chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (reoccurring). On 3rd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient developed another case of shingles. The patient was currently taking acyclovir for most recent outbreak of Shingles. No further details were reported.
Fever for 8 hours, max 101.7; Chills; body aches; Injection site pain; female patient who just got the COVID vaccine and is currently breastfeeding; female patient who just got the COVID vaccine and is currently breastfeeding; This is a spontaneous report from a contactable nurse (patient). This nurse reported for both mother and baby. This is maternal report.  A 30-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: Elt9899; expiration date: not known), via an unspecified route of administration on left arm on 19Dec2020 10:00 at single dose for covid-19 immunization, administered at workplace clinic. Medical history included childbirth in Jul2020 and currently (ongoing) breastfeeding. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included norethindrone (NORETHINDRONE [NORETHISTERONE]) and unspecified prenatal vitamin (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested with covid-19 since the vaccination. On 19Dec2020 10:00, the female patient who just got the COVID vaccine and is currently breastfeeding. On 19Dec2020 18:00, the patient experienced fever for 8 hours, max 101.7; chills and body aches for 30 hours; and injection site pain for 48 hours. The reported events were non-serious. There was no treatment received for the events fever, chills, body aches, and injection site pain. The outcome of the event 'fever' was recovered on 20Dec2020 02:00 (for 8 hours), of event "chills and body aches" was recovered on 21Dec2020 00:00 (for 30 hours), and of event "injection site pain" was recovered on 21Dec2020 18:00 (for 48 hours).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011500 baby case
First symptom was weakness and fatigue approximately 8 hours after injection. Onset of  fever of 101? F approximately 12 hours after injection, 24 hours after onset still had 100? F temperature, gone by beginning of day 3. Headache and body aches that lasted about 3 days. After fever was gone the weakness/fatigue/headache/body aches lasted an additional 12 hours or so. Approximately a day after all these symptoms disappeared I got a very minor sore throat and some congestion that has lasted a couple of days.  Treatment was Alleve every 8 hrs, lots of fluids and rest.
States that she has had a nosebleed.   States that she never has had a nosebleed before.   Bled on a tissue - less than the size of a quarter.
Patient felt lightheaded, afraid he was going to pass out. Offered to have him elevate his feet or lie down. Gave a bottle of water to drink. Kept him under observation for an hour. Symptoms subsided and he left.
C/O numbness and tingling of tongue.  25mg PO benadryl given and observed in waiting area for 15 minutes.  Left with significant other and stated symptoms improved. Instructed to seek medical attenting if symptoms return or worsen.  Verbalized understanding.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 13-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 05-Jan-2009, which expired 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the pediatric clinic on 21-oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic an only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Presented to emergency department 7/19 w/ syncope, vomiting. Had abnormal chest X-ray and started on antibiotics for pneumonia. Hospitalized for 3 days and discharged in usual state of health on 7/22/2021.
Bodyache, headache and chills after getting COVAX 2nd shot yesterday. Denies direct contact of COVID19. Tachycardia presents. Otherwise pt is afebrile.
Irregular period. Heavier flow than normal. More extreme cramping and nausea  than usual.
Pt recvd 2nd dose of vax & w/in 24 to 48 hrs devel a red pruritic erythematous fine pin-point rash on rt arm;
Information has been received from a consumer concerning her 20 year old daughter with asthma as a child and environmental allergies who sometime in 2009 was vaccinated with two doses of GARDASIL (lot number, dose and site of administration not reported). The consumer had never received a third dose of GARDASIL. Concomitant therapy included oral contraceptive. Also, the consumer reported that her daughter had recently had an unspecified abnormal cervical screening (Pap screening) positive for Human papillomavirus (HPV). The consumer also mentioned that her daughter had a urinary tract infection at the time of her cervical screening. No treatment was given for the adverse event. The patient sought medical attention by an office visit. At the time of the report, the patient's outcome was unknown. No further information is available.
