chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes 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.
COVID-19 infection in October; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 infection in October) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (COVID-19 infection in October). At the time of the report, COVID-19 (COVID-19 infection in October) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter. Company comment includes: This is a spontaneous case concerning a elderly female patient with no relevant medical history, who experienced the unexpected, non serious, ADR event of Covid-19. The event Covid-19 exact occurrence unknown but stated that the event occurred after the unknown date of primary doses of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a elderly female patient with no relevant medical history, who experienced the unexpected, non serious, ADR event of Covid-19. The event Covid-19 exact occurrence unknown but stated that the event occurred after the unknown date of primary doses of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Shingles outbreak this week; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included aciclovir (Acyclovir).   On 30-JUN-2023, the patient received the 1st dose of Shingrix. In OCT-2023, between 3 and 4 months after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak this week). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2023  The reporter was a patient. Concomitant product included steroid shot (unknown name) for unknown reason. Patient received the Shingrix and diagnosed with shingles outbreak in the reporting week. The reporter consented to follow up.
Patient presented to clinic with father and father approved flu vaccine and covid vaccine.  Vaccines showed due per local database.  They were both given without difficulty.  Per clinic manager, later, mother called to report patient had already received flu vaccine at another facility about 3 months ago.
fever; chills; body aches; slight nausea; sick; hives covering back neck and forehead; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2022 at 17:00 as dose 3 (booster), single (Lot number: J4991) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Thyroid" (unspecified if ongoing), notes: Thyroid; "HRT" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: yes. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: BNT162b2 (Dose Number: 2 , Batch/Lot No: EW0170 , Location of injection: Arm Left), administration date: 08May2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "lips and outer mouth area were very numb", "lips and outer mouth area were very numb"; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0170 , Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 54-year-old, for COVID-19 Immunization, reaction(s): "lips and outer mouth area were very numb", "lips and outer mouth area were very numb". The following information was reported: PAIN (non-serious) with onset 01Jul2022, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 01Jul2022, outcome "recovering"; PYREXIA (non-serious) with onset 01Jul2022, outcome "recovering", described as "fever"; URTICARIA (non-serious) with onset 01Jul2022, outcome "recovering", described as "hives covering back neck and forehead"; ILLNESS (non-serious) with onset 01Jul2022, outcome "recovering", described as "sick"; NAUSEA (non-serious) with onset 01Jul2022, outcome "recovering", described as "slight nausea". Therapeutic measures were taken as a result of pyrexia, chills, pain, nausea, illness, urticaria.  Additional Information: Dose #1 and 2: My lips and outer mouth area were very numb for about an hour after receiving the vaccine. Dose #3: That evening I had a fever chills body aches slight nausea. Was sick for about 24 hours. Then began hives covering back neck and forehead. Took Benadryl and Tylenol for relief. Patient received other medication in 2weeks. no any other vaccine in four weeks: other medications in two weeks for HRT and Thyroid Medications. No any treatment ae. Patient was not tested COVID post vaccination.
Patient called and spoke with pharmacist. She reported that her arm was red and swollen, and hot to the touch a few days later. Although, this could be a typical adverse event, as discussed, patient stated that she went to her physician. Patient's physician stated it could be cellulitis, and they discussed a possible antibiotic. That prescription was not called to us, and patient did not call back after this conversation. Patient perceived error, due to the redness/swelling.
itching; hives & welts; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (hives & welts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and URTICARIA (hives & welts). At the time of the report, PRURITUS (itching) and URTICARIA (hives & welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided
My booster vaccination is over 2 months of expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My booster vaccination is over 2 months of expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (My booster vaccination is over 2 months of expiration date). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (My booster vaccination is over 2 months of expiration date) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Headache, Myalgia, fatigue Narrative:  Reports no reaction to 1st vaccine, but headache, fatigue and myalgia with second vaccine. Of note, she had Covid in between vaccinations.
Initial report received on 26 September 2013 from a Registered nurse. A 11 years old male patient, with no known drug allergy, foramen ovale and surgically repaired and concomitant medications were unknown, was vaccinated  with (lot number U46688BA, intramuscularly on left arm) and possibly PRIORIX on 25 September 2013. Within 5 minutes of vaccination on 25 September 2013, the patient experienced diaphoresis, stomach pains, was anxious, he became pale, clavical just above the elbow became red, welts appeared, fever and vomiting. The patient was referred to the emergency room. The events were ongoing at the time of the report. No further relevant information was reported.
received the FLUZONE HD QUADRIVALENT today. When the patient got home, she realized that she had already gotten the flu-shot a month ago with no reported adverse event.; Initial information received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 85 years old female patient who received the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] today. when the patient got home, she realized that she had already gotten the flu-shot a month ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   n an unknown date in September 2023, the patient received a unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization. On 30-Oct-2023, the patient received a 0.7 ml (total) dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation: unknown and expiry date: 30-Jun-2024; lot UT8094AA) via unknown route in the left arm as immunization and received the fluzone hd quadrivalent today. when the patient got home, she realized that she had already gotten the flu-shot a month ago with no reported adverse event. (extra dose administered). Information on the batch number was requested.  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.
