chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 15-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021 subcutaneously (dose and route of administration were not provided) for routine vaccination. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit (F) for 12 hours and between 15 to 46F for 30 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001233: US-009507513-2009USA001256:
4/1@approx 1250-vaccine administered.  Approx 2 min later, immediate nausea, tongue went numb, face went tight, burning sensation, sense of impending doom, blood pressure dropped, rapid heart rate.  Four more liaises of same issues each lasting approx 2-5 minutes over next two hours.  Next seven hours, hot  waves, low body temp of 95, low blood pressure 88/60.  It is still happening now at 1939 CST.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX, ibuprofen and TYLENOL. On 24th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th May 2018, 1 days after receiving SHINGRIX and 80 days after receiving SHINGRIX, the patient experienced headache, general body pain and feeling unwell. On 26th May 2018, the patient experienced rash and viral rash. Rechallenge with SHINGRIX was positive. On 26th May 2018, the outcome of the headache and general body pain were recovered/resolved. On 28th May 2018, the outcome of the rash and viral rash were recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the headache, general body pain, feeling unwell, rash and viral rash to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist is the patient herself. On 25th May 2018, next day after receiving SHINGRIX, she experienced headache, and did not felt very good with body aches, which lasted only till Friday, 25th May 2018. On 26th May 2018, Saturday, 2 days after receiving SHINGRIX, she experienced a rash on her torso, which was same rash as she experienced with the 1st dose of SHINGRIX. The pharmacist stated, it looked like a viral rash. She also stated that, she did not experience chills nor fever like she did with the 1st dose of SHINGRIX. For tolerance after 1st dose of SHINGRIX, refer case US2018040164. Follow-up information was reported by the pharmacist on 26th June 2018: The reporter details were updated. The patient demographic details were updated. The patient experienced viral rash on torso region. The VAERS details were updated. Sender's Comments: US2018GSK102500: Previous VAERS submission in paper format.
Felt unwell; Headache; Bone pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (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: MALAISE (non-serious), outcome "unknown", described as "Felt unwell"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; BONE PAIN (non-serious), outcome "unknown", described as "Bone pain".  Additional information: A 54-year-old Consumer calls requesting information about the symptoms she experienced after receiving the COVID-19 vaccine from Pfizer. The Consumer reports that after administration of first dose of Pfizers COVID-19 vaccine, she felt unwell, with a headache and bone pain, but no fever or allergies. The Consumer reports that she has not seen a doctor for a diagnosis or management of the symptoms she experienced after administration of Pfizers COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe chest pain began 24 hours after receiving the vaccine.  It lasted for about 4 hours and only resolved after a dose of aspirin was taken and recipient slept.
1 of 4 pts vaxed from the same Tetramune lot who exp a fever 102-103, irritability (crying) w/in 1 hr p/vax & inject site react described as swelling & redness; pt also recvd Orimune; pt recovered;
This case was reported by a consumer via interactive digital media and described the occurrence of ankle fracture in a patient who received Herpes zoster (Shingrix) for prophylaxis. n an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ankle fracture. On an unknown date, the outcome of the ankle fracture was unknown. It was unknown if the reporter considered the ankle fracture to be related to Shingrix. Additional Information: GSK Receipt Date: 24-MAY-2022. Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine 3 years ago from reporting date but could not get the second shot because he/she had broken an ankle and could not get out of the house. The patient asked should he/she start the series over or forget the second shot altogether. Additional supportive information: The follow-up would not possible as no contact details were available.
Pt recv vax on 11/24/98; on same day pt exp vomiting
LA Menomune shot, swollen outer arm, given 7/31/06. PCP Dr will call him if swelling doesn't go down in next day or two.
