chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm was very sore for two days; Very tired for one week; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Very tired for one week) and MYALGIA (Left arm was very sore for two days) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (Very tired for one week). On 09-Jun-2021, the patient experienced MYALGIA (Left arm was very sore for two days). On 09-Jun-2021, FATIGUE (Very tired for one week) had resolved. On 11-Jun-2021, MYALGIA (Left arm was very sore for two days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Received 2nd dose of Moderna vaccine on 2/4/21. Became symptomatic on 4/26/21, tested positive for covid on 4/29/21.
Within minutes of receiving the vaccine, she became pale and diaphoretic. Asked for water, then she lost consciousness. Breathing erratic and shallow. Unresponsive. Called 911. Directed by 911 to place her in supine position. Breathing improved, but still not completely responsive. Emergency personnel arrived and assessed her. They reported she had orthostatic hypotension. Possible dehydration. She was transported to the ER.
Not doing well medically; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not doing well medically) and PSORIASIS (Psoriasis) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination, USTEKINUMAB (STELARA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. On an unknown date, received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient experienced MALAISE (Not doing well medically) and PSORIASIS (Psoriasis). At the time of the report, MALAISE (Not doing well medically) and PSORIASIS (Psoriasis) outcome was unknown.            The data for Moderna Covid 19 Vaccine was reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event of Not doing well medically and Psoriasis unknown onset with Humira was Not Provided.  No treatment medication was provided by the reporter.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-10-28.
COVID-19; COVID-19; Neuropathy; Diabetes; had no voice; sore arm; Psoriasis; Lower back pain; hip pain; Thyroid; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4251967-00 (AbbVie).  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; APHONIA (non-serious), outcome "unknown", described as "had no voice"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis"; BACK PAIN (non-serious), outcome "recovering", described as "Lower back pain"; ARTHRALGIA (non-serious), outcome "recovering", described as "hip pain"; THYROID DISORDER (non-serious), outcome "unknown", described as "Thyroid". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between all  the reported  events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Left arm with two separate circular red, inflamed rashes. one are directly over site of vaccine. Urgent Care MD reports reaction to Moderna, prednisone injection provided for reaction.
Patient was given smallpox vaccine 6/02/06. 6/9/06 patient started having pain around where he received his vaccination. Patient starting having symptoms chills, nausea, fever. 6/11/06 Patient felt fatigued. Patient went to local urgent care. Patient was diagnosed with cellulitis on left arm. Patient was prescribed Bactrim 800mg. Doctor discharged with Bactrim and gave patient Augmentin.
After receiving the vaccine I thought I was having a panic attack.  Short breaths and heart beating hard in my chest.  Shaky.   Had to have my husband come and drive me home. At 3 am Saturday morning my heart was BURNING with sharp, horrid pain.  My tongue and neck were so swollen and huge that I felt like I was breathing through a coffee straw.  I woke my spouse up to take me to the ER... instead, he called Dr's office who transferred him to my doctor's off hours line.  They said I should be FINE.  My husband did NOT take me in.   For 48 hours my throat and tongue were closed.  I tried to take an ibuprofen and it lodged in my throat for a full minute (I couldn't breath).  Small pill.  I couldn't eat.  Couldn't drink.  Heart hurt so bad.  I lost 8lbs on Sat/Sun.  Couldn't get out of bed.  Other symptoms were normal.   Bad headache.  Sore arm.  Body fatigue.  Dizzy.  Heart rate laying down was 50.  Stand up and it would jump to 90.
This spontaneous report has been received from a female patient in her 50s' years old, via a company representative. Information about medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with a unspecified pneumococcal vaccine (manufacturer unknown) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had a ton of inflammation and was holding about 3 pounds of water. At the time of this report, the patient felt back on track after some bad days and had more energy and power. The outcome of the event was considered as recovered as she felt good now. The causality assessment was not reported.
Itching on my upper back/shoulder, thighs and arms. Called pharmacist and they recommended Benadryl.
Patient given the wrong vaccine. He was supposed to have gotten the MMR. Instead was given the MMR & Varicella Combination.
