chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of swelling arm in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (Please refer the 1st dose case US2019GSK011459). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin discoloration, influenza-like symptoms and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the reactions were more severe after the 2nd dose. The patient experienced arm swell, turn red, and discolor, and experienced flu-like symptoms which necessitated a loss of a day of work. The patient also could not lift my arm up past a certain point. It was three days later and still experiencing these reactions. The patient had been in contact with my healthcare provider who had prescribed treatment. This case has been linked with case US2019GSK011459, reported by the same reporter.
Tinnitus.  Two weeks before taking the booster, I started hearing a low pitch whirring sound in my right ear, only in very quite rooms. It actually seemed to be getting better over a couple of weeks. Then, I got the Pfizer COVID vaccine booster, which caused fatigue and aches and also made my tinnitus much worse. I now hear a louder high pitched sound in my right ear. I saw an ENT who confirmed with audiology tests that there is no hearing loss. A course of oral steroids did not help.
The adverse event was clinically consistent with MIS-C.  The patient developed low-grade fever to 100 F several hours after vaccination.    These fevers persisted for 3 days.  On 12/11/21, fever increased to 102-103 accompanied by rash (palms, soles, eventually trunk), non-purulent conjunctivitis with limbic sparing, and mild strawberry tongue.  He had chest pain with inspiration, myalgias (especially neck), sore throat, headache, and dizziness.    Labs showed marked inflammation and echo showed cardiac dysfunction (see item 19).  He was treated with IVIG with only mild improvement in symptoms.  Infectious work-up was negative for active infection but did reveal an anti-SARS-CoV-2 antibody (spike) positive before IVIG.  He received a second infusion of IVIG and methylprednisolone 1 G IV with marked improvement in symptoms.  He had one additional fever spike, resulting in additional steroids and a steroid taper.  Echo abnormalities resolved, all labs improved, and symptoms improved except for fatigue.  He was discharged to home on 12/20/21.
Cushing's disease; they found a tumor and took it out, but he's not better; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization. The following information was reported: PITUITARY-DEPENDENT CUSHING'S SYNDROME (medically significant), outcome "unknown", described as "Cushing's disease"; NEOPLASM (medically significant), outcome "unknown", described as "they found a tumor and took it out, but he's not better". The events "cushing's disease" and "they found a tumor and took it out, but he's not better" required physician office visit. Therapeutic measures were taken as a result of neoplasm.  Additional information: It was reported that the reporter was calling in regards to the Covid-19 vaccine. The reporter had the vaccine in Feb2021 and the second one in Mar2021. Wound up with cushing's. Read that the vaccine could cause adrenal crisis. The reporter met the patient who got the vaccine around the same time, just a couple weeks apart, and they both have crushing's. The patient got Cushing's and so did the reporter. He looked worse than the reporter. His face was so swollen. The two of them both got Cushings and it was so rare, and they both got the vaccine around the same time. He went to the same Cushing's doctor as the reporter. They found a tumor and took it out, but he was not better. It was so weird that both the reporter and the patient would get Cushing's.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201317278 similar report from the same reporter;
2nd vaccine  fever and severe chills started 6 hours later. over the next 11 days he would show the same fever and chills.  @ extra strength tylenol  would help.  He also developed a slight cough and general malaise.  His blood sugar level which he takes 2x a day was much higher than normal even eating the same foods as usual. Concerned where he has so many health issues,  Called his doctor for him to be seen and they said he needs a covid test.  He will have had vaccine 2 weeks ago this upcoming Wednesday. 1st vaccine he had no symptoms until 5 days later and then fever and chills also. Called his doctor today 3/15/21
She reports, "I have no balance." She had second COVID-19 vaccine on 2/12/2021 and afterwards had myalgias.  Over the next few days she felt like her balance was off, particularly on 2/15/2021 when walking on the beach.   On 2/18/2021 she went to urgent care and was diagnosed with lumbosacral radiculopathy. She doesn't agree with the diagnosis and states, "I feel like I've had a stoke." She has trouble controlling her right leg. Her right arm is okay and she's had not trouble speaking or had a facial droop. She is taking the prednisone which was prescribed.   She started using a cane on 3/10/2021 due to dysequilibrium with veering towards the right. She felt more stable this morning but this afternoon is again needing to use the cane. She denies vertigo, nausea, vomiting.