SHORTNESS OF BREATH; BRAIN FOG; HOT FLASHES; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  The batch number was not reported. The company was unable to perform follow up to request batch number/lot number. No concomitant medications were reported. On 12-APR-2021 22:00, the subject experienced hot flashes. On 12-APR-2021 22:00, the subject experienced chills.  On 13-APR-2021, the subject experienced brain fog. On 14-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, hot flashes, and chills on 14-APR-2021, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
expired dose to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA576A, expiry date 31st July 2022) for prophylaxis.   On 3rd August 2022, the patient received Menveo. On 3rd August 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022114880   Additional Information: GSK Receipt Date: 03-AUG-2022. Reporter's Comments: The licensed practical nurse (LPN) reported that they administered today on the day of reporting an expired dose of Menveo to a patient.  The consent to follow up was granted. Additional Supportive Information: As patient received Menveo beyond expiry date, which led to expired vaccine used. This case was linked with US2022114880 reported by same reporter for same patient for Bexsero dose.; Sender's Comments:  US-GSK-US2022114880:Same reporter
no known adverse event, vaccine was expired on 10/13 and given on 10/19.  Moderna confirmed after investigation that the lot should give full coverage at the time of administration
Body aches, headache, upset stomach when eating food, high fevers (102 degrees, 103 degrees, and 100 degrees) spread out over two days
March 13, 2021.  27 hours after receiving the second dose of the Moderna vaccine we had to take my Mother to the hospital because she couldn't breathe.  They put her on oxygen for a bit and then switched her to a cpap as the oxygen wasn't doing anything. .  Her lungs were full of fluid.  They suspected a heart event and did all of the tests to look for a cardiac abnormality and found nothing.  Also, she had a defibrillator which showed no abnormalities.  They found no reason for the fluid in her lungs and basically did nothing for her except make sure she was stable and breathing normally before they discharged her. The completely ignored the fact that she had the Covid vaccine the day before, in fact. they didn't record the information in her admit file. I have given you the name of her Internist, but he didn't care for her when she was in the hospital and didn't have that much information about what was going on. She had a Hospitalist assigned to her.  The people who know the whole story are myself and my brother. She was discharged on March 18th. She had spent about 1 and a half days in ICU, then spent the rest of the time in a regular room until discharge.  They took her off of oxygen when her levels seemed fine, they didn't do anything for her other than that.  She continued to feel bad for the next two months.  She had stomach pain, no appetite, a head ache, was weak, and generally didn't feel well.  She didn't complain of having any issues with her breathing.  On May 24th we took her back to the hospital because she was having issues breathing again.  She passed away on May 29th.  During her stay this time, she never recovered her ability to breath well, she was on oxygen, was extremely tired, had a headache and was just exhausted.  On May 29th she passed peacefully while trying to eat her lunch.
Child experienced a fever to 40.3C and developed a febrile seizure.  By the time mom brought to office pt. was post-ictal.  Ibuprofen given in office, pt. fever decreased and able to go home.
Sore right arm ,Sore Right Arm,Sore injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032M20A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right arm ,Sore Right Arm,Sore injection site arm) outcome was unknown.     Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660901, US-MODERNATX, INC.-MOD-2022-660904 (Linked Report). This case was linked to MOD-2022-661014 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660901:MOD22-027076 Husband case US-MODERNATX, INC.-MOD-2022-660904:MOD22-027076 Husband case
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. The nurse reported that her office had improperly stored M-M-R II. It was possible that on an unspecified date, an unspecified number of patients might have been administered with this improperly stored M-M-R II (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No symptoms reported. It was unspecified if the patients had sought medical attention. This is one of the several reports received from the same reporter (MARRS# 1211USA012711, 1211USA012714, 1211USA012716 and 1211USA012717). Additional information has been requested.
