for ADEM, with elevated CSF protein and oligoclonal bands. Extubated after 5 days. Transferred to rehab on 10/23 with slow progress of muscle strength and abilities.
Full body myalgias, esp. left deltoid (injection site), fever 100.1 degrees F., chills, shakes.  Limited left arm ROM. Induration and heat (about 10cm diameter) with central red point area of Td delivery. No rash, hives, SOB, dysphagia/phonia. CTA without adenopathy and ED report faxed to our office, unable to make out names or identify vaccine info. We placed him on Zurtec 10 mg. Recovery per wife occurred throughout 8/18/03, without sequelae or complications.
Severe soreness at injection site, uncontrollable shaking and chills, severe joint pain, muscle aches, heaviness of limbs, migraine like headache, abdomen bloating and weakness all within 12 hours of vaccination.  Continued off and on over next 48-72 hours although symptoms were more mild within 48-72 hours.
Sore arm and headache on day 1, persisting for 4 days.  Around day 6-7, a rash begin. The rash consisted of pruritis, as well as a few small papules throughout the whole body. The rash has increased (though still mild) around day 10 and continues as of day 12.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 08:45 as dose 3 (booster), single (Lot number: FF2587) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: GERD; "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. Concomitant medication(s) included: EZETIMIBE, start date: Jan2020; LANSOPRAZOLE; FINASTERIDE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid treatment from 17Dec2022 to 21Dec2022. Recurrent Covid symptoms (worse than initial symptoms but still mild-moderate in severity) approximately 10 days after initial symptoms, and 2 days after completing paxlovid treatment. Paxlovid treatment had been started 48 hours after initial symptom onset.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
started with sore arm within hours.  Became very painful to even move it.  Nausea that evening. Headache, fever 100.9 aching joints, fatigue. Unbelievable pain similar to frozen shoulder but in the entire arm.  Severe burning into wrist.  Lasting until today June 16, I was finally able to get up to type.
Patient felt warm, slight redness/rash on the face. He was transferred to med ops for observation. Rash only seen on forehead/face. No visible swelling to throat or tongue.  25mg oral benadryl given x1 at 5:27.  Patient observed for 20 min post benadryl dose. No adverse reactions occurred.
At the  beginning of January, my husband and I had already been trying to conceive. I received my second dose vaccine on 01-07-2021. In the first week of February I found out I was pregnant. By the end of February I had a miscarriage. I had the miscarriage on 02-24-2021. The day I miscarried I was going to have my first gynecological appointment to check my baby.  I do not know if the vaccine had anything to do with my miscarriage. I was hesitant to getting my second dose but I still went through with it. I just think it is important for mothers who are expecting to wait at least till their second trimester to receive the Covid 19 vaccine, my opinion.
pt had high fever later that evening p/vax;mom gave APAP suppositories;pt awaken in middle of noc, dad felt pt & felt very hot;lt then appeared to dad that started to shake & eye rolled back into head;taken to ER:t103 in ER;
VACCINE ADMINISTERED MORE THAN 6 HOURS OF VIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 75 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced vaccine administered more than 6 hours of vial puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine administered more than 6 hours of vial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210547983.
This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways from a contactable Physician. A currently 66-year-old patient received a single dose of PREVNAR 13 via an unspecified route on unknown date for immunization. The patient medical history and concomitant medications were not reported. On unknown date the patient experienced allergy to the vaccine and rash. The outcome of the events was unknown. Follow-up (28SEP2016): Follow-up attempts are completed. No further information is expected. Follow-up (24Jan2017): New information reported from Pfizer sponsored program Pfizer RXPathways from a contactable Physician included: new event: rash.; Sender's Comments: Linked Report(s) : 2016395960 Legacy paper report number.
