chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who received vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On 13-Nov-2014, at the age of 14 yrs. the patient received a second dose 0.5ml of suspect MENACTRA lot U4833CA, expiry date 15-Jan-2016 via unknown route in the right deltoid. On unknown date, at the age of 11 yrs. he also received a first dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On unknown dated, at the age of 18 yrs. he also received a third dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was an actual medication error due to extra dose administered. It was reported that patient received 3 doses total of MENACTRA, at ages 11y, 14y, and 18y. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
On 11/18/01, pt developed pruritic rash on face, extremities and trunk. Pt was afebrile.
Headache, Myalgia, Fever, Chills, Fatigue, Injection site pain, Rigors Narrative:
Shot given 10:30 am on Saturday. By evening, had intense pain, with redness, swelling and hot to touch all over the deltoid muscle. Fever, body aches and muscle pains persisted through the night. Felt tired, weak and lightheaded the next morning along with headache and body aches. By Monday morning, most of these symptoms were gone, except the arm was still red and somewhat sore. Then it got itchy. This continued through Tuesday and finally subsided Wednesday after at least 96 hours since the shot was given.
Bruising, palatal petechiae. 6/30/2008 MR received for OV 4/25/2008 with c/o bruising following both Gardasil injections.  Petechiae noted on posterior palate and bruising on arms and legs.
No additional AE reported. No PQC.; Inbound call from nurse who reports expired ROTATEQ was administered to a patient.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On 16-OCT-2023, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid vial, 2 mL (lot #W002562, expiration date: 12-OCT-2023) administered orally as prophylaxis. The vaccine had not experienced any temperature excursion through the date of administration. No additional adverse events (AE) reported. No PQC.    This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from a nurse on 13-NOV-2023.   Upon receipt of follow-up information, it was determined that this case is now valid because patient's identifier was received.
Severe nausea and cramping starting less than 12 hours after infection and lasting approximately 48 hours, vomiting beginning approximately 18 hours after injection and lasting approximately 24 hours, diarrhoea beginning approximately 48 hours after injection and lasting approximately 36 hours.
2 weeks after vaccination patient is complaining of severe pain in the injection site, (like someone punched him), limited mobility, muscle cramp. No bruising, no swelling, no lump. He did not have any symptoms after injection, usual injection site pain next day after inoculation, nothing major. Then about 2 weeks later it started, it has been hurting him for about 3 days now. I advised to call his doctor, use ice or warm compress, Arnica gel on painful area.
Patient was noted to have a low blood pressure between 80 and 90 systolic during and after the seizure. Did have an syncopal episode later on during course of treatment but was treated with 500 mL of NaCl and oral crackers w/ peanut butter.
migraine; unable to function due to the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the parent. Other Case identifier(s): US-PFIZER INC-2021494042 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date 26Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "migraine"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "unable to function due to the pain".  Additional information: Reporter stated his son (patient) received COVID Vaccine doses 1 and 2. Patient acquired a migraine with the first dose hat never cleared his Migraine has now become debilitating since he received 2nd vaccine on 26 April. He has never suffered from migraines in the past. Asking that is this a side effect from vaccines and if so why isn't the public told. This vaccine has taken a very health active young man and turned him into a person unable to function due to the pain. What can be done or prescribed by his doctor to help clear them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Guillian Barre symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04May2021 17:00 (Lot number: EW0173) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetic and Rheumatoid Arthritis; "Rheumatoid Arthritis" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetic and Rheumatoid Arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: EW0153, Prev dose Lot unknown: False, Prev dose administration date: 12Apr2021, Prev dose administration time: 04:30 PM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 12Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, disability) with onset 06May2021 08:00, outcome "recovering", described as "Guillian Barre symptoms". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 5 day(s)). The event "guillian barre symptoms" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome. Facility type vaccine was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
pt rcvd vax; pt exp rash in genital area w/in 5 days following vax;
The patient then did not complete their vaccination series with the second; Different COVID-19 vaccine administered for second dose; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Different COVID-19 vaccine administered for second dose) and PRODUCT DOSE OMISSION ISSUE (The patient then did not complete their vaccination series with the second) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Different COVID-19 vaccine administered for second dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient then did not complete their vaccination series with the second). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Different COVID-19 vaccine administered for second dose) and PRODUCT DOSE OMISSION ISSUE (The patient then did not complete their vaccination series with the second) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL], IPRATROPIUM, OXYGEN, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-211730 (Patient Link).