Serious pain in the left arm; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 (at an unspecified age), as a single dose for COVID-19 vaccination. The patient's medical history included supraventricular tachycardia (SVT) and high cholesterol. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Lipitor (MANUFACTURER UNKNOWN), Multi-vitamin (MANUFACTURER UNKNOWN) and Vitamin D (MANUFACTURER UNKNOWN), all for unknown indications on unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to vaccination. On 26Feb2021, the patient experienced serious pain in her left arm (8-9 out of 10) first two days. There was a gradual decline in pain level. But she still had not regained full mobility without pain 4-5 out of 10. The patient did not receive any treatment for the adverse event. The clinical outcome of serious pain in the left arm was not recovered. No follow-up attempts are needed. No further information is expected.
Immediate syncopal event. Supine x 10 min. 2nd syncopal event after sitting up x approximately 5 min. This time w/some tonic-clonic jerks.
This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 04-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (route of administration, lot number and expiry date were not reported). On 10-AUG-2016, the patient was inadvertently administered the second dose of GARDASIL 9 (route of administration, lot number and expiry date were not reported). On 10-AUG-2016, following the administration of the second dose, the patient experienced sore arm. The primary reporter confirmed that the third dose in the series of three of GARDASIL 9 was not administered. The patient outcome was not reported. The relatedness between the adverse event of sore arm and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On 03-SEP-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K007784 and expiry date: 28-MAY-2016) (dose, frequency, route and site of administration not reported). No concomitant medications were reported. No adverse symptoms were reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 3 reports from the same reporter. Additional information has been requested.
Constant eyelid twitch for nearly 24 hours and extreme soreness at injection site.
Headache, Myalgia, Arthralgia & Fever Narrative:  dose 1-day1-2-bruised at inj site dose 2-day 1-3-bruised at inj site; day 2- TIRED, ACHES, HEADACHE, FEVER  Other Relevant History:
This case was reported by a other health professional and described the occurrence of injection site redness in a 15-month-old male patient who received INFANRIX (batch number 75H53, expiry date 27th September 2016). On 6th October 2014, the patient received INFANRIX .5 ml. On 8th October 2014, 2 days after receiving INFANRIX, the patient experienced injection site redness. On an unknown date, the patient experienced left ear infection. The patient was treated with BENADRYL and BACTRIM. On an unknown date, the outcome of the injection site redness and left ear infection were not recovered/not resolved. It was unknown if the reporter considered the injection site redness and left ear infection to be related to INFANRIX.
Muscle weakness, ptosis. Muscle weakness, progressive, requiring intubation, mechanical ventilation. Tracheostomy placed 8/20 and PEG tube, ileus followed. Pt requires ongoing supportive care. Ongoing hospitalization, transferred 8/8/18 to select specialty hospital.
migraine headache with vision interruption; migraine headache with vision interruption; extreme sleepiness; calls it narcolepsy; A spontaneous report was received from a consumer concerning a 69 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events narcolepsy, migraine headache with vision interruption/migraine, vision blurred. The patient's medical history includes excruciating pain in the back that went down to her left leg, She is able to put a little bit of weight on her leg; barely able to get water from fridge and barely able walk to go to the bathroom: Walking difficulty, She is not able to sleep through the pain. The concomitant medications on use were also not provided. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 011M20A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 15 Mar 2021, at 11:45am, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: 002B21A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 15 Mar 2021, from 2pm on wards patient experienced events extreme sleepiness. On 16 Mar 2021, around 8pm patient experienced migraine headache with vision interruption.  Self treating with paracetamol and ice packs.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
4 months old female baby was given Kinrix Vaccine by accident; Kinrix administered on left thigh; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 18-MAY-2023, the patient received the 1st dose of Kinrix (left thigh). On 18-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 months old female baby was given Kinrix Vaccine by accident) and vaccine administered at inappropriate site (Verbatim: Kinrix administered on left thigh). The outcome of the inappropriate age at vaccine administration and vaccine administered at inappropriate site were 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: 18-MAY-2023 The reporter was the Medical Assistant who stated a 4 months old patient was given Kinrix Vaccine by accident, which led to inappropriate age at vaccine administration. The Kinrix vaccine administered in patient's left thigh instead of the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Patient did not have reaction to the vaccine but did test positive for COVID on 09/02/2021
Left third cranial nerve palsy, causing severe diplopia. Started with pain in the left eye, which  progressed to diplopia associated with vertigo.  Retinal and corneal examinations were completely normal. Pain (requiring analgesics) and diplopia continued to progress over the next 5 days. Ultimately presented to the emergency room and diagnosis of third nerve palsy was made. Started on 60 mg of prednisone with rapid and dramatic improvement in the pain after 2 hours of dosing.
