chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes zoster; Post-Herpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 87 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster and post-Herpetic neuralgia. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster and post-Herpetic neuralgia. The outcome of the events herpes zoster and post-Herpetic neuralgia was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
immediate local injection site inflammation & urticaria lasting 4 days, later in day and over next 2 days minor throat swelling and feeling of facial fullness, all symptoms resolved without treatment over 4 days
made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included influenza and shingles.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2023AMR037453   Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient stated that the flu shot had made him/her sick. Additional Supportive Information: This case had been linked with US2023AMR037453, same patient. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR037453:Same Patient
11hr of lethargy, pallor, unresponsive occurring w/in 12hr of vax;
Fever (100.6 by mouth), body aches, strong headache, vomiting, raised red and hot area at injection site and even larger raised red and hot area below injection site, painful arm, burning at site even 5 days post-injection.
Pt. started to feel swelling in her lips, as well as started to get the hives and was itchy. Pt. was administered 0.3 EPI in Right thigh @ 10:35 A.M.  Pt. vital signs well and checked every 15 minutes.
WEIRD FEELING ON EATING NUTS; NUMB ARM; PAINFUL  ARM; This spontaneous report received from a patient via a company representative concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menorrhagia due to fibroids in uterus.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included cetirizine hydrochloride for seasonal allergy.  On APR-2021, the subject experienced painful arm. On APR-2021, the subject experienced weird feeling on eating nuts. On APR-2021, the subject experienced numb arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weird feeling on eating nuts, painful arm and numb arm was not reported. This report was non-serious.
Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with cases 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE via intramuscular route (Batch number: UI669AA, expiry date: 30-Jun-2017, dose, dose in series and site of administration were not reported) on 04-Oct-2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was unknown. Illness at the time of vaccination was also reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patient developed severe tenderness to entire left breast and axillary area, some swelling to the skin between my arm and upper breast, Small red area and deltoid tingly. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
This spontaneous report was received from a physician refers to an approximately 32 years old male patient. It was reported that the patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medication. On 07-APR-1986 the patient was vaccinated with first dose of M-M-R II (lot, expiry date, dosing regimen and frequency and route were unknown) for the prevention of measles, mumps and rubella. On 09-MAR-1999, the patient was vaccinated with second dose of M-M-R II (lot, expiry date, dosing regimen and frequency and route were unknown), On 24-OCT-2005 the patient was vaccinated with third dose of M-M-R II (lot, expiry date, dosing regimen and frequency and route were unknown) and On 21-SEP-2006, the patient was vaccinated with fourth dose of M-M-R II (lot, expiry date and route were unknown by the reporter) for the prevention of measles, mumps and rubella. Other suspect therapies included sterile diluent. On an unknown date "titers were drawn" after third dose of M-M-R II and the results showed the patient had low titers of measles and rubella. On an unknown date "titers were drawn" after fourth dose of M-M-R II and the results showed the patient now had a low mumps titer, but the antibody titers of measles and rubella are normal. It was reported that the patient sought medical attention by visiting the physician. The outcome of the events were unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Awoke on 4/16 with redness, swelling & discomfort at injection site- left arm. By 4/17 "could not see elbow," red, painful to move left arm. Arm described as a "balloon" from shoulder to wrist. On 4/18 redness, swelling/ pain began to diminish: almost "normal" by 4/22 morning. To doctor on 4/19: Prescribed Doxycycline for 7 days.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAX HIB injection, lot # L006545, expiry date 16-NOV-2017, 0.5 milliliter, intramuscular. No adverse effects reported. No product quality complaint (PQC) was involved. No additional information reported. Additional information has been requested.
Passed out approx. 3 times with confusiion had episode of blurred vision, weak, symptoms worse, car ride from office to ER. Symptoms started on car ride home from office.
This spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and gender. No information was provided regarding the patient's medical, drug and allergy history or concurrent conditions. On an unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported), VAQTA for prophylaxis, (strength, dose, frequency, route of administration, lot number and expiration date were not reported) and ROTATEQ orally, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). Temperature-Time frame: -0.3C for 35 Hours below 0°C, 9°C to 25°C (9.8C) for 20 Hours according to digital data logger. No adverse effects were reported.
Received H1N1 injection in L deltoid area. Started having pain at injection site on 11-12-09. Took TYLENOL for pain and has continued taking TYLENOL since 11-12-09. Has limited ROM to L arm since injection on 11-12-09. At present, unable to left arm above shoulder level. Has continuous pain especially at night.
