chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost her voice; achy ears; achy eyes; patient received expired product; coughing a lot; 99 F fever; lethargy; felt sick; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Elderly female (age at the of vaccination was 66 years) patient who experienced lost her voice (aphonia), coughing a lot (cough), 99 f fever (pyrexia), lethargy (lethargy), achy ears (ear pain), felt sick (malaise) and achy eyes (eye pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported and expiry date: 30-Jun-2019) via intramuscular route in the left arm.  On an unknown date, the patient experienced a non-serious lost her voice (aphonia), coughing a lot (cough), 99 f fever (pyrexia), lethargy (lethargy), achy ears (ear pain), felt sick (malaise) and achy eyes (eye pain), (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  This is also a case actual medication error due to expired vaccine used.   Relevant laboratory test results included: Body temperature - On an unknown date: 99 F  Final diagnosis was aphonia, ear pain, eye pain, lethargy, malaise, cough and pyrexia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for events aphonia, ear pain, eye pain, lethargy, malaise, cough and pyrexia.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
patient had bp at 189/89 but forgot to take her blood pressure medication in the morning; This is a spontaneous report from a non-contactable pharmacist. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in arm left on 20May2021 (at the age of 65 years old, Lot Number: ew0151) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had bp at 189/89 but forgot to take her blood pressure medication in the morning on 20May2021 with outcome of unknown. The patient was not pregnant. No other vaccine in four weeks. The event did not result in death, hospitalized, disability. No treatment received.  No follow-up attempts are possible. No further information is expected.
migraine next  2 following days after shot. Tiredness the day of the shot and the following day. Cold/allergy symptoms including nasal sinus congestion and runny nose all the way up until today. Also paying on the side of injection on the day of the shot and following day
I had a tongue swelling for about an hour; Weak for a day and half, pretty weak; One hive twelve hours after getting it; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202, expiration date: 30Jun2021), via an unspecified route of administration on an unspecified date (at the age of 63 years) as dose 1, single for COVID-19 immunization. The patient medical history included allergy to Erythromycin, Cipro and then Levaquin. For Levaquin she had extreme reaction 10 years ago involving her windpipe and throat and she went to the ER. The patient's concomitant medications were not reported. On an unspecified date the patient said she had tongue swelling for about an hour, she had one hive twelve hours after getting the vaccine and then she was weak for a day and half, pretty weak. She also mentioned that she didn't have to go to the hospital for the reactions. She was just reporting the connection between the three medications she was allergic to, and the Pfizer vaccine called Polyethylene glycol (PEG) which was an ingredient in all. She was thinking that could be her problem and it could be for other people, so she was reporting it so that someone else may be helped by that information or so that more information can be gathered. She said was very happy to get the vaccine but due to the reaction she was afraid to get the second dose, one because of the reactions to PEG in the past. Patient mentioned she did not take any treatment but kept Benadryl close in case the reactions got worse. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
no adverse effects; rubella titer was low; This spontaneous report was received from a currently 50-year-old male patient who is a pharmacist, referring to himself. The patient had no pertinent medical history, concomitant therapies or drug reactions and allergies. On an unknown date, when the patient was a child, he received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, injection site, route of administration, lot # and expiration date were not reported) as routine vaccination. On unknown date in 2019 (reported as earlier this year), the patient had titers drawn and the rubella titer was low. No adverse effects were reported. The outcome of event was unknown. There was no causality assessment provided by the reporter.
No additional adverse events; The vaccine was administered on 20-APR-2022 (expiration date 14-APR-2022); This spontaneous report was received from a registered nurse concerning a 4 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 20-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (expired product administered), subcutaneously, in the left arm, for prophylaxis, expiration date 14-APR-2022 (strength, dose and lot number were not provided) and with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) in the left deltoid, lot number E2L54, expiration date 03-MAR-2023 (strength, route of administration and indication were not provided).      No adverse event reported.
