chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Ipol product that was administered was expired(with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 12 years old female patient who received vaccine IPV (VERO) [IPOL] and the ipol product that was administered was expired(with no reported adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 11-Oct-2022, the patient received an dose of 0.5 ml of suspect IPV (VERO) (formulation, strength, route: unknown) lot T1E872M, expiration date: 10-Oct-2022 in the left arm as Immunization  On 11-OCT-2022 the ipol product that was administered was expired(with no reported adverse event (expired product administered) same day following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (The Ipol product that was administered was expired(with no reported adverse event).  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme itchiness from scalp to lower torso (including inside of ears, arms and palms). Rash would appear in areas where scratched and would stay for approximately 30 minutes. Dr. diagnosed urticaria and dermatographia. Was given prednisone shot and a regimen of Zyrtec and Allegra to take.
A few minutes after the injection was administered my face started feeling numbed. I notified one of the staff workers that were there. Rescue came and checked me out and took my blood pressure.
I have been diagnosed with Graves' disease. No one in my family carries this disease. My symptoms began slowly earlier this year approx 2-4 weeks after the second vaccine. I began noted hair thinning/hair loss, fatigue, fluctuating diarrhea and constipation, shortness of breath, and periodic mild tachycardia. These symptoms progressed to weight gain despite healthy eating and increased work outs (due to increased appetite),  severe anxiety and hand tremors,  irritability at family/friends/work colleagues, hyperactive behaviors, increasingly severe tachycardia with palpations/fluttering with HR as high as 160s with walking and 140s at rest/sleeping. More recently, I have been noted vocal hoarseness and a swollen neck as well as progressively worsening shortness of breath with ambulation/at rest and associated left chest pain with tachycardia.
feeling dizzy; disoriented; coughing up Phlegm; do not feel right; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 79 years 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-1), when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (DOSE-2), when the patient was 79 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "booster"; DIZZINESS (non-serious), outcome "unknown", described as "feeling dizzy"; DISORIENTATION (non-serious), outcome "unknown", described as "disoriented"; COUGH (non-serious), outcome "unknown", described as "coughing up Phlegm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "do not feel right".  Additional information: Reporter stated that he and his wife, began feeling dizzy, disoriented and coughing up Phlegm since being administered the Pfizer booster dose and want to know has this been reported by other. After the first and second doses of the vaccine he and his wife had no problems but began to experience symptoms after receiving the booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878234 different patient, same drug and event
Pt's grandmother called to report symptoms starting soon after injection - she states he has had a fever, hives  and lymphadenopathy on and off since the injection. His temp has been as high as 102. Grandmother is an NP.  Symptoms are improving.  There was no office visit.
Had syncopal episode, sweat, vomited and incontinent of urine approximately 25min. after administration.  Client refused to go to ER.  Client called from home to report to unit those reactions.    Benadryl 50mg po given at home.  At 1450 client feels better, no further events.  Clients Mother reports as a child was given "quarter doses" of vaccines.  Had fever, rash, and fussiness with childhood immunizations.
Friday morning 5/26/19 patient woke up, her legs felt rubbery. She felt her calves were tight and painful. She worked that day. When she tried climbing stairs that evening she couldn't move her hips, weakness had progressed. She went to the ED, had workup then was transferred. She underwent more testing. Neurology recommended transfer to higher level care. Patient was transferred to Medical Center. At Medical Center she received plasmaphoresis treatments. She was inpatient for 3 days. Had 3 more plasmaphoresis treatments outpatient
One hour of severe coughing followed by one hour of severe shaking and rapid heart beat. The following morning I fainted at 06:10 AM.
Dose administered after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 939901 and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided  Treatment medications were not provided  On 10-sep-2021 vials were stored in refrigerator. Reporter states Date of administration of vaccine on 4Oct, 5Oct, 6Oct with same batch number 939901 .   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: non significant follow up appended
0.25 influenza and 0.50 influenza administered in 2 different sites simultaneously in error.
pt complained of tighness in throat after 2nd dose of Pfizer.  Felt better in 10 min after removing mask.  VS stable, 90% on RA.  Exam negative.  May have been a panic attack rather than a vaccine reaction.  Discharged to home with po benedryl.  No meds given at blitz.
Severe pain in shoulder to entire arm. Unable to move or turn over in bed, used ice packs, lasted 4-5 days.
How long do you feel like crap after the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows:  The case was reported by patient. The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose of Shingrix and felt like crap. The patient told that its been 3 days from event occurrence and patient did not counting the day of vaccination.
I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out of it and dry mouth. I need help. The room keeps spinning!
The injection of the vaccine was fine.  My arm started getting sore about an hour afterwards.  The next morning I could not lift my arm at all.  About 18 hours after getting the vaccine I had severe body and joint aches, my lymh node in my armpit was swollen and sore (on injection arm), I had a headache, and I was exhausted.  This continued for 48 hours.  The swelling of the lymph node went down and the body and joint pain lessened.  However 5 days after I am still exhausted, dealing with a headache, my arm is still sore, and am experiencing joint pain and back pain.  I was diagnosed with COVID 19 on December 4, 2020, with COVID Pneumonia on Decemeber 13, 2020, and with Post Viral Syndrome on December 28, 2020.
Approx 48 hours after second injection, patient developed rash all over chest and back.  Rash lasted approx 36 hours.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 19-Jul-2022).    No concomitant medication was reported.  Patient received half dose of vaccine.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment information was provided.