Pt reported lightheadedness and dizziness to his previous CV19 vaccines. I explained this is likely to happen upon receipt of this and required him to sit down for 30 minutes upon receipt. 2-3 minutes after receipt he was walking around claiming he didn't feel well. He was helped to a chair where he appeared to lose consciousness briefly but didn't. He was given Orange Juice and monitored for approximately 20 minutes. As soon as he recovered, him and his family left without any signs/symptoms of syncope.
shingles come back with vengeance/ Suspected vaccination failure; shingles come back with vengeance; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   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 Information: GSK receipt date: 05-Nov-2022 Reporter's comment: This case was reported via interactive digital media. The physician told that it could get the shingles vaccines right after having the shingles. The pharmacist and chiropractor said no 6 months to a year as they could come back with a vengeance taking it so soon after. They had several patients that had that experienced. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been linked with US2022AMR104807, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR104807:Same reporter
Felt slight numbness right jaw line~ 15 min after injection. Denies any other S/S.  Observed 15 mins extra, provided water.  Symptoms resolved
This spontaneous report was received from a county health nurse/registered nurse and refers to 5 patients of unknown age and gender who, on unspecified date, were vaccinated by the physician with improperly stored VAQTA (route of administration, dose, frequency, lot and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
Patient states, "was mandated to receive vaccine because I'm a HCW, and after 2 hours of receiving vaccine had red blotches on right side of neck and felt dizzy.  Head began to itch as well.  Applied benadryl cream to neck.  Dizziness continued throughout night.
Death; This case was received via FDA VAERS on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Death occurred on 01-Apr-2021 The patient died on 01-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Symptom Text : Death reported to Health department from Medical Examiner office, no further details provided Company comment:This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med history and no concomitant medication were provided. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med hx and no conmeds were provided. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death
Pt was given 2 doses of Hep B vaccine 10mcg/0.5ml.
Pt with acute onset "irritability" less than 1 hour after shot. PE unremarkable except erythema of LE's (anterior aspect only) and consolable by () at exam.
Patient presented to the ED and was subsequently hospitalized for COVID-19 pneumonia within 6 weeks of receiving covid vaccination.
Patient has had a new onset of stuttering since 05/15/2021 and getting progressively worse.  Started as intermittent, once a sentence, and now is every word.  Pt has no control over this.  Now also has left sided headache, left ear and jaw pain.   Has significant pain in arms, legs, hands worsening.  Any touch to her skin she feels like it is burning.  Has swelling in hands and feet.  Lack of strength in arms/legs.  Kernig and Brudzinski signs negative.  CN Abnormalities- marked grip weakness, lower extremities with more strength than upper but still decreased, balance difficult, sluggish and discordant pupillary responses.
Rash around the shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine 7 days ago from the date of reporting and experienced rash around the shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Rash (red bumps) on trunk, arms, face, genital area and upper legs, I think as a result of the chicken pox vaccine.
Per patient: numbness to entire left arm at vaccine administration that lasted less than 30 min. 2-3 days later severe pain in shoulder and shooting down arm. pain in arm has persisted for 2 weeks without improvement. numbness/tingling/weakness to arm also.   On exam: weakness and altered sensation present to left hand. Pain reported.
In Sept '21 started having dysphagia,  by end of 2021, diagnosed with metastatic esophageal cancer stage 4
Case number PHEH2016US030151, is an initial spontaneous report received from a pharmacist on 14 Nov 2016. This report refers to a 49 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with a single dose of FLUVIRIN (seasonal, batch number: 1619021) at a dose of 0.5 ml intramuscularly on 14 Nov 2016. It was reported that the administered vaccine had a possible temperature excursion up to 54 Fahrenheit for up to 3 to 4 hours because of the power outage from 6:00 hours on 13 Nov 2016 to 09:00 hours on 14 Nov 2016. It was first time excursion and the patient had received the vaccine from the opened multi dose vial). No adverse event was reported following this medication error (incorrect storage of drug). The case was assessed as non serious by the pharmacist.
