chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINES THAT WE TOOK BUT  DON'T WORK; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, first dose start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included ethanol/thymol (Listerine Antiseptic Mouth wash) On an unspecified date, the patient's wife contracted the virus, then passed it on to the patient. The patient was happy to report that he and his wife both were covid free and never suffered medical problem, and he gave much of the credit, not to the vaccines that they took but don't work, but to Listerine that helped both to prevent the virus getting worse once both tested positive. The patient had covid but with the Listerine it was quickly recovered.  Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of vaccines that we took but don't work was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220919021. This case, from the same reporter is linked to 20220930558 and 20220918613. This report was associated with product quality complaint: 90000251621.; Sender's Comments: V0: 20220930432- covid-19 vaccine ad26.cov2.s- Vaccine that we took but don't work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Pt became lightheaded, nausea, began vomiting within 6 minutes of receiving vaccine, blood pressure was low. Pt was given water and monitored for 15 minutes after. Pt stated that he felt better.
Within the  first 5 minutes of the vaccine I became diaphoretic, increased heart rate and ligjtheaded.  It is continuing through the time of this writing, which is 3 hours later.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL, lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 472 hours, where the lowest recorded temperature was 26 F (-3.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
Adacel administered 9/19/07.  Next day felt sick - weak, nauseated, with decreased appetite.  Blood sugars low.  Has persisted through present day.  Cleans homes - has to rest after she's done.
Patient felt dizzy and passed out, did not hit head, was lowered to the ground. All vital signs were normal throughout experience. Patient was transported with a wheelchair, ate some crackers and drank some juice. No concerns noted, patient left clinic site, self ambulated.
Severe pain in left arm, tingling pain down my left arm and chest/ribs area. Extremely loopy the next day, tired, nausea. 5 days later and still having pain and tingling all down my left side and extremely tired.
patient felt ill in general 24 hours after, 48 hours after severe chest pain started. was advised to visit the ER via nurse line. d-dimer ran and was elevated. CT was normal
Vaccinated 4/4/18 late afternoon. 4/5 am, Felt nauseated and generally ill the next couple of days and also noticed redness and irritation at vaccination site left deltoid. She stated that the site was initially small and now is much more swollen and looks a little like it's getting a blister. 4/9/18 Sent to Dr's office who diagnosed cellulitis and began keflex. Follow up in 3 days. Other symptoms are better
Immediately after IM injection, patient stated she had a funny taste and reported lips felt like they were tingling.  Patient then began having difficulty breathing with throat swelling. Patient was unable to swallow and had difficulty speaking. Epinephrine was administered and EMS was notified. Patient improved after epinephrine administration and was transported by EMS to hospital.
On day 8 post vaccination, I started to develop a rash around the injections site. I was itchy, warm, raised, and red. It was not a perfect circle. Today is day 9, and the affected area has become larger.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-DEC-2012, the patient was inoculated with ZOSTAVAX at a health clinic as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-APR-2015, the patient was treated at a medical clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 14-APR-2015, he sought further treatment at a medical clinic for ongoing and worsening symptoms of zoster infections. On or about 27-AUG-2017, the patient was again treated at the medical clinic for ongoing symptoms and persistent pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and residual pain secondary to zoster outbreaks. The patient was prescribed LIPODERM, gabapentin, acyclovir and LYRICA for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
injection site pain, sinus inflammation, fatigue Narrative: Employee reports lethagy/fatigue, injection site pain/soreness, and sinus inflammation, all of which lasted approximately 24 hours. Reports he had the same symptoms after receiving the first dose.
