chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; malaise; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in November 2020). Concomitant products included COVID 19 VACCINE and COVID 19 VACCINE.   On 10th March 2021 11:00, the patient received the 2nd dose of Shingrix. On 10th March 2021, less than a day after receiving Shingrix, the patient experienced general body pain and malaise. On an unknown date, the outcome of the general body pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported before 2nd dose, the patient was vaccinated with two Covid Shots in January 2021 and 8th February 2021, Respectively. The patient received Shingrix at around 11Am and at 3 or 4 PM, the patient experienced body ache and malaise. The patient stated that, these symptoms got worse through the night and were still present and not resolved.  The patient did not consented to follow up. The patient declined to give any demographic information (including initials, gender, and date of birth), declined the consent to follow-up with the HCP (health care provider). The patient was unable to provide the dosage, route of administration, and lot or expiration date for the second dose.
Arm is swollen, red, warm to the touch and slightly itchy and sore which started two days after the vaccineand is ongoing at this time
Patient had previously received the Pfizer bivalent booster on 10/27/22 and was inappropriately administered the Moderna bivalent booster on 3/16/23. No adverse reaction at the time of this report.
Pt recv vax on 1/15/99; on 1/16/99 pt exp pruritus & red skin; tx=IV steroid, oral steroid & antibiotic
pt recvd vax;next 14-15 days devel lymphadenopathy;the adenopathy resolved a/ biopsy could be performed;redness & tenderness at inj site;pt had similar rxn to the 94-95 formula;
Rec'd DTP @ school, went home p/3hrs felt nauseated when to bathroom w/sister start to act different according to sister, hit herselt then fainted for 1-2min;
Information has been received from a 57 year old female with high blood pressure and sulfa allergy who in May 2008, was vaccinated with zoster vaccine live 0.65 mg (Oka/Merck) in her right arm (lot number and injection route not reported). Concomitant therapy included (VIVELLE-DOT), LISINOPRIL-HCTZ (manufacture unknown), (ZYRTEC), (NEXIUM), (AMBIEN) and MOBIC. In May 2008, a week or two after the vaccination the patient experienced right ear burning. She was seen by the doctor and was treated with an unnamed antibiotic for 10 days. On 28-MAY-2008, she saw doctor for some symptoms and was diagnosed an inflamed lymph node and possible shingles. She was treated with famciclovir for 10 days. On 20-JUN-2008 pain returned off and on and continued until the day reporting. The patient was taking (PERCOCET) for pain. Follow-up information was received from a physician stated that he was not sure if the patient has shingles or not. The patient still has burning in the area where this occurred. Additional information has been requested.
12 year 6 month old adolescent given Pfizer (orange cap, 5 - 11 yr formulation) instead of Pfizer (purple cap, 12 yr and older) as a booster dose.  Adolescent was boosted based on recent CDC recommendations.  No adverse events reported (via telephone call with Mother).  Conference with Health Department medical director, discussed administration of wrong formulation, revaccination not recommended.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 37-year-old female patient who received BOOSTRIX (batch number B4G4G, expiry date 5th November 2017. On 9th November 2016, the patient received BOOSTRIX. In November 2016, less than a week after receiving BOOSTIRX, the patient experienced pain in arm, tingling of extremity, pain, awakening early and numbness in hand were unknown. It was unknown if the reporter considered the pain in arm, tingling of extremity, pain, awakening early and numbness in hand to be related to BOOSTRIX. Additional details were provided as follow: The patient received BOOSTRIX on her left arm. The patient experienced sore all the time in her hand and it hurt to lift it, patient also said that the last two nights the pain, numbness and tingling has woken her up. The patient had not contacted her doctor yet because she wanted to know if this were a normal side effect of the BOOSTRIX. The call was transferred to Medical Information for assistance with side effect information for the BOOSTRIX. No other information was provided prior to transfer to Medical Information.
pt recvd vax; 1 day later broke out in rash over body; looked like mosquito bites
Pt came to our pharmacy today 10/8/2010 and mentioned that her injection side felt itching since after vaccination. We recommended to try BENADRYL and topical Aloe Vera. I check with Dr if gets worse.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient received 3/4ths of a dose of ZOSTAVAX (dose and frequency unknown) subcutaneous in error on 05-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. At the time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested. Follow up information received. Reporter stated not really pertinent, the problem was mechanical rather than biological. The needle and syringe became disattached during the immunization resulting in an incomplete dose given. No problem with the vaccine, the syringe/needle combo was the problem. Additional information is not expected.