Pfizer-BioNTech COVID-19 Vaccine .  Pt sitting in post-vac area c/o feeling dizzy and near-syncopal after receiving vaccine.  Pt denied any SOB, pruritus, pain, or other discomfort.  Pt stated that he had not eaten anything prior to coming to clinic.  Pt was given a bottle of water, some juice, and a granola bar while being monitored by nurse.  After eating and drinking Pt stated that his symptoms had resolved.  Pt was advised to eat a meal once he left the clinic and he verbalized understanding.  Pt left clinic with family, walking with a steady gait, without complaint, and without further incident;  RN
pt states that she woke up w/ headache, nauseated, SOB, and  pain in left arm.  she says these symptoms come and goes in waves.  pt went to urgent Care   on 3/8/2021.  Pt was ordered Chest X-Ray that came back normal.  Rapid Covid Test w/ negative results.  All vitals were good.  Pt was prescribed an inhaler.  Pt also went to her local pharmacy and took another Covid test on 3/10/2021 w/ pending results and then FU w/ PCP.
sharp pain in my rib cage; Flank pain; This case was reported by a consumer via call center representative and described the occurrence of rib pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rib pain and flank pain. On an unknown date, the outcome of the rib pain and flank pain were recovered/resolved.   It was unknown if the reporter considered the rib pain and flank pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in the left arm and had this sharp pain in my rib cage inside the right flank.  The pain started with the first dose and it never went away. The patient never had a pain like this before and then it subsided. The reporter consented to follow up. Lot Number and Expiry date was unknown but patient stated that he got the injections at his pharmacy and they have this information. For tolerances of 2nd dose, refer case US2020AMR148295, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148295:same reporter
hives go from face to chest both sides of body; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:00 AM, as single dose for COVID-19 immunization. Medical history included sjogren's syndrome, Afib regulated and PMR. No known allergies were reported. The patient did not take other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had covid prior vaccination and was not tested for covid post vaccination. On 28Feb2021, 12:00 AM, the patient experienced hives which went from face to chest both sides of body. It was reported that, sunday (28Feb2021) hives go from face to chest both sides of body, never had hives before. No change in medications, food, or product use. The patient received treatment with benadryl. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Pt had stroke just after returning to work from Covid 19 infection which was diagnosed via test on 6/27/22
Started feeling extremely tired at 5:00 pm. Became achy and began severely shaking at 6:30 pm. Ran a fever that started at 99 degrees and went up to 103 degrees by 11:00 pm.  Developed nausea and dry heaves. Fever continued throughout the night and resolved on 04/08 at 6:00 am.
loss of taste; loss of smell; tested positive for COVID; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ANOSMIA (loss of smell), COVID-19 (tested positive for COVID) and SINUSITIS (sinus infection) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included DOXYCYCLINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell), COVID-19 (tested positive for COVID) and SINUSITIS (sinus infection). At the time of the report, AGEUSIA (loss of taste), ANOSMIA (loss of smell), COVID-19 (tested positive for COVID) and SINUSITIS (sinus infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
COVID-19 infection symptoms began on 01/29/2023 at night. My nose and head was stuffed up. I had a raspy throat, moderate cough and body aches. I did a home test on 01/30/2023 which was positive.  I called my doctor on 01/31/2023 and did a telehealth. He prescribe me Paxlovid for 5 days  but I didn't take it because I did ok without it.  He also prescribe me cough medication which I took for the cough I had. I tested negative on 02/05/2023.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 13-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.
Tingling in left arm and shaking hand on 4th day. Also slight headache first day. Left arm very sore for several days.
Rash; Swollen at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen at the site of injection). At the time of the report, VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for the events. Concomitant product use was not provided by the reporter.  Company comment: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.; 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.
