chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on face, neck, arms, back, trunk, thighs;also has sore throat, h/a, fatigue, sore/stiff neck, temp99.1;chills prior to rash;started 6MAY98 w/rash et sore throat;
10/8/22 pt had a positive COVID test and was prescribed Paxlovid; worsening SOB; hypoxic with O2 saturation 88%; O2 supplementation; given ABX, Remdesivir, Dexamethasone; worsening hypoxia; transitioned to comfort care; pt passed away in the hospital
pt recv vax & exp pain, swelling, ince warmth, induration or lump w/o abscess;pt also exp t99.9, screaming episode high pitched abn cry or screaming lasting >4hr;
Patient has vaccination 4/30/19 and came to the pharmacy 5/01/19 to show the on duty pharmacist the reaction.  Her arm was red, swollen, and itchy.  The site wa hard and the size of a half dollar.   She contacted the pharmacy again on 5/4/19 saying  the rash was going down and there was no impingement.
my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; sick; moderate fever for 3 days; then a rash about a week about 10 days after; This is spontaneous stimulated report received from a contactable HCP. This contactable Female reported for her 6 months old baby (patient). A 6-month-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8727) via transmammary route of administration on 22Mar2021 at 10:00 AM as dose 2, single for COVID-19 immunization. Medical history included allergies to medications, food, or other products: penicillin, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) administered on 01Mar2021 at 10:00 AM for COVIID-19 immunization. Reported facility where the most recent COVID-19 vaccine was administered was Hospital. The patient's mother did not receive any other vaccines within 4 weeks prior to the COVID vaccine, not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient's mother was not diagnosed with COVID-19. Since the vaccination, the patient's mother has not been tested for COVID-19. On 26Mar2021 at 12:00 the patient experienced sick, moderate fever for 3 days; On an unspecified date in 2021 the patient experienced a rash about a week about 10 days after. It was reported that her baby, whom she was breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later." The mother received no treatment for the adverse events. The clinical outcome of the events was not resolved.  No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021388307 same reporter/drug, different patient/event(mother case)
Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil (Lot #not reported). Subsequently post vaccination the patient fainted. Subsequently, the patient recovered after about 20 minutes. Unspecified medical attention was sought. Additional information has been requested.
Had the shot got the Shingles/ Suspected vaccination failure; Had the shot got the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
1st dose 4 years ago, 2nd dose last year; 3rd dose last year; tiredness after 2nd; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose 4 years ago).   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced tiredness, drug dose administration interval too long and extra dose administered. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comments: The reporter was the husband of the patient. The patient received second dose and third dose of Shingrix last year in 2022, after her second dose, the patient experienced tiredness for one day which was resolved. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. The case was linked with case US2023008729, reported by same reporter.; Sender's Comments:  US-GSK-US2023008729:same reporter
Extreme fatigue, weakness, fever, chills. That night extreme night sweats had to shower 4 times that night. Chills, fever. Saturday fever over 104 degrees good part of the day causing fever blisters on lip (pictures taken) and throat begins to have problems. Sunday swollen glands in neck huge and full of pus. Could not swallow just spit saliva out all day. Skin sensitive, lower back hurting. Extreme pain and sicker then I have ever been in my life. Called the on call doctor Saturday to tell her I had a bad reaction. She brushed it off as nothing. I called immediately Monday morning upon doctors office opening again tell them I am in trouble sick bad need help. They had me come in at 9:45. They were shocked at how sick I was. They prescribed steroids for the tonsils to go down. Antibiotics, now added to that amoxicillin. Throat is not all the way back down even though I am finished with the steroids. Now what! Need help. I don't know if I have life long lasting effects. I just know I am still sick now today.
Feeling not well; On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling not well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe ).   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Feeling not well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose). At the time of the report, MALAISE (Feeling not well) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 5 Aug 2021, he received 1st dose and On 13 Sep 2021, he received 2nd dose) outcome was unknown.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality for the event(s) of feeling not well with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
My COVID-19 symptoms started on 03/07/2023 in the evening. I had sore throat, headaches, loss of taste, loss of smell, and cough. I test positive for COVID-19 infection on 03/09/2023. I called my doctor on 03/10/2023 and did a telehealth. He prescribe me PAXLOVID for 5 days. I tested negative on 03/17/2023. I tested positive again on the 03/20/2023. I didn't call my doctor again. As of today today I am still feeling tired along with loss of taste and loss of smell. I tested again on 03/25/2023 which was negative.
This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot: M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on an unspecified day in 2010. And the patient was in the office now to receive the second dose. No adverse symptoms reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Headaches severe, hot-cold flashes, muscle weakness, sweats, fatigue, pains in leg. Was given 4th shot by mistake.  7/31/2008 MR received for 2 OV's 6/27/08 and 7/9/08 with DX: Fatigue. Pt reports hot flashes, sweats, migraines, leg cramps and fatigue which began after receipt of 4th HPV4 vax (given in error). PE WNL. MD reports no obvious relation between vaccine and fatigue.  Seen again 7/9/08 with same c/o. MD reports no physical abnormalities found.
