chrisvoncsefalvay/vaers-outcomes huggingface dataset:
typical headache; center of my chest discomfort; a little tightening; back pain; chest pain; pain between my shoulder blades; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Sep2021 (at the age of 48-years-old ) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 07Sep2021, within few hours after vaccination the patient experienced typical headache, center of my chest discomfort, a little tightening, it would be intermittent on and off and she had that for few days and then started with a  back pain, pain  between shoulder blades and about 6th day her chest pain was really bad almost went to the ER, and then on the 6-7th day back pain was constant, now back pain not often, comes and goes. Patient stated that she was very concerned with getting a second dose because she would not want to go through the same or possibly something worse. Caller stated that she is trying to get the antibody test, stated that she may have had COVID before the vaccine but she is not 100% sure because testing was not available through her doctors office so she could not do that. As noted in the fact sheet for recipients, patient should not get the Pfizer-BioNTech COVID-19 vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They refer patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient healthcare provider knows her health situation and has access to information that can better help inform this decision. Seriousness of the events reported as non-serious. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Fever, chills,  severe headache,  fatigue, joint pain, body aches
COULD NOT BREATHE; CAME OUT LOOKING LIKE AN 80 YEAR OLD MAN; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced could not breathe and was hospitalized for over two weeks, he was on oxygen. He came out looking like an 80 year old man. Hospital discharge information not reported. SARS-CoV-2 test was performed and result was negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not breathe, came out looking like an 80 year old man and ended up in the hospital for over two weeks an oxygen was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210951067.; Sender's Comments: V0: 20210950516-Covid-19 vaccine ad26.cov2.s -Could not breathe. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
accidentally received last year's expired dose of fluzone high dose with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA417918(Cluster) and 2022SA420369(Cluster).  This case involves an unknown age female patient who accidentally received last year's expired dose of fluzone high dose with no reported adverse event. (Influenza quadrival A-B high dose HV vaccine) [Fluzone high-dose quadrivalent.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 06-Oct-2022, the patient accidentally received last year's expired dose of influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (0.7 ml 1X)(lot number: UJ748AA; expiry date : 30-Jun-2022: strength, formulation unknown) via unknown route in left deltoid for immunization, with no reported adverse event (expired product administered)(latency : same day).  It was reported Pharmacist reporting that 3 patients accidentally received last year's expired dose of FLUZONE HIGH DOSE and requesting revaccination recommendations regarding dosing and timing of administration. A nurse practitioner (same as prescriber) accidentally administered 3 expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022. The pharmacist identified the administration of expired products today, 10OCT2022, stating that she did not know "why last year's formulation was in the fridge." Pharmacist inquired what the recommendations are for the timing and need for revaccination with current FLUZONE HIGH DOSE QIV. SRDs emailed to requestor. Pharmacist denied any untoward effects from the administration of the expired vaccines at this time and advised that the patients would be revaccinated with current FLUZONE HIGH DOSE QIV    Action taken with was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
On 04/16/21 had Mammogram on Right breast, on 04/24/21 the right hand and arm swelled.  Went to primary care physician who sent to local hospital for ultra sound as he suspected blood clots.  Ultra sound was negative for any blood clots.  On -5/6/21 again doctor suspected blood clots and ordered another ultra sound which was negative again.  Then was sent to Lymphedema Therapy at Hospital.  Physical therapy eight (8) times beginning on 05/24/2021 to 06/17/2021.  Then was sent to other Hospital to a Lymphedema Specialist on 07/01/2021.  The NP there sent me to their Lymphedema Therapist nine (9) times beginning 07/13/2021 to 08/18/2021.  On 08/11/2021 I was sent for a Lymphocintography and that test showed blockage and I will need a procedure (out patient) to re-route Lymph Fluid.  The therapist recommended a System for at home therapy.  This machine cost approximately 5500.00 and I am having to pay out of pocket 1300.00 plus 20.00 for each PT session (17 visits)
Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immediate after vaccine.  Treated with Benadryl.   27 weeks pregnant - Due May 31, 2021.