Swelling of lymph nodes at neck; Slight fatigue and lethargy; Swelling of arm at injection site; Slight fatigue and lethargy; This spontaneous case was received on 07-Oct-2021 from other non-health professional (reference number: SEQW21-03493) and concerned a 66-year-old, female patient.  The patient's medical history and concomitant medications were unknown.  On 05-Oct-2021, at about 14:40 EDT, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) for unknown indication. The batch number was not reported.  On 06-Oct-2021, one day after receiving Fluad Tetra and reported about 16:30 EDT, the patient experienced mild symptoms which included swelling of arm at injection site, swelling of lymph nodes at neck and slight fatigue and lethargy. No medical attention was required.  On 07-Oct-2021, the patient recovered from all events.  The reporter assessed these events as related to Fluad Quadrivalent which were reported as mild reaction to vaccine.  The events of lethargy, 'vaccination site swelling', 'lymph nodes cervical swollen' and fatigue were assessed as non-serious.  Company comment: A 66-year-old patient was vaccinated with Fluad Tetra. One day later, the patient experienced vaccination site swelling, swelling of lymph nodes at neck, fatigue and lethargy. Causal role of the suspect vaccine is assessed as possibly related, due to chronological and biological implausibility.; Reporter's Comments: Mild reaction to Fluad Quadrivalent.; Sender's Comments: A 66-year-old patient was vaccinated with Fluad Tetra. One day later, the patient experienced vaccination site swelling, swelling of lymph nodes at neck, fatigue and lethargy. Causal role of the suspect vaccine is assessed as possibly related, due to chronological and biological implausibility.
patient fainted in the room; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot# AN2721 and Exp. 20Apr2021, 1st dose), hpv vaccine and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA); all via unspecified routes of administration on 16Sep2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. Three minutes after being vaccinated on 16Sep2019, the patient fainted in the room. After a few minutes of resting in the room she was allowed to walk out with parent and fainted again at checkout. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product 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, as appropriate. The case will be reassessed if additional information becomes available.
About 12 hours after receiving shot, I woke up and my whole body felt like it was burning. No fever and I was able to have a blanket over me. For the next 48 hours, this happened off and on (lasting as long as 20 minutes).  After this initial 48 hours, the burning sensation continues to happen off and on, but only in my hands and feet now (can last up to an hour). No changes in skin color.
pt recvd vax; devel scattered varicella-like lesions, marks on skin; no prior exposure to varicella;
Doses were given after expiration date; Vaccine was stored after expiration date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment were reported.  No adverse events reported.   No temperature excursion of the product was reported.  There was no product complaint associated. Vaccine was refrigerated on 02-Nov-2021.   This case was linked to MOD-2022-491837 (Patient Link).
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 68-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Swelling arm, breast and chest; Swelling arm, breast and chest; Swelling arm, breast and chest; Hurts; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm, breast and chest), BREAST SWELLING (Swelling arm, breast and chest), SWELLING (Swelling arm, breast and chest) and PAIN (Hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm, breast and chest), BREAST SWELLING (Swelling arm, breast and chest), SWELLING (Swelling arm, breast and chest) and PAIN (Hurts). At the time of the report, PERIPHERAL SWELLING (Swelling arm, breast and chest), BREAST SWELLING (Swelling arm, breast and chest), SWELLING (Swelling arm, breast and chest) and PAIN (Hurts) had resolved. Not Provided. Cocomitant medications are not provided. Treatment medications are not provided. Patient called regarding side effects she's been experiencing after receiving second dose of Moderna Vaccine on 13Mar2021. Patient mentioned swelling under her left arm (injection arm), breast and chest. It started 5 days after vaccination and she still has it. During the call, patient mentioned her sister experienced the same as her, though her sister got the vaccine somewhere else and didn't specify where or when. This case was linked to MOD-2021-056070 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up document received on 15-jun-2021 updated on AE outcomes.
Information has been received from a registered nurse concerning a 17 year old female who on 28-JUL-1998 was vaccinated with the first dose of VARIVAX (Merck), SC, 0.5 ml. On 05-MAY-2010, was vaccinated with the second dose of VARIVAX (Merck) (Lot# 666695/1706Y), SC, 0.5 ml. On 07-MAY-2010 the patient was diagnosed with cellulitis in her left arm after receiving her second dose of VARIVAX (Merck). She was given KEFLEX (manufacturer unspecified) 500 mg for treatment. The patient had sought unspecified medical attention. At the time of the report, the outcome was unknown. Additional information has been requested.