Information has been received from a physician and a registered nurse concerning an 18 year old female who on 18-Mar-2009 was vaccinated with the first 0.5ml dose of GARDASIL (659655/0940X, site not reported). There were no concomitant vaccines administered with GARDASIL. The patient experienced slurred speech, elevated blood pressure and felt light headed after receiving GARDASIL. The patient had sought unspecified medical attention. It was unknown if the patient was hospitalized. The patient was not scheduled for a follow-up visit to see the physician and was not going to complete the vaccination series. She recovered after 3 days on approximately 21-Mar-2009. Additional information has been requested.
pt had a severe 1min episode of arms & legs shaking p/which pt fell asleep
Diarrhea, onset about 12-16 hours post dose. Multiple times for roughly 24 hours. Self limiting, not requiring any treatment beyond oral fluids.  Injection arm soreness, swelling and small contusion, starting about 8-12 post dose lasting for 48-72 hours. Self limiting did not require any treatment.  Fatigue, developed within 18-24 hours post injection. Self limiting not requiring any treatment.
bad reaction/Booster was the worst; Three days couldn't get out of bed until third day; Seems like  tinnitus left ear; tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (bad reaction/Booster was the worst), MOBILITY DECREASED (Three days couldn't get out of bed until third day), TINNITUS (Seems like  tinnitus left ear), FATIGUE (tired) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (bad reaction/Booster was the worst), MOBILITY DECREASED (Three days couldn't get out of bed until third day), TINNITUS (Seems like  tinnitus left ear), FATIGUE (tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, IMMUNISATION REACTION (bad reaction/Booster was the worst), MOBILITY DECREASED (Three days couldn't get out of bed until third day), TINNITUS (Seems like  tinnitus left ear), FATIGUE (tired) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided by the reporter.   Headache had lingered and patient got it more often. Per report, patient was not sure if it was a good thing to get second booster.   This case was linked to MOD-2021-091871, MOD-2021-091890 (Patient Link).
I tested positive for Covid-19 on 1/3/22.  I had a sore throat, light congestion.  About a week into it, I developed a fever of 101.80, and chills.  went to doc to get a chest x-ray and it revealed mild bacterial pneumonia.  took antibiotics for that and am feeling good.
a patient received one dose of improperly stored PROQUAD; No adverse effects were reported.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # N034561, expiration date 03-JUN-2019, 1 dose; route, strength and frequency were not reported) with properly stored sterile diluent (MERCK STERILE DILUENT) for prophylaxis.   The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-13.3 degrees Celsius) for 26 minutes. The previous excursions were in the range of -14 degrees Celsius to -10 degrees Celsius (-13.1 degrees Celsius) for 31 minutes. The call was because of a data logger. No adverse effects were reported.
Pt experienced R eye twitch. BP 144/90; HR 80; RR 18. Pt was stable & released from vaccination site
T78.3XXA ANGIOEDEMA, INIT 4/13/2023 DM 2 W MONONEUROPATHY T78.3XXD ANGIOEDEMA, SUBSEQ 4/15/2023 DM 2 W MONONEUROPATHY
Pt recvd MMR vax on 15AUG90; 22Aug90 devel fever; On 25AUG90 pt devel rash; fever resolved @ this time; On approx 27AUG90 pt exp irritability, nasal congestion, & cough; given APAP;
Spike high fever, over 100°, light headed, dizzy dehydration, aches, chills for approx 8 hrs
Started with stomach pain and generally not feeling well. I thought maybe it was indigestion from lunch and took pesto bismol.  About 20 min later, stomach felt worse amd i vomited.  Stomach did not feel better. Started to get severe stomach cramping that got worse and got chills. Took my temperature when the stomach cramps let me move, but temp was 97.9. So just wrapped up in a blanket. Cramps amd chills subsided about 6 oclock. Was able to eat a light dinner about 6:30.
immediately felt sedated sleepy and silly for approx 5 hours then the evening of the 10th runny nose and sort of  a head cold and this morning the 11th s runny nose and a head cold   I did not have these symtons prior to the vaccination
about 2 hrs p/2nd sereis began crying loud cry lasting for 3 1/2 hrs; had APAP imed p/the inject; no fever;