Narrative: esophageal cancer status post chemotherapy and esophagectomy, Covid +, decrease fluids, weakness,fatigue. Moderna 1/6/21 and 2/1/21.  received 1 dose of remdesivir and Decadron. Admitted 11/7, discharged  11/8/21
Pt received her 2nd dose of the Moderna COVID19 vaccine and while sitting in observation reported feeling very light headed. Pt reported this did not happen with her first dose. BP 128/86, HR 78, RR 16, O2Sat 98% . Repeat BP 118/76 HR 74, RR 16 O2sat 98% standing.  No other symptoms noted. Pt was offered EMS evaluation to which the pt declined. Representative release form signed. Triaged by MD.
This spontaneous report as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of RECOMBIVAX HB; lot # L038018, expiry date: 13-SEP-2017, L043213/, expiry date: 28-AUG-2017 (dose, route, site of administration and dose# were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation." No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports received from the same reporter.
Information has been received from a physician concerning a 46 year old female with no known allergies and no reported medical history who on 10-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine intramuscularly in the right deltoid. There was no concomitant medication. Within a few hours the patient developed a red spot the size of a silver dollar at the injection site. The next evening, on 11-NOV-2007 the patient reported the area was very warm and itchy and felt better when ice was applied. On 12-NOV-2007, the patient had a fever and the injection site area got bigger. When the patient went in to see the physician on 13-NOV-2007 there was no fever but the area was 13 X 15 cm irregular erythema that was warm to the touch and slightly raised at the injection site. The patient was given topical chloroxine (+) triamcinolone acetonide (Triamcinolone 0.1%) applied three times daily and KEFLEX, 500 mg 4 times daily for 1 week. The patient was seen again on 16-NOV-2007 and the area had almost completely resolved. That was the first time the patient received pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Unremitting headache for 10 days. I never get headaches. This was not a "sinus" headache or related to any congestion. I do not suffer from migraines or other similar disorders. The onset was coincident with the administration of the vaccine, several hours later, and persisted for 10 days, gradually lessening. It was bilateral. Only partially responsive to analgesics.
Discovered the patient and his family that abused the system and obtained numerous COVID vaccinations most likely for financial gain of the gift cards issued at each patient encounter.
Admitted 7/9 with left temporal ICH with vasogenic edema and mass effect.  Found to have hemorrhagic conversion of a venous infarct due to thormbosis of the left transverse sinus sigmoid sinus, left IJ vein and several  left temporal draining cortical veins.
TINNITUS HAD BEEN CONSTANT SINCE ONSET; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tinnitus had been constant since onset. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tinnitus had been constant since onset. This report was non-serious. This case, from the same reporter is linked to 20210600421.
Information has been received from a company representative concerning an unidentified patient who was exposed to a younger relative who was vaccinated with varicella virus vaccine live. It was reported that the relative "developed a condition that "might" or "could have" been contracted by the young child's symptoms of zoster. Additional information has been requested.
mom reports pt was @ daycare when devel s sz;pt was seen in ER then transferred to another hosp x 2 days;pt is now on phenobarb;sz occurred on 31JUL97;mom says may have had fever that day but not sure;
Admit for weakness x 2 weeks, cough, HA. COVID+. Hx of HTN, CKD, A-fib. CXR shows no infiltrates. During stay required no oxygen. Supportive care -Vit C, Vit D, zinc. DC'd back to SNF.
lump (undulation), itchy, red at vaccine site - 2 days later it is less of a lump, not itchy or red - no other symptoms
Muscle aches; vomiting; nausea; headache; chills; Maternal Exposure During Pregnancy; Dose number=3; This is a spontaneous report from a contactable consumer (patient) reported information for both mother and fetus/baby. This is a mother report. A 30-year-old pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 06Oct2021 at 10:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy, type-1 diabetic and hashimotos thyroiditis. Concomitant medications included insulin aspart (NOVOLOG); insulin detemir (LEVEMIR); levothyroxine sodium (LEVOXYL) and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 10:00 (at the age of 30-year-old) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 10:00 (at the age of 30-year-old), both as a single dose for COVID-19 immunisation and exposed during pregnancy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was pregnant, gestational period: 34, Last menstrual date was in Feb2021, and due date of delivery is 16Nov2021. On 06Oct2021 at 23:00 the patient was pregnant and experienced muscle aches, vomiting, nausea, headache and chills. Patient did not receive treatment for the event. The clinical outcome of the muscle aches, vomiting, nausea, headache, chills, booster was not recovered and other, event was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 37-year old female who on 09/09/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (643249/0358M), and developed fever, pain and tenderness at the injection site on that day.  It was reported, "her condition is worsening".  She had a "7x4 inch" area of redness, swelling and induration, which was still spreading after 4 days.  Unspecified medical attention was sought.  Additional information has been requested.
Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
started to experience itching around 12:00 AM that evening; red rash from the point of injection to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow) outcome was unknown.            The patient received her 3rd dose around 4:00 PM, she then started to experience itching around 12:00 AM that evening. The next morning she had a red rash extending from the injection site to her elbow  No Concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-SEP-2021 and does not contain any new information On 01-Sep-2021: TCR received on 01-SEP-2021 and does not contain any new information
The vaccine was prepared incorrectly. The adjuvant suspension component was mixed with sterile diluent which is not part of this vaccine instead of being mixed with its own supplied Lyophilized gE antigen component. No symptoms or treatments. Will need to re-vaccinate patient.
pain in Lymph nodes; Swelling in Lymph nodes; headache; fever; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (pain in Lymph nodes), LYMPHADENOPATHY (Swelling in Lymph nodes), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced LYMPH NODE PAIN (pain in Lymph nodes), LYMPHADENOPATHY (Swelling in Lymph nodes), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle pain). At the time of the report, LYMPH NODE PAIN (pain in Lymph nodes), LYMPHADENOPATHY (Swelling in Lymph nodes), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle pain) outcome was unknown.            Concomitant medication was not provided  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081444 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081444:Case for dose 1
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 15-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
Began with rash on face, spreading down body. On trunk, arms, legs, abd and groin. C/O headache. No fever. Prescribed Dytan and Acyclovir.
allergic reaction to the first dose (signs and symptoms: rash (injection site,upper chest and neck)); This is a literature report.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), 10 min after the suspect product administration, outcome "recovered", described as "allergic reaction to the first dose (signs and symptoms: rash (injection site, upper chest and neck))". The patient underwent the following laboratory tests and procedures: Brighton score: unknown result, notes: insufficient information to meet case definition. Therapeutic measures were taken as a result of hypersensitivity which included diphenhydramine. Clinical course: Time to symptoms resolution is 1-2 hours. The patient has no atopic history and no anaphylaxis history. Insufficient information to meet case definition was reported for National Institute of Allergy and Infectious Disease and the Food Allergy and Anaphylaxis Network criteria.  A specialized vaccine clinic evaluated patients referred for suspected immediate allergic reactions to the first dose of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine or suspected PEG/polysorbate allergy. All patients were evaluated from May2021 to February 2022. Nine patients were evaluated after experiencing an allergic reaction to the first dose.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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-PV202300015137 Same article/ drug and different patient/ event;
I experienced a breakthrough case of COVID-19 with a sore throat, body aches, tiredness and coughing.
High fevers up to 104 degrees F, muscle rigidity & fussiness. These sxs occurred x6 (each time vaccines were administered with no other acute illness).
neuropathy in foot and calf.; muscle pain; joint pain in the hip, knee and ankle.; is having trouble sitting because of the pain; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2021, the patient received the 1st dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), muscle pain, joint pain and mobility decreased. On an unknown date, the outcome of the peripheral neuropathy, muscle pain and joint pain were not recovered/not resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the peripheral neuropathy, muscle pain, joint pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient had some complications.  The next day after receiving Shingrix, the patient had muscle pain and joint pain in the hip, knee and ankle.  She was having trouble sitting because of the pain and neuropathy in foot and calf. The reporter did not consent to follow-up.
covid symptoms including fever, sore throat, and cough started on 11/26/21 while pt was hospitalized for UTI/C diff
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient reported during 2nd dose visit: His first dose of Moderna caused a small hard bump/swelling below the injection site (he specified the reaction did not occur at the actual injection site). This hard bump was present for 10 days. Patient states hard bump resolved on it's own, however, once the bump disappeared-patient states when he showers a red rash appears on his arm. Patient specified the rash only appears when he showers and that is a few inches BELOW the actual injection site.
rash, hives radiating from lower abdomen up to arms, torso and shoulder.  Self medicating with loratidine and benadryl.