chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case, received on 19-Oct-2017, reported by other health professional concerning a 29-year-old adult female patient. The patient's current condition was immunocompromised. On 18-Oct-2017, the patient received AFLURIA QUADRIVALENT (route of administration: intramuscular/subcutaneous (IM and maybe SC: as reported), batch number: 01444621A (as reported), expiry date: 30-Jun-2018, dose and anatomical location was not reported). At the time of administration, the patient's skin was pulled to the side, kind of little on her skin to the left and not sure of the quantity of vaccine received through intramuscular and through subcutaneous. The patient did not received full dose (explicitly coded as under dose), because the pharma jet injector slipped during the administration (explicitly coded as drug administration error). No adverse events were reported after vaccination. As stated, the patient was immunocompromised, however the reporter doesn't know whether the events were due to a particular disease as it was not provided by the patient. At the time of this report, the outcome of the event (injection site abrasion) was recovered and other events were not reported. The reporter assessed this case as non-serious. Significant case correction was received with IRD 19-Oct-2017: The event 'drug administration error' was deleted.
Suspected Covid-19; Suspected Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: Fe3592) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Suspected Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Patient received COVID 19 Treatment, brand: Pfizer, Treatment start date: 06May2022, Treatment stop date: 11May2022.
5 days after injection, pt dvlped redness, itching, & swelling at injection site; which lasted for 3 days.
This spontaneous reprot as received from a nurse refers to unknown number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were inadvertently vaccinated with improperly stored GARDASIL injection, lot # K016966, exp. date: 10-MAY-2017 and lot# J002641, exp. date: 10-DEC-2015 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
hive near my hair line; felt lousy / was kind of in a fog and didn't feel great.; This is a spontaneous report received from a non-contactable consumer reported for 74-Year-old female patient that:  A 74 years female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration, on 01MAR2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller states she received the Pfizer Covid vaccine first dose on the 01Mar2021, and experienced "I got a hive near my hair line, 4 or 5 days after I got my vaccine, I felt lousy for 2 weeks after the shot. but I always have bad reactions to everything. I didn't have SOB or fever, but I took Tylenol after the vaccine. I took Benadryl, I took 2 on Saturday night and 1 on Sunday and one on Monday. I went back to normal on Friday, I was kind of in a fog and didn't feel great. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster).    It is unknown if patient was under any concomitant or regular medication.   Reporter did not allow further contact
Sore throat, fever, vomiting and diarrhea (continuous for 8 hours). In hospital had IV's and IV antibiotic (I had taken charcoal prior to hospital stay). 7 hour hospital stay.
Previously physically fit and healthy patient experienced progressive autoimmune symptoms coincident with successive anthrax shots. First three shots from FAV034 administered on 08 Oct 98, 22 Oct 98, 05 Nov 98; followed by flaking/peeling skin on palms of hands and soles of feet, onset approximately two to three weeks after third shot. Has continued intermittently through 2007. Possibly unrelated: Followed EKC infection to left eye in December 98, stabbing pains, dryness, irritation, and persistent infiltrates on cornea. Treated with prednisone acetate drops for eight months, followed by fluorometholone for two years. Infiltrates reduced, symptoms of dryness, pain, eased by continuing through 2007, recurrences apparent with other autoimmune symptoms. Fourth shot lot FAV043 on 21Apr99, fifth shot FAV044 29 Nov 99. Sixth shot in series, lot 048B, given 06 Jun 00. 02 July 00, onset of burning on urination with discharge, 05 July 00 onset of severe joint swelling, leading to ER visit 07 Jul 00, discharge 08 Jul 00. No infection present. Diagnosed as Reiter's Syndrome. No history of infections associated with Reiters. Treated with sulphasalazine with some success. Symptoms recurring through 2007, to extent walking only possible with aid of crutches. General loss of energy and loss of adrenal function, onset 2001, persistent through 2007. Recurrent of painful urination Jan 2003, unresponsive to treatment, coincident with chronic epididymitis, and burning semen accompanied by skin inflammation after semen contact. Occasional hematospermia. Cyst development on site of pain on epididymis 2005. Multiple cyst development on skin 2003 to 2005. All symptoms persistent through 2007. Possibly unrelated: Tinnitus onset 2002, no associated hearing loss. Persistent 2007. 1/31/08-records received from reporter, Diagnosis of Reiter's Disease. Right knee swelling. Epidermal keratoconjunctivitis. Epididymitis.  Neck pain. Dysuria. Urethritis.
fatigue; achy joints; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and ARTHRALGIA (achy joints) 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 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and ARTHRALGIA (achy joints). At the time of the report, FATIGUE (fatigue) and ARTHRALGIA (achy joints) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Reporter stated is he doesn't not want to speak about the case. He declined Further FU.
Mild case of varicella (10 lesions) and fever of 99 deg. F.
