chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 067H22A and 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    This case was for 14th patient out of 27 patients. Patients was an over the age of 65 years.  Concomitant medications were not reported.  It was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  The vaccine was administered in the deltoid site. On 11-May-2023 26 patients were contacted, on 12-May-2023 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone.   Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
PATIENT WAS ERRENTLY ADMINISTERED MODERNA INSTEAD OF THE FLU VACCINE, SHE HAD A PFIZER VACCIEne 10/02/2022 and tested positive for covid the next week. this is an error, patient as of two hours later still had no reaction
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The pertinent medical history was not reported. On 09-MAR-2015, the patient was vaccinated with GARDASIL dose 3, 0.5 ml, intramuscularly which underwent a supported temperature excursion. No adverse event was reported. Additional information has been requested.
Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved.  She was dismissed from ED at 20:03.
Around the dates of vaccination(s), between 6th and 10th every month, my nose runs tremendously. Stuffy nose, watery eyes and constant nose blowing.
Administered to Newborn; Vaccine administered at inappropriate site; Initial Report Received on 15-Dec-2020  A pharmacist reported that a newborn female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or known drug allergies were reported.   No concomitant medications were reported.  On 09-Dec-2020, on the day of birth, the patient received a dose of HEPLISAV-B (Lot # 933839, expiration date 28-Feb-2021 and NDC # not reported) to the right thigh.  At the time of report, no adverse reactions had been reported.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Kidney pain and UTI began day after first injection.  Diagnosed and treated for 5 UTIs since initial vaccine.
Menstrual cycle changes; Menstrual cycle changes heavier bleeding; Shorter cycles between periods; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 21May2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient had menstrual cycle changes, heavier bleeding and shorter cycles between periods. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual cycle changes, heavier bleeding and shorter cycles between periods was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist via a Vaccine Account Representative and refers to two patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route and site of administration, lot # and expiration date were not reported). On an unknown dates, the patients experienced the same side effects which was: injection site redness, injection site swelling and injection site soreness. The outcome of the events was reported as recovered. The pharmacist mentioned that both patients was doing "fine" at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Acute reaction within two minutes of vaccine: dizziness, increased heart rate, weakness, slight confusion. Increased in severity quickly. Pharmacist called EMT. Very ill feeling lasted for about five minutes then began to recover by the time EMT arrived. Taken to rescue truck and all vitals checked out OK: blood, O2 levels, heart monitor, blood pressure, temperature. Refused transport to ER, released after five minutes, feeling much more normal. Listless rest of day, normal next day. Had just come from gym workout, may have been dehydrated.
H1N1-2nd shot given approx. 12:30 PM 12/17/09-Mthr. notified of rash and fever approx. 13:30 PM 12/17/09. Pt presents today with rash-macular-erythema from head to groin area-Temperature 102.9 degrees.
This spontaneous report was received from the grandmother of an 11 year old female patient.  Medical history and concomitant medications were not reported.  In 2012, the patient received her first dose of GARDASIL at age 11 (she was 15 years old at the time of this report).  The patient began "getting sick right after" receipt of the vaccine.  The grandmother clarified that the symptoms may have begun within a total timeframe of four months after the vaccination.  The patient's illness has progressively gotten worse over the years.  At the time of the report, the patient was bedridden and suffered from double vision, general pain and nerve pain and stated "her immune system is gone".  The patient sought unspecified medical care over the years.  In terms of treatment, the patient now received "home infusions on a consistent basis".  The outcome of the events was not recovered/not resolved.  The reporter stated she would like to "see us [Merck] in court for having this vaccine off the market".  The reporter also stated that three and a half weeks ago, a fried of her granddaughter's died (it was not clear from this statement whether the girls had received GARDASIL before her death) (see case #  1612USA005706). Bedridden was considered disabling by the reporter. Additional information is not expected as the reporter did not provide contact information. Sender's Comments:  US-009507513-1612USA005706.
Our son regress in cognitive abilities that he once had, such such writing, drawing, eye contact, and communication.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 13-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
aches; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. One day after receiving the first dose of the COVID vaccine the patient experienced aches. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had typical arm soreness after injection but arm has been sore ever since. I have had flu shots before and never had this happen. My arm has been sore everyday since the shot especially when I move it to reach something.
