chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 74-year-old male with a history of shingles in April 2007, who on 24-OCT-2007 was vaccinated with a dose of ZOSTAVAX.  On 07-Nov-2007 the patient called the clinic stating that he had a very mild case of shingles outbreak, but no pain.  It was unknown where the rash was located.  The outcome was reported as recovering.  It was reported that the VZV ID program information was not discussed with the nurse.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has beenreceived from a registered nurse concerning a 74-year-old male with a history of shingles in April 2007, who on 24-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 07-Nov-2007 the patient called the clinic stating that he had a very mild case of shingles outbreak, but no pain. It was unknown where the rash was located. The outcome was reported as recovering. It was reported that the VZV ID program information was not discussed with the nurse. No product quality complaint was involved. Follow-up information has been received from a nurse practitioner indicating that the patient is retired with a history of shingles outbreaks on 26-Apr-2007 and 24-Aug-2007 and allergies to CYCLOBENZAPRINE HYDROCHLORIDE (manufacturer unknown, WAES# 0801USA02777), ASPIRIN and MORPHINE. He was vaccinated in the left upper arm with a first dose of ZOSTAVAX (Merk) (lot#*1406*). There was no illness at the time of vaccination. On 04-Nov-2007 (previously reported as 07-Nov-2007) he had an onset of a rash on his right breast (one vesicle) 11 days after receiving the vaccination. The pain was rated a 0 scale of 1-10 (0 being the least and 10 being the worst). It was reported that there was a "remote" history of chickenpox. It was unknown it there was a recent exposure to chickenpox or herpes zoster. There was no specimen collected for the PCR. There were no photos taken and a direct flourescent antibody was not done. The symptoms have resolved. Additional information is not expected.
Pt was given 2 doses of Tdap vaccine (BOOSTRIX). Admin error.
This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment for the event included diphenhydramine, naproxen and warm compresses.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on 11Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of meningococcal group b rlp2086 on an unspecified date and experienced pain. On 11Jun2018, the patient experienced pain immediately after shot. The next day, on 12Jun2018, the patient experienced red and swollen below injection site with pain, and unable to lift arm above head. The patient stated that the pain experienced was much different than when had gotten the first dose of meningococcal group b rlp2086. The patient had to take MOTRIN that helped with the pain. Clinical outcome of the events pain immediately after shot/ Pain lasted up to 4 days/ pain experiencing was much different than when had gotten the first dose of meningococcal group b rlp2086 and unable to lift arm above head was unknown. The event red below injection site with pain/still slightly red below injection site was not recovered while the event swollen below injection site recovered on an unspecified date. It was reported that the pain lasted up to 4 days (morning of office visit) and was still slightly red below injection site. No swelling noted at time of office visit on 14Jun2018. Information on batch number has been requested.
Gave patient dose subcut instead of IM. Patient did not have nay adverse event or irritation at site. T-called to primary care Dr and immunization center. Said to repeat dose in 1 week.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JAN-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-JAN-2017, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Information has been received from a physician concerning a 5 year old female patient who on 05-AUG-2010 was vaccinated with a dose VARIVAX (Merck) (Lot # 666367/0248Z; expiration date 04-FEB-2010). Secondary suspect vaccine given on the same day included a dose of MMR II (MSD) (Lot # 666295Y/1776Y; expiration date 16-DEC-2010). Concomitant vaccine given on the same day included a dose of KINRIX. It was reported that the parent called office on 10-AUG-2010 stating child had injection site reaction. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was not reported. The office requested a lot check. A lot check has been initiated. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 666367/0248Z was satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
patient was wondering if flu shot was responsible for a flare in hidradenitis suppurativa creating abscesses which started within a week. patient went to doctor on 9/24 and referred to surgeon. no other treatment or medication was given by primary.
