chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became profoundly weak, lethargic, depressed and anorexic. He lives in a retirement community in an apartment alone He became unable to care for himself and was transferred to Skilled Nursing Facility which was onsight. He had a positive PCR test at time of admission on 2/9/2021. He had no respiratory symptoms or hypoxemia. He had 12 lb weight loss. He remained in skilled nursing until 2/25/2021. He looked moribund initially. He was severely depressed, dehydrated and was refusing to eat. He gradually came back to his normal, vibrant self after 13 days.
vaccinated with an expired Havrix dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 15-Aug-2022 Reporter's comment: The patient was vaccinated with an expired Havrix dose. Vaccination date not specified. The consent to follow up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
diagnosed with Frozen shoulder; Pain in the Shoulder and wrist; Pain in the Arm,forearm,hand; Could not sleep well; The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day; Feeling sore on the location of the administration site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day), PERIARTHRITIS (diagnosed with Frozen shoulder), ARTHRALGIA (Pain in the Shoulder and wrist) and MYALGIA (Pain in the Arm,forearm,hand) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since November 1997 and Drug allergy. Concomitant products included LISINOPRIL, OMEPRAZOLE, INTERFERON BETA-1A (AVONEX), ALPRAZOLAM and HYDROCODONE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Feeling sore on the location of the administration site). On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day) and MYALGIA (Pain in the Arm,forearm,hand). On an unknown date, the patient experienced PERIARTHRITIS (diagnosed with Frozen shoulder) and ARTHRALGIA (Pain in the Shoulder and wrist). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Vaccination site pain and Pain in extremity, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Could not sleep well), PAIN IN EXTREMITY (The soreness moving down to the middle arm/ soreness getting worse,I feel the soreness 24 hrs a day), PERIARTHRITIS (diagnosed with Frozen shoulder), ARTHRALGIA (Pain in the Shoulder and wrist), MYALGIA (Pain in the Arm,forearm,hand) and VACCINATION SITE PAIN (Feeling sore on the location of the administration site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Concomitant medications and other relevant history were updated On 17-Jun-2021: Initial Additional-1 : VAERS, AE details and outcome On 17-Jun-2021: Non Significant follow up appended to AER
needle separated from the syringe and only partial dose was administered; only partial dose was administered; A spontaneous report was received from a nurse concerning a 72-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced needle separated from the syringe and only partial dose was administered (device connection issue) (underdose).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 17 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 023M20A] intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 17 Feb 2021, when the vaccinator (nurse) pushed the plunger down, the needle separated from the syringe and only partial dose was administered to the patient. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events needle separated from the syringe and only partial dose was administered was resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of Syringe connection issue and Vaccine underdose for mRNA-1273, lot # 023M20A  with no associated AEs.
Arm felt warm, could feel a small knot at injection site, began to gently massage nodule to try and soften it, cause site to become itchy, red, hotter and the red spot became about 2 inches in diameter. No treatment. Event just began today so hasn't ended yet.
The Pt had no adverse experiences following receipt of prior immunizations. and no known drug allergies. There were no concurrent medications. On 4/17/02, the pt rec'd his 1st injection of Engerix-B. On 4/18/02, the pt experienced swelling in his R thumb. On 4/19/02, the swelling in his thumb had subsided, but he had swelling in his L ankle. On 4/20/02, the swelling in his L ankle subsided, but he had swelling in his R knee. On 4/21/200, all swelling had subsided
Tinnitus started the morning after. Very sore arm. Stomach a little queasy. Achy muscles. Mild headache and brain fogginess. All symptoms started the morning after, except the sore arm, which started the evening of the shot(7-9 hours later)
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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 15Mar2023 to 19Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. During 2016 the patient was treated at a medical facility for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Advised to use ice pack on injection site for swelling, redness, soreness, 15-20 minutes on /off Advised to use IBU, APAP or pain reliever for overall aches, pains, low grade fever, headache
3 weeks very mild flu like feeling no temperature after that two weeks much worse 99 to 101 temperature sore throat headache and severe muscle aches almost couldn?t walk in the middle of that went into a fib and was hospitalized for three days and brought  undercontrol CT scan of lungs negative to PC your Covid test was found negative now feeling better but very weak on blood thinner and beta blockers also echocardiogram was fine
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported). It was reported that someone the physician came into contact with, developed chicken pox. It was unspecified whether the patient sought for medical attention. The outcome of chicken pox was unknown. Additional information has been requested.
