chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe cramping, like when I am on a very heavy day of my period, including right ovary pain.; Severe cramping, like when I am on a very heavy day of my period, including right ovary pain.; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0162348-18053) via an unspecified route of administration in the left arm on 17Apr2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, Inflammatory bowel syndrome (IBS) and known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rizatriptan (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN), norethisterone (NORLYDA) and iron supplements (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received thiomersal (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 17:00, the patient experienced severe cramping like on a very heavy day of her period, including right ovary pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe cramping and right ovary pain were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Developed a rare type of cancer in his arm where he was injected; This serious case was reported by a consumer via research programs and described the occurrence of cancer in a adult male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   On an unknown date, the patient received Hz/su + AS01B (unknown arm). On an unknown date, an unknown time after receiving Hz/su + AS01B, the patient experienced cancer (Verbatim: Developed a rare type of cancer in his arm where he was injected) (serious criteria death and GSK medically significant).The reported cause of death was cancer.   The reporter considered the cancer to be possibly related to Hz/su + AS01B.   The company considered the cancer to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by patient's wife via research programs.  The reporter stated that her late husband had vaccine and had developed a rare type of cancer in his arm where he was injected. It spread and killed him. The question was asked to her as what would motivate you to get the Shingles vaccine in the next three months and to which she responded that, to know without a doubt that, the vaccine did not cause her husband's cancer.  The reporter had thought that the event might be related to the product/device.  The reporter had consented to follow-up.; Reported Cause(s) of Death: cancer
veins in my feet are. bulging; there are whelps; This case was reported by a consumer via interactive digital media and described the occurrence of vein disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (allergic to penicillin and all its derivatives). Concomitant products included rasagiline mesilate (Azilect).   On 20th November 2020, the patient received Shingrix. On 24th November 2020, 4 days after receiving Shingrix, the patient experienced vein disorder and welts. On an unknown date, the outcome of the vein disorder and welts were not recovered/not resolved.   It was unknown if the reporter considered the vein disorder and welts to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself/herself. The age group was not reported but was selected as adult as per vaccine indication. It was reported that on the night of  24th November 2020 the patient's veins in feet were bulging and there were whelps.  The patient could not find what the ingredients were for the vaccine.  The patient said some medicines react to Azilect.
Pharmacist gave vaccine to 9 patients which looks like the lots were expired; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist gave vaccine to 9 patients which looks like the lots were expired).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  There were no specific dates when administration occurred, but they had the lot number, and it was before 13 Jul 2023 and Lot numbers were AS7165B, 020H22A, 021H22A, 017H22A. The patients were fine.   Dosage text for suspect product was reported as unknown.  No treatment medication was provided.  This case contains information for the patient 8 out of 9 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-734387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734387:Master case (Patient 1)
pt recvd vax;24 hrs later exp dizziness, weakness of legs,nausea,neck & shoulder pain;not seen by MD; events resolved;
Chronic Hives breakout all over and all of sudden allergic to insulin that I had been on for 3 and a half years with no problems. Nightly breakouts and pain swelling all over!
Infant was given Rotarix vaccine IM instead of Orally, afternoon of 02/11/2020. No adverse event in office, phone follow-up 02/17/2020 - no adverse event observed at home. No treatment required
vaccine brand other=Janssen; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 3 (booster), single (Lot number: GL0446) at the age of 75 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Apr2021 as dose 1, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies Rosemary" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering", described as "vaccine brand other=Janssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Feb2023 to 06Mar2023.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
sore; Slightly warm; A little red; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain, feeling of warmth and erythema. On an unknown date, the outcome of the pain, feeling of warmth and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pain, feeling of warmth and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-June-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient after receiving the Shingrix vaccine experienced slightly warm and little red and it was still sore. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Severe bruising was almost 2 inches below the actual injection site.  Bruising covered large area of arm just above elbow--again not near actual site.
Information has been received from a registered nurse concerning a now 29 year old female who in 2006 was vaccinated with 2 doses of VARIVAX (Merck). Concomitant therapy included LEVOTHROID. On an unspecified date, titer was negative. The patient did not seek medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Burning in throat, flushed face and neck. Developed stridor. Benadryl 25 mg PO given, Epinephrine 0.5mg given IM, albuterol inhaler 4 puffs. Transferred to the Emergency department and admitted to the hospital.
Pt recvd vax & pt began to exp a serum sickness type react consisting of joint pain, weakness, &/or diarrhea;
Patient wanted to get Bivalent booster and received monovalent instead. No symptoms reported at this time.
Five minutes after leaving site.  Left side of face started to go numb for about 10 minutes. No other signs of stroke symptoms. After gave numbness was ok, right foot was warm for 5 minutes.  Symptoms stopped and did not occur after
i got my first moderna shot mid april lost the vaccine card is it too late for me to get my; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (i got my first moderna shot mid april lost the vaccine card is it too late for me to get my) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (i got my first moderna shot mid april lost the vaccine card is it too late for me to get my). At the time of the report, PRODUCT DOSE OMISSION ISSUE (i got my first moderna shot mid april lost the vaccine card is it too late for me to get my) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Pt reports she started having left thigh pain and burning the day she got the H1N1 vaccine 3/5/10. On 3/10/10 she developed a red, irregular rash on posterior left thigh and it is now spreading around to anterior thigh/groin area. Continues to have pain.
