chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 days after receiving the shot (1/13/2021) a lump formed at the injection site. It was hot to the touch, very itchy, and red. hot to the touch.  I contacted my physician immediately to report this event. The office instructed me to continue to monitor and report back if any more swelling occurred. Thursday 1/14/2021, I contacted the doctor again as the swelling in my arm more than doubled in size. It was very red and hot, my left arm from shoulder to elbow was swelled and hard. Friday morning (1/15/2021) at 7am I went to the emergency room to be seen as I was experiencing pain and the heat and prickling sensation gave me cause to worry. It was at the hospital that I was diagnosed with Cellulitis.
Immediately after receiving vax started having  general pain in arm and tingling in fingers. Started radiated to her neck . Has been constant for 2 wks. Reporter advised Pt to see MD.
Fatigue, body aches head ache and  sore arm at injection site; 0100 05/10/2012 chill and fever and muscle and joint aches; took Motrin; 05/10/2012 left arm sore, red, and hard, other symptoms ongoing; 05/11/2012; feeling better, but arm still red, swollen and hard; continues Motrin and ice compresses.
After giving shot, patient reported feeling flushed. Her tongue was tingling. She was given 25mg of liquid Benadryl PO. We notified the doctor who was working in the clinic that day. She assessed the patient and administered 60mg of Solumedrol (IM) in the right arm. Pulse oximeter remained 98%. Patient reported no hives or itching. After about half an hour the patient began to feel better and was able to ambulate out of the building and drive away.
Child still not willing to crawl or put weight on legs even after 10 days after vaccine.
Fully vaccinated patient tested Covid-19 postive with full blown symptoms; Fully vaccinated patient tested Covid-19 postive with full blown symptoms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EL9262) as a single dose; and dose 2 via an unspecified route of administration in the left arm on 09Feb2021 08:00 (Lot Number: EL1283) as a single dose for covid-19 immunisation. The medical history and concomitant medications of the patient were none. The patient was not diagnosed with covid-19 prior to vaccination. The patient has no known allergies. The patient did not have other vaccine in four weeks and did not have other medications in two weeks. The patient received the vaccine in a hospital. The patient reported that he was fully vaccinated on 09Feb2021. On Monday (05Apr2021), the patient mentioned that his two stepsons tested positive contracted it from their father that they saw on 01Apr2021. He further stated that his stepsons "interacted it house last week and they were tested positive Monday and Tuesday this week, this past week."He got tested on 09Apr2021 because he wanted to be safe for his restaurant employees and as a first responder. He was told he was positive. He mentioned that he had full blown symptoms and they said it's unheard of they said I should report it. He got fever, congestion and cough. He further added that he had systems coughing, stuffy nose and a fever of 104 last night (09Apr2021) and shortness of breathe. The doctor's office told him to reach out. This was very unusual. He inquired what do he do now, was he contagious, does he need 10-day quarantine even with the vaccine. The patient was Covid tested post vaccination with nasal swab rapid on 09Apr2021 with result of positive. It was reported that the treatment was unknown. The outcome of the events was unknown.
Fever, rash over entire body, itching, nausea, vomiting and headache. Required ER visit the night of 10/26/14 and a.m. of 10/27/14. Steroids, BENADRYL and IV fluids.
Rapid heartbeat lasting about two hours, started about eight hours after injection, upon retiring. Started after lying down trying to sleep. No other side effects. Did not report this at the time and was normal in the morning.
This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 29-Jul-2022).    No concomitant product use was reported.  It was reported that, patient received half dose. The vial did not undergo any temperature excursions.  The vial was initially stored in the refrigerator on 4 Jun 2022  No treatment information was provided.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2107 (dose, strength, and route unknown) (incorrect product storage). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has bee requested.
Chest pains, Leg cramps, shivering, low grade fever (99.2-100.3).
Pt came into the pharmacy stating she had a severe reaction to PREVNAR. She had cellulitis which required an antibiotic prescription, was ill in bed for a few days and could not move her arm for a few days. Arm still extremely red and inflamed.
No adverse effect; Administered improperly stored dose of Proquad; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant medication included sterile diluent (DILUENT MRK).  On 16-APR-2019, the patient was vaccinated with 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# R017628 (expiry date 18-DEC-2019) (frequency, strength, route, anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of -14 Celsius (C)  to -10 C (-11 C) for 30 minutes and also at -9 degree C to 8 degree C (-7.1 Celsius) for 45 minutes. There was no previous temperature excursion. The patient did not experience any adverse effects. The call was because of a data logger. No product quality complaint (PQC) was involved.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009840: US-009507513-1904USA009353: US-009507513-1904USA009842: US-009507513-1904USA009842:
1st Apr2019, 2nd June 2019, 3rd 11Nov2022; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on April 2019) and Shingrix (2nd dose received on June 2019).   On 11th November 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 11th November 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-NOV-2022 Reporter's comments: The reporter was the husband of the patient who had reported that his wife stated that her HCP had gave her a third Shingrix vaccine (extra dose) on the day of reporting, in the left arm. The reporter reported that his wife's physician did not had the second dose documented, so she had given her another Shingrix vaccine on the day of reporting. The reporter had consent to follow-up. Additional supportive information: At the time of reporting, the patient had received the 3rd dose of Shingrix vaccine, which had led to extra dose administered and wrong vaccine administered.