Hematuria with resultant urinary obstruction requiring cystoscopy for clot removal.   07/30/2007 MR received for several ER visits and hospital admission DOS 3/18-20/2007.  1st ER visit 3/12/07 for c/o weakness, feeling faint and light-headed. Improvement noted and D/Cd with Impression: Generalized weakness.  Difficulty walking. Next ER visit 3/17/07 for c/o blood in urine. Dxd w/ UTI and Gross hematuria with mild Coumadin toxicity. Seen in ER again 3/18/07 and admitted for Urinary retention and hematuria with clots.   Pt was txd with bladder irrigation and cystoscopy with clot evacuation. DX:  Hematuria.  urinary retention.  Hx of prostate CA.  Hx of atrial fibrillation.  Anti-coagulation therapy
I had a cough that would not stop. I had a slight fever of 101, and then my blood oxygen when down from 98 to 93. The cough was awful. I went to urgent care and was tested for Flu and COVID-19 and was negative for both.  My symptoms lasted about two weeks longer and got better very slowly. Now I feel terrific,
any additional AE; V ARlV AX on 9/29/2021 with a labeled expiry; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-SEP-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # S024369, expiration date06-AUG-2021) (formulation, strength and route of administration were not reported) for prophylaxis. There was no temperature excursions involved. No adverse event was reported.
PATIENT REPORTED PAIN IN HER ARM 15 DAYS AFTER HER FLU SHOT.  SHE SAID IT HURTS WHEN SHE ROTATES HER SHOULDER.
No signs and symptoms of adverse reaction noted. Pt monitored for 15 minutes after receiving vaccine.
ARM SORENESS; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and arm soreness. This report was non-serious.
rash on face; facial swelling; throat was tightening but no trouble breathing; swollen lips; This is a spontaneous report from a contactable healthcare professional and physician. A 16-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA) strength: 0.5 ml, lot no: CM1497, expiration date: 30Jun2022, via an unspecified route of administration in left deltoid on 26Mar2020 12:02 at 0.5 mL, single for immunization. The patient's medical history was not reported. Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) lot no: U6575AA, expiration date: 08May2021, and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) lot no: U6621BA, expiration date: 21Mar2022, both received on 26Mar2020 for immunization. The patient previously received TDAP and MENACTRA doses as it was reported that TDAP and Menactra vaccines had been administered before to the patient with no adverse reaction. The healthcare professional wanted to know if it is okay to give second dose of TRUMENBA if patient had an adverse reaction to it on 27Mar2020. The female patient was 16 years old at the time of events: rash on face, facial swelling, throat was tightening but no trouble breathing, and swollen lips. She said the patient also got 2 other vaccines administered at the same time, but the TRUMENBA was the only new vaccine. She stated that the doctor would like to know if it is recommended to give the second TRUMENBA vaccine, since the patient may have had a possible reaction to TRUMENBA. She added that after receiving the TRUMENBA vaccine, the patient had a rash on her face the following morning (27May2020) and tried cetirizine cetirizine (ZYRTEC). The rash got worse, with the patient experiencing facial swelling, and saying it felt like her throat was getting tight, but the patient's throat was not closing. The patient did not have any trouble breathing. The patient was given a steroid and an epinephrine (EPI-PEN) injection because the patient's lips were swollen, as well. No relevant tests done. The patient recovered from the events.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the events "rash on face, facial swelling, throat was tightening but no trouble breathing, and swollen lips" with TRUMENBA can not be fully excluded.  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.
Vaccine dose administered five days past its beyond use date (BUD was 01/11/2023). No adverse reaction observed or reported to Health Department.
I had Afib, a fairly long duration that happened several times over a period of a couple weeks.