pt recvd vax & devel hives over body; parents told to use DPH;
Employee reports what he terms normal soreness at the injection site for the first couple of days following vaccination.  On the morning of 10/17 he states that he felt severe pain of the left shoulder with limitation of normal range of motion.  He states that he was able to move his left elbow, wrist and hand normally however was unable to lift his arm.  He states that he can shrug his shoulders bilaterally but is unable to raise his left arm from the shoulder without using his right arm to assist.  He notes discomfort of his left shoulder when lying in bed, especially if he rolls onto the affected left side.  Employee states that he was seen by his primary medical provider on 10/27/14 due to persistence of discomfort and loss of function of the left arm.  He states he was diagnosed with an adverse vaccine reaction, and was advised to utilize anti-inflammatory agents and ice.  He was encouraged to use his left arm as much as possible, even if it required him to use his right hand/arm to assist.  He was further advised that if there was no improvement within 1 week, he was to return to their office for additional exam and treatment.  As of today (10/30) employee reports that he believes symptoms to be slightly improved and that the anti-inflammatory agents have started to work.  He states that he is starting to recover range of motion to his left shoulder slightly, and states that this is an improvement over the condition since 10/17/2014.
Pt recvd HIB/DTP/OPV & devel erythema all over body mostly in inject site & chest abdomen & back areas; mild irritability observed;
Immediately felt a scary  tingling working its way from my head to my toes and felt like I would be unsteady to walk at the time. lasted about 20 mins.
Patient received Flu vaccine IM on 27 October 2014. Patient reports two days later started having pain in left thigh. Pain progressed to twitching and spasms whole walking/standing, but relieved when sitting/squatting) also left lower back pain. Patient seen by Orthopedist   3MRI's with no problems found. Pain meds and steroids were delivered IM with no pain relief in first 4 days.  Patient reports started on muscle relaxer, received relief with reduction in muscle twitching. Patient  started to have some tingling in left foot and now some twitching in  right leg as well as left arm. Patient saw a neurologist November 7th. Patient seen by a neurologist who diagnosed her with radiculoneuritis secondary to flu vaccine.
Hives or hivelike rashes all over body that come and go, starting about two weeks after vaccination (moderna booster). I am almost on week four with no change. There has been no change in diet, or detergent, and it worsens at night, but can happen anywhere--ruling out bedbugs. Oral allergy medications relieve the itching but the hives are still there.
Itchy rash appeared at injection site 7 days after the shot, followed by fever, body aches and fatigue.
red spot 4.5 inches below the vaccination sport and it was 2 and a half inches long and 2 inches wide; not feeling very good; diarrhea; headache; temperature; achy joint; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FEELING ABNORMAL (not feeling very good), RASH MACULAR (red spot 4.5 inches below the vaccination sport and it was 2 and a half inches long and 2 inches wide), HEADACHE (headache) and PYREXIA (temperature) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Bone disorder (NOS). Concomitant products included RALOXIFENE for Bone disorder (NOS), OMEPRAZOLE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache), PYREXIA (temperature) and ARTHRALGIA (achy joint). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (not feeling very good). On 14-Mar-2021, the patient experienced RASH MACULAR (red spot 4.5 inches below the vaccination sport and it was 2 and a half inches long and 2 inches wide). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), FEELING ABNORMAL (not feeling very good), RASH MACULAR (red spot 4.5 inches below the vaccination sport and it was 2 and a half inches long and 2 inches wide), HEADACHE (headache), PYREXIA (temperature) and ARTHRALGIA (achy joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medication included medication for depression
Patient had fever up to 103.2 and febrile seizures. Seizure at 2300 night of vaccination at home times 2, went to the ER and had another seizure at 0200 without fever. Admitted to Hospital on 7-12-18 and discharged 7-13-18.