Redness, swelling of arm within 4-6 hours of Pneumo vaccine. No fever. No other complaints. Swelling and redness resolved within three days of injection.
immobility; swelling; insomnia; hives around the injection site; More pain than the average vaccines; This spontaneous report  was received from a consumer referring to his wife a 58-year-old female patient.. Patient's concurrent conditions included cancer and allergy to sulfur based medications. Concomitant medications included, atorvastatin calcium (LIPITOR) and semaglutide (OZEMPIC). Information regarding  patient's historical conditions was not provided.   On an unspecified date in 2020 (reported as "roughly a month ago"),  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form in the right arm, to prevent pneumonia  (prophylaxis) (strength, administration route, lot number and expiration date were not provided).       On 01-DEC-2020 (reported as "6 weeks ago"),  the patient experienced Immobility (paralysis), more pain than the average vaccine caused, swelling, insomnia and then she developed hives around the injection site. No treatment was given for the events, and a blood work was performed.   The outcome of the events was reported as recovered/resolved.     The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, Immobility was determined to be a medically significant event.
received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today) 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.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 vaccine on 05Apr2021 and now wants to get the second dose today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
one week later developed shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: one week later developed shingles).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 29-Aug-2023 The patient received the dose of Shingrix and one week later developed Shingles. The physician did not remember who the patient was. The reporter did not consent to follow up.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 18-month-old patient of unknown gender. On 07-AUG-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot number was confirmed as L001325 with an expiry date of 04-FEB-2017. This is one of several reports received from the same source. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. In 2017 (reported as within the last two weeks), the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date were not reported) intradermally for prevention of shingles. The patient thought that the ZOSTAVAX was administered intradermally because, on an unknown date in 2017, the patient developed a raised area in their skin at the injection site similar to what would occur with a tuberculosis (TB) test. The reported also stated that the patient had a rash at the injection site. The patient sought medical attention by calling the pharmacist. It was unknown if the patient received any treatment or if they had performed any laboratory diagnostic tests. At the time of this report, the patient had not recovered from the events. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
RECEIVED THE VACCINE WITH NO ISSUES.  ONE WEEK LATER, BABY STOPPED GROWING.  MISCARRIAGE CONFIRMED ON APRIL 16, 2021
I had a breakthrough case of Covid-19 around November 24th, started having lung issues coughing and fatigue, I went to urgent care originally then sent to a doctors office and was advised it was pneumonia, was placed on multiple antibiotics.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 months old male patient who received vaccines PENTACEL and DAPTACEL on 13 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine; Hepatitis B Vaccine for Immunisation; and Pneumococcal Vaccine for Immunisation. On 13-Sep-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, lot C551CAA via intramuscular route in the right thigh. On 13-Sep-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, lot C5254AA via intramuscular route in the left thigh. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Loss of feeling in mouth. Difficulty in swallowing,  dry mouth.  Increase heart rate.  Anxiety.  Hands shaking.  Lasted for approx 10 minutes.  Mouth  dryness and difficulty in swallowing for approximately 24 hours.
Patient developed symptoms of headache, nasal congestion, sore throat, and mild cough on 07/20.  She tested positive for COVID on 7/22/2021.
LOOSING WEIGHT; PAIN ALL OVER THE BODY; MALAISE; CHILLS; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the patient experienced loosing weight, pain all over the body, malaise, chills, weakness and headache. The patient had not contacted Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache, and had not recovered from malaise, pain all over the body, weakness, and loosing weight. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210424184.; Sender's Comments: V0 20210424121-Covid-19 vaccine ad26.cov2.s -Losing weight. This event is considered unassessable. The event 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.
