chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with dry eyes; Sore in her eye; Diagnosed with lichen sclerosus / Severe case of lichen sclerosus; Itching in her crotch; Discomfort in her crotch; Arm became very swollen; Arm became hard as a rock; Arm became hot; Arm became achy; didn't feel well; headaches; tiredness; Couldn't move her arm; Felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and influenza like illness. In February 2020, the patient experienced lichen sclerosus, localized itching and discomfort. On an unknown date, the patient experienced eye dryness and sore eye. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)) and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and sore eye were recovered/resolved and the outcome of the influenza like illness and eye dryness were unknown and the outcome of the lichen sclerosus, localized itching and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased, influenza like illness, eye dryness and sore eye to be related to Shingrix. The reporter considered the lichen sclerosus, localized itching and discomfort to be related to Shingrix.  Additional details were reported as follows: Caller reports that she received Shingrix and that day her arm became very swollen, hard as a rock, hot and achy. She also didn't feel well, with headaches and tiredness. She couldn't move her arm and felt like she had the flu. The symptoms lasted for over 1 week before resolving. A couple weeks after getting Shingrix she developed a sore in her eye. She saw her ophthalmologist and was diagnosed with dry eyes. She was given a steroid eye drop and the sore resolved and she now takes drops for dry eyes. About 3 weeks after getting Shingrix she developed itching and discomfort in her crotch. She thought it was a yest infection and treated it as such, but the symptoms did not resolve. She saw her gynecologist and was diagnosed with lichen sclerosus and is now using a steroid cream. It was a severe case of lichen sclerosus. She thoughts Shingrix caused the lichen sclerosus. Consented to follow up. ER Visit Required.
After-1-week site was not healing - Pus and redness was very noticeable. I kept cleaning it. It would scab over, drop off and form again. Doctor looked at it, and set up an apt with dermatologist. One look she diagnosed, skin cancer - removed it and sent to the lab to confirm. Came back "yes" cancer.
I started having water retention in my lower extremities below the knees especially in my ankles. There is also swelling as well. I was prescribed a water pill, but the water retention is still persistent. It makes it harder for me to walk, and my feet are swollen. The water retention does go down when I take the water pill, but after awhile that same day it still comes back.
left arm at site of injection was warm and painful to touch that progressively got worse after 2 days
At approximately 1130 pm I began shaking, what I initially thought was chills. For two hours I continued to shake, my hands, fingers, feet, and toes turned purple and my extremities were pale.  I was able to stay at home until symptoms resolved.
pt recv vax; started itching; broke out into hives; to ER and was given Cortisone shot; still kept itching for 1 more wk;
PATIENT REPORTED A RAISED, FIRM BUMP AT THE SITE OF THE INJECTION. THE SIZE OF THE BUMP WAS ABOUT THE DIAMETER OF A QUARTER AND FELT ITCHY. PATIENT DID NOT HAVE ANY OTHER SYMPTOMS.
Nausea, shortness of breath, instructed patient to call 911, EMS saw patient, patient refused transport to hosp. Saw her own doctor.
the patient received improperly stored VAQTAvaccination / storage in clinical practice; No side effects or symptoms reported at time of call. No additional AE/no PQC.; This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. For all patients, concurrent conditions, medical history and concomitant medications were not provided.    On multiple an unknown dates, the patients were vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis; and the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, lot #, and expiry date were not provided); and with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided)  The nurse reported that these vaccines doses were administered on multiple unspecified dates to multiple patients and the vaccines were improperly stored (product storage error). They presented a temperature excursion with a temperature and time frame still unknown. No adverse events were reported. Additionally, it was reported that there were previous temperature excursions and it was because of a data logger. There were unable to provide an outcome at that time due to incomplete data.  Follow-up information was received on 12-JUL-2023.  It was reported that the customer only provided the lowest excursion of all the excursions and not all the data. This is a non-valid report due to the lack of patients' identifiers.  Follow-up information was received from a Physician on 14-JUL-2023. This spontaneous report was received from the vaccine provider referring to a 18-month-old female patient. The patient's concurrent conditions and medical history were not reported.   Concomitant therapy included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella zoster vaccin, hepatitis b vaccine and measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN).     On 06-JUN-2023, the patient was vaccinated with the first dose of hepatitis A Vaccine, inactivated (VAQTA) lot# x003791 and expiration date 01-JUN-2024 in the left arm as prophylaxis (strength, dose, route, and frequency were not provided).  It was reported that vaccine temperature excursion was not viable and occurred from a digital data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice.  The action taken with the vaccine was reported as "returned, waste in progress". No adverse effects.  This is one of several cases by the same reporter.; Sender's Comments:  US-009507513-2307USA009456:
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/18/2021, 03/18/2021, 12/03/2021, and 04/26/2022. They were seen in emergency department on 08/10/2022 and diagnosed with atrial flutter. They were hospitalized for this reason until 08/28/2022. On 09/19/2022, they were found unresponsive and brought to emergency department. They were found to be COVID-19 positive at that time. They were found to be experiencing a pulmonary embolism, severe coronary artery disease, and low ejection fraction non-ST elevation myocardial infarction. They went into cardiac arrest and died on 09/25/2022.
