chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little achy; Became very cold; feel warm; This case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (1st dose received on an unknown date).   On 8th January 2022, the patient received the 2nd dose of Shingles vaccine. On 8th January 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling cold and feeling of warmth. On an unknown date, the patient experienced pain. On 8th January 2022, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the feeling of warmth and pain were recovered/resolved.   It was unknown if the reporter considered the feeling cold, feeling of warmth and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient self reported the case. On the reporting day, the patient was given 2nd dose of Shingles vaccine. The patient became very cold for about 4 hours and then felt warm and a little achy. The patient commented that, he/she knew peoples who got shingles. Reporter did not consented to follow up.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that improperly stored doses of (Oka/Merck) VARIVAX (dose, strength, lot #, expiration date and route not reported) were administered to unspecified number of patients. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of two reports received from the same source. Additional information is not expected.
administered Shingrix by subcutaneous route; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number Y537X, expiry date 19th May 2023) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 6th April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: The reporter was pharmacy technician. The patient realized the error after reading over paperwork which noted vaccine should be administered intramuscularly. The reporter consented to follow up. Additional Supportive Information:The reporter reported that a nurse administered a dose of Shingrix to a patient in the right arm by subcutaneous route, which led to intramuscular formulation administered by other route.
bad charlie horse; Charley horse/ cramps right leg and arm; suffered with sciatic nerve pain; walks slowly now; clothing she wears around her waist causes her pain.; hasn't slept but two hours each night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad charlie horse), MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain), PAIN (clothing she wears around her waist causes her pain.) and INSOMNIA (hasn't slept but two hours each night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21A and 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (clothing she wears around her waist causes her pain.) and INSOMNIA (hasn't slept but two hours each night). On 24-Apr-2021, the patient experienced MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain) and GAIT DISTURBANCE (walks slowly now). On an unknown date, the patient experienced MYALGIA (bad charlie horse). At the time of the report, MYALGIA (bad charlie horse), MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain), PAIN (clothing she wears around her waist causes her pain.), INSOMNIA (hasn't slept but two hours each night) and GAIT DISTURBANCE (walks slowly now) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: significant Follow-up  received and events updated and added new events.
Hot red rash at the injection site; Hot red rash at the injection site; Hot red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot red rash at the injection site), VACCINATION SITE ERYTHEMA (Hot red rash at the injection site) and VACCINATION SITE RASH (Hot red rash at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ALLOPURINOL and NAPROXEN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot red rash at the injection site), VACCINATION SITE ERYTHEMA (Hot red rash at the injection site) and VACCINATION SITE RASH (Hot red rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot red rash at the injection site), VACCINATION SITE ERYTHEMA (Hot red rash at the injection site) and VACCINATION SITE RASH (Hot red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Saturday morning had rash on face, neck, hands & genital area;went to MD who rx w/decadron inj & pills on decreasing dose;made several visits to MD including an allergist;
Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in the left deltoid.  Per mother, patient did not have a reaction to the vaccine.
Child was breast feeding.  Mom describes her eyes rolling back and 10-15 seconds of tonic-clonic jerking, then resumed breast feeding.
P/vax pt had butterfly rash on face & fatigue;progressed to full blown lupus (SLE) w/in weeks;all abnormal results detected lupus;Annual follow-up dated 02/21/01 provided no additional data.
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of fainting in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included hepatitis A inactivated and hepatitis B recombinant vaccine; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received unspecified dose of CERVARIX (details unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced fainting, hit head and low blood pressure. The subject hit her head while fainting. The subject was seen in the emergency room. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, (lot number: X13882 and expiration: 01Sep2020), intramuscularly at the left deltoid, on an unspecified date at a single dose for immunization. Medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient had little red spots on her legs after receiving the vaccine. The patient described the reaction as being similar to the reaction she gets after having penicillin. The patient took BENADRYL and it went away, but returned on her face and eyes on an unspecified date. The doctor suggested she take diphenhydramine again. The patient recovered from the event at an unknown date.
