chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late second dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late second dose of shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Aug-2023 A pharmacist called in to report that a patient over 50 years of age wished to know how to proceed. Information about the event, vaccine and patient was scarce and was not provided as the provider mentioned they had not received consent from the patient. The provider stated that they had previously spoken to an agent but the call dropped and never got a call back. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Pt reports that the same day after she had her vaccines on her last visit on 10-14-2022 she started having strong shoulder pain and could not elevate her arm above her head. Since that time she has been trying stretching and topical pain creams and has noticed it has gotten a little bit better, but still to this day she cannot elevate her arm and still has significant pain.   It is difficult for her to do anything with that arm that involves elevation of her arm. She has never had problems with this shoulder in the past and she has not had any injuries
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of an unknown age. The patients were vaccinated with a dose of ROTATEQ on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
left the Rabavert out / Patient has already used the dose; This case was reported by a pharmacist via licensee and described the occurrence of incorrect storage of drug in a 66-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Rabavert (first 2 dose were received on an unknown date).   On 10th November 2020, the patient received the 3rd dose of RabAvert and Rabavert Needle Device. On an unknown date, the patient started Rabavert Pre-Filled Syringe Device. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 was provided as follows: The age at vaccination was not reported. The reporter wanted to know stability information.  The patient left the Rabavert out before taking to the MD office to get his injection. It was out about 18 hours. Patient hasd already used the dose, which led to incorrect storage of drug. The reporter did not know when the patient received his first 2 doses as they were given at the clinic, but stated a dose had not been missed.  The reporter stated the clinic did not have a dose in for the patient's 3rd dose and that was why the patient picked it up from the pharmacy to take to the clinic for 3rd dose. The reporter stated the pharmacy sold dose on 9th November 2020 thinks does was given on 10th November 2020 at MD office. It was unknown if exposure was for pre or post exposure prophylaxis
This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th March 2019, 1 days after receiving SHINGRIX, the patient experienced fever, chills, pain, injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the fever, chills, pain, injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, chills, pain, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX the patient experienced low grade fever, aches, chills and left arm soreness. The patient could barely lift his arm because of the soreness. The reporter did not consent to follow-up.
Nausea,  stomach pain,  vomiting starting at midnight,   chills,  headache, dehydration 5:00 PM Tuesday.   Fluids, pain meds and 2 anti nausea drugs Next morning was fine Had mild tinnitus for 4 months.   On Saturday my tinnitus got worse and has been pretty constant.
At injection site on left arm pt c/o it swelling, turning red, & hurt.  Pt also c/o fever, chills, & being achy.
Pt presented to clinic on yesterday 10/02/06, at 3pm with a reddened rash to entire body.
This spontaneous report as received from a nurse practitioner via a field representative regarding a 26 year old male patient. His concurrent conditions, medical history, and concomitant medications were unknown. On 19-OCT-2018, the patient was vaccinated with first dose of GARDASIL 9 in the right arm (lot# N023238, expiry 25-JUN-2020) for preventing human papilloma virus (HPV). On an unknown date in November 2018 (reported as about a month after the vaccine), the patient experienced anal warts (anogenital warts). The patient sought medical attention with an office visit and was treated with unspecified treatment. The outcome of anogenital warts was reported as recovering/resolving. Causality was unknown.
