chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient tested positive for COVID-19 3 days after the first dose; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient tested positive for COVID-19 3 days after the first dose (medically significant). The clinical course was reported as follows: The patient's son reported that his mother had the first dose on 20Jan2021. The patient tested positive for COVID-19 on 23Jan2021, and received an antibody shot on 24Jan2021. The patient's son reported "that's why his mother was not able to get the second dose of the vaccine."  The patient underwent lab tests and procedures which included COVID-19 test: positive on 23Jan2021.  Therapeutic measures were taken as a result of the event. The clinical outcome of the event, COVID-19, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with PEDVAXHIB (route, dose, lot # and expiration date were not reported). It was reported that PEDVAXHIB was improperly stored and the temperature excursion was found to be unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within 24 hrs of receiving my Covid vaccination in my right shoulder I started to have joint pain there and throughout the rest of my body in other joints like my other shoulder and knees.  The joint pain in all joints except my right injection site shoulder subsided.  Almost a month later I still have significant right shoulder joint pain especially when working out at the gym.  It feels more like a joint pain than a muscle pain.  I have received injections for flu and other vaccines in both shoulders in the past and never had extended joint pain like this. I have been treating the pain with ibuprofen, heat and cold packs periodically and mostly after using it at the gym.  There is a constant pain in the shoulder now that I mostly just deal with during the day.  After the ibuprofen wears off the shoulder starts to hurt again.  I have never had any issues with my right shoulder in my life.
Vomiting once in afternoon. No treatment. First time the child has ever vomited.
Patient came into the clinic for a Moderna booster (3rd shot). The actual vaccine given was 0.25 ml of Janssen. Patient was notified of the error on 2/17. Spoke with patient on 2/18 and he was not experiencing any adverse reactions.
This patient is a 55 year old female who is being seen in the office today for redness, swelling, pain at site of meningococcal vaccine. Onset after vaccine. Has had fever and chills as well as myalgias. No other infectious focus.
Myalgia, NauseaVomiting, hot/cold chills Narrative:
COVID 19 Treatment with Paxlovid; COVID 19 Treatment with Paxlovid; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: el3247), in left arm, on 24Feb2021 as dose 2, single (Lot number: el3247), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: ff8841), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: fl3197) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Purfumes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment with Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2018, the patient was vaccinated with ROTATEQ, orally lot # N028248, expiration date 01-MAY-2019 (formulation, strength, dose, frequency, were not reported) for prophylaxis. On an unknown date, the patient experienced vomiting. The outcome of vomiting and action taken with ROTATEQ was unknown. The causal relationship between the event and ROTATEQ was not provided.
PT developed Rash site on LT deltoid, and on arms, and on back several days after receiving  Moderna #1 Covid vaccine
Shot given at office 06/23/2003.  Ran (10-11 am).  Patient left and went back to work.  Status post developed: difficult breathing, sore throat, weakness, paleness, dizzyness, blotches (hives?) especially on face/head.  Patient did not let anyone know until effects were quite moderate.  then to md.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 21-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 12 of several reports from same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's pertinent medical history included removal of lymph nodes from her left arm several years ago and had no known drug allergies. On 17-SEP-2015, the patient was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # L008664 and expiry date: 03-NOV-2016) intramuscularly in the left arm. Concomitant medications were none. On 17-SEP-2015 several hours post administration, the patient experienced redness, warmth and swelling of her left arm from vaccine administration site to elbow. The patient went to the pharmacist for treatment advice and was recommended ice to site and BENADRYL. At the time of reporting (unknown date in September 2015), the outcome of redness was reported as recovered/resolved. The outcome of warmth and swelling was reported as not recovered/not resolved (reported as continued). The relatedness of the events with PNEUMOVAX23 was not reported. Additional information has been requested.