Chills; Nausea; This is a spontaneous report from a contactable physician reporting for himself. A male patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient indicated the he was experiencing "all listed side effects e.g. chills, nausea" on an unspecified date. He asked if he can take Advil. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
She woke up at 4:00am and experienced body tremors. She had a fever that morning of 38.5 C and I advised to take 2 Tylenol every 6 hours as needed for fever. Early that morning, she also experienced vomiting and it hasn't stopped, so I suggested for her to drink some Pedialyte to rehydrate. She also developed some chest discomfort when she draws in a breath, and I advised her to watch and if the fever does not break or any symptoms do not improve, then to seek immediate medical attention.
swelling; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B2IA and 0128AZIA) for COVID-19 vaccination.     No medical history provided.  Concomitant products included FINASTERIDE, ARIPIPRAZOLE (ABILIFY) and SERTRALINE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced SWELLING (swelling) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN for Joint pain, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling) and ARTHRALGIA (joint pain) outcome was unknown.            This case was linked to MOD-2021-168672 (Patient Link).
pt recvd flu vax 24NOV92 & 2DEC92 pt presented w/ a rash described as tiny red spots which enlarged & thickened over face, neck, behind the ears & on lt hand; pt noted purple discoloration of fingers & desquamation of skin; swelling;
1st covid shot on 1/16/21.  Then on 1/19/21 I had ortho inject a steroid in my thumb.  Right after the steroid shot, I started reactions---Severe headache, chills, nausea, cough, upper chest pain, severe weakness, blood pressure up and down.  Went to family doctor 1/22 and covid shot in office showed negative.  Worse on 1/24/21 and went to ED.  They did a chest x-ray, CTA chest, lots of bloodwork and covid test that took 2 hours to receive results.  All was negative except the D-dimer test.  Thye thought it might be a result of the 2 injections within days of each other.
Immediately /p vax, pt started to cry & held breath, mom blew into childs mouth w/o response,I took pt blew into face & then cleared mouth & percussion to back, still pt did not respond or breath, cyanotic @ mouth & face, summonded help-CPR
This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at 17:00 (at the age of 67-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure and heart racing. The concomitant medication(s) included irbesartan (AVAPRO) 300 mg orally once a day taken for blood pressure measurement orally taking for three or fours years, and glimepiride (GLIMEPRID) 4 mg orally twice a day taken for diabetes mellitus orally taking for ten years (both ongoing). The patient had not received any other vaccination within four weeks. On 24Feb2021, the patient reported she doesn't remember much about the day of the vaccination after the shot because they didn't get home until 08:00 pm. Adds that day she think she had pain in her left arm and shoulder. The next day on 25Feb2021, she had a headache that was not bad and she had it for a day or two; she had chills and felt feverish that night/ little bit feverish. Adds she didn't took her temperature so she doesn't know if she had a fever and she didn't take anything for it. The next morning, on 26Feb2021, she still had the chills and felt feverish for a day or so then that went away. On 28Feb202, Sunday night she noticed her heart rate going fast; it has been worse especially at night and there was a loud thumping in her ears. This lasted nearly a week. The patient reported that she went to see her primary care but the doctor didn't think the thumping had to do with the vaccine and said maybe the patient had inflammation on her ear previously and could not hear the thumping so she can hear better now. The doctor gave her Flonase nasal spray for her ears but she only took it twice. The heart racing has gotten better and better and has finally gone away. It lasted for five or six days until last Monday. She still has the headache, but the thumping was gone. The patient was scheduled for the next dose of the vaccine on 17Mar2021 and was asking by having these symptoms should she get the next dose of the vaccine. The patient's any AE(s) required a visit to physician saw a doctor but no hospitalization for loud thumping in her ears. The outcome of the headache not recovered, and pain left arm and shoulder, chills, little bit feverish was recovered on 26Feb2021, and loud thumping in her ears and heart racing recovered on 08Mar2021. Follow-up attempts completed. No further information expected.