No adverse event Covid 19 vaccine expired 8/23/2022 Given 8/29/2022
Reports pain and swelling at the injection site.  11/9/09 reports no improvement with ice and OTC anti-inflammatories.  Checked by Dr. put on Cefadroxil 500mg bid x 5 day.  11/10/09 improving. Recheck 11/13/2009.
Received the Janssen vaccine on 6/3/2021 at clinc.  Pt. noticed red spots to back of calves on 6/15/2021, 11 days after vaccination.  3 days after noticing the red spots he started to notice bruising to bilateral arms.  No complaints of pain or itching.  Has not gone to see primary care physician before reporting to today.  Examined skin today.   Multiple bruising to bilateral arms, wrist and left palm.  Red spots noted to bilateral calves and back.
Lot A2AK3 exp  6/30/22 felt tingling in tongue and throat after shot was given, treatment was epi pen and 25 mg benadryl
diagnosed with breast cancer July 2021 - DCIS in left breast; LCIS in left breast; ILC in right breast
Pt. Reported numbness, "tingling", brought to med. screening for evaluation. Felt better upon lying down, drinking water . left in stable condition @10:07 Vital signs at 10:00 Pulse: 64        PO2:99%   BP: 108/70 Recorded by RN Evaluated
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history and current condition was not reported. On 06-NOV-2014 date the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine. On 07-DEC-2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Swelling, redness, itching in an area about 5x3. Also area was hard. Low grade fever.
Patient became pale, diaphoretic. She was moved to a room where her feet were elevated and BP was taken. BP was low, pulse normal, but I was told patient lost consciousness and had seizure-like activity. Lasted less than 15 seconds and patient came to. Juice given to patient as she states she has a history of hypoglycemia. She reported eating something an hour before her appointment. Patient was examined by doctor. BP was back to normal and patient states she was feeling much better after drinking juice. Patient had ride home and was told by provider to follow up with PCP as soon as possible.
I believe patient was given the 12 year and older dose of Pfizer by a medical assistant/ family practice MD. I did not witness or participate in the event. However,  per the documentation it appears the patient was given the incorrect vaccine. Our COVID vaccine medical assistant was out sick on this day. Staff who were not trained on COVID vaccine administration were asked to give the vaccine.  I submitted an incident report about this error to my supervisor. I do not believe the patient's parent was notified/informed of this error.
Swollen circle at injection site; Swollen glands under arm pit; Developed a black and blue arm; This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, axillary lymph nodes enlarged and skin discoloration. On an unknown date, the outcome of the injection site swelling, axillary lymph nodes enlarged and skin discoloration were unknown.   It was unknown if the reporter considered the injection site swelling, axillary lymph nodes enlarged and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's brother-in law. The patient received 1st dose of Shingrix and she developed a black and blue arm, a swollen circle at the injection site, and swollen glands under her arm pit. The reporter declined to provide any additional information about the patient and her adverse event. The reporter stated that he would tell the patient to contact if she would like to provide more information. The reporter did not consent to follow-up. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248587:same reporter US-GLAXOSMITHKLINE-US2020248569:Same reporter US-GLAXOSMITHKLINE-US2020248574:Same reporter US-GLAXOSMITHKLINE-US2020248583:Same reporter
Patient came back to the pharmacy about a week after receiving the 2 vaccines and stated that he had a bad reaction the following morning involving temporary shortness of breath. He said that it had stopped quickly and ended up being ok. He wasn't sure if this incident was related to having both vaccines at the same time, but I told him that he should follow-up with his primary doctor and that I will report this to VAERS.
runny/stuffy; runny/stuffy; sore throat; This is a spontaneous report from a contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Upon woke up on Monday, 05Apr21, the patient experienced runny/stuffy and sore throat.  Outcome for events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Patient received their 1st dose of the Moderna COVID-19 vaccine @ approximately 12:15 pm. While waiting their 30 minutes (@ approximately 12:25pm) after vaccination patient experienced an alarming tightening of the throat. Patient was still able to swallow, temperature 97.7 and able to hold conversation with pharmacy staff. Do to patient's past infection with COVID-19 and subsequent recurring rash post-infection, Pharmacist decided to call 911 and EMS on site. EMS arrived and evaluated the patient, 2 diphenhydramine 25 mg capsules were given to patient to take in pharmacy. Patient was released to their own care by EMS staff at approximately 12:45 pm.
tinnitus; fever; on and off headache; A spontaneous report was received from a Pharmacist  concerning a 43-years-old Female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tinnitus, fever, on and off headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, patient received first of two planned doses of mRNA-1273 (lot/batch: unknown). On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event tinnitus. On 17 Feb 2021, the patient experienced the events  fever. On and off headache.  Treatment details included For the symptoms: Tylenol, 19Feb2021.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable.   On 18 Feb 2021 the outcome of event(s), fever was resolved. The outcome of events, tinnitus, on and off headache was unknown.
This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot number as lot validation has been received M014310, expiration date: 26-MAY-2017 (strength, dose, route of administration were not reported). The administered dose of ZOSTAVAX experienced temperature excursion of 35 degree Fahrenheit for unknown time, reported as "worse case cumulative 35 hours', on unknown date. There was no data logger involved. No adverse events were reported. Additional information is not expected because there was no consent to contact.
Patient is reporting high fever from day of vaccination to still now (from 8/5/2021 to 8/8/2021) which is 101.4 which is getting on and off with Tylenol. Today, patient has started loss of taste and started to worry about.