This spontaneous report was received from a medical assistant concerning a male patient of unknown age. The medical history, concomitant medication and drug reactions/allergies were not provided. On 26-AUG-2013, the patient received his first dose of GARDASIL (lot#, expired date, dose were unknown) for prophylaxis. On 12-OCT-2016 and 12-DEC-2016, the patient received his second and third doses of GARDASIL 9 (lot #, expired date and dose were unknown for the second dose; lot # M032650, expired date on 31-MAR-2019 and dose was unknown for the third dose) for prophylaxis, respectively. No adverse effect was reported. Additional information has been requested.
Fever of 104 starting at 4am next morning. Chills, body aches. Generalized rash. pain at injection site. Symptoms lasted 12 hours
pt recvd vax; onset od chills, fever, malaise at approx 1 wk after vax; also exp upper resp congestion; duration approx 1 1/2 wks; sxs resolved by 21nov94;
Injection Site pain - 3-31  ~7pm to current (4-2 ~2pm) currently just in left shoulder, lat, left pec and under arm area ribs Tiredness - 3-31 ~8-10pm  to 4-1 ~11pm-12am Headache - 4-1 ~7am to ~1pm went away with Advil  Muscle pain - 4-1 ~7am to  about 4-2 ~1:30am went away over night Joint pain - 4-1 ~7am to  about 4-2 ~1:30am went away over night
Very swollen lymph nodes starting 7 days after shot #1. Very swollen arm on top where injection site is starting 10 days after shot #1. Both are very swollen and painful. Using warm compresses and ibuprofen to manage pain.
On 5/18/2021 patient admitted in Hospital with SOB   Patient died 9/25/21 in hospice care  Also significant- Patient had about 5 days of Votrient (half dose) before this episode.  He had just started this chemo agent.
1st dose on 9/28/2021, never went back for the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received first shot on 28th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comments: The patient never went back for the second one.  The patient asked that he/she need to start from the beginning with the first shot again or just get the 2nd one. Additional Supportive Information: The patient did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination
had shingles outbreaks  / Suspected vaccination faliure; has had shingles outbreaks; Covid; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had shingles outbreaks  / Suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: has had shingles outbreaks) and covid-19 (Verbatim: Covid). The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient received Shingrix vaccine two or three years ago from reporting. The patient had shingles outbreaks after contracting covid.  The physician could not remember patient's name and was going to have research. The physician would see the patient back in office in 2 to 3 weeks. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Complaints of warm, red and tight arm from slightly below shoulder to elbow.  No itchiness or draining.  Advised to use cool compress, Advil or Tylenol for discomfort and to check temperature of patient.
joint pain/knees and feet; Muscle pain belowknees to feet; fever in the arm; injection site redness; injection site itching; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever,redness and itching around the injection site,joint pain in both knees down to her feet and muscle pain below both knees to her feet.  The patient's medical history was not reported. Concomitant medication was not reported.  18-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) for prophylaxis of COVID-19 infection.  On 22-JAN-2021, The patient experienced fever,redness and itching around the injection site On 29-Jan-2021,she had joint pain in both knees down to her feet and muscle pain below both knees to her feet. Her arm was not as red or itchy at the time of the report. No Laboratory details provided.  Treatment information o f cold pack,zyrtec,cortizone 10 was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fever,injection site redness,injection site itchiness,arthralgia,myalgia are Unknown
7/17/2021: No pain during injection, injection rate was a bit too fast, probably about 1.2 seconds.  Slight stinging around 30 minutes after, but for only about 5 seconds.  Slightly sore arm.  By 8:30pm, the core at the base of my tongue had a bit of tingle radiating toward the full surface of the tongue.  By about 9:30, the back left of my knee felt a pain or soreness (vaccine would be the only cause for this type of pain). 9/10/2021: Since 7/18/2021 I have had burning sensations occuring most every day, and which is occuring right now.  Similar to what would happen if one were to eat very spicy food and then never return to a normal state after eating the spicy food.
Administered Heplisav-B  While 5 Months Pregnant; Initial Report Received on 18-NOV-2022  This is a spontaneous report, received from a consumer regarding a female patient, aged 31 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 06-OCT-2022, dose 1 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route not specified, was administered in the left arm for hepatitis B immunisation.   The patient was administered the HEPLISAV B vaccine when she was 5 months pregnant. No adverse reactions were reported.  Action taken with HEPLISAV B was not reported.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Bitter metal taste; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historically the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced bitter metal taste. It was reported that, the patient experienced bitter metal taste after the second covid vaccine shot. She enquired will this go away and was there any way to get rid of it and said she was 84 years old, and no one seemed to be able to answer this question for her, not doctors or health department. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
2 doses of Pfizer Bivalent were given. 1st booster was 9-20-2022
Received vaccine at 5:00 pm. At 5:10, noticed heavy/fast breathing; at 5:12, tightness in throat; at 5:18, puffy tongue. No medical intervention; symptoms resolved on their own after 30-45 minutes.