12/01/2022 I thought I had an extremely bad head and chest cold. My temperature only went up to 99.5. This lasted for a couple of days. 12/3/22 I found out I was exposed to COVID. I tested with an at home COVID test and it was positive. I emailed my doctor and she told to take MUCINEX. It hung on for about a week and a half, not as bad. I emailed my doctor to see if it should take this long. Around 12/12/22 I tested negative with an at home COVID test. She said it could and to just stay home and take it easy. Between the third and fourth week of December, I finally recovered. I can still feel it in my chest, however.
I was giving vaccines for Pharmacy Care Associates to employees and residents at a nursing home. I gave a vaccine to an employee who is 16. There were no adverse events when the vaccine was given.
passed out; dizzy; This is a spontaneous report received from a contactable pharmacist via Pfizer sponsored program. A 28 years old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left deltoid on 18May2021 6:00 PM central time (Lot Number: EW0185, Expiry Date: Aug2021, NDC Number: 5926-1000-01) at single dose for COVID-19 immunization. The patient's medical history, family medical history and concomitant medications was none. The patient has not had any other vaccines within the last 8 weeks. The patient got dizzy and passed out on 18May2021 after 6:00 PM after the first dose of the vaccine. They ended up calling 911 and the paramedics came. The paramedics checked him and released him, said he was good to go. He was not taken to the hospital. The patient did not visit emergency room neither physician office. The pharmacist assessed the events related to the vaccine and assessed as serious due to medically significant. The outcome of event was recovered completely. The pharmacist asked if he should get the second dose.; Sender's Comments: As there is limited information in the case provided, the causal association between the events loss of consciousness and dizziness and the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees, and Investigators, as appropriate.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
I experienced pronounced chest pain 7-10 days after both the first and second vaccine shots.  The chest pain is less sharp now (5 weeks after 2nd dose) but still constant and present.
Received their first doses/Tested positive for covid illness; Received their first doses/Tested positive for covid illness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (patient herself and husband). This is the first of two reports.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history included COVID-19 exposure.  Concomitant medications were not reported. The patient and her husband received their first doses of COVID-19 vaccine in Apr2021, and both tested positive for COVID illness in Apr2021. They believe their exposure was the day they received their vaccination, as her husband came in contact with COVID-19 the same day. The patient had two negative tests for COVID-19 in Apr2021. Their second dose is scheduled on 23Apr2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421935 Same reporter, product, event; different patient
Breakthrough case admission after 2 vaccines Pfizer 12/7/21 lot# FH8027;  Pfizer 1/6/22 lot# FJ1611
2 inch diameter bump on right leg, and dime size bump on left leg where vaccines were administered. Still there 3 weeks later.
Injection site is moderately swollen and moderately painful; Injection site is moderately swollen and moderately painful; Range of motion is affected; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (Lot Number: EK5730), via an unspecified route of administration in right arm, on 28Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergies, and allergies to sulfa, kiwi, sunflower seeds, and herbal tea. The patient's concomitant medications included paracetamol (TYLENOL), loratadine (CLARITINE), ibuprofen (ADVIL), famotidine (PEPCID), ergocalciferol (VIT D), and ascorbic acid (VIT C). The patient previously took oseltamivir phosphate (TAMIFLU) and nickel and experienced allergies to both. No other vaccine was administered in four weeks. On 29Dec2020 at 11:00 AM, the injection site was moderately swollen and moderately painful and the patient's range of motion was affected (pending clarification). The patient was reporting this because she had never in her life had injection site swelling. The site was not itchy or red. There was no rash. It's just markedly swollen and painful. No treatment was given for the adverse events. The patient did not have COVID-19 prior to vaccination and the patient did not test for COVID-19 post-vaccination. The patient had not recovered from the events.
I started having chills, full body aches, joint pain and a headache within 6 hours. I went to bed early and woke up feeling like the worst flu I?ve ever had. I did not take my temperature, but it felt high. My arm was also extremely sore and heavy. The flu-like symptoms lasted for more than 24 hours. When I woke up on the next day (44 hours after my shot), my flu-like symptoms were completely gone, but general headache and joint pain remained. These lasted for another 8-ish hours. Arm is still sore, but much better.
