chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via patient support programs and described the occurrence of vaccination adverse reaction in a 65-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included FLOVENT 110 inhaler (batch number BG8J, expiry date December 2018) for asthma. The patient's past medical history included blood pressure. Concomitant products included Losartan and VENTOLIN HFA. In November 2017, the patient received Influenza vaccine Quadrivalent. In 2010, the patient started FLOVENT 110 (inhaled) 2 puff(s) twice daily (4 puff(s) daily). In November 2017, less than a month after receiving Influenza vaccine Quadrivalent and not applicable after starting FLOVENT 110, the patient experienced vaccination adverse reaction, influenza-like symptoms, sinus congestion, unwell and tiredness. FLOVENT 110 was continued with no change. In December 2017, the outcome of the vaccination adverse reaction, influenza-like symptoms, sinus congestion, unwell and tiredness were recovered/resolved. It was unknown if the reporter considered the vaccination adverse reaction, influenza-like symptoms, sinus congestion, unwell and tiredness to be related to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the influenza-like symptoms, sinus congestion, unwell and tiredness to be related to FLOVENT 110. Additional details were provided as follows: The patient was transferred from the GlaxoSmithKline patient assistance program to report the above symptoms that the patient believes were caused by her flu shot that she received at her local pharmacy. She did not believe these symptoms were caused by FLOVENT received in 2010.
One hour after became dizzy, weak, blurred vision,one hour later developed swelling in throat,proceed to hospital admitted at 2:19 pm and treated for allergic reaction. I was given 60 mg of Prednisone and zantac. Was given Rx for 3 days off prednisone
Worsening of dry eyes; Low energy; Fatigue upon exertion/felt fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Worsening of dry eyes), ASTHENIA (Low energy), FATIGUE (Fatigue upon exertion/felt fatigue) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's syndrome.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DRY EYE (Worsening of dry eyes), ASTHENIA (Low energy), FATIGUE (Fatigue upon exertion/felt fatigue) and HEADACHE (Headache). At the time of the report, DRY EYE (Worsening of dry eyes), ASTHENIA (Low energy), FATIGUE (Fatigue upon exertion/felt fatigue) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated from unknown to recovering/resolving.
Tonic-clonic seizure that lasted 15-20 secs. Seen in the ER.
Pt received the polio vaccine and the Hep A vaccine in her R. deltoid on 04/29/2020 per IR. The parent pointed out that the pt's R. upper arm/deltoid is red when the pt came back to have her PPD skin test read. There is a red area that measures 65 mm long and 75 mm wide that is warm to touch which, per the pt's parent,  appeared after receiving the vaccines. The parent stated that there has been no other symptoms. The parent was encouraged to seek care from a provider for an assessment of this red and warm area on the pt's arm. She was also encouraged to consult with a provider before getting those vaccines again. Parent was informed about which vaccines were given in the R. deltoid on 04/29/2020.
Full-body hives accompanied by dermatagraphia. Improved but not definitively treated with Benadryl; 5-day course of prednisone beginning 8 January 2022.
Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; This spontaneous case  was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a 67-year-old female patient.  The patient's concurrent conditions included allergies to pollen. The patient's concomitant medications included omeprazole, HCTZ and meloxicam, all used for unreported indications.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was 283847 and expiry date 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient experienced redness, swelling, warmth, and severe itch on injection site. The patient was treated with cetirizine and hydrocortisone cream for the events.  On 21-Oct-2020, the patient was recovering from the events, as reported symptoms were resolving, but still had symptoms.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed all the events as non-serious.  This case is linked to cases 202005407, 202005408, 202005409 and 202005414 due to the same reporter.  Company comment: A 67-year-old female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. The patient's concurrent conditions included allergies to pollen. The patient's concomitant medications included omeprazole, HCTZ and meloxicam, all used for unreported indications. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 67-year-old female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. The patient's concurrent conditions included allergies to pollen. The patient's concomitant medications included omeprazole, HCTZ and meloxicam, all used for unreported indications. Causal role of the suspect vaccine is assessed as possibly related for all events.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L035283, expiry date 15-DEC-2016, dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion (14.7 F for 2 hours and 15 minutes). There were no previous temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and the 64 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient had penicillin allergy. Concomitant therapies included COVARYX HS and cyclobenzaprine hydrochloride. On 20-FEB-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (anatomical location was not reported) (lot # M035147 and expiration date 25-OCT-2017) to prevent shingles. On the same date (reported as right after receiving ZOSTAVAX), the patient experienced soreness at the injection site and she recovered of it on an unspecified date. On 24-FEB-2017 (reported as 4 days after taking ZOSTAVAX), the patient had pain in her stomach which radiated to her back; additionally she had a fever and was bedridden. These symptoms lasted for four days and the patient recovered on 27-FEB-2017. Then, on an unspecified date in 2017, the patient had pain (pain in extremity), swelling and redness of both feet; she also had a knot on each leg above her ankles which were sore. These symptoms also lasted 4 days and then, the patient recovered on an unspecified date. The patient did not experience any rashes or blisters. She did not seek medical attention when she was experiencing any symptoms and neither received any treatment. None diagnostic laboratory studies were performed. On 15-MAR-2017, the patient no longer had symptoms. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Vaccines administered too close together - Rx includes mild swelling, redness, and tenderness in L deltoid.