Hospital Occupational Health Provider Telephone f/u note: 35-year-old with history of asthma, eczema, and severe vaccine reaction to Gardasil called to state she has been having an urticarial rash and some fatigue since receiving Pfizer booster (bivalent) on 12/9. A day or two after receiving she began experienceing intermittent hives which have responded to benadryl 25 mg at hs. She has a hx of vague "inflammatory reactions" but a severe anaphyllactic reaction gardasill requiring hospitalization. She has not called her doctor as she states her symptoms were controlled with dose benadryl at bedtime. Also, last week had an episode of throat tightness and difficulty swallowing which resolved without rx and has not recurred. Has been working through all of this. Advised to contact PCP
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately 2014, the patient was inoculated with the ZOSTAVAX vaccine at physician office as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On 11-MAY-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. On 11-MAY-2015, the patient was prescribed famciclovir for the management of her zoster-related symptoms. On 11-AUG-2016, she was again treated by a physician for shingles and was prescribed famciclovir for the management of her zoster related symptoms. As a direct and proximate result of 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Pt on warfarin. Developed blood shot eyes. Pt went to hospital Dr recommended BENADRYL. Pt eyes better Fri AM 10/8/10.
Patient had apparent atypical varicella noted 8/31/03 that resolved after 1 week but then recurred 9/10/03. Lesions seemed to become infected with spreading 9/22/03 and resolved with Keflex but returned again 10/5/03. Resolved with Keflex.
The vaccine vial was dilated on 8/31/21 at 5:40pm. The vaccine vial should have been discarded at 11:40pm on 8/31/21 however the clinical staff administered the vaccine in error more than 36+ hours after it had been diluted. This error was not recognized until after the patient had been observed for 15 minutes and discharged.
22JAN93 entire lt arm became swollen down wrist; was told allergic reaction to something; 23JAN93 redness around inject site extending under arm; unk temp; skin very warm; crying from arm pain; taken to ER told allerg react to shot;
The patient received varicella #1 on 04May10 and noticed swelling on 06May10. The site was examined on 07May10. There were signs of swelling and warmth to the touch.
Patient reports receiving his second COVID-19 vaccine on 6/10/2021. Presented to the ED on the 22nd due to pain to hos right lower extremity. Tightness sensation and feels as if there is a "tourniquet on his legs". Patient does report some shortness of breathe  Patient reports receiving his second dose of COVID-19 vaccine on June 10th. Vaccine history not in system and at time of report patient discharged from the hospital on eliquis. Attempted to contact patient to obtain additional information and was unable to reach patient.
Right arm had slight welling, redness, and warm to the touch. Symptoms began on the night of the injection.
10 hours after shot, became nauseous, had a headache and had chills. Felt mildly sick for 3 days.
Pt complained of extremely sore arm with swelling and pain and believes that the shot was administered too high on the arm. Symptoms were improving but was still extremely sore as of 9/24/2018. Pt was counseled to seek medical attention if improvement did not continue.
Severe pain in lower abdomen.  Much gas.  Diarrhea with odd odor.  As of today it is still there but less painful. Also headache that felt like pressure on top of my head.
yelled out loudly when he received the vaccine but was fine immediately after. He was sitting for about 5 minutes before his mother said that he was feeling dizzy. The doctor was going to grab an ice pop for him when he fainted.  was there as he was sliding off of the chair and had him in her arms. He then began to have a tonic-clonic seizure that lasted approximately 1 minute. The mother called 911. He woke up and asked what happened. The ambulance arrived and suggested that he go the hospital. The mother was on the phone with his father and he said he did not think an ER visit was necessary. The ambulance left and after waiting another 30 minutes, mom took  home.
A few minutes after vaccinating, the patient felt faint. He did not fall or lose consciousness.  Patient rested and he recovered immediately with no further intervention needed. He had had a small snack before he was vaccinated. He left with his parents and was feeling fine. He are supper when he got home and had no further reaction.
Headache off and on, the night she got GARDASIL she had (L) eye drooping and shoulder drooping and resolved the next day.
10/9/14: felt dizzy after shot. Evening of 10/9/14: Stomach discomfort (stabbing pains, gas), intense headache, difficulty sleeping, slight muscle ache. On 10/10/14, I went to work, left early due to extreme tiredness, stomach pain and intense headache. Chills and hot flashes all day. I then slept on and off for 24 hours, continuing to experience symptoms listed above. Evening on 10/11/14, I felt well enough to get out of bed. Still intense pounding headache. Managed to eat some soup. Took Advil and ibuprofen all day for headache on 10/11/14 and 10/12/14. Still headache on 11/13/14, and stomach still feels tentative -- only able to eat bland foods.