broke out w/hives on arms, legs, back & abd;started on 10/29/99 still present 11/1/99;no rxn OTC;advised to report to own MD;given DPH;
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 102. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 28Sep2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) and all described as "He has given approximately 5 doses out of the first box. Noticed some particles floating in the syringe.". Additional information:White particles floating around in 2nd and 3rd box with one PFS having a 'white blob'. He still noticed the presence of the white particles after shaking the product vigorously. Patient has given approximately  doses out of the first box. Noticed some particles floating in the syringe.After vigorously shaking it has to be homogenous suspension before administration. He went and looked that up in the package insert to check the suspension. After shaking one syringe there was a white blob. He said several syringes had multiple particles. He has opened the other 2 boxes to make observations.   The reporter considered "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "he has given approximately 5 doses out of the first box. noticed some particles floating in the syringe." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320516 same reporter/product, different patient;US-PFIZER INC-202300322487 same reporter/product/event, different patient;US-PFIZER INC-202300322488 same reporter/product/event, different patient;US-PFIZER INC-202300322489 same reporter/product/event, different patient;
pain and swelling at injection site; pain and swelling at injection site; This is a spontaneous report from a non-contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Jan2021, at 13:30 (Lot Number: EL3246, at the age of 27 years old) as dose 1, single for COVID-19 immunisation. The patient has no known allergies and no other medical history. She was not pregnant at the time of report. Concomitant medications included meloxicam. She did not receive any other vaccine in four weeks prior to vaccination. On an unspecified date in 2021, the patient experienced pain and swelling at injection site for 36 hours. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. The patient recovered from the events on an unspecified date in 2021. The patient also received the second dose of BNT162B2, administered in the left arm on 08Feb2021, at 16:00 (Lot Number: EM9810, at the age of 27 years old) for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
25 minutes post vax, the pt's guardian phoned from home to say the pt's eyes were severely swollen. Guardian had pt taken to ER via paramedics. According to the ER's nursing staff, the pt was treated with epinephrine, Benadryl, Solu-medrol, and IV fluids and discharged home a few hours after he arrived to ER.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR; AMLODIPINE. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: tested negative after 7 days; Positive, notes: tested positive 6 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took other medication in 2weeks. Patient took paxlovid for Treatment of COVID 19. Treatment stop date was 29Jul2022. Adverse event was took Paxlovid, tested negative after 7 days, symptoms returned and tested positive 6 days later.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 1month afterward starting having facial swelling and tingling from jaw/lips to eyeball on the right side, with eyeball pressue.  I also have tingling, numbness, burning to both lower legs from the knee down to the feet.  I can have burning and sometimes my feet are freezing at the same time. Lower back pain also.  The burning and sensations have gone on for awhile now.  Also tinnittis which is currently off the charts with pain, lost 30 lbs as I get so ill from the noise I cannot eat---have nausea when the symptoms are to bad.
Approx dime sized induration, quarter sized redness to R arm injection site, no dyspnea, no SOB or swelling to other sites.
High temperature second day after vacination.  Tylenol treatment to drop the high temperature. Passed away by pulmonary embolism suddenly.
Sick on 9-18-07. Woke up with every muscle in my body hurting. I was so weak that going to the bathroom was difficult. At the site where the shot was given - red and hot the size of a silver dollar. On 9-20-07 the red started to travel down my arm. (Ibuprofen)
Headache, exhaustion and chills for 36 hours.  Then symptoms returned after 48 hours for approximately 6 hours  and returned again for 4-6 hours 24 hours after that.
Rash and swelling at injections site approximately  36 hours after injection. Headache, lightheaded, and general malaise about 8 hours after injection.
Approximately 2 weeks post vax the pt developed a low grade fever and broke out in a rash. The pt was seen by a physician who reported that the pt was covered with very, very small papular lesions. The lesions were all over the child's body and she definitely has more than 50. Additionally the physician reported that the pt developed coryza. The physician expressed a concern about the lot number. Follow up information from a physician reported the rash became generalized and was small vesicular and pruritic is nature. The physician was unable to obtain fluid culture as the vesicles were reportedly too small. The pt was treated conservatively. The pt recovered without sequelae.
13 x 10cm area anterior right thigh indurated and warm, 3cm round area lateral left thigh erythematous and sl raised, not indurated. Treatment: cephalexin 250mg/5mL 1 tsp bid x 10 days. At DTaP site.
Per ED chart, family reported coughing, shortness of breath, chills and nausea/vomiting started about 4 days ago. Patient was confused with date and time.  At ER, patient was found to have hypoxemia, Covid test: positive.  Chest x-ray showed signs of pneumonia.
7x9 cm erythematous, warm to touch, tender, mildly edematous area on left shoulder where shin grid was injected 48 hours ago (this was written by Minute Clinic on 3/16/2019). Skin is warm and dry. There is erythema. I had chills and slept a lot the day after the shot. On 3/18/2019 I still have rash and arm still sore and now itchy, but I feel better.
I ran a 102-103 fever for two days, my arm swelled up, became itchy, and red. Im also having problems with my memory.