Moderna COVID-19 Vaccine EUA: Guillain-Barre Syndrome  Patient received Moderna COVID-19 vaccines from non-health care system location on 2/5/2021 and 3/4/2021. On 4/15 patient presented to physician office with complaints of fatigue, general weakness, and edema. Patient had an ED visit and admission on 4/18/2021 for gradual worsening weakness, difficulty with mobility, and pedal edema with a discharge on 4/23/2021. Patient presented back to ED on 4/27/2021 and readmitted with worsening neuropathy and difficulty ambulating, and subsequently discharged on 5/11/2021 to rehab. During this admission patient had a LP on 5/7/21 which revealed elevated protein, patient diagnosed with Guillain-Barre Syndrome and treated with 5 days of IV.  Immune Globulin. Prior to the admission patient was independent with no use of DME.
Maladministration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix. On an unknown date, an unknown time after receiving Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Maladministration after temperature excursion). The action taken with Menveo was unknown. 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: GSK Receipt date: 13-APR-2023 The other healthcare professional stated that several vaccines like Shingrix, Pediarix, Infanrix, Menveo (2 vials presentation), Havrix, Engerix-B and Boostrix suffered temperature excursion on 31st December 2022 at 0.4 degree Celsius for 1 hour below the recommended storage conditions for GlaxoSmithKline vaccines. The reporter consented to follow up and requested to send an email with all adverse event details instead of providing them on the phone. The case was linked with case US2023AMR055743, reported by same reporter. The patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:Same reporter. US-GSK-US2023AMR056407:same reporter
Pt felt dizzy and though he was going to pass out a couple of minutes after the shot.   Blood pressure dropped to 109/63
Burning sensation when vaccine was injected & the shot hurt.  During the rest of evening my left arm was sore. During the night, I couldn't get comfortable because my left arm pit started to hurt and could tell it was somewhat swollen.  Woke up next morning and I had a low grade fever and my lymph nodes were tender and hurt to touch.  Fever lasted all day & into the late night day after vaccine, but the arm pit lymph nodes lasted three and a half days.  They are still a bit tender but not swollen today (02/10/2021). I had NO body aches but a little chills.
I got the vaccine on 30th of Dec. Had a sore arm, runny nose, woke up the next day to puffy eyes and bruises under my eyes (still hasn't gone away) Since then I have had GI issues. Constipation. It aggravated my face. I had nausea. I had a rash on my arm and on my chest the following Tuesday. My face were tingling and very flush. I had a lot of allergy and sinus issues. Sinus pressure. This all unfolded the first few weeks after receiving the vaccine. I do have fibromyalgia. I had allergy testing done. I am allergic to bee stings. Was having a lot of vaginal issues. Watery eyes and have hot flashes followed by chills. Hives on chest. Difficulty swallowing. Rapid heart rate. I have seen three doctors that have told me my hear rate was fast. Glands have been swollen for two weeks. The night after I got the shot it was really rough with body aches.
Received vaccine afternoon of 1/20.  I am a hospital pharmacist and expected potential adverse reaction on 2nd vaccine based on moderna studies.  I felt fatigued that evening and was starting to get a headache, so took 2 extra strength Tylenol and went to bed.  Woke 1/21 with a headache, took 2 extra strength tylenol that morning.  At noon, developed fever of 100F, chills, and worsening headache.  Fever did not break until around 2am the following morning.  Headache remained until 1/22 afternoon, then subsided.