This is a spontaneous report from a contactable consumer (a Pfizer Employee, working in Customer Service) reporting on behalf of her son. A 18-year-old male patient received the first dose of TRUMENBA on 17Aug2017, in left arm, at 0.5 ml single, for immunisation. The patient was coming back to college and wanted to get vaccinated before going back to school. No other vaccines were administered on the same date or within 4 weeks prior. Medical history, family history and concomitant medications were none. The patient had a lot of pain in his left arm where he received the product since 17Aug2017, flu like symptoms on 18Aug2017, general malaise on 18Aug2017 around 07:30 or 08:00, was feeling really lousy on 18Aug2017 around 09:00, had nausea on 18Aug2017 around 10:00 or 11:00 and could not even eat on 18Aug2017 around 10:00 or 11:00. His arm was killing him, describing the pain. His arm became more and more painful, down into his armpit. When he got home at around 22:00 he told he could not believe that the physician made him get this vaccine. While packing stuff to move he said his arm was killing him and pain was into his body. The pain he was experiencing was in his left arm where he received the product. The reporter thought initially that the patient's pain was typical after some shots but it got worse and worse. On 17Aug2017 night he took some acetaminophen. His arm still hurt him but it was not as bad or as prevalent.  He took also some ibuprofen (ADVIL) on 18Aug2017. On 18Aug2017 morning he woke up and was ok for a little while by mid morning he said he did not feel right. He had more flu like symptoms which were described as he was feeling really lousy, with nausea, general malaise, and could not even eat (he ate very little). He felt fluish, meaning flu like symptoms. No treatment other than acetaminophen and ibuprofen was given. He did eat a little more about an hour before the report, when he started feeling better. The patient was instructed to eat half a sandwich and maybe he would feel better. The patient had an MRI of his back with dye, back in the spring. He did not know results, thought it was fine. The events did not require a physician or ER visit. All the events resolved on 18Aug2017.
This case was reported by a healthcare professional (who is also the subject) via sales representative and described the occurrence of injection site pruritus in an adult female subject who was vaccinated with FLUARIX TETRA (GlaxoSmithKline). On 22 October 2013 the subject received a dose of FLUARIX TETRA (.5 ml, unknown, unknown arm) and experienced wrong injection technique. On 26 October 2013, 4 days after vaccination with FLUARIX TETRA, the subject experienced injection site pruritus. The subject received an injection of FLUARIX TETRA on approximately 22 October 2013. Approximately four days later, she reported itching at the injection site. The subject noted that she felt "the vaccine injection was not given exactly in the deltoid, but up higher on the arm". No other events were reported. At the time of reporting the outcome of the injection site pruritus was unspecified. Follow-up information was received on 03 December 2013 via nurse (who is also the subject). On 22 October 2013, the 56-year-old subject received FLUARIX TETRA in the left arm. The nurse reported additional events of hot to touch, swollen and sore at injection site. The events occurred approximately three to four days after injection with FLUARIX TETRA on 25 October 2013, previously reported as 26 October 2013. The nurse did not consider the events serious; she associated the events with erroneous administration of FLUARIX TETRA in which the vaccine "could have been given higher". No action was taken with FLUARIX TETRA. On 29 October 2013 the events resolved. The reporting subject denied permission to contact healthcare provider.
Joint pain, severe muscle spasms, constant muscle twitches, head aches, skin sensations
Lips hurting and swollen when awake 2 days after receiving the vaccine. Continued to get worse, now hurting and burning more 10 out of 1-10 pain after taking Motrin for the pain.
Received smallpox 14 Jan 11 - read 21 Jan as major reaction - on 28 Jan experienced burning sensation on nose and at immunization site - has bumps along axilla of (R) arm - along breast bone - in groin area.
Fever to 101F, within 24 hours of vax, treatment with acetaminophen.
Hives. Stayed in office x 1 hr to watch pt. Sent home told to take BENADRYL. Referred to allergist. F/U after 24 hrs no rash/hives.
One day post vax the pt developed varicella like rash. It was indicated that the pt had approximately fifty lesions located mainly on his arm. No medical attention was sought. Additional information has been requested.
Sore left arm, shaking, shortness of breath that lasted for 3 hours. Did not go see Dr.
Information has been received from a physician concerning a female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2007 the patient fainted after the administration of Gardasil. It was reported that this patient may have fainted while on the way to the car and hit her head at an unspecified area. Medical attention was sought and the patient's mother was requesting a computed axial tomography because the patient was experiencing bad headaches. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA approx 4:45 pm on 3/20/21: severe bloating, abdominal cramps, nausea, headache, fatigue (lasted throughout the time).  Nausea was severe. Symptoms occurred again approx 2:45pm on 3/21/21: nausea, headache, fatigue.  Lasted into the evening .
