chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 10:51, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
She cant lift her right arm; Rght arm had pain in shoulder and down her back/throbbing pain; Right arm had pain in shoulder and down her back; Joint pain that is on going; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (She cant lift her right arm), PAIN IN EXTREMITY (Rght arm had pain in shoulder and down her back/throbbing pain), BACK PAIN (Right arm had pain in shoulder and down her back) and ARTHRALGIA (Joint pain that is on going) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Rght arm had pain in shoulder and down her back/throbbing pain), BACK PAIN (Right arm had pain in shoulder and down her back) and ARTHRALGIA (Joint pain that is on going). On an unknown date, the patient experienced MOBILITY DECREASED (She cant lift her right arm). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (She cant lift her right arm), PAIN IN EXTREMITY (Rght arm had pain in shoulder and down her back/throbbing pain) and BACK PAIN (Right arm had pain in shoulder and down her back) outcome was unknown and ARTHRALGIA (Joint pain that is on going) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Other treatment information included application of ice and heat.
head felt like it would explode, upset stomach, diarrhea, achiness all over, very tired;
vial was initially stored in refrigerator on 10may2023 and administered on 24JUN2023; No adverse event; 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 10may2023 and administered on 24JUN2023) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-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 24-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 10may2023 and administered on 24JUN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 10may2023 and administered on 24JUN2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 10may2023 and administered on 24JUN2023).    No concomitant medication information was provided.  It was reported that the vial was initially stored in refrigerator on 10May2023. The vial size was reported as 2.5 ml. It was confirmed that the vial had not undergone any temperature excursion issue  No treatment medication information was provided.  The case corresponds to 9th out of 9 adult patients who had received the vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732805 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732805:master case (pt. 9)
One week later - intense itching in left shoulder, scratching so much she thought she was going to; waking up out of her sleep with left arm pain, pain was uncomfortable and she was unable to go; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (waking up out of her sleep with left arm pain, pain was uncomfortable and she was unable to go) and PRURITUS (One week later - intense itching in left shoulder, scratching so much she thought she was going to) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (waking up out of her sleep with left arm pain, pain was uncomfortable and she was unable to go). On 16-Mar-2021, the patient experienced PRURITUS (One week later - intense itching in left shoulder, scratching so much she thought she was going to). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 1 dosage form every four hours. On 10-Mar-2021, PAIN IN EXTREMITY (waking up out of her sleep with left arm pain, pain was uncomfortable and she was unable to go) had resolved. On 17-Mar-2021, PRURITUS (One week later - intense itching in left shoulder, scratching so much she thought she was going to) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the second dose of Moderna Covid-19 Vaccine scheduled on 7-Apr-2021. Concomitant medication included blood pressure medication.
Systemic: Fainting / Unresponsive-Severe, Additional Details: pt fell off the chair, faced down after 5 minutes of vaccine injection. 911 was called and paramedics took her to ER.
The day following the immunization patient experienced swollen eye lids and the surrounding areas. She was treating pink eye at the time so she did not attribute the swelling to the vaccine. However, later that day she developed rashes and hives on her torso. She began a regimen of OTC benadryl and self treated at home. She called the pharmacy on Thursday, 4 days post vaccination asking if she needed to do more. The Benadryl was helping but the reaction was ongoing. It was recommended she visit the urgent care to be evaluated and treated appropriately. Her second dose appointment was cancelled.
Bilateral pneumonia; Painful herpes zoster/shingles.; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation and refers to a male patient of unspecified age. Patient's medical history, concomitant medications, drug reactions or allergies were not reported. On or around 07-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving the vaccine, the patient experienced painful herpes zoster (shingles). In addition, he was hospitalized due to shortness of breath and it was diagnosed with bilateral pneumonia. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had incurred medical expenses, loss of accumulations and other economic and non-economic damages as a direct result of use of Zoster Vaccine Live (ZOSTAVAX). At the reporting time, the patient had not recovered from the events. The reporter considered the events of bilateral pneumonia and shingles (herpes zoster) to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event bilateral pneumonia was determined to be medically significant. The reporter considered bilateral pneumonia and shingles (herpes zoster) as disabling events.
Information has been received from a pharmacist concerning a nurse who was vaccinated with RECOMBIVAX HB, "a while ago". The nurse recently had a titer drawn and failed to seroconvert. Her physician wants her to receive a booster dose of RECOMBIVAX HB. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pt walked to front making next appointment. The next thing the pt fainted. Pt got up rested a few minutes and was fine. Pt walked to front of the office and fell down.  We helped her up a made her rest we gave her water/pop and crakers.