red, warm, itching face  red vaccine site  Has had many flu vaccines in past with no problem
Headache; Coughing; Chest pain; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 at 14:15 (Lot number: PH8030) at the age of 17 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pulmonary stenosis" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot number: ER8737 Anatomical location : Arm Left Vaccine Administration Time: 12:45), administration date: 09Apr2021, when the patient was 16 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot number: EN6207 Anatomical location : Arm Left Vaccine Administration Time: 12:45), administration date: 19Mar2021, when the patient was 16 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 at 14:15, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 19Dec2021 at 19:30, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Headache"; COUGH (non-serious) with onset 19Dec2021 at 19:30, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Coughing"; CHEST PAIN (non-serious) with onset 19Dec2021 at 19:30, outcome "recovered with sequelae" (an unknown date in Dec2021), described as "Chest pain". Therapeutic measures were not taken as a result of headache, cough and chest pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events were recovered with lasting effects. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
pt recvd vax & devel a nodule @ inj site which persisted up to 6months;
Thursday, April 8, evening: hives, redness, swelling around injection site Friday, April 9: redness and more swelling -- entire deltoid was super tight. Loose bowels. Exhaustion. Slept over 11 hours straight. Saturday, April 10: arm still red, less swelling, no other symptoms. Sunday, April 11: still some redness, little to no swelling, some itchiness. Monday, April 12: very mild itchiness, looks bruised. Tuesday, April 13: rash expanded to cover deltoid and most of bicep. Occasional itchiness.
Within three hours developed left arm swelling, pain, itching and redness. Fevers, chills, nausea, headache and body aches. Upset stomach but no diarrhea or vomiting.
Patient developed chest pain and shortness of breath 3 days after his 2nd moderna vaccine. Was diagnosised and treated for acute pericarditis. Cardiac enzymes were normal so no myocarditis. He did have a viral URI illness 1-3 weeks before his 2nd vaccine and also developed shingles 3 days after the vaccine.
Large lumps grew in my arm pits the size of a half tennis ball. Lumps have shrunken but are still there somewhat; Hives started 2 days later on my forearms and calves for about 2 days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:00 (Lot number: EW0158 7/21) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Candida Albicon airborne" (unspecified if ongoing), notes: excessive Candida Albicon airborne in house during that, period, since then addressed and corrected.; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: TURMERIC CURCUMIN; CYMBALTA. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 10Apr2021 08:00, outcome "not recovered", described as "Large lumps grew in my arm pits the size of a half tennis ball. Lumps have shrunken but are still there somewhat"; URTICARIA (non-serious) with onset 10Apr2021 08:00, outcome "recovered" (11Apr2021), described as "Hives started 2 days later on my forearms and calves for about 2 days.". Therapeutic measures were not taken as a result of lymphadenopathy, urticaria.  Additional information: The patient did not receive any other vaccine in four weeks. Hives started 2 days later on his forearms and calves for about 2 days. Large lumps grew in his arm pits the size of a half tennis ball. Lumps have shrunken but are still there somewhat. Covid hotline told him to ask hid doctor before his next shot. He has not received his second shot because his doctor recommended that he should wait for more information. Nobody seems to know what he should do? He was looking for an answer.   No follow-up attempts are possible. No further information is expected.
work up at midnight with extreme itching. I discovered hives/ rash on groin area,  hips, side torso, collar bone and neck area, bottom of head at hairline, stomach, back, butt. Rash/ hives are itchy. I treated with benadryll capsule and hydrocortisone ointment which offered relief until morning. Scheduled a call with teledoc, met with a physician who recommended Xyzal antihistamine.
h/a, fatigue, arm swollen to size of about a half dollar, red & sore, diarrhea, lack of appetite;
Patient reported:  Extreme nausea, migraine, and menstrual cycle activated (even though patient typically does not have a period).
Huge swilling for over seven days, 4" across and a chills about 18 hours after, with a 100.5 temperature temperature 3.5 days.
Pt recvd 1st dose Hep B vax on 10APR91 & 2 days later exp pain & stiffness in knees; Over the next 3 days pain radiated to ankles, wrists, neck & shoulders; 16APR91 1 shoulder remained painful; 17APR91 sx subsided & pt recovered;
Patient is having  moderate to severe arm soreness on occasion with certain positions for over 11 weeks after 2nd COVID vaccine. Had annual physical exam 5 weeks after vaccine and PCP did not think much of it at the time however the pain has persisted.