W/in 1 hr p/DTP/OPV/HIB-TITER vax pt cried continuously for 24-36 hrs; Mom reported that pt felt hot to the touch, but temp recording was not taken; pt asymptomatic on F/U visit;
fever 103.6, pain, swelling, rash x 4 days rt deltoid;
Pt vaccinated pm of 6/4/18; underside of pt's right arm developed a swollen circular area the morning after vaccination; area is a little itchy and outer ring is red; pt states no other discomfort. Pt states he has never had any type of reaction to a vaccine before. Recommended benadryl and continued observation for treatment; recommended pt follow up with pcp if symptoms worsen or do not resolve quickly.
On the 4-5th days after the shot I developed painful lymph nodes in the armpit, on the 8th day I got the red slightly itchy spot around the  place where the shot was done. Size of a silver dollar. Slightly raised. Also notices swollen lymph nodes all around neck on the left side (received the shot in the left arm).
Information has been received from a nurse concerning a 24 year old female with an allergy to "laughing gas" who on 03-JUN-2009 was vaccinated IM with the first dose of GARDASIL. On 03-AUG-2009 the patient was vaccinated IM with the second dose of GARDASIL (Lot#662404/0312Y). Concomitant therapy included NUVARING. On 04-AUG-2009 this morning the patient called the office stated that she woke up with stomach ache, nausea, soreness at the injection site and a "generalized feeling of not feeling well". There were no laboratory or diagnostic tests performed. At the time of report the patient's status was recovering. Follow-up information has been received from a registered nurse concerning a 24 year old female patient with allergic to laughing gas and with no illness at time of vaccination who was vaccinated with the second dose of GARDASIL (Lot#662404/0312Y) at left deltoid at 9:00 on 03-AUG-2009. The patient had no adverse event after vaccination with the first dose of GARDASIL. On 04-AUG-2009 at 8:00am the patient had nausea and felt like she wanted to vomit. She described that she was feeling of "not feeling well all". The patient had not sought medical attention. There were no relevant diagnostic tests. On 05-AUG-2009 the patient had recovered. Additional information is not expected.
I only had a fever, chills, fatigue, and I felt tired. Those symptoms lasted for about 12 hours.
I tested positive for Covid-19 on November 26, 2022 and I experienced runny nose, and sneezing, fever, cough, and headache also very achy.
Patient passed out in waiting area and hit head on floor about 2-3 minutes after vaccination- my technician called 911. Patient came to quickly but remained very pale with a BP around  70/60 upon evaluation and she also involuntarily urinated.  Patient was responsive and able to answer questions but was not improving and BP remained low.  She was taken away by the squad about 10-15 minutes after vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Has side effects) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Has side effects). At the time of the report, VACCINATION COMPLICATION (Has side effects) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-409793 (Patient Link).   Reporter did not allow further contact
KNOTS FORMED AT SITE OF INJECTION ON BOTH LEGS.  STILL HAD A KNOT FROM 4 MONTH INJECTION SITE AS WELL.  BOTH KNOTS FROM 6 MONTH INJECTIONS HAVE COME TO A HEAD AND INFECTION HAS DRAINED.
Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced pneumococcal meningitis and pneumococcal meningitis. The patient received a dose on an unspecified date. On 05-Nov-2009, the patient experienced pneumococcal meningitis and was hospitalized. Treatment included antibiotics (unspecified). The outcome was unknown. No additional information was available at the time of this report.
Patient called pharmacy on 10/14/21 to report that she has been experiencing at  least two migraines daily since she received the Johnson and Johnson vaccination. Patient states she has not had prior history of migraines previous to receiving this shot. To remedy migraine, patient has been taking Aleve and/or Tylenol as directed on box. She will also schedule a doctor's appointment if migraines continue.