This spontaneous case reported by a patient, describes the occurrence of COVID-19 (COVID-19 positive after vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced COVID-19 (COVID-19 positive after vaccination). At the time of the report, COVID-19 (COVID-19 positive after vaccination) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain.  Left left leg numbness.  Decreased mobility, difficulty sitting, walking, and even lying in bed.  Started very quickly without andy known injury.  Pain continued to worsen.  Pain even worse after second injection.  Now two weeks after second shot, the pain is going away.  It is like the nerve irritation is subsiding.  The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg.  Left leg pain and numbness.  Thought I had done something to damage the nerve.  Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility.  Took Advil, Aspiring, Tylenol and nothing helped.  Received second vaccine 1/12/2021 the pain continued and even got worse.  It was to the point I couldn't even walk.  I couldn't figure out how I had damaged the nerve.  I am now thinking it was from the vaccine.  I believe the vaccine irritated the nerve.  The nerve pain is starting to go away.  Normally if you  have a sciatic nerve issue, it just doesn't go away on its own.  I know there have been reports of severe back and neck pain.  I believe it can irritate the nerves which cause severe pain.  I wanted this reported in cases others complain of similar issues.  The good thing it is improving.
sore knee; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (sore knee) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore knee). The patient was treated with MELOXICAM for Pain in knee, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (sore knee) outcome was unknown.            No concomitant medication was reported.   Reporter did not allow further contact
redness, induration to site onset 1 day after injection (approximately 30 hours from injection time) unclear if cellulitis started on Keflex.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB lot # L051124 and expiration date: 14-OCT-2018; lot # M014927 and expiration date: 18-FEB-2019; (strength, dosage and route unspecified). No adverse effect reported. No product quality complaint involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
pain in the arm; 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 (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in the arm".  Additional information: Reporter was consumer that received 2 doses of vaccine outside of the country (in a country that had a different language). He does not have any documentation regarding the vaccination and states that when he visited the Doctors office, the doctor mentioned it is Pfizer COVID vaccine and that was all the information he has. (First dose on 26May2021 and Second dose on 16Jun2021). He has contacted (City Name Withheld) health department and was told to start the series of vaccination all over again. Reporter does not think this information was very Correct and he was concerned about starting the vaccination again which would sum up the total doses to 4-5 doses. He was concerned that the lack of paperwork would hinder him from travelling internationally and cause of that he has to start the vaccination series from the beginning. He stated that he showed normal symptoms after the vaccination such as pain in the arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Significant pain in arm "couldn't move my arm" Redness pain, swelling of (L) Bicep area. Pt reports 4 inches x 6 inches
Pt reports being itchy on various places on his body. Hives. Treating it with BENADRYL 25 mg po q 6 hrs.
Within 4 hours of the Moderna shot I felt injection site pain - a little swelling, then I got very tired.  the pain lasted for around 24 hours. A week after my first injection, I started experiencing stomach pain - from under my breasts to my belly button.  It started around 5pm on Sunday, March 28th. I am still experiencing stomach pain and a little cramping on my right side.  I am waiting it out...
This spontaneous report was received concerning a 15 months old male patient from his mother. On 02-OCT-2012, the patient was vaccinated with a dose of VARIVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On 28-DEC-2012, the patient experienced a red rash on his left leg (described as raised bumps). The rash then spread to the patient's lower back described as a horizontal line of red, raised, scaly patches on both sides of the patients back (exact time frame of spread was unspecified). The physician saw the patient on 01-JAN-2013 and called the rash on the patient as shingles. On 31-DEC-2012, the patient also experienced croup (barky cough). The patient sought medical attention (contacted office). The patient was given one dose of steroids (exact date steroid taken, name of steroid and dose of steroid was unspecified) as a treatment for the croup. At the time of the report, the rash was reported to be getting better but the crop was continuing or worse. The relatedness for shingles and croup (barky cough) was unknown for VARIVAX. Reporter also stated that grandmother of the patient went to visit in the past summer (exact date of visit unspecified) and immediately after the visit developed shingles (Grand mother had not received ZOSTAVAX. Additional information has been requested.