6NOV91 4PM exp dizziness; 8PM dizzy-room spinning, unable to get OOB; vomiting; adm to hosp & remains hospitalized x 5 days; MD r/o middle ear disorder;
Fever up to 101 degrees Fahrenheit, swelling at injection site, severe joint pain, headache, extreme fatigue
Shingrix vaccine arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received shingrix and experinced arm pain.
23 year old patient identified in transit to have had reaction to smallpox vaccine  physician evaluation required.  Vaccinated with Dryvax (WAL 4020071) on 26 June 2003, left deltoid region.  Patient noted onset of flu-like symptoms on 3 July 2003.  Patient noted symptoms worsened on 4 July to include fever (undocumented max temp), chills, myalgias, headache and nausea.  AM of 5 July, noted onset of left-sided acne-like reaction across chest, upper back and under his arm.  Denies significant lymphadenopathy or vaccine site swelling or pain.  Seen by a civilian provider who diagnosed disseminated vaccinia, prescribed ibuprofen for constitutional symptoms and limiting exposure to immunocompromised persons.  Patient notes since 6 July, the pustular rash has improved, the lesions are diminishing and his constitutional symptoms have resolved.   He notes having kept his primary vaccination site covered (Op-Site and gauze).  Notes having worn shirt during transit; denies direct contact of "rash" or primary vaccination site and other persons.
Mom states child received vaccines around 3:30 pm, had some facial swelling and itching.  Called on call doctor, advised Benadryl 50 mg and all symptoms were gone in 2 hours.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the 1st shot of vaccine on 05Feb2021. On 14Feb2021, the patient was not feeling well. On 16Feb2021, the patient tested positive for COVID-19. The patient wanted to know if she needs to be tested before the 2nd dose. She has been quarantined for 3 weeks in her home; even though the health department had said "quarantine for 14 days", but she did not go out because the weather was too cold. She had a problem of getting her second shot of the Pfizer COVID-19 Vaccine. She was supposed to get the second dose of the Pfizer COVID-19 vaccine on 26Feb2021 but could not due to being quarantined. She asked what is the timeframe that she should get the second dose is relative to having COVID. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
The patient did not report any adverse events.  Technician administered pediatric pfizer instead of pfizer (patient recently turned 12 years old; 6 days prior)
grandmother reports mild fever in first 48 hours, typical soreness at site.  Day 2 after immunization itching and redness increased.  Seen 9/14/07 1100,  at clinic, 4 days after immz , Left arm redness with warmth.  Redness from deltoid area to elbow on frontal aspect.  Received Pediarix in L deltoid at 1600 9/10/07.  No treatment, monitor, increased site reaction.  Consider benadryl prior to future immunz.
Patient's grandmother called pharmacy stating that patient had received the flu shot and shortly after she got home, her arm was extremely painful and she could not lift her arm.  Grandmother stated that the pain her granddaughter felt was intense and very painful.  She told me that they would monitor it and would take OTC medication for the pain.
Fever 102 started on day of inject; no paleness, or limpness; Irritability did occur on 2nd day p/vax fever was 104; On 3rd day 103.5; Mom called hlth dept;
Received tetanus shot routine on 11/15/2002. Seen 12/31/2002, 01/17/2003, and 01/31/2003. Complaints of generalized aching and warmth proximal weakness. Unable to get up from bed. Trouble lifting head off bed. Process actually better when seen 01/01/2003 and entire process acts to be in process of resolution.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old female patient. On 18-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 006M20A) for COVID-19 vaccination.     Patient had no allergies.  Concurrent medical conditions included Hypothyroidism (no recent change in condition status) since 28-Sep-2020. Concomitant products included LEVOTHYROXINE from 28-Sep-2020 to an unknown date for an unknown indication.   On 02-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Mar-2021 at 12:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Mar-2021 at 12:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-Mar-2021 and Dose 2 on 26-Mar-2021) to be not related.    Patient did not experience any adverse event including signs and symptoms. clinical course and or treatment with dates/timelines. Patient did not experience any symptoms during  the temperature excursion.   This case was linked to MOD-2022-503346 (Patient Link).
Patient described having tender face and scalp three days after Afluria and Prevnar vaccinations. Patient had never had Prevnar before. Patient also experienced malaise/aching/fatigue and rash/skin peeling on forehead starting three days after which lasted for about 7 days.