Test positive for Covid-19; Test positive for Covid-19; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E11284 and expiration date was not reported) via an unspecified route of administration in arm on 09Feb2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E11284 and expiration date was not reported) via unspecified route of administration in right arm on 19Jan2021 both as single dose for COVID-19 immunisation. The patient medical history included allergy to morphine and adhesive. Concomitant medications were not reported. The patient was on other medications within two weeks prior to vaccination. Patient did not take other vaccine within four weeks prior to vaccination. On 11Feb2021 the patient tested positive for Covid-19. The patient did not have covid prior to vaccination and had tested for covid post vaccination. The patient underwent lab test which included SARS-COV-2-PCR on 11Feb2021 and results positive. The outcome of the event was unknown.  Follow-up (17Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mother) that: Caller submitted her mother's information and where it was given online. The lot number on the card is E11284 or EL1284 or EI1284. Given on 19Jan2021 and the second one was given on 09Feb2021.  Information about lot and batch number was requested
This spontaneous report as received from a pharmacist refers to an approximately 55 year old female patient. No medical history and concurrent conditions were reported. It was reported that the patient had no drug allergies or reactions. On 18-DEC-2015 the patient was vaccinated with ZOSTAVAX (lot # L032399, expiry date 26-NOV-2016) (dosing regimen and frequency unknown) subcutaneously in the right arm. Concomitant therapies included methylphenidate (manufacturer unknown), INVOKANA, fenofibrate (manufacturer unknown), simvastatin (manufacturer unknown), gabapentin (manufacturer unknown) and acyclovir (manufacturer unknown). On approximately 18-DEC-2015, after receipt of ZOSTAVAX the patient experienced a red spot on her arm which took a long time to disappear and also complained of left shoulder pain which radiates from the shoulder to the elbow causing difficulty in sleeping and the patient was unable to do any scrubbing (details unspecified). On approximately 17-DEC-2015 the patient had discontinued acyclovir (manufacturer unknown) 24 hours prior to the receipt of ZOSTAVAX (drug administration error). It was also reported that the patient did not resume therapy with acyclovir (manufacturer unknown) until 14 days after ZOSTAVAX. It was reported that the patient would be having an office visit with her physician on an unspecified date to discuss about the pain. There was no product quality complaint reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of erythema, insomnia and musculoskeletal pain was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. This case is related to case number 1602USA009457 via same reporter link. Additional information has been requested.
extreme fatique followed by very high fever, extreme achiness, became semi-delusional (I would guess from high fever), unable to stand up without falling down
Red rash a few inches in diameter at the site of injection. Warm and hard to the touch. Slightly itchy.
Muscle sore and itchy around injection site.  No redness.  EMS evaluated and removed band aid.  Had client do arm stretching exercised and felt better.. BP 120/82 P72 O2 98% lung sounds clear
Urticaria left thigh starting 4 hrs after immunization.  Prescribed: Zyrtec
patient has not received 2nd dose of the vaccine yet; patient has not received 2nd dose of the vaccine yet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd dose of the vaccine yet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received 2nd dose of the vaccine yet) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd dose of the vaccine yet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received 2nd dose of the vaccine yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd dose of the vaccine yet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received 2nd dose of the vaccine yet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  It was reported that, the Pharmacist administered some vaccinations this morning from a Moderna COVID-19 vial that had been punctured on 04-NOV-2021 and was now past the 12 hours beyond use date and 10 patients received vaccine from this vial.
Pain, fever, redness, joint pain. Dx with cellulitis in the E.R. on 4-10-11.
Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, legs and face; tightness in jaw, tongue and face swelling with numbness and tingling.
Arm soreness that began 6 hours after administration and is still sore on 6/13/18 when the shot was received 6/8/18.
Pt with cellulitis and extensive reaction at vaccine site. Mild itching, no pain, no fever.
I got the 2nd dose and, on that  very next day, I found out I COVID. I had the covid symptoms right away. I still could not taste correctly. I was itching all over my skin, I was seeing rashes. I was extreme fatigued. This is currently going on. I had hair loss and I am on Viton . I am constantly tired and have a rash developing in my hands. Blister like almost.
32 yo female with a C/C of Dizziness post vaccination.  according to pt shortly after being vaccinated she felt a sudden in onset of dizziness, pt states she has a history of DM, she recently got an insulin pump but has not put it on.  pt has been battling with uncontrolled DM. pt was transported to hospital via medic.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 11 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse 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 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. List of documents held by sender: none.
This spontaneous report as received from a registered nurse via company representative refers to a 4 months old infant patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
The patient stated after 2 minutes of receiving the vaccine had sudden onset of loss in his right peripheral vision. He could see a constant flash of light in his right peripheral vision that became larger. the flash of light was jagged. patient taken to ED to be evaluated.
Pt recvd Hep B vax on 1OCT91 & that evening pt had dinner @ ethnic restaurant & exp nausea during meal resulting in vomiting; On 3OCT91 pt exp a generalized rash;
Information has been received from a physician concerning a 24 or 36 months old child female who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) on an unknown site (lot number not reported). The physician reported that the on the same day as the vaccination the patient had fever. The second day, post vaccination the patient's mother called the physician and said her daughter's entire body was covered with a rash that appeared to be chicken pox. The patient's mother brought her to the physician's office on day three and the rash was gone and the patient recovered (date unspecified). Additional information has been requested.
pt recv vax & reported soreness/redness, swelling @ site w/nausea  & vomit;
Weight loss, generally not feeling well and worsening over a few days - joint pain, fatigue, aches, swollen lymph glands, decreased appetite (severe dehydration per patient report), low grade fever, nausea and neutropenia, non-specific abdominal pain, headache, diarrhea, muscle pain, skin pain, eye pain, kidney (back flank area) pain, pale, throbbing for 3 hours at injection site on day 14, pressure 4" diameter.