chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost like cellulitis; Had significant pain and swelling in their arm; Had significant pain and swelling in their arm; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for 3 patients. This is 1st of 3 reports.   A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on an unspecified date for immunization.  Relevant medical history and concomitant medications were unknown.  On an unspecified date, after the vaccination, the patient experienced significant pain and swelling in the arm. The doctor reported "it was almost like cellulitis". Clinical outcome of the events was unknown at time of this report.  The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role towards the occurrence of significant pain and swelling in the arm like cellulitis.  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 and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2019267626 same reporter/drug/event, different patient;US-PFIZER INC-2019267627 same reporter/drug/event, different patient
Initial report received on 19 February 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 2 doses of PENTACEL; lot number C3498AA received on 22 December 2009 and lot number C3226AA received on 11 March 2009, and 2 doses of DAPTACEL; lot number C2956AA received on 12 November 2008 and lot number C2957AA received on 12 January 2009 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 16 January 2013, approximately three years after the last dose. On 17 January 2013, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 January 2013 for five days. The subject was not hospitalized. At the time of final contact on 30 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. Patient's medical history was unknown. On an unknown date of 2012, patient received first dose injection of GARDASIL (strength, dose unit, route, lot# and expiry date unknown). On 13-DEC-2013, the patient was vaccinated with second dose injection of GARDASIL (strength, dose, unit, route, lot# and expiry date unknown). On 19-MAR-2014 (also reported as today), patient was in office to have the third dose of GARDSIL administer. The nurse reported that GARDASIL doses were administered outside of the PI recommended spacing. No adverse effects were reported. The outcome of doses was administered outside of the pi recommended spacing and no adverse effects is unknown. The reporter considered doses were administer outside of the pi recommended spacing and no adverse effect to be not related to GARDASIL. No further information provided. Additional information has been requested.
This spontaneous case initially received on 12-Jan-2017, was reported by a health authority and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient was nauseated (outcome: not reported). Linked Case ID(s): US-BEH-2017077176 (same patient) 27-DEB-2017 (System Update): Linked Case ID(s):2017077176 (Patient Link).
14.5 cm x 8.5 cm tenderness and swelling to (L) thigh.
On Sunday, 9/5/21, I began developing itchy rash/hives on my face, elbow creases, forearms, underarms and groin. The affected areas became more red, inflamed and itchy over the next couple days and the rashes spread to my neck, upper extremities (biceps, forearms, wrists and palms), trunk (sides and under breasts), groin, inner thighs and intergluteal cleft. On Tuesday, 9/7/21, I was seen at a local urgent care facility to be evaluated and treated for my rashes/hives. The provider diagnosed my condition as contact dermatitis, prescribed me Methylprednisolone 4 mg Dospak and recommended that I make an appointment with my dermatologist. She also encouraged me to report my reaction to VAERS since the rashes/hives occurred after receiving the COVID-19 vaccine. During the visit, I mentioned being seen by my primary care doctor on Saturday, 8/21/21 after experiencing a severe facial rash/hives earlier that week since it occurred after the first dose of the COVID-19 vaccine (received on Thursday, 8/12/21). I did not piece the events together until my urgent care visit. It seemed like the facial rash appeared more delayed following the first dose of the vaccine. I experienced more severe itching, inflammation and pain/discomfort over the next couple days. On Thursday, 9/9/21, I visited my dermatologist who examined me and said the rashes/hives appear to be a drug reaction and/or dermal hypersensitivity (possibly related to the COVID-19 vaccine). The doctor advised me to continue the Methylprednisolone Dospak, take Zyrtec 10 mg one (1) capsule once a day in the morning and Benadryl 25 mg one to two (1-2) capsules once a day in the evening and stop all unnecessary medications and supplements (e.g., no Ibuprofen, Tylenol, Colace, prenatal vitamins). She also prescribed Triamcinolone 0.1% Ointment 454 gm (apply to affected areas 2-3x a day for up to three weeks) and recommended applying Vaseline to the sensitive areas where ointment cannot be applied (face, underarms and groin area). I'm still experiencing severe itching, inflammation and redness today and haven't had much relief with the medications or treatments.