I had a sore arm. The initial day after - very, very cold, sore arm; body aches - couldn't get settled down because of it; dull headache. At the end of the day, I went to get my mail outside and I became dizzy and nauseated. I went back in the house, and talked myself into not throwing up. I didn't have any nausea with previous COVID shots. I had night sweats but no fever. The next day, I had fatigue and a little dizziness, but not bad. And then night sweats that night. My arm was still sore. The next day, I found that I had developed an infection in left lower nostril - in the opening. Acyclovir ointment - it responded to that and to Acyclovir capsules that I eventually took. It took a month to get rid of it. I had something similar many, many years ago that showed up under stress. But this was different and lasted an extra week or two. I developed severe abdominal pain, cramps, bloating queasiness and extreme  slowdown in bowels. My whole digestion system changed. Similar to IBS but nothing to that degree. Once my husband wanted to take me to ER but I took a walk and it subsided some. It's been six weeks since it started. I developed red - from the shot area to just above my elbow. It was warm too but not infected. It itched. That lasted a couple of weeks. I had some dizziness that comes back in a waves and then goes away. I have been seeing alternative medical people for the intestinal issues - one did visceral manipulation - and she worked on vagal nerve and kinds of things that can help with that kind of thing. I now see an acupuncturist - and I have seen him three times. I have two days that I can string together that I have felt better. I was able to have lunch today. I hover around 99 and 100. Last time was  96 lbs.
first dose 16-NOV-21, second 30-NOV-21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old male patient who received HBV (Engerix B) (batch number 39tz2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 30th November 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the 2nd dose of Engerix-B earlier than the recommended interval, which led to shortening of vaccination schedule. No known side effect was reported. The reporter consented to follow up.
No additional AE/PQC information; a dose of ROTATEQ was administered to a patient after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-months-old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 01-DEC-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, 0.5 ml, route defaulted to oral, lot # 1742428, has been confirmed to be a valid lot #, expiration date 01-SEP-2022) (route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 50 degrees Fahrenheit for 5 minutes. There was no adverse event reported. There were no previous excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001112:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; LEVOCETRIZINE HYDROCHLORIDE; BREZTRI AEROSPHERE; VENTOLINE [SALBUTAMOL]; VITAMIN D NOS; ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]; IBUPROFEN; FLONASE SENSIMIST ALLERGY RELIEF; ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13May2022) Negative, notes: I tested negative and felt well by day 7; (20May2022) Positive, notes: Tested positive on day 14 and felt very I'll with breathing difficulties, body wide pain, nasal congestion the days before, headache, and facial/sinus pain. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Vaccination site rash; Injection site redness; 15 minutes after injection, arm pain which gradually increased 6 hours later; sleep unwell; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (15 minutes after injection, arm pain which gradually increased 6 hours later), POOR QUALITY SLEEP (sleep unwell), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and HR038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Crustaceans/Shrimp Burning in mouth and throat for about 8 hours after eating shrimp) since 01-Jun-1990. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (15 minutes after injection, arm pain which gradually increased 6 hours later), POOR QUALITY SLEEP (sleep unwell) and VACCINATION SITE PRURITUS (Injection site itching). On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash). 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). On 19-Mar-2021, POOR QUALITY SLEEP (sleep unwell) had resolved. On 24-Mar-2021, PAIN IN EXTREMITY (15 minutes after injection, arm pain which gradually increased 6 hours later) had resolved. On 30-Mar-2021, VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. On 31-Mar-2021, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Vaccination site rash) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.    Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up Received: Added Patient Demographics, Medical History, Event Outcome was added.
Inflammation in neck, fever, general malaise, muscle pain, loss of mobility in the left arm that lasts two days. Acetaminophen 500 mg, 2 tabs every 4 hours
A 74-years-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 27Jan2021, at 74 yeras of age, at single dose for COVID-19 immunization. The patient's medical history included allergy to codine. The patient was not pregnant at the time of vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC). On 27Jan2021 by 15:00 the patient felt extremely tired and her eyes burned a lot. The reported events resolved on an unknown date without any treatment. . Information on the lot/batch number has been requested.
Localized redness, swelling, chills, dizziness, elevated BP, headache, neck pain
pt lived in SNF, from 3/31/21 - 11/21/21; pt expired in the facility after having a positive COVID test 11/10/21 with severe hydration; death certificate and med records have been sent per VAERS request