chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID- 19 Vaccine EUA.  Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020.   On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak.    On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant.  She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises.    She is pending occupational health follow-up.
A spontaneous report has been received from a Physician concerning a male patient, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent had been started on an unknown date. The patient experienced two patients accidentally received expired FLUMIST Quadrivalent. The outcome of the event of two patients accidentally received expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
lethargic; doesn't feel good/malaise; neck sore; arm sore; body aches; fever; Pain during injection; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (lethargic), MALAISE (doesn't feel good/malaise), NECK PAIN (neck sore), PAIN IN EXTREMITY (arm sore) and MYALGIA (body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 01-Apr-2020.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain during injection). On 04-Mar-2021, the patient experienced LETHARGY (lethargic), MALAISE (doesn't feel good/malaise), NECK PAIN (neck sore), PAIN IN EXTREMITY (arm sore), MYALGIA (body aches) and PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), MALAISE (doesn't feel good/malaise), NECK PAIN (neck sore), PAIN IN EXTREMITY (arm sore), MYALGIA (body aches), PYREXIA (fever) and VACCINATION SITE PAIN (Pain during injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
After recieving the Gardasil vaccine, about 3-4 ours later she had severe abdominal pain that did not stop. I gave her motrin but it didnt help.  After she begain to yell, I drove her to hosp.  The ER Docs refused to think Gardasil had anything to do with her pain because they claim to have never heard of such an event happening with a patient before.  I happen to disagree with them.  9/28/09 ER records received DOS 8/4/09 to 8/5/09. Assessment: Chest pain, abdominal pain, allergic reaction to Gardasil. Patient c/o stabbing pain in middle of chest. Hurts with movement. Cough. Stabbing abdominal pain. Headache, nausea, "shakes", crying. Abdominal gas and distention as etiology for pain. Chest pain now resolved. Patient in no distress.   9/28/09 Received ICD9 codes: 786.59; 789.00; V14.0./ss
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored VARIVAX (merck) 0.5 milliliter (ml) doses have been administered subcutaneously to unspecified number of patients on unspecified dates. The vaccine have been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. This is one of two reports. The case is linked to 1406USA010764 (same reporter link). Additional information has been requested.
Atrial fibrillation/ had atrial fibrillation 7/24; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient).     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced atrial fibrillation for two days after the first dose and had atrial fibrillation 7/24 for four months after the second dose. This necessitated ablation surgery. The outcome of the event was reported as recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
RASH ON SIDE OF FACE, NECK AND DOWN CHEST.  C/O PAIN.  DX WITH SHINGLE ON 9/25/08
Initial report received from a consumers' grandmother on 23 May 2011. A 16-year-old female patient received an intramuscular injection of FLUZONE SV, sanofi pasteur lot number U3784AA, on 06 January 2011. The patient had received influenza vaccines in the past. She had no known allergies (NKA). The patient had no illness at the time of vaccination. Since 08 January 2011, the patient had symptoms of a headache from the crown to forehead, dizzy feeling, stumbling gait, lack of balance, shaking hands, and weakness. She was diagnosed at hospital with "disautonomia". The patient has not been able to attend school and has been having difficulty swallowing. The outcome was reported as not recovered. Documents held by sender: None.
Patient reports immediately after receiving vaccine, she felt "woozy." Withing 3-4 minutes post-vaccination, she attempted to get out of car to get water/juice from vaccine staff and patient lost consciousness and was caught and lowered to ground by staff at vaccine site.  She regain consciousness prior to being lowered on ground.  VITALS at time of event: HR 60, RR 16 even and unlabored, BP 90/62 lying down.  Feet were elevated until patient felt she could sit up. No c/o of n/v/diaphoresis. No dermatological changes. After lying down for approximately 5 mins, patient was able to stand and get into chair at 10:45 AM. BP at that tim e98/60, HR 74, RR 16.    At 10:50 AM, patient reports she felt back at baseline in NAD. A&O x 4, her parents did come and pick up her for transport home.  Patient self reported history of syncope with medical procedures and events in past.
I woke up feeling out of sort--drowsy, listless. Around 11 a.m. I went back to bed and stayed there until 3.30. As the day wore on, I felt better and better.