Patient said that he went to eat the evening in Park and after eating, he fell shaking cold with lots of headache.  His daughter in law which work for dispatching, took him to the ER.  He said the hospital took 5 pints of blood for different tests .  All came negative.    Patient came in today to the pharmacy and complained still of very red eyes.  I suggest him to see the doctor for check up today.   I was able to make apt to see doctor today at 3pm.  He just left the pharmacy to go straight to see his doctor
5JAN94 arm sore (burning) & breast on lt side where shot was given sore & burning (mastitis);6JAN94 lt arm & hand numb, fatigue;choking sensation in throat;later numbness in arms & legs;lt breast still sore mastitis;fatigue;
Was sitting at dinner table, abrupt onset of shakiness, nausea, severe HA,  Went to ER, CT of head negative, was given compazine, toradol, benadryl.  Did UA, CBC, chem 2 panel with no major abnormalities. Tested for COVID and said I was reinfected, but PCP told me I was still positive from previous infection 12/10/20.  PCP later tested antibodies and COVID IGG was pos.
PASSED OUT; FALL OVER; COLD; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old white, not Hispanic or Latino male. 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 not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that day after vaccination on 11-APR-2021 in early morning, the patient had chills and fever. The patient went down to get some unspecified medications and he passed out for roughly 5 minutes and fell over. The patient had headache at the time of this report. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, cold, chills, and fever on 11-APR-2021, had not recovered from headache, and the outcome of fall over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421495 - covid-19 vaccine ad26.cov2.s- Passed out. 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).
Headaches, Period lasted longer than 12 days normally only 4. Huge softball size red lump appeared a week later on vaccination arm/hot and itchy
lost her sense of taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 88 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 1958. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 25Jan2021, for Covid-19 immunisation. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste".  Additional information: Reporter, a consumer calling about her second shot that she had with Covid-19 vaccine. She lost her taste buds. She was wondering if there was anything we had found out that they had a problem. She was wondering what she could do. She had all the shots up to the 5th shot and she had that couple of days ago, Sunday. she had it in (Shopping mall name withheld) everything was fine no complains about any now. but the second shot she had, she lost her taste buds came and they kind of came and went, came and went and now it was getting to the point she had not been able to taste anything. Patient lost her taste buds after the 2nd shot. Some people experience a little discomfort and can continue to go about their day. Others had side effects that affect their ability to do daily activities. She had all the Pfizer COVID vaccine, her latest shot was last Sunday and she just want to know recommendations from Pfizer and how we get back her taste buds. But it was been off and on and she might had in the morning and then she might had been able to taste at noon. It just was not like that all the time but the last two weeks she had not had that it was if she not had any taste at all, so she just thought she need to call to see if there is something that could be done, that may they had. Consumer stated, the date was 25Jan2021 and the next one was 24Feb2021, 14Oct2021, 30Mar2022 and 05Apr2023. The last one would have been on 15Oct2023. That was the dates she got the shots. She got one of the shots, because her husband had a shot on same day but it did not bother him. Patient took other medication, but it was for thyroid medication. Not had any lab test done.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
The evening of the vaccine I had pain at the injection site that grew worse overnight.  I repeatedly woke up whenever I rolled onto my left arm because of the pain.  I took Tylenol the morning of the 30th.  I started to get joint pain in my left elbow and fingers beginning around 9am.  By 11am my whole body was sore and I was exhausted.  At around 1pm I developed chills and a fever of 100.8.  Beginning at 2pm I took 2 Tylenol every 4 hours.  My temparature was between 99.8 and 101 until 05/01/21 at 9am.  Besides the joint pain and fever, I had a headache, nausea and 2 enlarged lymph nodes: left armpit and left groin.  The lymph node in my arm pit was hard, sore and got to be about as big as a small lime.  It was so tender I could not put my arm down at my side.  The lymph node in my going was enlarged but not as sore.  I stayed in bed and slept from 5pm 4/30/21 to 9am 5/1/20.  My temp when I woke up was 99.0.  My only symptoms on 5/1/20 were headache and very large lymph node under left armpit.  Although still large, it was softer than the day before.  Today, 5/2/20 I still have headache and enlarged lymph node in left arm.
Confirmed no other AE occurred; The caller said an expired dose was administered; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 03-OCT-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (expired product administered) (lot number w004863 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), with an expiration date established as 21-AUG-2023), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse event was reported for this patient.