Experienced and allergic reaction; Fever; Arm swelling; Body aches; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced allergic reaction, fever, swelling arm and general body pain. On an unknown date, the outcome of the allergic reaction, fever, swelling arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, fever, swelling arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient received the dose of Shingrix two years before reporting date and less than 2 years after the vaccination the patient had allergic reactions with fever, arm swelling, and body aches. The patient wanted to know if she would have the same reaction from taking the COVID-19 vaccine. The patient state that she had not taken the vaccine yet but her doctor told her to check the list of ingredients in the vaccine to make sure they did not line up with the Shingrix vaccine. The reporter was provided the attached list of ingredients to compare to the Shingrix ingredients with her provider.
feels like she's getting a fever now; she felt like somebody hit her with a bat, her whole body was aching pretty bad; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she felt like somebody hit her with a bat, her whole body was aching pretty bad), HEADACHE (headache) and PYREXIA (feels like she's getting a fever now) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (she felt like somebody hit her with a bat, her whole body was aching pretty bad) and HEADACHE (headache). On 24-Feb-2021, the patient experienced PYREXIA (feels like she's getting a fever now). At the time of the report, PAIN (she felt like somebody hit her with a bat, her whole body was aching pretty bad), HEADACHE (headache) and PYREXIA (feels like she's getting a fever now) had resolved.            Concomitant product use was  not reported by reporter    Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: fallow up received on 3-jun-202 out come of the events was updated from unknown to recovered /resolved; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient made an appointment through the scheduler and was vaccinated at 17 years old. He was 23 days shy of his 18th birthday.
Information has been received from GlaxoSmithKline for Hib-MenCY-TT (manufacturer report # B0484182A). A 12 month old male with a history of respiratory syncytial virus bronchiolitis at 3 months of age (from 26-NOV-2006 to 28-NOV-2006) was enrolled in the prophylactic booster study 105067 (Hib-MenCY-TT-010) which is single blind on study vaccines but double-blind on lot numbers of Hib-MenCY-TT. On 09-AUG-2007, the patient was vaccinated SC in the left upper arm with a dose of MMR II. Suspect vaccination on the same day included an IM dose in the right upper thigh of PedvaxHIB, a SC dose in the right upper arm of Varivax, and an IM Dose in the left upper thigh of Prevnar. On 13-AUG-2007, four days after the fourth dose of Hib-MenCY-TT, four days after the first dose of MMR II, four days after the first dose of Varivax and four days after the fourth dose of Prevnar, the patient developed reactive airway disease. The patient was hospitalized. The patient was treated with salbutamol sulphate and prednisolone. The event resolved on 20-AUG-2007. The investigator considered that there was a reasonable possibility that the reactive airway disease may have been caused by Hib-MenCY-TT, MMR II, Varivax, and Prevnar and that the event was possibly due to the patient's medical conditions. The investigator comments indicated that the event began with symptoms on 13-AUG-2007 with complaints of fever of 103 rectal, coughing, difficulty breathing, and wheezing. The patient was taken to the emergency room on 15-AUG-2007 where he was treated with albuterol nebulizers and oral prednisolone. He was admitted for observation and continued on albuterol nebulizers and oral prednisolone. He was discharged from the hospital on 16-AUG-2007. All symptoms resolved on 20-AUG-2007. Follow-up was received on 23-AUG-2007 which indicated that the patient received the fourth dose of the study vaccine on 09-AUG-2007. Symptoms of fever, cough, and wheeze started on 13-AUG-2007 and the patient was admitted to another hospital on 15-16-AUG-2007 where he was treated for reactive airway disease with albuterol and prednisolone. All symptoms resolved by 20-AUG-2007. This possibly could represent an allergic reaction to the fourth dose of investigational vaccine or just an episode of reactive airway disease in an infant predisposed to reactive airway disease on the basis of past history and respiratory syncytial virus bronchiolitis and a history of asthma in the maternal grandmother and the patient's siblings. This was originally reported by a physician. No further information is available.
Information has been received from healthcare worker referring to a 16 year old male patient. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date, strength and route were not reported). Concomitant medications was not reported. No adverse reactions were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Shot received was the SpikeVex Mederma Booster Headache throught out the evening  Redness, swelling, pain at site of shot Fatigue (slept for two days) Increased sinus mucus  Lasted almost 3 days; stayed home almoat two weeks to make sure my immune sytem adjusted to the shot and I have continued ro where my mask despite others having stopped and I stay clear of tight enclosed buildings without good a/c and proper ventilation.  If out in an outdoor area I stay clear of others without masks if I am not wearing one which happened on once and I had it in my pocket in case need - this was Sat Oct 14.  And if dining in, I stay far off to the rear or near the lessor populated areas of the restaurant.