Headache, Myalgia, Arthralgia, Fever, chills Narrative:  onset of s/s noted above within ~8 hours of 2nd injection
eceiving the 4th shot along with flu shot/receiving Pfizer with a Flu Shot at the same time; I began to feel like having cold; car sick; I'm still having a mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose 4 (booster), single (Lot number: GH9697), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Jan2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin (no memory, was told this)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Unknown Manufacturer), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single, Unknown Manufacturer), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster), Unknown Manufacturer), administration date: Nov2022, for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jan2023, outcome "recovering", described as "I began to feel like having cold"; HEADACHE (non-serious) with onset Jan2023, outcome "recovering", described as "I'm still having a mild headache"; MOTION SICKNESS (non-serious) with onset Jan2023, outcome "recovering", described as "car sick"; PRODUCT USE ISSUE (non-serious) with onset 19Jan2023, outcome "unknown", described as "eceiving the 4th shot along with flu shot/receiving Pfizer with a Flu Shot at the same time".  Additional information: Previous shots (2 in Mid-2021, 3rd on Nov2022) gave the patient little to no side effects after receiving, little to no impact of his daily activities. However, this time after receiving the 4th shot along with flu shot, the patient began to feel like having cold and was car sick. At the time of the report, it is the 3rd day after injection and he is still having a mild headache. Since all previous 3 shots barely affected me, the patient was unsure if this change is due to the updated Pfizer vaccine, or due to receiving Pfizer with a flu Shot at the same time.
On 2/4, I had discomfort near my armpit under the left arm. There also was some swelling.
SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID 19 INFECTION; BAD REACTION; This spontaneous report received from a health care professional concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 13-Oct-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered at the end of APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bad reaction, and was hospitalized. The patient experienced a breakthrough Covid-19 vaccine and thought it was a delta variant (suspected clinical vaccination failure). The duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad reaction, breakthrough covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000197407; Sender's Comments: V0:20211022886-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211022886-covid-19 vaccine ad26.cov2.s-breakthrough covid 19 infection, bad reaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A serious report of tonsillitis and sleep apnea has been received from a study investigator concerning a 43-month-old male participating in a post-marketing study for FluMist, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The subject's medical history included myrigotomy with tubes for acute otitis media. On 01-Oct-2009, the subject received FluMist, 0.25 ml per nostril. He received a total of one dose of FluMist before onset of the event given on 01-Oct-2009. On 17-Aug-2009, the subject was seen in pediatric clinic for complaint of sleep apnea, snoring, daytime fatigue, being congested all the time and not feeling better after taking allergy medications. He seemed to have phlegm all the time. Also, the subject had bilateral myringotomies and ventilating tube insertion previously which had since fallen out. The subject was examined well except for oral exam which showed severe hypertrophy (4+) of tonsils. Tonsillectomy and adenoidectomy was recommended. On 01-Oct-2009, preoperative examination went well and procedure was scheduled for 13-Oct-2009. On 13-Oct-2009, the subject was admitted to the hospital, and tonsillectomy and adenoidectomy procedures were performed without complications. On 14-Oct-2009, the subject recovered and was discharged from the hospital. On 15-Oct-2009, the subject's parents reported that he had not interest in drinking, popsicles, etc., and also would not take pills to help with pain and was becoming dehydrated. The subject was seen in emergency and examined well. He was discharged from the emergency room on the same day, 15-Oct-2005. The events of tonsillitis and sleep apnea resolved on 14-Oct-2009. The investigator assessed the causality for the events of tonsillitis and sleep apnea to FluMist as none. The severity of the events was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the events of tonsillitis and sleep apnea as not related to FluMist.
pt  recv vax 16APR96 & devel ax lymphadenopathy & pain in lt arm, which resolved on 19APR96;21APR96 devel hives, erythema, swelling of lower eyelids & itchiness;pt seen by MD who was uncertain of etiology of sx;was allerg rxn to Td
didn't receive second shot; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 10 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Jansen COVID-19 Vaccine EAU.  Fever and headache.  Started approximately 9 hours after receiving vaccine.  Subsided after taking 400mg of Tylenol.
Swollen arm for 8 weeks, 2cm Soft Tissue mass. Arm was Swollen after Shot for about 8 weeks, then a small Scab appeared at the injection site and Just kept getting bigger and sore. Soft tissue mass, Left upper extremity overlying Deltoid is raised about 1.5 x 1.5cm. ulcerated, crusted, red, tender.