Received the shot 12 pm on Friday 4/9 and at 7:30 pm that night started with fever,chills and body aches this lasted till Sunday 4/11 mid afternoon. Monday extreme exhaustion left side of the if the body leg pain tiredness arm in extreme pain.  4/13/21 woke up with leg and arm and now neck and throat achy and foggy brain. Called doctor and she was not concerned stated to take Advil and drink a lot of water
About 4 hrs later, I had a headache and neck ache. Around 8hrs after injection, I grew ill with a fever, severe muscle and joint aches, nausea, and the headache worsened into neck pain. I have had a bit of anxiety and all around emotional swings. I felt foggy and "off" at this time, like my head isn't clear. There has also been constant aching at the site of injection in my left arm.
This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and unknown gender. On an unspecified date six years ago (assumed in 2008) the patient was vaccinated with the first dose GARDASIL, 0.5 ml, intramuscular. On 21-MAR-2014 the patient was vaccinated with the second dose GARDASIL 0.5 ml, intramuscular. No adverse effects were reported. No consent for follow up. Additional information is not expected.
Patient received 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 31-month-old female patient who received HAV (Havrix) (batch number 2k57n, expiry date 11th December 2022) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix on 27th April 2021, batch number CE74N and expiry date 19th June 2022). Concomitant products included HAV (Havrix).   On 7th December 2021, the patient received the 3rd dose of Havrix. On 7th December 2021, unknown after receiving Havrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: Age at vaccination was unknown, however could be 30 months or 31 months at the time of vaccination. The patient received third dose of Havrix, which led to extra dose administration. Consent to follow up was granted.
This case was reported by a consumer (also the subject) and described the occurrence of flu-like symptoms in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 27 June 2012 the subject received a dose of BOOSTRIX (details unknown). On 27 June 2012, less than one day after vaccination with BOOSTRIX, the subject experienced flu-like symptoms. The subject was told by her urgent care that the "tetanus-only vaccine" (not a combination product) administered to her was a GlaxoSmithKline (GSK) product. The subject was not given the name of the product and she planned to call the urgent care back to get further details. The subject declined to provide any further information. GSK does not make a tetanus-only product so the report was entered as BOOSTRIX since the subject stated it was a GSK product. At the time of reporting the event was unresolved.
no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medications was reported.  Beyond use date was reported as 08-Jan-2023. Administration dates are as follows: 09-Jan-2023 (2 patients), 10-Jan-2023 (2 patients), 11-Jan-2023 (4 patients), 12-Jan-2023 (4 patients), 13-Jan-2023 (3 patients). All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.  No treatment medications was reported.  This case contains information for the 09 out of 15 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
On day due for 2nd dose, Patient was found unresponsive at work in the hospital.  Patient pupils were fixed and dilated.  Full ACLS was initiated for 55 minutes with multiple rounds of bicarb, calcium chloride, magnesium, and epinephrine. Patient was intubated.  Patient continued into V. Fib arrest and was shocked multiple times.
Chills and fever felt approximately 12 hours after the second dose. Muscle soreness all over the body, fatigue, and mild throbbing headaches when standing up quickly we?re felt upon waking up the following morning and lasted through the entire day. Side effects slowly waned after eating dinner, approximately 30 hours after the second dose. No painkillers/pain relievers were used.
Vaccine that administered beyond use date after the thaw process; Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml); This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml)) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25 ml)) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 29 years and 11 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process.  There was no adverse reaction noted or reported  regarding the administrations.Patient got Moderna with vaccine Ndc code 80777-0273-99.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Master case
Information has been received from the patient's mother referring to a currently 7 years old female patient. There were no drug reactions/allergies, concomitant medication or pertinent medical history with respect to the patient. In approximately September 2015, when the patient was four and a half years old, she got M-M-R II (lot#, expiration date, dose and frequency were unknown) subcutaneously vaccinated to prevent disease. The patient experienced a measles-like rash from head to toe and extreme lethargy exactly one week after the vaccination. Then, the patient was taken to physician and diagnosed with reaction to M-M-R II. After returning home that night, the patient's mother noticed that the patient had a high fever of 106 (units not provided) and began convulsing. The patient was admitted for one night. After being discharged from the hospital, the patient's mother reported that the patient was experiencing low body temperature for several days and did not start to really improve until a week after being in the hospital (Body temperature decreased). No treatment was given for the events. Some unspecified tests were performed to rule out other viruses, the result of tests was not provided. The patient was recovered at the time of reporting. The causality between the events of "measles-like rash" and lethargy and the suspect therapies was related. The causality between the other events and the suspect therapies was not reported.