SEVERE HA, ACCOMPANIED WITH DIZZINESS, NAUSEA, VOMITED X1, BAD TASTE, FATIGUE, VERY SLEEPY
This spontaneous report as received from a 80 year old male patient regarding himself. The patient had Allergy to ZETIA. On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX dose (unspecified), frequency (unspecified), route (unspecified), for prevention of shingles. Concomitant therapies included medication for heart issue (manufacturer unspecified). on 20-DEC-2013, he felt a burning sensation on his back left by the shoulder blade which was running around to the front of his chest. Patient also felt that vaccine gave him the shingles instead of protecting him from it. The outcome of events was unknown. Patient sought unspecified medical attention. No product quality complaint was involved. Causality was unknown. This is one of the two reports received from the same patient (#1401USA001174). Additional information has been requested.
This spontaneous report as received from a health worker refers to unspecified patients of unknown age. On an unknown date, the patients were vaccinated with (Oka/Merck) PROQUAD (dose, frequency, route and lot number not provided), which was exposed to temperatures outside of recommended condition and no adverse events were reported. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
symptoms: fever/chills, headache, fatigue, body aches, muscle pain (at injection site) onset: 11 hours post-injection course: 24 hours (fatigue persisted for 48 hours from onset of symptoms) treatment: tylenol, rest, hydration outcome: symptoms resolved by 4:30pm on 02/02/21
Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely dizzy and getting "tunnel vision." Patient sat down on the floor of her own accord without injury or difficulty. Had patient elevate her legs above heart level. Checked patients vitals, her blood pressure was low, but O2, respiration and pulse were within normal range. Patient was shaking and reported her tongue felt "tingly" and "heavy on my chest." Patient reported she had a smoothie prior to coming in for her appointment. She was given sprite. Patient felt better, but approximately 7 minutes later reported her stomach felt queezy. Blood pressure had improved and other vitals were still stable. Patient still reported her tongue felt "tingly," but no swelling, trouble breathing, or throat tightness. Patient was picked up by her father 45 minutes later and was able to ambulate to the car (with supervision) of her own accord without assistance.
AS SOON AS THE VARICELLA AND MMR WAS GIVEN LOCAL REACTION OCCURRED IN THE FORM OF WHEAL, TWO OF THEM AND SOME REDNESS.  WE GAVE HER BENADRYL AND AFTER 40 MINUTES OBSERVATION THE WHEALS HAVE DISAPPEAR AND DURING THIS TIME NO RESPIRATORY DISTRESS WAS ELICITED.  SHE WAS SENT HOME.
This is a hospitalized in-patient that received the vaccine on 4/12/21 and aspirated on 4/16/21. Unclear of causality.
Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2019 in left arm).   On an unknown date, the patient did nor receive the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-May-2023  The patient received the 1st dose of Shingrix at a pharmacy location at the end of October 2019. The patient reports she received the vaccine in her left arm.  Patient reports that she did not receive the 2nd dose of the vaccine.  Lot number and expiry date information were unknown at the moment of the call. Not all information was available.  Customer reports that covid pandemic started at the time and the 2nd dose was never received.  The reporter said she got the covid vaccines and the boosters but not the 2nd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Shingles detected on 2/8/2021 by patient. Visited dermatologist on 2/9/2021. Diagnosed with shingles. Provider suggested I report such to the CDC. Given a prescription for Valacyclovir.
Bruise at vaccine site on arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site bruising in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had a bruise at the vaccination site and enquired if this was normal. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Four days after vaccine pt developed lower back pain, then abd pain, constipation. On 3/19 she developed painful rash right anterior thigh/buttock and right suprapubic area. Seen in ofc 3/20 and had classic Herpes zoster rash. Treated with oral valcyclovir and on follow-up 3/28 rash is improving, but has 10/10 post-herpetic neuralgia. To begin gabapentin 100 mg tid and return for f/u 2-3 weeks.
Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (652965/0622F) ZOSTAVAX on 23-OCT-2006. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
it started within 10 hrs of injections...severed body aches, headaches, ear ache, chills and nausea and then exactly 9 days later I had severe rash outbreak. When I received my first Moderna vaccine  (3-12-21) I also had  same reaction and then severe rash outbreak 9 days after the injection and bumps that were itchy from my neck down to my ankles (total body covered with rash) . I went to dermatology first, then to my primary who referred me to an allergist but no diagnosis was determined to the cause
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: Jun2014; ALBUTEROL [SALBUTAMOL] nasal, start date: Jan2015; ATIVAN, start date: Jun2013, stop date: 09May2022; FLOVENT nasal, start date: Feb2018. Past drug history included: Minocyclin, reaction(s): "Known allergies:Minocyclin", notes: known allergies : Minocyclin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I had a return of COVID symptoms and a new positive antigen test 5 days after completing the course of Paxlovid. Therapeutic measures were taken as a result of covid-19.  Additional information: Adverse event: I had a return of COVID symptoms and a new positive antigen test 5 days after completing the course of Paxlovid.