Extreme abdominal pain on left side all day on June 28th, nausea, vomiting, fever.
whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle; in her ankle she had a round spot on the side; She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle), VACCINATION SITE REACTION (in her ankle she had a round spot on the side) and PAIN (She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M29A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Back pain.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING HOT (whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle), VACCINATION SITE REACTION (in her ankle she had a round spot on the side) and PAIN (She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle). On 07-Mar-2021, FEELING HOT (whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle), VACCINATION SITE REACTION (in her ankle she had a round spot on the side) and PAIN (She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Experiencing extreme itching on site of vaccine.; This is a spontaneous report from a contactable consumer reported for himself.  A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot # EN6201, via unknown route at left arm on 18Feb2021 at 12:15 (at the age of 78-year-old) at single dose for covid-19 immunization. The patient received the first dose of the same vaccine on 28Jan2021 at 12:15 AM at the left arm from lot # EL3248. The patient experienced extreme itching on site of vaccine. The outcome of the event was not recovered. No COVID prior vaccination. Patient has not been tested for COVID-19. Adverse event result in hospitalization, Life threatening illness, Disability or permanent damage, Congenital anomaly.
Combined initial and follow up report received from a healthcare professional on 29 Jun 2010 and on 30 Jun 2010, respectively: This patient was vaccinated with FLUVIRIN (batch number 960355P) 0.5ml dose, intramuscularly on 07 Oct 2009. 30 to 45 minutes after vaccination, the patient experienced wheezing, shortness of breath and swelling of face and was rushed to the emergency room. Final outcome of the events was not reported. The causality was reported as suspected.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with drug reactions/allergies to latex. Pertinent medical history was unknown. On 06-NOV-2013 the patient was vaccinated with GARDASIL lot # J009788 and expiry date 17-MAR-2016, dose 1, 0.5 ml, intramuscular. On an unknown date in November 2013, within approximately one week and progressing over time, patient was complained of fatigue, lack of energy, puffy eyes, cough, feeling hot and cold intermittently, and a low grade fever. As of 09-DEC-2013 (reported as yesterday), patient was not as fatigued but other symptoms remained. Patient's mother began giving her multi-vitamins because she thought her daughter was anemic. Anemia was ruled out with testing. Lab tests performed were CBC (Complete Blood Count), CMP (comprehensive metabolic panel). TSH (thyroid stimulating hormone), Mononucleosis ; PTH (parathyroid hormone level), Phosphorus Calcium and Parathyroid Hormone. All lab work completed was negative with exception of Phosphorus Calcium and Parathyroid Hormone, which results are not back yet. The outcome of fatigue was reported as recovering/resolving. The outcome of lack of energy, low grade fever, feeling hot and cold intermittently, cough and puffy eyes was reported as not recovered/not resolved. The patient had sought medical attention. Additional information has been requested.
Starting coughing as mother and patient were leaving office. Mother called clinic reporting that patient had started itching, cough worsened and mom reported facial swelling.
This is the patient I had that developed PMR with a few days after a Pfizer COVID immunization; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "This is the patient I had that developed PMR with a few days after a Pfizer COVID immunization".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relation, the association between the event POLYMYALGIA RHEUMATICA  and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202300206787 Same reporter/drug, different patient;
Initial misuse report received from a healthcare professional on 23 December 2013. The cases were received at GPV on 21 March 2014. It was reported that patient (no information was provided regarding the patient) had received intravenous does of FLUZONE. No adverse event was reported. List of documenst held by sender: none
2 doses of / Moderna Covid-19 and / 2nd dose of Shingrix. Shortly after / diagnosed with Lyme's; This case was reported by a pharmacist via call center representative and described the occurrence of lyme disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for covid-19 prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Covid 19 Moderna (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 2nd dose of COVID-19 VACCINE MODERNA. On an unknown date, immediately after receiving Shingrix, the patient experienced lyme disease (serious criteria GSK medically significant). On an unknown date, the outcome of the lyme disease was unknown.   It was unknown if the reporter considered the lyme disease to be related to Shingrix.  Additional details were provided as follows: The case was reported by retired pharmacist for himself. The age at vaccination was not reported. The patient recently received 2nd dose of Shingrix and 2 doses of the Moderna Covid-19 and shortly after, the patient was diagnosed with Lyme's disease, which was said to be latent.  The reporter consented to follow up.  No additional information was shared.
Bad rash over entire torso, some on the arms and legs.  Itchy and painful.  Very red.  Day 3 and still major.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medica history or drug reactions/allergies. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011335, expiration date 13-DEC-2014, 0.65 ml, subcutaneously for preventing shingles. On 17-JUN-2014 the patient developed redness, inflammation, and warm to touch at the injection site after receiving ZOSTAVAX. The injection site was "a little more painful" a "day or two later" after receiving the ZOSTAVAX. The patient also stated that it felt like a "burn wound" at the injection site and that the injection site was red and swollen. The patient said that it felt like there was a "breast under her arm". The patient called and spoke with the pharmacist The outcome of the events was reported as not recovered. Additional information has been requested.