Initially it was the same reaction as first with arm soreness. The arm was sore went away faster. 2 days after vaccine, (02/14/2021) I had the tiredness, body aches, but it went away quickly. A week and a half after vaccine I noticed a rash on mid back close to side on my right side. I felt fine and my husband said it looked like shingles but I've always heard shingles hurt and I didn't even feel it. I waited a couple days but it was spreading and it was still minor and covered area 4 inches long and 2 inches tall. It did start to tingle and in the meantime as its spreading I started feeling like I had the flu. I was tired, had a dull headache behind eyes, body aches. I went to see my Doctor and he checked out my back and said it was shingles and that's why i felt bad. He put me on a steroid and I immediately started feeling better and within a week or week and a half after appointment the rash was completely gone. I just thought it was interesting that I never had the shingles and soon after shot I got shingles. It was very minor and almost like the vaccine triggered it.
Patient described pain at time of immunization, more than normal. Patient reports swelling starting the same day. The swelling was below the site of injection. Patient reports muscular discomfort and pain that comes and goes down the arm. Patient does not report limitations to range of motion.
Right thigh to knee swelling, slightly red, warm to the touch. Treated with: AUGMENTIN 600/5 - 6cc Bid x 7 days. ATARAX 10/5 4cc every 6 hours.
This spontaneous report was received from an office manager, via a company representative, referring to a 10 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 05-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 06-JUL-2018, the patient developed a knot around the injection site, redness and pain. It was unknown by the reporter whether the patient received treatment, sought medical attention or if any laboratory tests were carried out. The outcome of injection site nodule, injection site erythema and infusion site pain was unknown. Causality assessment was not provided.
Severe headache and eye pain, fever 102.9, chills,rigors, vomiting profusely for 4 hours.  Had to miss work and not get paid.
Patient recieved the Prevnar 13 shot on 8/13/15. She returned to the pharmacy on 8/15/15 complaining of redness/rash at injection site. Pt said her arm was very sore the day after the shot and the morning of 8/15/15, she had a rash/redness around the injection site and some itching, but the soreness was better. Told pt she could use a cold compress on the site for 15 minutes, take acetaminophen for soreness, and an antihistamine for the itching if needed. Pt was fine, just wanting to make sure she didn't need to seek medical treatment. Told pt the redness/rash and pain were both possible side effects of the shot. Followed up with the patient on 8/16/15 and she reported she was doing fine and the redness was gone now.
The day following the COVID vaccine I experienced heavy and irregular menstrual bleeding. My period had ended 3 days prior and was not expected to begin for 4 more weeks.   Prior to the vaccine, my periods averaged 3-4 days. Since the vaccine they have been longer (4-6 days), irregular, heavier, with more painful cramping. I am not on birth control at this time. No treatment given.
Felt off; heart was beating faster; sore arm; Fatigue; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt off), HEART RATE INCREASED (heart was beating faster), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (Felt off), HEART RATE INCREASED (heart was beating faster), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue), CHILLS (chills) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Felt off), HEART RATE INCREASED (heart was beating faster), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue), CHILLS (chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About 5 hours after flu shot (double dose) had shakes for about 2 hours, then had sweats and fever for all next day. Took 2 TYLENOL every 4 hours and later took BENADRYL for next 2 days.
Diagnosed with Covid after receiving first dose of vaccine; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with COVID-19 after receiving first dose of vaccine. The patient wanted to know if patient should receive second dose of vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            Patient is on concomitant medication reported but not specified which ones.  No treatment drug reported.