At 1910 client reported to EMT "feeling a headache." EMT contacted RN  for assistance while he set up the anti-gravity chair. RN  arrived and client stated she felt fine to transfer to anti-gravity chair. Vitals at 1912: blood pressure 176/96. Client reported feeling tingling and numbness to her tongue, chest pressure and headache. PHN  arrived as RN  was discussing Benadryl medication with client. PHN  asked client to remove mask to assess for swelling and rash. No swelling, flushing or rash noted on face, tongue or neck. Client denied shortness of breath at this time, client describes as "just a tingling sensation." Client accepted Benadryl and PHN administered Benadryl 50 mg IM at 1914. Within a minute of administration client reported feeling her mouth dry and "feeling sensation was going down towards throat." Vitals at 1916: blood pressure 159/108, pulse 96, oxygen sat 99%. Client reported medical history of bipolar disorder, current medication of Abilify, and allergy to avocados. At 1916 client reported chest pressure was improving, headache improving, sensation to tongue returning, and stated, "I feel like it's opening", when PHN asked regarding her throat. Client alert and oriented x4. Client denied itching, nausea, or blurry vision. Client asked staff for water as her mouth felt dry. EMT  gave water and PHN  instructed client to take a small sip. Per client, was able to swallow normally. Vitals at 1921: blood pressure 148/100, pulse 91, oxygen at 99%. Client reported improvement of all symptoms. At 1923 client reported all symptoms had resolved. Client asked if she could leave. PHN  advised to complete 30 min observation as she had received medication. PHN  reviewed with client and client's husband ER precautions and advised to follow up with medical provider. Per client, client's husband would drive her home. Client reported "feeling fine." Vitals at 1930: blood pressure 158/103, pulse 97, oxygen sat 96%. PHN  reviewed clients blood pressure readings and suggested she follow up with provider. Client verbalized understanding. At 1937 client reported headache was returning and "felt left side of tongue was beginning to feel numb.". At 1937 911 activated by RN. PHN  assessed again for swelling on face, tongue, neck. No swelling noted. Client denied shortness of breath. PHN continued to speak with client who was alert and oriented x4, speaking clearly and in full sentences. Fire Department and Paramedics assumed care at 1944. Client left facility via gurney at 1947. Upon leaving client had not decided if she wanted to be taken to another medical facility.
pt recv vax 13JAN99 & 2 days later devel a fever of 102 & diarrhea;
pt recv vax 24JUN96-25JUN to evening; urgent care w/swollen, painful arm;
Photophobia; Blurred vision; Fever ranging from 101.6/101.7 degrees Fahrenheit; Body aches; Headaches; This spontaneous case was reported by an other caregiver and describes the occurrence of PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches). The patient was treated with ZINC for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] for Adverse event, at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Body temperature: 101.6/101.7 (High) Fever ranging from 101.6/101.7 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided.
TIA (transient ischemic attack); symptoms appeared a week prior to presentation to ED but subsided then reappeared again so she came to ED and was admitted for observation.  Under observation symptoms subsided again, except for a decreased sensation on the left arm and right foot.  Patient is currently on stroke work up and was started on dual antiplatelet therapy with aspirin and plavix for 21 days.
Both (R) and (L) deltoids swollen and inflamed, tender to touch. Less "tight" than 2 days before, loose stools today, fever today - T-100 yest. TYLENOL with relief. Cold compresses with relief.
Extreme muscle weakness, nausea, heart palpitations, sleeping 20-22 hours a day for 2 weeks, sleeping 18-20 hours a day for another week. Inability to walk between rooms, shortness of breath
Per patient father, patient tensed up and fell to the floor while standing.  When I first observed the patient, he was beginning to come to and was speaking.  EMTs arrived shortly after and they did not observe any other abnormalities.  Patient did vomit when first sitting up.  EMTs gave patient an IV and took to ER for observation of head injury.
PT LEFT ARM (DELTOID REGION) SWELLED UP AND WAS WARM AND RED. SYMPTOMS BEGAN THE NEXT MORNING (12 TO 18 HOURS LATER) AFTER RECEIVING THE VACCINES THE DAY BEFORE. IT WAS A LARGE AREA OF 6 INCHES REDNESS WHEN SHE CAME IN TO THE PHARMACY 9/28/17.  I RECOMMENDED SHE BE SEEN BY THE DR. THEY WENT TO THE CLINIC AND RECEIVED A STEROID SHOT AND A ANTIBIOTIC SHOT. AND WAS TOLD TO ICE IT AND ALTERNATE WITH HEAT AND THEN FOLLOW UP IN THE NEXT MORNING.
Pain throughout arm/hand when got the shot. Severe pain continually got worse unable to use left arm to complete daily tasks. Interfered w/bathing, dressing, etc. Went to MD. Was placed in sling & given anti-inflammatory meds.