Suspected vaccination failure / shingles in the vaginal area after receiving the second dose of Shingrix; vaginal shingles / shingles in the vaginal area; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that female patient had vaginal shingles after administration of Shingrix. Occurred a week ago with no exact date informed. The reporter consented to follow up.  No patient's identifiers, batch number or vaccines expiration date. No vaccination date informed. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event, and laboratory confirmation were not provided. The case has been linked with the case US2020196134 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196134:Same reporter
COVID symptoms started on 05/18/22; tested positive on 05/25/22. Symptoms included tiredness, sleepiness, dizziness, headache, sore throat, my asthma was acting up, it was hard to breathe, couldn't taste or smell. I still have lingered effect of everything tasting like salt and smelling like baby poop. I had general flu like symptoms but no fever. The taste and smell is still ongoing but other symptoms lasted 3-4 days. I was given PAXLOVID, steroids, and antibiotics from my Doctor and symptoms subsided a couple of days later and as of today my tests have come back negative.
didn't feel well; broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (didn't feel well) and RASH (broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Hay fever and Urticaria (Hives). Concurrent medical conditions included Blood pressure high since 2015, GERD since 2008, Asthma, Penicillin allergy and Drug allergy (Sulfa). Concomitant products included LISINOPRIL, DEXLANSOPRAZOLE (DEXILANT) from 06-Jan-2008 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID) and LEVOTHYROXINE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (didn't feel well) and RASH (broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere). The patient was treated with HYDROCHLOROTHIAZIDE (oral) at a dose of 12.5 mg daily. At the time of the report, VACCINATION COMPLICATION (didn't feel well) and RASH (broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Directions for first dose were not provided.   This case was linked to MOD-2021-296654, MOD-2021-296286 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Significant Follow up updated patient history.
**Please note that the same adverse reaction (diarrhea) occurred after each of my two Covid -19 vaccinations. See separate VAERS form for the second incidence.**  I had my first Covid-19 vaccination shot on 1/11/2021. About five days later (1/16/2021), I awoke with an episode of diarrhea. This continued for about 10 days, until 1/25/21. On most days, these episodes were first thing in the morning only (on waking), but some days had more episodes, with some in the middle of the night. I had loss of appetite but no vomiting or fever and only slight weight loss.  [I had started the antibiotic Sulfamethoxazole ? TMP SS in December 2020 and wondered if this might be a cause, but I checked with my urologist and we agreed that I had likely taken it for too long for it to be an issue.]  **Please note that diarrhea started again on 2/2/2021, the morning after my second Covid shot. See separate VAERS form for this incidence.**
Approximately 7 hours after receiving the Moderna vaccine, I began coughing with an identical cough to the one I had been sick with in January. A very wheezy, crackling, popping congestion overtook my lungs causing me to cough repeatedly for several hours. It was severe enough to wake the entire household as well as keep me awake for a few hours. By morning it was completely resolved.
Pt recvd vax @ approx 11AM, @ approx 9PM devel high pitched, continuous crying; temp inc 99.8 @ highest recorded temp; Seen by MD 20NOV91;
Headache, chills, body aches, nausea, vomiting, diarrhea, fatigue,  worsening of tinnitus.  Symptoms stated on evening of injection  (4/13/21) and lasted through 4/18/21.
neurological sx-3wk p/vax lasted 3-4months-later dx w/multiple sclerosis @ age 57-no prior hx;no subsequent similar event in last 3yr;
Tingly mouth; Tired; Lump on arm where the injection was; This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, after the first dose of COVID vaccine, the patient had a tingly mouth, tired, and lump on arm where the injection was given. All the side effects resolved within 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events tingly mouth, tired, and lump on arm where the injection was given were recovered within 48 hours on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She received the 2nd dose 3/16/21 and got sick on 3/27/21 and I took her to her doctor on 3/29/21 and she was order for x-ray and antibiotic, she was lethargic and had no energy. she was diagnosed with pneumonia and fluid overload. she didn't seem to be getting better and on 4/4/21 was taken to hospital and got IV antibiotics and was given a diacritic to take fluid off. DC'd on 4/15/2021 and was home with home health nurse and on nurse noticed on 4/27 and her o2 lovers were fluctuating and she said to send her back to the hospital. Again, diagnosed with pneumonia in both upper lobes and pulmonologist didn't know what was going on.
A pre-diluted grey-top Pfizer covid vaccine vial (adult) was diluted with 1.8 mL of normal saline. Subsequently, an over-diluted 0.3 mL vaccine was administered to the patient for their booster. The patient was called and notified of this and the CDC recommendation that they are to repeat the dose immediately. The patient stated that she prefers to not repeat the dose. No adverse events or clinical consequences were reported.
Pt was given Pfizer vaccine that had BUD of 10/21/2021.
Patient had Fever for 24 hours after vaccine. Sleepiness/malaise for 36 hours after vaccination. Slept for 24 hours over 48 hour period.
After 12 hours, I had a red patch that is about two inches wide and five inches long surrounding the injection site. It is very hot to touch, itchy, swollen, and painful. It has now lasted for almost 2 days.
Red area  on and around the vaccination site.  Growing from  2 inches in diameter  to about 5 inches in the last three days. It covers most of my upper arm.  it feels sensitive to the touch.  Skin feels warm.  ongoing at this point.
tingling from the entire body neck down; numbness from entire body neck down; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from the entire body neck down) and HYPOAESTHESIA (numbness from entire body neck down) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 7:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced PARAESTHESIA (tingling from the entire body neck down) and HYPOAESTHESIA (numbness from entire body neck down). At the time of the report, PARAESTHESIA (tingling from the entire body neck down) and HYPOAESTHESIA (numbness from entire body neck down) had not resolved.            The patient was not taking any concomitant medication. Treatment information was not provided.   The patient had received the booster dose and woke up on the next morning of 02-Apr-2022 experiencing the adverse events. The patient went to the emergency room and visited the primary care provider (PCP) to rule out anything else that could have caused these side effects.
Was out shopping with parent about 11/2 hrs after office visit and vaccines. Mom said pt fell to ground and was moaning. Shaking noted. EMS was called and pt transported to ED. Pt was referred to neurologist - will have ECG and MRI.
Rt deltoid area red, swollen-hot to touch- 12/26/08. Swelling gone 12/29/08. Pain gone 12/29/08.