Baby developed vomiting, bloody stools. Seen in urgent care -> transferred to hospital for enema reduction of intussusception.
Dizzy, light headed, pounding heart, slight difficulty breathing, metallic taste in mouth. Onset about 10 minutes after the shot. Lasted about 5-10 minutes. Similar, but more mild, reaction after the 2nd Moderna shot - only had the pounding heart and metallic taste in my mouth then, but I was sitting. After my 3rd shot/booster, I was standing.
Itchy rash on arms, legs, and neck.  Advised to use OTC hydrocortisone cream and calamine.  She will follow-up with her doctor Monday.
Had first dose yesterday experienced normal side effects also had diarrhea asking how long it will go; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: Not Provided) via an unknown route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The reporter (type of HCP the reporter was, not clarified) stated that she had the first dose on 26Jan2021 and was experiencing normal side effects and also experienced diarrhea. Reporter did not provide what the normal side effects were. Outcome of the event was not reported (unknown)   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pt recvd vax; arthralgia, myalgia, swelling, inflammation involving joints of shoulders,hands,wrists,fingers,knees,hips,jaw & ankle;sx migrated through these areas concurrently & consecutively over last 11 mo recurrently; recovering;
Headache beginning from time of wake-up about 0730. Pain slightly diminished but not relieved with migraine medication 4 hours later.
Pain and soreness around my rightankle; stiffness; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the right arm on 13Apr2021 at 08:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol and anxiety. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 08:00, the patient experienced pain and soreness around right ankle, stiffness and difficulty walking. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain and soreness around right ankle, stiffness and difficulty walking were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to doctor. The age at vaccination was not reported. The reporter indicated that she had a patient that received the SHINGRIX vaccination and experienced flu-like symptoms, fatigue, and arm pain. These symptoms lasted for approximately 4 to 5 days. The field representative indicated that the reporter had already reported these adverse events to VAERS. The field representative was unable to provide additional information.
Dose 1 on Nov 2019, Dose 2: 03/06/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 22-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix in November 2019).   On 6th March 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th March 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported but could be 21 or 22 years. The patient received 2nd dose, later then the recommended schedule, which led to lengthening of vaccination schedule. The pharmacist wanted to know whether to restart series for 3rd dose. No further information was reported. The reporter consented to follow up.
Patient was given Fluarix and Pneumovax 23 due to special circumstances on 09/23/2019, administered on the left deltoid per mother request. Mother stated that reaction started at 9:00PM at the same day, with itchiness, tenderness, redness, and mild swelling. Patient came to the clinic to get checked on 09/26/2019. Patient is continuing to take Tylenol for pain and antibiotic for otitis media. Rxd Benadryl as well.
Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) in a 60-year-old 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter had stated that no adverse events were reported by patient.  No treatment medications were reported.
19JAn99 started w/mild wheezing in the afternoon, later that evening hives appeared on chest & upper arms-today hives have spread to other parts of body w/itching;advised DPH for itching if any worse, see PMD;
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter realized one patient had not received a Moderna vaccine.  So, the total number reported was 47 . Concomitant drugs were not reported. Treatment details were not given.
This spontaneous case reported by a consumer, describes the occurrence of injection site urticaria (red bumps that looks like hives at the site of injection) and injection site pruritus (slight itchiness at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A) for COVID-19 immunization. No medical history reported. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient experienced injection site urticaria (red bumps that looks like hives at the site of injection) and injection site pruritus (slight itchiness at injection site). At the time of the report, injection site urticaria (red bumps that looks like hives at the site of injection) and injection site pruritus (slight itchiness at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Blood count was low; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sickle cell traits" (unspecified if ongoing), notes: Scheduled for Vitamin B shot on 11May2021 - sickle cell traits. Was getting shot every 2 weeks. The patient's concomitant medications were not reported.  The following information was reported: FULL BLOOD COUNT DECREASED (non-serious), outcome "unknown", described as "Blood count was low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she received the 1st dose of the vaccine on April 29th and scheduled to get the 2nd dose on May 20th. She said she was scheduled for a Vitamin B shot on May 11th for her sickle cell traits. She also said she was regularly getting shots every 2 weeks and her blood count was low.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, body/muscle aches, fatigue, chills  for 24 hours. Pain in arm.
This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date the multiple patients were vaccinated with improperly stored ROTATEQ (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursion reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received izs in our office on 8/13/12. Pt was very fussy, would not sleep & had 31/2" by 31/2 " reaction on bilateral legs were injections were given. Pts mom concerned & brought baby back into be seen on 8/15/12.