chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received shingles vaccinations then shingles/ suspected vaccination failure; Shingles; Nerve pain in back; Painful; Rash in back; Stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received shingles vaccinations then shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Nerve pain in back), pain (Verbatim: Painful), rash (Verbatim: Rash in back) and stress (Verbatim: Stress). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia, pain, rash and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain, rash and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, pain, rash and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received earlier Shingles vaccine since then this was his or her second time with shingles. The patient stated that first time shingles left him or her with nerve pain in his or her back which was four years ago. The patient have shingles now again and it was very painful. The patient stated that the rash is in his or her back again at different area. The physician stated that this was from stress. The patient reported that he or she have to wait to receive the more potent vaccine now because he or she did not wish this on anyone. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Achy; Tired; Energy levels are way down, barely had enough energy to get through workout; Tremendous joint and muscle pain; Tremendous joint and muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 20May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included spinal stenosis and degenerative disc disease. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other medications within two weeks of vaccination. The patient had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 39-years-old), as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21May2021, since receiving the second shot, the patient felt achy and tired. The energy levels were way down and as a weight lifter, patient barely had enough energy to get through workout. The patient also experienced tremendous joint and muscle pain at night. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 achy, tired, energy levels were way down, barely had enough energy to get through workout, tremendous joint and muscle pain was not recovered at the time of this report.
This case was reported by a consumer and described the occurrence of autism in a male subject of unspecified age who was vaccinated with Dtap (SmithKline), PEDVAXHIB, IPOL, HEPTAVAX, PREVNAR. A physician or other health care professional has not verified this report. On 1 August 2001, 15 October 2001 and 15 August 2002 the subject received 1st dose, 2nd dose and 3rd dose of Dtap (unknown). On 1 August 2001 the subject received 2nd dose of PEDVAXHIB (unknown), 2nd dose of IPOL (unknown), 2nd dose of HEPTAVAX (unknown). 3rd dose of PEDVAXHIB (unknown), 3rd dose of PREVNAR (unknown). The reporter indicated that it was documented in the chart that the subject received "Dtp/Dtap by SmithKline." In 2001, at an unspecified time after vaccination with INFANRIX, HEPTAVAX, PEDVAXHIB, IPOL and PREVNAR, as an infant the subject experienced respiratory issues such as colds. The reporter later noted that she was not certain whether the respiratory issues started before or after the dtp/dtap doses. The reporter related the respiratory issues to the subject's formula and changed from milk based formula to soy-based formula which helped the respiratory issues. In 2002, at an unspecified time after vaccinations, the subject was diagnosed with asthma. He was treated with albuterol nebulizer treatments. The respiratory issues and the asthma resolved in 2003. In 2003, approximately two years following vaccinations, the subject began to pound on the walls and have insomnia. The mother believed that these were early signs of autism. On 18 May 2005, approximately four and one half years after the first vaccinations, the subject was diagnosed with autism. She noted that prior to the diagnosis of autism as a toddler, the subject had always talked and over the last 2 years his talking had diminished and his speech had only developed to a certain extent. The subject also experienced a delayed administration and inappropriate schedule of vaccine administered according to the dates provided in the report. At the time of reporting it was noted that the respiratory issues and asthma resolved in September 2003. It was unknown if the insomnia continued. The autism continues. The outcome of the other events were unspecified. The mother considered that the events were disabling and jeopardized the patient or required intervention. The mother also reported that another son developed autism. See GSK A0721937A for details.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AF1416B) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date). No concomitant medication was reported. On 05-Aug-2022, the vial was initially stored in the refrigerator. The dose was administered on 06-Sep-2022 from 9:15 to 9:45. Reportedly, 5 Pediatric patients received Moderna COVID-19 vaccine 30 days past its beyond use date. The vial did not undergo any temperature excursions. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642052, US-MODERNATX, INC.-MOD-2022-642059, US-MODERNATX, INC.-MOD-2022-642869 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Live follow up received included, patient details and suspect product dosing details. Sender's Comments: US-MODERNATX, INC.-MOD-2022-642057: Same reporter; US-MODERNATX, INC.-MOD-2022-642052: Same reporter; US-MODERNATX, INC.-MOD-2022-642059: Same reporter; US-MODERNATX, INC.-MOD-2022-642869: Same reporter.