My son was normal until these shots were done. On 6/14/05, he was given 6 shots. The doctor never explained the risks to me because I would have never allowed it. My son had sick effects with every shot. He had swelling with every injection and was very irritable. I was told to put ice at the sites and TYLENOL. Now my son has been dx'd with autism. My son was developing normally until vaccinated on 6/14/05. After that, his eye contact decreased and whatever speech he had, decreased to none. He would often call out mama and dada and now nothing. I had him evaluated in 1/06 and was told he had PDD NOS. Then I had him re-evaluated on 6/20/06 and was told he had Autism. He has been receiving services since 1/06. Now they have increased to ABA and speech effective 8/06. My son is exhibiting all the classic signs of mercury poisoning and yet the doctor that I took him to, doesn't know how to test him. I now take my son to a DAN doctor, who is trained in this field. We are seeing progress with Chelation therapy and it has only been 2 weeks. I cannot believe the garbage that is injected into these children and did my son really need a Hep-B shot when he was born, was he really going to have unprotected sex and use IV drugs. I will never immunize my children again. Thanks again for the beginning of a nightmare and a costly one to fix your cover-up. 9/18/06 Received medical records from new PCP which reveal patient was evaluated & diagnosed by a clinical psychologist as PDD initially 1/06 & again 6/06.  Evals included with medical records/ss
long COVID symptom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (disability), outcome "unknown", described as "long COVID symptom". Clinical course: Reporter have 2 friends with long COVID symptoms after they were vaccinated. Neither had COVID before but now they are battling with long COVID symptoms to the point of being disabled.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lethargy, poor feeding, fever to 103.5 - Given TYLENOL. Rapid recovery this AM.
Left shoulder - 2-3cm induration at site of injection. Erythema reported earlier by pt. - now visible on exam.
caller states they have received four booster (doses); This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (caller states they have received four booster (doses)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Type 2 diabetes mellitus, Asthma and Heart disease, unspecified.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced EXTRA DOSE ADMINISTERED (caller states they have received four booster (doses)). At the time of the report, EXTRA DOSE ADMINISTERED (caller states they have received four booster (doses)) outcome was unknown.            No concomitant medications were reported.  He received fourth booster was a couple days ago. Caller stated that he received two full doses plus 1 booster very 6 months. Caller initially stated they received a booster every 6 months after dose 2 and then they stated some of the intervals "may" have been about 4 months.   No treatment medications were reported.
Chest pain; The caller's heart is not racing and she does not think anything is going on; The pain is under the sternum; trouble breathing; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration on 10Mar2021 as dose 1, single for covid-19 immunisation  .  Medical history included epilepsy, mitochondrial disease, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient received her first dose on 10Mar2021 and was waiting in the waiting area she had chest pain and a little trouble breathing, she has COPD and they let her use her inhaler. The chest pain, which is atypical, resolved. Patient's heart is not racing and she does not think anything is going on. The pain is under the sternum. The outcome of chest pain was recovered while outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/ITCHINESS/BUMPS/REDNESS; SLIGHT SORE ARM; MILD HEADACHE; KIND OF PRESSURE BEHIND ONE EYE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 150 pounds, and height was 62 inches. The patient's concurrent conditions included non-smoker, non-alcohol user, and overweight, and other pre-existing medical conditions included the patient does not have any medical conditions and not taking any medication, the patient had no known allergies, the patient had no history of drug abuse or illicit drug use, the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced kind of pressure behind one eye. On 06-APR-2021, the subject experienced slight sore arm. On 06-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore arm on 08-APR-2021, and mild headache on 06-APR-2021, had not recovered from eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness, and the outcome of kind of pressure behind one eye was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX23. The nurse reported that the PNEUMOVAX23 was exposed to temperature of 11C. On an unknown date in December 2012, there were 13 excursions for a total time of 112 hours. On an unknown date in January 2013, there were 9 excursions for a total time of 72 hours. On an unknown date in February 2013, there were 11 excursions for a total time of 96 hours. On an unknown date in March 2013, there were 7 excursions for a total time of 56 hours. On an unknown date in April 2013, there were 12 unknown date in June 2013, there were 6 excursions for a total time of 49 hours. On an unknown date in July 2013, there were 11 excursions for a total time of 104.5 hours. On an unknown date in October 2013, there were 2 excursions for a total time of 17 hours. The nurse stated that the doses were administered to unspecified number of patients on unspecified dates throughout the year. No adverse effects reported. Action taken with PNEUMOVAX23 was unknown. The outcome of the event was unknown. This case was linked to the same reporter linked cases 1401USA000217 and 1401USA000218. Additional information has been requested.
Localized erythema, swelling, itching and soreness.  Directly applied ice to reduce swelling.
Significant discomfort and loss of some mobility in left arm approximately 1-2 hours after administration, still continuing after 24 hours. She saw her physician, unsure of treatment. She reported significant discomfort with initial administration.
This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Bilateral pulmonary embolism, Heprin drip for 3 days, Eloquis daily
Joint pain, muscle aches, dizziness, trouble digesting food, constipation, low energy, weakness, loss  of balance, fell down, broke nose in 3 places, injured face, busted lip,  injured right shoulder, injured left knee; injured fingers.  Right arm not working. Going to physical therapy once weekly. Will need plastic surgery. Will need possible shoulder surgery.