On 10/04/2022 a 10-year-old female patient received a covid 5yr-11yr (orange cap) vaccine by LPN without problem.  When documenting the vaccine before administration an expiration date of 10/05/2022 populated. Lot number matched, patient name and DOB was verified. Consent form was signed. Vaccine was administered.  On 10/05/2022, Immunization Program Coordinator informed our office she received an alert that an expired vaccine was given to patient.  Program Coordinator provided additional education on the expiration dates. Each COVID vaccine will have two expiration dates and whichever expiration date comes first is the one we must go by. We have a 10 wk Fridge expiration date of 10/18/2022 and an IRIS expiration date of 09/30/2022 for lot number FL2757.  Pfizer was called. The information given to Pfizer is we have a 10-year-old patient who received her second covid vaccine on 10/04/2022. We were going off the 10 wk Fridge expiration date. Our clinic was under the impression our fridge date and iris expiration date were the same. It was brought to our attention the patient did in fact receive an expired covid vaccine. The Pfizer Pharmacist, states " We do not have any specific information for this situation"  Storage and Handling information was found for this vaccine which states: ?Contact Manufacturer on stability of Vaccine, if manufacturer does not have data to support the stability of the vaccine, repeat dose immediately (no minimum interval).? Clinic manager, notified parent of the administration of an expired vaccine during her 10/04/2022 appointment and the recommendation of getting another dose immediately. Parent verbalized understanding and will bring patient in on 10/11/2022 to get another COVID vaccine (orange cap).
took me ten years to get over what the last flu shot did to my immune system; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious social media case received from non-health care professional via social media.  This case involves a patient of unknown demographics who took ten years to get over what the last flu shot did to immune system (Immune system disorder), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported that took ten years to get over what the last flu shot did to immune system (Immune system disorder), (non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for immune imbalance, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
General malaise, muscle aches began evening after vaccine administration- 3/28/15. Stayed in bed next 2 days. No relief with NSAIDs able to work from home from home for next 2 days-did report symptoms to clinic. Was seen in clinic 4/3/15- advised to continue INDOCIN (found old Rx at home) stay home. Abrupt resolution of symptoms reported 4/4/15. One exam had found tender, enlarged lymph nodes (R) axilla, groin and fever.
pt recvd vax & w/in 24 hrs had dizziness, insomnia, joints felt like sand; took DPH;
patient was administered expired DAPTACEL with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case from other health professional.  This case is linked to case 2022SA426580.  This case involves an unknown age and unknown gender patient who was administered expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 13-Oct-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml total (lot C5774CA, expiry date: 18-Sep-2022) via unknown route in unknown administration site for prophylactic vaccination(immunisation) (expired product administered, latency: same day).   Action taken: Not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to unspecified number of patient of unknown age and gender. On an unknown date the patient was vaccinated with hepatitis a vaccine, inactivated(HEPATITIS A VACCINE, INACTIVATED) for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to Hepatitis A Vaccine, Inactivated(HEPATITIS A VACCINE, INACTIVATED).    This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA000508: US-009507513-1707USA000509: US-009507513-1705USA009596: US-009507513-1707USA000511:
One day after vaccination I woke up with mild anaphylactic symptoms in my mouth, some swelling in my lower lip. However two days after, I woke up with my lower lip with extreme anaphylactic swelling. I did not go to the ER, but was close. It subsided after about 4 hours. I am not certain that it was related to the COVID vaccination, but the timing, severity, and rarity of the symptoms led me to make this report.
Hair loss starting February 6, 2021 and continuing.  Approximately 40% of the hair on my head has fallen out.  I am taking Biotin  and Hair, skin, & nails pills to help correct this.
Time from first puncture: 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Time from first puncture: 2 days) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Time from first puncture: 2 days). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Time from first puncture: 2 days) had resolved. Not Provided      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 information was not provided by the reporter.   This case was linked to MOD-2021-332686 (Patient Link).
Redness at injection site started day after injection. No itching or unusual swelling. May be spreading and patient will monitor.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 128 hours. The highest recorded temperature was 49 F (9.444444444 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
In the late morning 2/9, I was driving and felt a little bit off and went into a grocery store. I had to leave and because of the vertigo and I tried to drive but I couldn?t do it so I had to pull over. I had to keep my head completely still otherwise the vertigo would trigger. I was able to make it home 7 miles. I went home and I could only sit and any other movement would trigger it. I had a friend come over and watched me. I also had extreme projectile vomiting that lasted for 6-7 hours before subsiding. From that day on, I had smaller episodes of dizziness ? off centered but not vertigo that lasted a month. I saw my PCP and an ENT and they didn?t see anything abnormal. I?ve had no imaging done. It did subside ? it took a month for it to subside. Historically I?ve had vertigo once to elevation climb and lasted about 20 seconds. I?ve had that vertigo before, but it was never anything like this episode before. I thought it could perhaps be part of the process of vaccination.
she started getting hives all over her body along with intense itching; she started getting hives all over her body along with intense itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Itching, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Hives and Itching, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itching, at a dose of 1 dosage form. At the time of the report, URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching) was resolving.            No Concomitant medications were reported.  Patient reported that she has taken Zyrtec, Claritin, and Benadryl. She said that the Zyrtec and Claritin didn't really work but the Benadryl seemed to have worked in alleviating her symptoms somewhat. She said that it made her too sleepy, so she is not sure if it really worked. She said that she just had an appointment with her Internal Medicine doctor who said that it may be an allergic reaction to the Moderna vaccine. She will be getting food allergy testing done to rule out allergies to anything else.