Information has been received from a registered nurse concerning a patient (it was no reported if the patient was a child or an adult), who on 06-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route not reported) instead of receiving a dose of VARIVAX (Merck). No symptoms reported. Additional information has been requested.
4/2/2021    was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 0920. Alert and oriented.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.   VS - BP-175/89, P-100, recheck after juice and crackers , BP- 176/90, P- 84.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/2/2021  9:10 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
2 hours after receiving  vaccine started having severe pain in shoulder. Progressively got worse as the night went on. Jolting sharp pain with certain movements.
Immediately post vaccination pt experienced flushing/sweating, nausea, trouble standing, and pt felt so tired that he had trouble holding his head up.  Pt was moved to observation area and noted to have a low BP that recovered over 3-5mins.  Vitals: 11:59 100/60, 79, 12 -- > 12:04 107/77, 82 Pt's pallor improved with increase in BP.  Pt walked to the car w/o assist.  Pt stable and released from the vaccination site w/ mother and sister.
Patient started feeling short of breath and had chest pains.  Patient was given 20ml of benardyl and an epipen and 911 was called.  She was taken to the hospital.
NAUSEA VOMITING X 36 HRS  SHAKING CHILLS SHIVERING SEVERE DIAPHORESIS  WAS SEEN IN ER  GIVEN ZOFRAN
Pt reports that she started running fever (did not take temp) had arm pain shoulder pain, & chest pain with nausea 7/13/2010 PM. Reports today that she still has arm, shoulder & chest pain.
Pt had hives and rash all over body.  He had facial swelling, tongue swelling, and itching per mom.
Tinnitus.  I'm not sure if the tinnitus began after COVID vaccine # 4 or beforehand.  The Tinnitus worsened after dose # 4 causing me to seek follow-up medial care, which is still in progress.
Information has been received regarding a case in litigation from a lawyer and male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 24-FEB-2017, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose:  the prevention of shingles (herpes zoster). One week after receiving the ZOSTAVAX, the patient suffered an immunization reaction and was diagnosed with Herpes zoster, which affected his right side from anterior mid-axillary line around side toward the spine. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the ZOSTAVAX, patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were not resolved. Causality assessment was related. Immunization reaction and Herpes zoster were considered to be disabling. Additional information has been requested.
Pt was given a pneumococcal vaccine instead of a Prevnar. 24 hour fever, T max 103 (R), irritability, increased flatus, inconsolable. Advil reassurance, observation, office follow up 9-12-07.
9:05am pt had just received 1st dose Pfizer vaccine and lost consciousness at the table with seizure like activity. Pt was lowered to floor with assistance of several staff members. Pt very diaphoretic with decrease in skin color.  Didn't hit head. Pt mother called per pt request and states him having no hx of seizures and NKA. BP 94/60 and HR 84. 9:20 am pt assisted to stretcher with heavy assist. 9:24am A&O when EMS unit arrived to transport pt to hospital for further evaluation and care.
Patient didn't receive full dose; Leakage from needle to arm; Leakage from needle to arm; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 44-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number GF3N2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09 JAN 2023 Reporters comment: Registered Nurse called to inquire should patient repeat the dose. The nurse reported that the patient administered a Flulaval dose. The nurse administered the dose and withdrew the needle from the patient's arm, vaccine came out.  The patient did not receive the full dose of vaccine. RN confirmed not the leakage from prefilled syringe portion but from needle to arm. The reporter did not consent to follow up. Additional supportive information: As patient didn't receive the full dose of vaccine, which led to  incomplete dose administered,  exposure via skin contact and inadvertent exposure to vaccine.
Severe chills after 7 hours, terrible headache, ?brain zaps,? nausea, fever of 103.5 around 12am, after 2 hours of sleep. Took tylenol and ibuprofen, drank lots of water, felt better by 10am.  The pain was intense and I feared a bad reaction.
PATIENT RECEIVED VACCINE AND WAS ASKED TO SIT DOWN FOR OBSERVATION PERIOD,  PATIENT WAS NOTICED TO BE QUIET, LOST CONSCIOUSNESS, EYES ROLLED BACK AND STARTED WITH TONIC-CLONIS SEIZURES THAT LASTED ABOUT 1-1 1/2 MINUTES. PATIENT THEN REGAINED CONSCIOUSNESS, OPENED EYES, AND ASKED WHAT HAPPENED.