Rash appeared on 11/7/01, and on 11/8/01, pt had rash over entire body.
August 29th - It started with a tickle in my throat and I got a runny nose. I had a headache. And then I would be exhausted but would wake up in the middle of the night and be wide awake. Sore throat, runny nose and headache first three days. Somehow I got dehydrated and then I got a bladder infection. That happened. After that, I seemed to be more tired and dizzy; headache, nausea, too. I did have a cough, too. And the cough I still seem to have a little bit of. I did a telemed visit with doctor - I did get an antibiotic which I didn't take and they gave me something for nausea (pills that dissolve under the tongue) - don't remember the name - but I did take that for the dizziness and nausea. That helped with those symptoms.
Headache lasting 48 hours without relief.  To relieve headache, attempted hydration IV with magnesium approximately 36 hrs post injection.  Experienced tachycardia and chest pain, infusion stopped after approximately 150cc. Took benadryl and rested. Symptoms subsided in about an hr.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 19-DEC-2019, the patient was vaccinated with and improperly stored (product storage error), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Therapy type: Digital Data Logger), lot number R034878  and expiration date 11-SEP-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).   The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Hepetic whitlow present on finger 2 days after injection  General fatigue for less than 24 hrs, minor headache, moderate arm pain for 24 hrs mainly on covid vaccine arm
Incorrectly reconstituted with bacteriostatic NaCl. Patient was contacted and provided additional dose.
Diagnosed with face/eye shingles after first dose of Pfeizer COVID-19 vaccine.  Symptoms started 4 days after receiving vaccine.
Date 4.21.2021 - sore arm after injection, moderate Date 4.22.2021 - approx 12 hours after injection fever, chills, body aches, fever,  inability to sleep, moderate Date 4.23.2021 - 24-48 hours after injection fever, chills, body aches, fever inability to sleep resolve Date 4.25.2021 - moderate stomach upset, intestinal gas Date 4.26.2021 - severe stomach and intestinal gas, severe diarrhea, severe bowl movement watery stool every hour for 14 hours Date 4.27.2021 - severe intestinal gas and severe diarrhea continues and resolves ~ 24 hours later.  Headache remains
slight headache; fatigue; This is a spontaneous report received from a contactable pharmacist (patient, self-reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that i received the COVID vaccine yesterday through Pfizer and experienced a slight headache and fatigue today. I am not certain that these symptoms were related to the vaccine or not. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse referring to a patient unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 21-SEP-2016, the patient was administered an improperly stored dose of VARIVAX (lot # M027346, expiration date 01-JUN-2018) 0.65 ml, subcutaneously. The vaccine was stored under temperature 47.1 Fahrenheit degree for 40 hours. There was no previous temperature excursion. Digital data logger was involved. The temperature had been back in range. No adverse effects were reported. Additional information has been requested.
Weeks after getting the vaccination and continuing to this day more than six months later, I feel periodic injection site pain. The pain is not debilitating, just annoying. It comes and goes. I have also experienced other pain that has been periodically debilitating in my left shoulder.  (I received both Moderna injections in my left bicep.)  It may be unrelated, but began it too began after my vaccinations.   I have had no shoulder symptoms on my right shoulder.   And I had no issues whatsoever with my left shoulder until I had my vaccines.
Worsened tinnitus; more frequent migraines; sinusitis requiring treatment with azithromycin x2; telogen effluvium Typical reaction (fatigue, myalgia, mild headache) resolved in 2 days
I thought I had the PENTACEL vaccine for a patient and administered the GARDASIL 9.
Sudden Onset AFIB. No personal history.No family history. Had shock and heart cath today. Shock has worked so far.
8/25 flank pain and cramps, went to Dr, blood in urine, diagnosed with kidney infection
On day 1 and day 2 (4/23-4/24) experienced headache and mild fatique. On day 5, (4/27) started noticing involuntary twitching in legs, feet, arms, abdomen, shoulders, and back. This has been occuring daily since the onset.
hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week); hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 004L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HOT FLUSH (hot flashes). In August 2021, the patient experienced HALLUCINATION (hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week)) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinations (saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week)) outcome was unknown and HOT FLUSH (hot flashes) had resolved.            No treatment drug information provided. No concomitant drug information provided.  Company comment- This case concerns a 58-year-old, male patient with no previous relevant medical history, who experienced the unexpected event of hallucination. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was negative. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-317611 (E2B Linked Report). This case was linked to MOD-2021-317637 (Patient Link).; Sender's Comments: This case concerns a 58-year-old, male patient with no previous relevant medical history, who experienced the unexpected event of hallucination. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was negative. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2021-317611:Same reporter and Patient but different patient