Severe itching, large blisters all over body, temperature, headache. Saw dermatologist (2) bi ops to rule out mites, prednisone, permethrin cream 5% and fluocinonide 0.05% cream.
Product recalled 10/12/22 due to incorrect expiration date  - Product expired 9/30/22 - Vaccine was given 10/10/22 - Parents report no adverse reaction
hives on the face; Initial information received on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Infant (6 months and older) and unknown gender patient who was diagnosed with hives on the face while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization    On an unknown date the patient had hives on the face (urticaria) 4 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (hives on the face).  At time of reporting, the outcome was Unknown for the event hives on the face.
Patient was feverish and vomited before passing out. Evaluated at emergency room and found no health problems so assumed maybe result of vaccination.
Patient presented to emergency department on 1/15/2021 with nausea, vomiting, headache, and chills. Patient was given supportive care and discharged home in stable condition.
Patient seen on 06/26/2006, for rash he had for 3 to 4 days. Rash was diagnosed as atypical chicken pox. Treated with Aveeno oatmeal bath, Atarax and calamine.
Discomfort; Arm pain; The student nurse aimed very high on my shoulder/thinks that Fluad was administered to high/ Near the shoulder; This spontaneous case was received on 25-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05011) and concerned a 74-year-old, male patient.  The patient's medical history and concomitant medication were not reported.  On an unspecified day in Oct-2022, between 16-Oct-2022 and 22-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4; dose: 0.5 ml, route of administration, anatomical location: not reported) for prevention of influenza disease. The batch number was not reported. As it was reported that the student nurse administered Fluad to high on patient shoulder (explicitly coded as 'Vaccine administered at inappropriate site').  On unspecified date in Oct-2022, between 16-Oct-2022 and 22-Oct-2022, after vaccine administration, the patient experienced discomfort and pain in the arm. The patient had to take ibuprofen for the arm pain.  On an unspecified date, reported as three days after onset, the patient recovered from the event of discomfort.  The outcome of the event of pain in arm was unknown.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 74-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As it was reported that the student nurse administered Fluad to high on patient shoulder (explicitly coded as 'Vaccine administered at inappropriate site'). An unknown amount of tie after vaccination the patient developed discomfort and pain in arm. Causality for vaccine administered at inappropriate site is assessed as not related. Causality for the remaining events could not be ruled out and is assessed as possibly related.; Reporter's Comments: .; Sender's Comments: A 74-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As it was reported that the student nurse administered Fluad to high on patient shoulder (explicitly coded as 'Vaccine administered at inappropriate site'). An unknown amount of tie after vaccination the patient developed discomfort and pain in arm. Causality for vaccine administered at inappropriate site is assessed as not related. Causality for the remaining events could not be ruled out and is assessed as possibly related.
Pt here for well child ck. Offered HPV #2. Pt's mother declined said last HPV we admin on 10/4/10 caused nausea, vomiting within 24 hrs after shot lasting 7 days.
Severe aches from neck to hips, and very tired, slight headache. Symptoms lasted 5 to 6 hrs.
This spontaneous report was received from an office manager refers to a patient of unknown age and gender. On 30-JUL-2013, the patient ws vaccinated with a dose of GARDASIL (lot # H021346, expiration date 01-OCT-2015) that underwent unsupported excursions. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient was given a full dose (0.5ml) of moderna covid 19 vaccine instead of the indicated 0.25ml dose. pt had recieved j&j as their first dose in 3/2021, their booster dose of moderna in october 2021, and had come in for their additional dose due to being immunocompromised. however, their 2nd dose was 0.5ml, a full additional dose, so they should have gotten 0.25ml as their 1st booster dose. patient was informed of the incident via phone 3/31/22
Patient felt dizzy, lightheaded, and flushed about 10 minutes after receiving vaccine. Patient was advised to sit quietly. Was given cold compresses and BP checked twice. First reading was 138/78 P 93, second one 5 minutes later was 132/75 P 90. Patient sat for 15 minutes longer, then claimed she felt better.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The vial was initially stored in the refrigerator on 17-Dec-2021. The vial did not undergo any temperature excursions and vaccine beyond use date was 16-Jan-2022.   No Treatment medications were reported.
fainted in car approx 10min post vax;mom reports still not acting like self when home;feels like off some place;seen in ER, blood drawn OK so far, all results not back;instructed not to get any more shots;arm becams swollen & looked burnt;
14 hrs after vaccine developed fever, headache, chills, cough, and severe all over body aches.  Monday 1/11 through today 1/13 still feeling feverish with chills and body aches but no actual fever and deep dull back pain that is making me vomit.  Also injection site redness started 48hrs after vaccine and only continues to worsen and spread each day still today 1/13.  Have been taking  Tylenol, Motrin, antihistamine, and at times Zofran.