HEADACHE/MIGRAINE; ACHY; TREMBLING; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced headache/migraine. On 26-MAR-2021, the subject experienced achy. On 26-MAR-2021, the subject experienced trembling. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache/migraine, fever, achy and trembling was not reported. This report was non-serious. This case, from the same reporter is linked to 20210358539.
Days 1-4: very sore arm at injection sight but especially sore in the armpit to the pectoral area only on injection side..  Day 9: started developing hives and itching around neck, face and scalp. Began taking antihistamines. Day 10: covered in rash, raised welts/Hives on chest, back, arms, heads, legs and feet.  Day 12: rashes and intense itching continue and now get bouts of asthmatic symptoms wheezing and shortness of breath. Usually bouts last about an hour then resolve naturally(while still on oral antihistamines). Day 16: Today. Still having all the same symptoms and found many similar cases by searching the internet with people having similar reactions to the booster shot and realized that my symptoms are in line with many others. I can?t skip a dose of antihistamine without suffering.
This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with VARIVAX (Merck), (strength, dose, frequency, route, anatomical location and lot number were not provided), which was improperly stored. Other suspect or concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Began vomiting at 4pm. Symptoms worsens with increasing episodes and frequency of vomiting. Went to ER at 7pm with the diagnosis of constipation. Abdominal xray findings revealed an ileus. She had no prior problems with vomiting or constipation prior to administration of vaccines.
a little bit more soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit more soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Knee pain. Concomitant products included METFORMIN for Diabetes, INSULIN and WARFARIN for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit more soreness). At the time of the report, PAIN IN EXTREMITY (a little bit more soreness) outcome was unknown.            Patient's concomitant medications include blood pressure pills. (unspecified)   No treatment information was reported.   This case was linked to MOD-2021-049827 (Patient Link).
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: PT DEVELOPED RASH ON ARM STARTING AT INJECTION SITE AND SPREAD OUTWARD OVER ARM. PT STATES FEELING ITCHY ALL OVER. PT TRIED BENADRYL, BUT DID NOT HELP. ADVISED PT TO SEE MD ASAP.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID". The patient ang his wife got the Pfizer COVID bivalent vaccine in Sep2022. The both took a five day course of Paxlovid and had two days of negative test. Commented to please consider recommending 3 month vaccinations for sensitive groups along with a ten day course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101212 same reporter, product and events; different patients;
pt recvd vax & 4 hrs later started crying & staring ahead like a "baby possessed"; w/in 8 hrs did not have the head control that had a/vax; w/in 24 hrs began to exhibit sudden drawing up of legs; EEG revealed hypsarrhythmic tracing;
throat irritation/burning in her throat "like acid reflux"; immunocompromised/ already received the first dose of the vaccine; immunocompromised/ already received the first dose of the vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 61-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "history of stem cell transplant " (unspecified if ongoing); "immunocompromised" (ongoing); and "allergic to 'a lot of medications'" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset 24Mar2021, outcome "unknown", described as "throat irritation/burning in her throat "like acid reflux""; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Mar2021, outcome "unknown" and all described as "immunocompromised/ already received the first dose of the vaccine". Additional information: The patient already received the first Pfizer Covid vaccine dose and wanted to know if it was safe for her to get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361915 different patient, same drug and similar event
Headache, dizziness, lightheaded, nausea, tired all lasting for a half hour after vaccination
I am feeling weak; I had a severe back; muscle pain; joint pain; headache; tiredness; chills; nausea; I had difficulty breathing; Arm sore; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A patient of unspecified age and gender received bnt162b2 ,( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 23Mar2021 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced i am feeling weak , i had a severe back, muscle pain, joint pain, headache, tiredness, chills, nausea, i had difficulty breathing , arm sore. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
7/1/2021 - ACUTE RESPIRATORY FAILURE - J96.00 7/1/2021 - CARDIOGENIC SHOCK - R57.0 7/19/2021 - CHRONIC RESPIRATORY FAILURE - J96.10
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a male 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 01-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.  It was reported that her brother also got the same side effect. Side effect: Shingles.   This case was linked to MOD-2021-293374 (Patient Link).
patient was feeling well before vaccines, got both in same arm at the same time. next morning patient reports severe arm discomfort, pain shotting through her neck and jaw, sustained fever of 101 degrees F