Immunodeficiency; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency) in a 32-year-old 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.    Concurrent medical conditions included Hidradenitis (MODERATE TO SEVERE).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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) UNK,Solution for injection in pre-filled pen. In 2021, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criterion medically significant). In 2021, IMMUNODEFICIENCY (Immunodeficiency) had resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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. No treatment medication was provided.  Company comment-This spontaneous case concerns a male patient aged 32 years with no relevant medical history reported, who experienced the unexpected serious (medically significant ) event of Immunodeficiency that occurred on an unknown date in 2021 in the context of mRNA-1273 vaccination. Patient had received 1st and 2nd dose of vaccination at an interval of 28 days in 2021. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 32 years with no relevant medical history reported, who experienced the unexpected serious (medically significant ) event of Immunodeficiency that occurred on an unknown date in 2021 in the context of mRNA-1273 vaccination. Patient had received 1st and 2nd dose of vaccination at an interval of 28 days in 2021. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Pt has just finished IVIG treatment for GUILLAIN BARRE Syndrome. He received his flu shot at 12:15 p.m. By evening he was not feeling well and during the night he developed neurologic symptoms - tingling, toes, feet, fingers, hands etc. Kept getting sicker - couldn't sleep (3 weeks). Couldn't move bowels, pain kept increasing - thighs, knees, stiffness of body - went above waist - couldn't focus - body at war. This peaked between 2nd and 3rd week. Lumbar Puncture showed high protein.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 03-MAY-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N020620 and expiration date 22-JAN-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Delayed injection site reaction; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Delayed injection site reaction) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (Delayed injection site reaction). At the time of the report, INJECTION SITE REACTION (Delayed injection site reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
BLISTER AT ADMINISTRATION SITE OF FLU VACCINE WITH ITCHING AND REDNESS AT IM SITE
PT REPORTED SWOLLEN TONGUE NAUSEA THAT LASTED 4-5 DAYS WITH RANDOM DIZZINESS AND RASH/HIVES THAT COME AND GO WITH LOTS OF ITCHING.
admitted to our ICU thru the ED for progressive and worsening shortness of breath with Large biltateral pulmonary embolus. remains hospitalized
Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not provided). Subsequently, the patient experienced burning and pain at the injection site. Unspecified medical attention was sought. It was unknown at the time of the report if the patient had recovered. Additional information has been requested.
DAY 1-red face, itching face and neck,headache, sore armsore throat, swollen lymph node in neck, cough that night/took benadryl and put caladryl lotion on face and neck DAY 2-arm sore, neck and chest itching/took ibprofen and benadrylDAY3itching is worse/took 3 benadryl during day and used hydrocortisone creamDAY4 same itching, headache/took tylenol and benadrylDAY5face red, eyes sensitive to lightDAY6 cough,congestion, headache/took zyrtec,tylenolDAY7 cough, congestion,side of tongue sore/took musinexDAY8cough and diahreah/took zyrtecDAY9cough,sorethroat/zyrtec Day10 rash on arm, swollen, hot to touch/ibprofen and BCDay11rash on arm bigger,arm itching, headache,eyes sensitive to light/took zyrtec and ibprofenDAY12 still rash on arm
The patient presented to the pharmacy 3 days after receiving the vaccine with a red, swollen arm from the injection site down to the elbow. The arm was also hot to the touch. She went to the doctor the following day and received an antibiotic.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015780, Exp date 11-JUN-2014), dose and route unspecified. On an unknown date the patient developed a "larger than normal red spot on his arm" after receiving PNEUMOVAX23. Pharmacist requested that the lot#/Exp date of the specific vial of PNEUMOVAX23 that was administered to this patient be evaluated to see if the remaining doses in this multi-dose vial could be administered to other patients safely. The outcome of the patient was unknown. Additional information has been requested.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The patient experienced headache after receiving Shingrix. The patient wanted to know whether is it advisable to take advil for headache.
pt states that she developed chills.  She had shivers and was very achy like she had the flu.  After a few hours these symptoms subsided.