A report has been received from a physician concerning a patient, female subject, who had been receiving nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter received expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications in 2weeks. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive; (May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid, start date: 21Apr2022, stop date: 26Apr2022. Positive Covid test 8 days after completing Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Soreness at the arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: EW0165) as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "Soreness at the arm where the injection was".  Additional information: Reporter added, "My daughter has disability (Further clarification was unknown if daughter was financially disabled or physically, hence not captured as event), it's not the grandkids mother." Prior vaccination: Reporter stated, "No".  Follow-up attempts are completed. No further information is expected.
The afternoon after I developed chills and had goose bumps all over.  I didnt have a fever but the chills went on for several hrs so I took 2 500mg tylenol and the chills ended around 5pm.  I developed a headache and still had to continue to drink plenty water because my mouth got that super dry feeling again.  I went home ate and relaxed until I fell asleep.  I had body aches and because my arm was hurting I couldnt lay on that side.  I took benedryl and tylenol before bed. Today I still feel very very tired, fatigued and my body still aches.  My arm is still really red, warm to the touch and has a nice knot at the injection site and the headache comes and goes.
Nausea, diarrhea, body aches, headache, disorientation. Severe to moderate for 48 hours, light or intermittent for another 12 hours. Tylenol, liquids, and bed rest.
Information has been received from a medical assistant referring to two patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On 02_SEP-2015 the patients were respectively vaccinated with a dose of improperly stored (Merck) VARIVAX (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Within 5 minutes, I felt lightheaded/dizzy, and nauseated. We stayed in the car on site for 30 minutes, and at which time the symptoms had subsided. Doctor on site monitored my blood pressure and pulse during this time,  both were slightly elevated, but ok.  About 20 minutes after leaving, I developed sustained, moderate left sided chest pain. We drove to Emergency Dept. where I was monitored,  treated with Benedryl and steroids and released the same day.
Sore shoulder; tired; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Sore shoulder) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 939909) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Asthma, Irritable bowel syndrome, Chronic migraine, Allergy to NSAIDs, Gluten intolerance and Cystitis interstitial. Concomitant products included BACLOFEN, RIZATRIPTAN, PSEUDOEPHEDRINE and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder) and FATIGUE (tired). At the time of the report, ARTHRALGIA (Sore shoulder) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient took OTC nasal spray as concomitant drug.  In Feb2022, she had bladder pain that was worse than her usual bladder pain. She has also had a chronic migraine which she felt was leveling out now, as well as fatigue. She believed she has an undiagnosed history of interstitial cystitis, and thought her increased bladder pain was due to a UTI.  She has not taken any medications or treatments for her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-710279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710279:Master case, Bivalent dose
developed sore throat 8/2/21 PCR COVID positive 8/2/21
When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied; sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation; sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation), PRURITUS (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) and URTICARIA (When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BURNING SENSATION (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) and PRURITUS (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation). On an unknown date, the patient experienced URTICARIA (When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied). In April 2022, BURNING SENSATION (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) and PRURITUS (sudden reaction of itching/burning sensation to different parts of my body/itching and burning sensation) had resolved. At the time of the report, URTICARIA (When I itch those areas my skin welts/welting of my skin with the lest amount of itching or external pressure that's applied) had not resolved.            Concomitant medications was not provided by the reporter.  Patient received two doses of the Moderna vaccine. Patient delaying getting the booster because after patient received second dose in October 2021. About approximately three months later patient started having a sudden reaction of itching or burning sensation to different parts of  the body. When itched those areas had skin welts.   April 2022 was the last time patient  experienced the itching and burning sensation, however patient still experiencing a welting of skin with the lest amount of itching or external pressure that was applied.  Patient was very concerned about getting the booster shot because of side effects.  Treatment information was not provided.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's dad and son both had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient took the shingles shot and shortly afterwards, he/she came down with the worst case of the shingles ever. The shingles developed under the breast and around back down to mid thigh. The patient had to go to hospital and was prescribed with steroid shots and creams. It was horrible thing for him/her. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.