EMS activated since pt had grandmal seziure for 30 seconds after getting HPV vaccine, loss of conciousness less than 10 seconds alert & oriented, no acute distress noted, vitals signs within normal limit. Pt and family member refused and left the clinic prior to EMS arrival. EMS arrived @1426 on 8/22/2020.
Nausea 2 days after shot, dizziness, vertigo, brain fog started 4 days after shot and has not subsided after 4 weeks and 2cnd shot.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a nurse practitioner for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Pt reported itching to the bilateral eyes approximately 25 minutes after vaccine administration. No swelling, redness, or hives noted to the face or throughout body. No anaphylactic symptoms. Pt speaking in clear and full sentences, breathing unlabored, and in no apparent distress. Pt and mother declined further observation or ED transfer and preferred to go home and take Benadryl. ER precautions given.
Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 28 days past expiration.
Patient experienced pain on left shoulder after receiving flu shot. She reported that this pain intensified that evening to a pain level of 9/10 and diminished over the course of the next 24 hours but never went away. On 12/5/15, she reported a continuous dull pain at level of 3/10. It hurt when raising arm or with pulling motion. She went to see orthopedic doctor on 12/1/15 who recommended MRI if no improvement in 1-2 weeks.
Patient presented to the ER with compaints of SOB and cough x 2 days. Patient was noted to be hypoxic on arrival, placed on 2L of oxygen. Tested positive for Covid-19. Patient passed walk study and able to wean off oxygen. Patient received steroids, remdesivir.
Patient arrived to check in for appointment with his wife. Patient does not speak English so his wife translated and shared that the patient wasn't feeling well due to allergies to the pollen and wasn't sure if he could take the shot. I checked the patient's temperature and it was 98.7F. I asked the patient what his symptoms were. Patient reported mucus draining causing irritation to the back of his throat. I recommended OTC nasal spray for the post-nasal drip. I asked if patient had any history of allergic reaction to any vaccine, fainting, or history of seizures and patient denied. I stated patient was in the clear to take the shot if he was comfortable. Patient said okay. Pharmacist administered the shot and patient and his wife were seating in our waiting area to wait 20 min. After 10 min, patient's wife screams that her husband is not feeling well. Pharmacist rushes to the patient and sees his body shaking in the seat and asks a customer to lay him on the ground. Customer calls 911. Seizing lasted less than a minute. I approach the scene and immediately lay the patient to his side. Patient is conscious and breathing. Patient denied chest paint, headache, or tingling sensation in hands and feet. Patient vitals were checked. Paramedics arrive and did a full check up and everything was within normal limits. Patient openly reported he had not eaten all day and has history of fainting after shot due to anxiety of needles. Paramedics encouraged patient to seek medical attention, but patient denied. Patient was given water and a banana and went home.
Employee was waiting to be observed for the required 15 minutes post vaccination.  She started to complain of not feeling well and feeling short of breath.  She was immediately assessed by staff and transported to Emergency Department for further evaluation.
severe generalized itching, urticaria, rash, dermographism on bilat lower extremities, scalp, palms,neck bilat, forearms  Rx - prednisone , benadryl, famotidine
Sore and uncomfortable injection site Fatigue Chills Headache Bouts of nauseousness Currently 37 weeks pregnant. Have not delivered at this time and baby is still active. Due date is 7/26/21
pt had rxn but mom did not come to office until 23FEB 10 cm long,8cm wide (lt deltoid) local react-pink mildly edematous @ site;ring of vesicles
Received vaccine Wednesday; light itchy only Thursday. Friday evening, site was hard, red, itchy and swelling 4 inches in diameter. Rx with ice. Yesterday and today, site is itchy, red, and very warm. Advised to continue to observe. No systemic symptoms reported.
pt had a short stay for OT and PT in Healthcare Center from 5/30 - 6/28/22; dc'd to home with Hospice; pt had a positive COVID test 6/28/22 from Healthcare Center; pt passed away in the home
10 days after vaccination, patient developed pre-vesicular erythematous papula's at site of vaccination right upper thigh and low grade temp 99.
Pain, swelling at site. Patient came to clinic to report arm swelling and pain. Induration 6X6 inches. Patient advised to take Benadryl, Tylenol or Advil for pain and apply ice off and on 15 min. at a time. Report to ER or call 911 if breathing difficulties.