Received immunization on 3/12/09. Parent of child noticed pain, swelling on 3/19/09 came into clinic on 3/20 with area of redness, swelling and pain increasing in size. CEPHALEXIN, BENADRYL, sling given on 3/20. PREDNISONE RX written on 3/21 after another office visit.
Headache, Myalgia, Fever, fever chills muscle aches Narrative:  Other Relevant History:
Severe migraine headaches, chills, shaking, neck pain, rash -red dots on back
Persistant discomfort in left arm where vaccine was administered.  Continues everytime I move this arm and is very painful when pressure is applied and when I bend my arm.  My arm was fine prior to this and these symptoms began as soon as I had the vaccine.  Mentioned it to my doctor on November 15, 2011, November 29, 2011 and again on December 12,2011.  On December 12, 2011 I was informed by my doctor's nurse that this discomfort was entirely not related to the vaccine.  I disagreed with her opinion and told her it was too much of a coincidence since the pain began after I had the vaccine.  I hope this is not a permanent condition in my arm now.
Redness to left anterior thigh, measures 10.0 L x 7.5 W, warm to touch. No open areas. No blisters present. No discomfort upon assessment.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 29-SEP-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L019130, expiration date 27-MAY-2015) that was improperly stored. No adverse effects were reported. The primary reporter reported that these doses were administered following an excursion of 14F from 28-AUG-2015 through 17-NOV-2015. This is one of 3 reports from the same reporter. Additional information has been requested.
Within 30 minutes of receiving the vaccine, my daughter began feeling extremely exhausted and tired.  Within 2 hours she was extremely nauseous and had a terrible headache. These side effects lasted for about 1 full day (24 hours). After the 2nd day she was back to normal and has not had any problems since. There was no treatment needed, just rest.
Patient created appointment 45 minutes prior to appointment with a mass vaccination event, on 4/7/21, via an offsite call center. Patient received first dose of Moderna series on 4/7/21. Upon documentation it was recognized the patient had the first and second doses of the Pfizer vaccine on 2/2/21 and 2/23/21, respectively. In the patient's chart it was found she has a diagnosis of dementia and memory problems, with her son being listed as her main point of contact for appointments due to her memory problems. Son contacted and message was left.
Immediately upon vaccination -  dizziness, fast heart rate (~130 bpm), restlessness, jittery, trembling, flushing of face. Diarrhea after 15 minutes. Symptoms resolved within the hour on their own. Blood oxygen and blood pressure within normal limits.
7 days after being vaccinated developed swelling, redness, tender, and warmth at injection site.Size of grapefruit.
1/2 hr p/vax pt became nauseated, had vomiting for 4 days, still has some problems w/digestation; has muscle aches, tiredness; has pos TB skin test; Did not go to MD unable to afford visit;
It has been exactly one week since my first shot, and I am developing a very itchy rash and swelling at my injection site.
TINGLING IN LEFT FOREARM DIZZINESS LASTING APPROXIMATELY 4 MINUTES TIGHTNESS IN THROAT LASTING APPROXIMATELY 2 MINUTES
Patient returned to office ~15 minutes after MMR vaccine due to acute onset of b/l eye edema and yellow discharge as well as hives. 911 was dialed immediately and Epipen was administered immediately- his lungs were clear with good AE to the bases. O2 sat was 80s, O2 was started, EMS services arrived, Decadron 10mg IM was given. He continued to be less responsive and lethargic. He was transfered immediately to the ambulance. Father was patient side. Patient was sent to Medical Center ED, and received 3 more doses of epi and oxygen via Nasal canula
pt recv vax 22AUG96 & pt exp worsening of abd discomfort & upper resp sx;AUG96 pt devel a "1/2' x 3/8' lesion that persisted for 1month;mom concerned that the lesion would scar the child;
light headed, caused him to pass out; dizzy; A spontaneous report was received from a consumer concerning, a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced light headed caused him to pass out and dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   It was also reported that after receiving his first dose, the patient reported symptoms of fatigue, headache and chills.  On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  After receiving the second dose, the patient reported feeling dizzy and lightheaded when he woke up the next morning. He then passed out and hit his head. No treatment information was provided.  Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the events, light headed caused him to pass out and dizzy were unknown.; Reporter'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.