chrisvoncsefalvay/vaers-outcomes huggingface dataset:
frustrated; doesn't make her feel good; Scared; Loss of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: ANOSMIA (non-serious) with onset May2021, outcome "not recovered", described as "Loss of smell"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "frustrated"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "doesn't make her feel good"; FEAR (non-serious), outcome "unknown", described as "Scared". The event "loss of smell" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia.  Additional information: Reason for no lot number: of COVID-19 Vaccine was Complainant does not have the product with them at the time of call. No other conditions provided. Patient got her second COVID-19 Vaccine in May2021. Thought it would go away, but she hasn't been able to smell again. She's getting very frustrated and had seen different doctors and they were still working on the same thing. Her loss of smell hasn't been resolved and it doesn't make her feel good. When she cooks, she can't smell anything anymore. She didn't think the loss of smell would stay. Thought maybe it was a temporary thing. Treatment: Yes, the first doctor did an MRI or CT scan, and checked everything. Clarifies she thinks it was a CT scan, not an MRI. Everything seems to be ok. She was given her some medicine to use, it didn't help. She went to a different doctor and was also given medication and it didn't help. She does not provide the product names of the medications she was given. She can't smell. She can taste. She can tell if something is sweet, but states she can't smell anything. She wanted to get another COVID-19 vaccine because she was due for it, but she's kind of scared. Does not have COVID-19 Vaccine card at time of call to provide any information regarding both doses. She didn't go to the hospital because the doctor told her it would go away and she would be fine. She also thought it would go away too, but it didn't. Vaccine not Administered at Facility. Facility Name was Pharmacy. No Prior Vaccinations (within 4 weeks), Family Medical History Relevant to Adverse Events (AEs) was None. AE required visit to Physician's offices  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient experienced syncope after vaccination. It was brief. Patient struck his head. Patient had no focal deficits. EMS was called. Patient declined transport.
pt presents to hosp with a decrease in mental status over past week; tested positive for COVID 4 days prior to hosp admission; O2 supplementation; A Fib; decadron, remdesivir; pt's condition worsened; family opted for comfort measures and pt died in the hosp
One hour post vaccination my top lip felt tight. On inspection my buccal mucosa of my top and bottom lips were swollen greater on the top lip.  My soft palate felt numb as well as my tongue from the tip to middle.  My nose was also slightly swollen.  24 hours later the I have a slight swelling of areas mentioned with the exception of my nose.   I was instructed to take Benadryl on the day of the event 25mg  x 2 doses.   the day after 12/21 I was given Claritin 10mg x 1 dose and Famatodine 20mg x 1 dose by mouth.
had  severe arm redness, itching , hives  with first and second dose of Moderna. However, developed generalized hives about a week post booster requiring steroid and antihistamine
Sore arm for 2 days and 100.5 degree fever for 6 hours
Pt recd 1st dose of Hep B vax on MAR91 & w/in 24 hrs of receiving vax pt devel fever, h/a & nause; lab eval revealed nl blood counts; fever persisted over 101 for approx 5 days;
Fatigue; Chills; This is a spontaneous report from a contactable Nurse (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 05Jan2021 08:00 in left arm, via an unspecified route of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunization. The patient experienced fatigue and chills on 05Jan2021 22:00 with outcome of recovering. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the adverse event. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report was received from a medical assistant refers to female patient of 16-years-old. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 14-JAN-2020, the patient was administered with a dose (1 dosage form) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number R030808, expiration date 24-OCT-2020; dose number, anatomical location and route of administration were unknown) for prophylaxis (product storage error). No lot information was provided for properly stored sterile diluent used to reconstitute improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003277: US-009507513-2005USA003276: US-009507513-2005USA003275:
This spontaneous report as received from a patient's husband - pharmacist refers to a female patient of unknown age. The patient's concurrent condition included erythromycin allergy. On 24-OCT-2014, the patient was vaccinated with the single dose of ZOSTAVAX, (exact dose and anatomical location was not reported) subcutaneous. There were none concomitant medications reported. On 25-OCT-2014, the patient experienced red, raised, tender reaction at the injection site. The area of reaction was initially "the size of the baseball", but at the time of reporting, it was improving. The patient was not given any treatment. None lab diagnostic studies were performed. The outcome of the events was reported as recovering/resolving. The patient sought medical attention by informing her pharmacist. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified) for prophylaxis. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information is not expected because follow-up request letter was returned by post office. Sender's Comments:  US-009507513-1608USA005743: MERCK 1610USA006401: Mfr number.
Fever, shivering, nausea, dizziness, clamminess, sweating, headache, pain at injection site, muscle pain, fainting, blood pressure drop, weakness
i can barely walk. severe muscle spasms and cramping. fever sore arm nausea and severe fatigue and overall pain. Such severe stiffness and cramping that it causes severe pain to move- body in lock down. Have not had this severe cramping in over 24 months when diagnosed with neuromyotonia.  Started this morning around 10 and is worsening. Last 2 pfizer vaccines didnt give any other symptoms except mild soreness in arm and a liitle fatigue on second dose- July 3, 2021
Blood pressure spike resulting in starting meds to control blood pressure. Heart Palpitations (A fib), no remedy.
Eighth day after first vaccine dose, the injection site became itchy, red, hot to the touch, with hard, raised welt (about 3? in diameter). Injection arm was sore, too painful to lift arm above shoulder. All symptoms subsided after 48 hours.