2 hours after vaccine patient developed left-sided chest and arm pain. Took nito SL(+hx CAD, no symptom in a year) with temporary relief Symptoms increased in frequency and severity until presented to ER on 03/09/2021. Diagnosed with NSTEMI, Troponin up to 7. Left heart cath uncharged from prior, discharged home on brillinta, no recurrence of symptoms as of 03/18/21
coughing, sneezing, facial swelling, rash, low blood pressure, low oxygen saturation; epinephrine and oxygen given, taken to ER for observation where benadryl was also given,
Flu-like symptoms; Shivering; Tired; does not have a good immune system; Body aches; Injection was very painful/Arm in very sore/Body aches / Pain all over her body; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included polymyalgia rheumatica (experienced before receiving Shingrix). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th September 2019 and experienced painful arm,flu-like symptoms, tenderness in throat and neck,refer case US2019203805).   On 7th November 2019, the patient received the 2nd dose of Shingrix. On 7th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 8th November 2019, the patient experienced influenza-like symptoms, shivering, fatigue, immune system disorder and general body pain. The patient was treated with prednisone and methotrexate. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, influenza-like symptoms and shivering were not recovered/not resolved and the outcome of the fatigue, immune system disorder and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, shivering, fatigue, immune system disorder and general body pain to be related to Shingrix.  Additional details were provided as follows: At 3:00 pm, the patient received a dose of Shingrix. The patient experienced very painful injection site when Shingrix was administered and her her arm was very sore. The patient felt terrible going in.  The patient also experienced flu-like symptoms, including body aches, shivering, and pain all over her body.   The patient was very tired and her arm hurted terribly. On the day of reporting, she went to her rheumatologist and was told to rest because she did not have a good immune system.  The patient was treated with low dose prednisone daily, and methotrexate weekly. The reporter did not consent to follow-up. The reporter could not provide any additional information.
Legs and ankles swelled up, ankles and feet color tint changed to dark reddish brown (reddish tint was bright colored), pain and instant bruising on front inside corner of ankles and then sunk down in (I think where blood vessels, arteries, or veins are at), body and joint aches, knees had fluid building up, fatigue
CAN BARELY WALK; SEVERE BACK PAIN; HEADACHES; CHILLS; FELT LIKE FREEZING; FEVER; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced chills. On 05-AUG-2021, the patient experienced felt like freezing. On 05-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Not reported. On 06-AUG-2021, the patient experienced can barely walk. On 06-AUG-2021, the patient experienced severe back pain. On 06-AUG-2021, the patient experienced headaches. Laboratory data included: Pain scale (NR: not provided) On a scale of 1 to 10, pain is at 9 or 10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain, can barely walk, and headaches, and the outcome of fever, chills and felt like freezing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home). In December 2021, EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   The reporter stated that the beyond the use date was 09-Dec-2021 at 10:00 pm. The vaccine was administered from 10-Dec-2021 to 13-Dec-2021. Number of doses/vials was 14; date the vial was initially stored in the refrigerator was 28-Nov-2021 (in the afternoon); it was not known to the reporter if the vials underwent any temperature excursions.
Patient called to report a sharp stabbing pain in right arm where flu shot was given. It happens only when laying on it or after using the deltoid muscle for awhile.
box of vaccines without an expiration date administered to patient; expired vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (box of vaccines without an expiration date administered to patient) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT EXPIRATION DATE ISSUE (box of vaccines without an expiration date administered to patient) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). In February 2021, PRODUCT EXPIRATION DATE ISSUE (box of vaccines without an expiration date administered to patient) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported.  The vial was good for 30 days once removed from the freezer as long as the refrigerator stayed within temperature range. The expiration date has only come into question recently because individuals who were vaccinated with this lot number after 25-Feb-2021 were applying for the Green Pass.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: follow-up received on 18-Nov-2021 and reporter occupation updated (non significant) On 23-Nov-2021: Non-Significant Follow-up Appended
Moderna COVID-19 Vaccine EUA. Day of the vaccine and day after, slight nausea and dizziness.  On the third day after the shot until now, have a ringing in my left ear.  Vaccine was administered in my left arm.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Two days after the vaccine I was experiencing extreme tiredness and I was very cold. I felt cold intermittently I was exhausted every afternoon. The symptoms lasted 3-4 weeks. My blood work and Liver Function tests were not Normal. My Proteins and Liver Enzymes were high. The tiredness came and went. Any amount of Alcohol made me feel like I had a hangover in the morning. It improved gradually. I feel recovered now.