The patient received Tdap and experienced fever, bodyache and headaches. Symptoms subsided in 4 days.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, once, lot # L03343, expiration date: 13-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 61 years old female patient. The patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneous on 08-AUG-2012 "it was recommended due to her age". Lot# was reported as 0018AE, exp date September 2013 (lot verification result pending). It was reported that after getting ZOSTAVAX, the patient experienced itchiness all over her body and erythema and a rash at the injection site. On 14-SEP-2012 she was prescribed hydroxyzine and a topical steroid cream. The pharmacist hadn't see her since she picked up the prescription so he didn't have additional information on her current status. Additional information has been requested.
Immediately after receiving the vaccine I felt burning at the site and shoulder that went away after a few minutes. My left arm was tingling , this lasted the rest of the night. The next day i experienced numbness/tingling and dull aching pain in my elbow, down my arm to my palm and two fingers (middle and ring). This has been intermittent for a week now, really effecting me while i drive and work as a travel nurse.
runny nose, tight chest, throat swelling, rash, itchy arms, 0.3 mg epipen, benedryl in right arm, steroid in left thigh (folumeerol) chills, diarrhea
I was vaccinated on 4/8 and experienced discomforted of the throat within 15 mins; 30 mins later experienced numbness from the upper lip took ibuprofen. A few days(4/11) later began experiencing increase heart rate and chest heating up at the same time found out I am unable to eat specific foods anymore (Tomatoes, Bananas, Milk, Blueberries); Same night I went to the Hospital which they prescribed Prednisone (50 mg) this made things worse. Since now I was not able to sleep and my heart was still racing and chest heating up. 4/12 - I went to an Allergist to find out if this was a side effect or allergic reaction but she stated could be both but not sure. She recommended I reduce the amount of the Prednisone to half. 4/13 - I went to my primary care doctor and they did an echo of my heart but also referred me to a cardiologist. I was able to make an appointment with the cardiologist was 4/21 and noticed heart elevation was high. He scheduled an echo for 5/4.
Case number PHEH2012US008036 is an initial spontaneous report received from a nurse on 10 Apr 2012: This case refers to an 11-years-old female patient. Previously she was vaccinated with first dose of MENVEO (batch number: unknown) intramuscularly on 13 Oct 2011. She was also vaccinated with second dose of MENVEO (batch number: A10042) subcutaneously instead of intramuscularly on 10 Apr 2012. No adverse event was occurred following this administration error.
When recipient arrived, it was believed she had received Pfizer in the past due to a screening issue before recipient saw the vaccinator. Previous dose was not documented in VAMS. Vaccinator administered the Pfizer vaccine, then the patient brought back her card to show that she initially got the moderna vaccine. Patient showed no adverse signs or symptoms. Vitals normal. We took her information. After 20 minutes of observation, the patient felt fine, so we sent her home and told her to seek medical attention if she felt symptoms. Nothing follows.
This spontaneous report as received from a Doctor of pharmacy refers to a 70 years old male patient with allergy contrast dye. On 17-OCT-2012, the patient was vaccinated subcutaneously with dose of ZOSTAVAX (lot number H013014 in process of validation, expiration date: 03-OCT-2013). No other co-suspects were reported. Concomitant medication included: FLUVIRIN. The pharmacist reported that the patient developed a rash in the same spot on the back of thighs on 17-OCT-2012. Labs diagnostics studies were not performed. The patient sought unspecified medical attention. The patient was treated with anti itch cream. At the time of the report, the patient had not recovered from adverse event. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Child started Pfizer 6M-4Y Primary Series.  Received 1st dose of Pfizer 6M-4Y monovalent (maroon cap) COVID-19 on 9/19 & 2nd dose Pfizer 6M-4Y monovalent (maroon cap) COVID-19 vaccine on 10/18.   Child turned 5 y/o on 10/24/22. Scheduled in error as additional dose on Pfizer 5-11 Booster scheduler.   Patient received Covid Vaccine - PFIZER BIVALENT BOOSTER for ages 5-11 years of age on 12/28.