Started having numbness in left little finger, up forearm to elbow on 06/10/2006. On 06/11/2006, numbness spread to index finger and palm. On 06/12/2006, numbness now includes left shoulder, half of the back, left side of the chest including half of the left breast. Seen by P.A. on 06/14/2006. Had MRI and X-ray on 06/21/2006. Seen by neurologist on 07/05/2006.  7/25/06 Received medical records from 2nd hospital which included D/C summary, H&P  & labs which reveal patient hospitalized from 7/6/06 to 7/10/06 w/final diagnosis of probable multiple sclerosis & s/p LP headache, markedly improved.  Patient's s/s began mid June 2006 16 days s/p MMR w/left arm numbness & migrated into the shoulder & chest.  Left leg numbness also developed.  PMH: neg.  Family hx: sister has transverse myelitis & possibly MS. Recent MRI of c-spine was WNL but interpreted by this hospital radiology chief as showing posterior column demyelinating plaque on left coinciding w/C5-6 area.  MRI of brain showed single area of abnormality.  LP done, report not included in records. Left side numbness cleared w/course of steroids.  Labs were essentially WNL. MS profile pending at time of d/c.  Continued on tapering steroids at d/c to home and was to f/u w/PCP./ss   7/25/06 Received v/m from reporter that they do not have any medical records beyond the vax record.  No further requests will be made to them/ss 8/1/06 Received medical records from 1st hospital which consisted only of 2 x-ray reports: c-spine series & MRI of c-spine, both of which were WNL./ss Follow-up: I am not sure which to MMR - the MS was not an adverse event from the MMR just correlated with timing. 10-19-2007 pt was diagnosed with MS June 2006 the MMR was given 5.25.06. A VAERS was filled out 7-13-06. The pt. still has MS and is symptomatic with no change to her medical condition.
It's an idiosyncratic reaction that happens periodically; flushing; palpitations; shaking chills (violent shaking); difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL3246; expiration date not provided), via an unspecified route of administration on 12Jan2021 16:30 at a single dose at left arm for COVID-19 immunisation, glatiramer acetate (COPAXONE), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for unspecified indication. Medical history included multiple sclerosis, hypothyroidism and osteoporosis. The patient was not pregnant. The patient received the first dose of BNT162B2 (lot number: EKS730) on 22Dec2020. The evening after the patient had her second Covid vaccine, the patient gave herself Copaxone shot. On 14Jan2021, the patient stated that there was an idiosyncratic reaction that happens periodically. Symptoms were flushing and palpitations. It ends quickly. About 15 minutes after that occurred, the patient had shaking chills (violent shaking) and difficulty breathing. The symptoms lasted about 1 hour. During that hour, the patient had someone drive her to the hospital but during the drive the symptoms calmed down. The patient spoke with one of the nurses that does screening in the lobby and they said many people had been reacting to their second shots, so she didn't really need to be seen in the ED since her symptoms had resolved. No treatment was received. The action taken in response to the event for glatiramer acetate was unknown. The outcome of the events was recovered on an unspecified date.
her morning (fasting) blood glucose was increased; This non-serious case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included metformin.   On 13-OCT-2023, the patient received Arexvy. On 15-OCT-2023, 2 days after receiving Arexvy, the patient experienced blood glucose increased (Verbatim: her morning (fasting) blood glucose was increased). The outcome of the blood glucose increased was not resolved.   It was unknown if the reporter considered the blood glucose increased to be related to Arexvy.     It was unknown if the company considered the blood glucose increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 The patient self-reported this case. The patient was a type-2 diabetic previously well-controlled on metformin 500 mg twice a day. The patient received an Arexvy vaccine and 2 days later her morning (fasting) blood glucose was increased. Since then her fasting blood glucose had been 150-165 every morning, her normal fasting blood glucose was 120-130s. Blood glucose returned to normal (110s-120s) every afternoon. The patient consulted her physician who said the increase in blood glucose was an expected metabolic response to vaccination. The physician suggested she increased metformin by 500 mg daily. The patient had not done this and she had a follow up appointment with her doctor in about 6 weeks. Nothing else was reported. The reporter consented to follow up.
Shingles Virus- Rash began Friday 1/15/21 (about 48 hours after vaccination) on back left side, rash spread to underneath left breast
Excruciating shoulder pain began in evening. Range of motion gone. Couldn't lift left arm. Notified Health Department and employer on 3/1/21, missed work.  Told to heat and take ibuprofen.  Did as instructed and 2 weeks later still have excruciating pain with certain movements.  Injection was administered very high and far back on shoulder.