Broke out in bumps on Sunday 09/18/2005 described as raised and red and itching. Babysitter called mother Monday afternoon to let her know child was itching and had these bumps on him which were bigger after he was outside and sweating. Saw Dr late afternoon for physical and to have ears checked. Put on Bactrim for ears, no other medication prescribed. Had been taking OTC Benadryl for runny nose. Still had some spots on trunk and extremities today, vary in size with largest size of dime. Parents say they are better.
severe very swollen arm; Severe very sore arm; coughing; abdominal pain; raising phlegm; fever/high fever; chills; vomiting; nausea; higher than usual blood pressure; eyes running; nose running; sweating at night mostly; lower abdominal pain; some bloating; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling arm in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included diverticulitis. Previously administered products included Antibiotics.   On 20-SEP-2023, the patient received Arexvy (intramuscular) .5 ml. In SEP-2023, less than a month after receiving Arexvy, the patient experienced swelling arm (Verbatim: severe very swollen arm), pain in arm (Verbatim: Severe very sore arm), cough (Verbatim: coughing), abdominal pain (Verbatim: abdominal pain), phlegm (Verbatim: raising phlegm), fever (Verbatim: fever/high fever), chills (Verbatim: chills), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea), blood pressure high (Verbatim: higher than usual blood pressure), eye discharge (Verbatim: eyes running), runny nose (Verbatim: nose running), sweating (Verbatim: sweating at night mostly), lower abdominal pain (Verbatim: lower abdominal pain) and bloating (Verbatim: some bloating).  The patient was treated with antiemetics and antinauseants (Anti Nausea Tablet (Nos)). In SEP-2023, the outcome of the swelling arm, pain in arm, cough, abdominal pain, phlegm, chills, vomiting, nausea, blood pressure high, eye discharge and runny nose were resolved (duration 4 days) and the outcome of the fever, sweating, lower abdominal pain and bloating were resolved (duration 6 days).   The reporter considered the swelling arm, pain in arm, cough, abdominal pain, phlegm, fever, chills, vomiting, nausea, blood pressure high, eye discharge, runny nose, sweating, lower abdominal pain and bloating to be related to Arexvy.     The company considered the swelling arm, pain in arm, cough, abdominal pain, phlegm, fever, chills, vomiting, nausea, blood pressure high, eye discharge, runny nose, sweating, lower abdominal pain and bloating to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-SEP-2023 It was reported that initial 4.5 days of duration after vaccination, patient experienced severe very sore swollen arm, coughing, abdominal pain, raising phlegm, fever, chills, vomiting and was better with anti nausea medication. The patient experienced higher than usual blood pressure, eyes and nose running, high fever, chills, sweating at night mostly, then broke and had mild chills. Additionally, lasting the next 2 days patient reported fever, sweats, no chills, lower abdominal pain, some bloating not as bad. The reporter did believed the event was related to the product The reporter stated that the patient had previously been treated for diverticulitis, including antibiotics. This was during the summer months. The patient was feeling great when she went to be vaccinated. The reporter consented to follow up.
Bi lateral shin pain (for two weeks at onset of symptoms), bi lateral calf pain (ongoing), left thigh pain (ongoing),  right arm paralysis (one week at onset), bi lateral numbness in  hands & fingers (2 months), bi lateral leg muscle spasms (ongoing), burning skin (new symptom), sore feet (new symptom), weakness in lower legs making me unable to walk (ongoing but improving), brain fog (ongoing but improving), dizziness (ongoing), off balance (improved), loss of appetite (2 months), unable to drive still. Treatments: PCP & Neurologists unable to find me help or answers and unwilling to even prescribe Prednisone. Naturopath and Chiropractic Neurologist have been most helpful with acupuncture treatment, supplements, red laster therapy, and brain based exercises for vestibular issues and autonomic dysfunction.
Initial report received on 05 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13 month old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 16 September 2011, 21 November 2011, and 23 January 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 10 August 2012, approximately 7 months after the last dose, and a paroxysmal cough with a whoop on 20 August 2012. The subject also developed catarrhal illness, posttusive vomiting, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 24 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 28 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient presented to the clinic without a form of ID. Mother and child confirmed her date of birth on paperwork and verbally to the staff. First dose of pfizer was given and patient was discharged after 15 minute waiting period. Data entry personnel found patient's information in two different vaccine tracking systems. Her birthdate was not what was originally reported. 3 attempts to reach the mother were unsuccessful. The patient was flagged in the clinic's tracking system and will have staff re-educate mother on the need to wait until the patient turns 12 in November 2021. No adverse reaction to the vaccine was noted in the clinic prior to discharge.
No adverse event; patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025J20-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first Moderna Covid-19 vaccine Primary Series Dose on 20-JAN-2021 and second dose of the Moderna Covid-19 vaccine on 26-FEB-2021).    No adverse reactions reported after receiving first and second dose of vaccine. No treatment drug was reported.   This case was linked to MOD-2022-657599 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-AUG-2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 26-AUG-2010, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered (emotional distress) significant medical expenses, pain, suffering (emotional distress) and other damages (injury) on unspecified dates. The final outcome of the events was not specified and they were considered to be related to ZOSTAVAX.