Information has been received from a physician concerning a 20 year old male with rhinitis allergic and atopic dermatitis who was vaccinated with one dose of hepatitis A virus vaccine inactivated. Within a few hours of vaccination, the patient experienced urticaria. The physician reported that the patient now develops urticaria upon exertion/exercise. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
No adverse reactions. PEDIARIX given on 3/29/10 had expired on 3/26/10 Lot# ACB149AA. Reported to provider.
Localized pain, itching, redness, heat and swelling at injection site. Gave Benadryl for itching and swelling and possible allergic reaction and Motrin/Tylenol for pain.
DIARRHEA; CHILLS; FEVER; BODY ACHE; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney disease stage 3, and other pre-existing medical conditions included the patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from diarrhea. This report was non-serious.
No adverse effects were reported.; The patient was administered a dose of PROQUAD by intramuscular injection; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies or concomitant medications were not provided.  On 17-AUG-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, intramuscular route (incorrect route of product administration) as prophylaxis (concentration, dose, dose number, and anatomical location of vaccination were not provided); lot number was reported as R009616 and has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live; (expiration date: 30-SET-2019). Also a sterile diluent (DILUENT MERCK) was used (concentration, dose, and indication was not reported), lot number was reported as R036399 and has been verified to be valid for sterile diluent; (expiration date: 20-JUL-2021). No adverse effects were reported.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VAQTA (lot # N005274 with expiration date 03-APR-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006507: US-009507513-1707USA006676.
Rash described as "hives" to chest and stomach with itching. No other symptoms reported.
received second dose, 49 years old; received fiirst dose, 49 years old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number B93K4, expiry date 7th May 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7323T, expiry date 6th May 2022) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 18th September 2020, the patient received the 1st dose of Shingrix. On 18th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 1st December 2020, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix at 49 years of age, which led to inappropriate age at vaccine administration. The health care professional mentioned that the patient she did not had immunosuppressive diseases.  The reporter did not consent to follow-up.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Itchiness on the ankle and a day later she started to have itchiness on the groin area; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchiness on the ankle and a day later she started to have itchiness on the groin area) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Hashimoto's disease (in treatment with Levothyroxine), Penicillin allergy, Allergy to antibiotic (Amoxicillin allergy) and Allergy to plants (Poison Ivy allergy).    On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023,  after starting , the patient experienced PRURITUS (Itchiness on the ankle and a day later she started to have itchiness on the groin area). At the time of the report, PRURITUS (Itchiness on the ankle and a day later she started to have itchiness on the groin area) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 19 OCT 2023 patient was having itchiness on the ankle and a day later she started to have itchiness on the groin area, the patient complained that the itching was getting worse at night.  No treatment medication was reported.
Fever and cough 24 hrs post flu vaccine. Took Sudafed and had headaches and numbness of legs and hands. Also had chest, abdominal pain and thoracic back pain. Started to have right facial numbness on 11/22/02 which progressed to the whole face. (See note on neurological consult/possible Guillain Barre). "I was called by MD to see this pt for emergency neurology consultation of bilateral hand, state numbness, nausea and vomiting and facial weakness. The pt developed some fever and coughing within 24 hrs after the flu shot injection. She presented to the ER on 11/22/02. ER workup including head CT, chest x-ray, thoracic spine x-ray which was unremarkable except chest CT showed minor bilateral atelectasis/infiltrate.  The pt deny urine and bowel incontinence but do complain of some shortness of breath.
it was rpt a nurse was exposed to pt who was vax w/varivax & subsequently devel breakthrough chickenpox
Near Syncopal episode, treated on site by Ems and transported to Emergency Dept for further assessment.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-NOV-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Initial report received on 09 December 2011 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject was identified by the investigator based on review of data from the database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3404AA received on 07 September 2010, lot number C3494AA received on 04 November 2010, and lot number C3451AA received 04 January 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 27 July 2011, approximately 6 months after the last dose. On 16 August 2011, the subject developed a paroxysmal cough without a whoop and posttusive vomiting. Laboratory testing included positive PCR on 16 August 2011. Corrective treatments consisted of azithromycin for 5 days starting on 17 August 2011. The subject was not hospitalized. At the time of final contact on 02 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 34 days. The outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
HEADACHE, BODY PAIN FIRST THREE DAYS; DAY FIVE:  BELL PALSY-PARTIALFACIAL DROP
This spontaneous report was received from a registered nurse and refers to a 18 month old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 20-NOV-2017, the patient was vaccinated with PROQUAD lot # N014759 for prophylaxis (dose, route of administration, expiration date and anatomical location were not reported) and VARIVAX lot# M048200 with an expiration date 07-DEC-2018 (dose, route of administration and anatomical location were not reported). No adverse effects was reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA009053:
Kinrix vaccine was administered to a 2-year-old patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 18-SEP-2023, the patient received Kinrix. On 18-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine was administered to a 2-year-old patient.). The outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 22-SEP-2023 The reporter was Medical assistant. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Pt reported pain in upper arm from time of administration that lasted ~20 days. Pt follow up with clinic and reported that MD felt that the injection was delivered too high. No redness or swelling at inj site at any time.
Left deltoid  with two areas of redness, warmth and induration. The first area measured 9 x 5.5 cm. with a smaller area directly underneath measuring 2.5 cm. in diameter. Both areas tender to touch. Patient was placed on doxycycline 100mg. BID x 10 days to cover unlikely cellulitis.