Severe body aches starting day after getting PREVNAR 13 and lasting until given Rx of Prednisone on 10/28/15.
armpit pain; Redness; A report was received from a consumer concerning a female patient who experienced pain and redness in her armpit after receiving the Moderna COVID-19 vaccine.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (batch# was not provided) for prophylaxis of COVID-19 infection on 30 Dec 2020. She expressed that she experienced axillary pain and noticed also that her axillary area had a reddish discoloration. The patient informed that she felt pain in her arm when it rested on her side.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, axillary pain and redness, is unknown.   The reporter did not provide an assessment for the events of axillary pain and redness.; Sender's Comments: This case concerns a female of unknown age who experienced NS events of unexpected Erythema and expected Axillary pain.  Erythema occurred Day 1 after the first dose of mRNA-1273, followed by Axillary pain Day 8. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-002918:case invalid US-MODERNATX, INC.-MOD-2021-002925:
I got ready to get into the shower and I looked at my left arm from my elbow up my arm and it looked like Pop Eye muscle it was so swollen and big and that was the arm that I had the shot in.  Over the course after a few months I thought it would get smaller and I went to my primary doctor and no one had heard of COVID-19 arm and everyone was saying to use cold compresses and take Volteran but it started to travel down my arm even to my wrist.  Volteran just disguised it and I went to the Orthopedic Surgeon and he knew it was from the shot and he was going to treat it like Tennis elbow and he gave me a Cortisone shot and that relieved everything for about 5 months but my arm remained hard and it took about a good year for it to be ok.  I had some the second year and had another episode and had some residual pain and it eventually subsided on its own.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0161), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid treatment from 25Oct2022 to 30Oct2022.
The symptoms started on Sunday on July 3, 2022. I tested positive for COVID-19 on July 5, 2022. I took ibuprofen and Mucinex. I called my doctor's office on July 9, 2022. I did not take an antivirals. My symptoms were mild sore throat, tiredness, and congestion. I had a second wave of symptoms. The symptoms were a headache. On day 8, I had diarrhea. I also had a loss of appetite. Today on July 14, 2022 I am still testing positive for COVID- 19. I was exposed at a wedding. The wedding was a super spreader.
Information has been received from a patient's mother concerning her daughter (with a twin sister) with coeliac disease who on an unspecified date, at the age of 13 months was vaccinated with a dose of VARIVAX (Merck). Secondary suspect therapy included a dose of MMR II that was given 3 months after the VARIVAX (Merck) (when the patient was 16 months of age). It was reported that the patient was sick for a year after vaccination with  "post viral syndrome", "vitaminosis", and vitamin and mineral deficiencies for a year. It was also reported that the patient had kidney and liver problems and low white blood cell counts. It was reported that the patient recovered on an unspecified date. It was reported that the patient's twin sister experienced the same adverse experiences following vaccination (WAES # 0904USA03573). This is on of several cases from the same source. No further information is available.
pt recv vax devel an inj site rxn characterized by a big wheal & knot;
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with 1st of 0.5 ml VARIVAX (Merck), (lot number was not reported), subcutaneously on an unknown date in 1998 and the second dose of VARIVAX (Merck), on an unknown date in 2010. Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.
Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have.  I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.
I started having a sore throat, with a slight fever, achy. I did a home COVID-19 test, the first one was negative the second came back positive. I called my doctor's office, had a telehealth visit, they had me come in for an antigen COVID-19 test that came back positive. I was prescribed PAXLOVID for three days. I felt a little rough for a couple days but day five I was testing negative. I am still experiencing the stuffy of a head in the morning but by afternoon it is gone.
Headache within 1 hour . Flu like symptoms 12 hours later. 101.5 fever, nausea, arm sore, chills , headache
This spontaneous report as received from a medical assistant refers to a 14 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case: 1701USA004150; US-009507513-1701USA007912: Original Case: 1701USA007906; US-009507513-1701USA007922: Original Case: 1701USA007910; US-009507513-1701USA007881: Original Case: 1701USA007910; US-009507513-1701USA007913: Original Case: 1701USA007910; US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient had no medical history or drug allergy. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K001389, expired date: 29-JAN-2016), 0.5 ml , once, subcutaneous. There was no concomitant medication. On an unknown date "2 to 3 days after" the unspecified patient received (Oka/Merck) VARIVAX, he developed significant erythema, "from the shoulder to elbow", mild induration, tenderness and pruritis. The patient was taken to an unspecified Emergency Room where he received unspecified antibiotics, "for possible cellulitis", and BENADRYL. The physician stated the patient was still experiencing "some" of the reported symptoms. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient) received via COVID-19 VaccineReporting System. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Aug2021 10:00 (Lot Number: EW0170; at the age of 55-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, allergy to sesame seeds and penicillin. The patient's concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 03Aug2021 17:00, The patient experienced rash, itching at the injection site, and across the chest and up towards the neck, nausea, and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as the result of the events which included Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Flu booster agency gave free flu shots to workers and spouse. Pt is the spouse-she received flu immunization 11-12-08 8am- pt had 2 inch hot, red swollen area (L) deltoid-pt. saw her own Dr 11-14-08- supportive rare only
Extreme soreness for 2 days following injection which improved.  Now, 10 days later, swelling, itchiness, and redness at injection site.
runny nose, headache, body aches and chills  Mucinex Tessalon Perles Tylenol
5/17/2021 pt. c/o "bad" period & increased heaviness with clots @ 5/18/2021. c/o feeling tired, cramps, slight nausea