I had a very mild cough; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 06Jan2021 at single dose for COVID-19 immunisation. Medical history included being exposed at home to a symptomatic COVID patient on 04Jan2021.  Concomitant medications were not reported. Patient previously received first dose of BNT162B2 on 16Dec2020 for COVID-19 immunisation. Patient received the second COVID vaccine on 06Jan2021 and had a very mild cough from 06Jan2021 to 09Jan2021. Patient had PCR COVID test on 09Jan2021 and pending result. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
high fever; aches; sweats; chills; no sleep; my arm hurts!!!; you will not be able to do anything for a couple of days; feeling crappy for the 24-48 hours after shot; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced feeling bad, fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased. On an unknown date, the outcome of the feeling bad was recovered/resolved and the outcome of the fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the feeling bad, fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased to be related to Shingles vaccine.  Addition details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that bad side effects were experienced after receiving both the doses but it was worth it. The patient experienced high fever, aches, sweats, chills, no sleep and pain in arm after 36 hours of vaccination. The patient stated of feeling creepy for 24 to 48 hours after the shot and not able to do anything for a couple of days. The patient also mentioned that drink water frequently throughout and only take medicine like Tylenol, Advil, Aleve after the dose. If these medicines taken prior to the shot, the proper immunity would not build up. The case is patient link with US2021AMR063134 for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063134:Same reporter
This spontaneous report was received from a healthcare worker and refers to an unknown number of patients of unknown age and gender. On an unknown date, an unspecified amount of doses of (Oka/Merck) VARIVAX (dose, route, lot numbers and expiration dates were not provided), that underwent a temperature excursion, were administered to an unspecified amount of patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Around bedtime on the day of injection, developed a fever of 99.8 and a terrible headache. My left arm was very painful, even when not touching it or moving it. When I woke up in the morning, fever was higher (100.7) and I was so weak I could barely walk to the bathroom. I felt very dizzy and tired. I drank water and took ibuprofen for the pain. Stayed on the couch all day and took ibuprofen PM to sleep last night. Woke up very early today with a fever of 99.4 and still a bad headache and weak. Walking to the bathroom makes me feel like I need a nap.
102.6 fever, body joint aches, brain fog, swollen lymph node (arm pit) of arm of vaccine received.
Patient was given the COVID-19 mRNA Comirnaty and this has been discontinued.
08jun9 pt vax 2nd hepta B. 10min after pt devel urticaria, wheezing, and hoarseness. pt adm to er tx w/ steroids and recovered.  after discharge wheezing more severe. readm to er.
Almost a week after receiving the first vaccine with no major side effects other than a sore arm, I had a sudden itching/ rash develop on the same arm that quickly began to spread, itch, and become swollen and hot.  It was much further down from my original injection site. NO relief found from over the counter antihistamine medicine or topical medications. Went to Urgent Care the following evening because the redness had spread and nothing was working. Urgent Care stated it was a vaccination reaction and not cellulitis or staph infection and to continue to take antihistamine and return the next day if not better. Returned home and 12 hours later, the injection site became red and raised and itchy as well, no changes in color or reduction of size to the larger area that is red and hot and swollen.
fever; body aches; headaches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
arm was really sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore). At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment details not provided.
single episode of diarrhea 20 minute after vaccine administration, no other systemic symptoms, no other complaints or concerns
I95.9 HYPOTENSION 6/17/2022 WEAKNESS R09.02 HYPOXIA 6/10/2022 WEAKNESS
No additional AE reported.; Nurse calling for information on expired MMR II administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included sterile diluent that was used for vaccine reconstitution.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, lot # T033814, expiration date 05-OCT-2022 (dose, dose number, strength, route and site of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Received flu shot in my (L) arm. Toward back of arm. Later that afternoon noticed a bruise and redness and swelling about 3 inches down my arm and 2 inches wide. Went to the Drs. about my arm on 10/11/11. Dr. told me to put cortisone cream on the site for itching, take some BENADRYL and use a warm soak. That night put warm corn bag on my arm the pocket went down by the next morning redness went away a couple of days later.
client vaccinated under the age authorized by current agency EUA for Moderna COVID-19 vaccine.  client experienced no reported adverse reactions to vaccination.  Client received 2nd dose of vaccination series as per guidance from Manufacture and other agency.
After a few hours, runny nose, rubbing eyes and nose; later fever over 101, very irritable; head-banging and biting (occured after previous 2 Dtap, but had resolved)
Initial Report Received: 27-Feb-2019. Non-significant Follow-up Report Received on 06-Mar-2019 included duplicative data that was already received for this report. A nurse reported that patient, a 56-year-old female patient (race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was reported to be stored at the wrong temperature. She was also administered with an extra dose of HEPLISAV-B. Relevant medical history and concomitant medications were reported as unknown. Allergies were reported as unknown. On an unknown date, the patient received the third injection of HEPLISAV-B (lot #1036463, expiration date 28-Jul-2019, NDC #43528-002-05) by a physician. On 27-Feb-2019, a nurse reported that she received a call from a customer service representative at the distributor on this day. The nurse was instructed to remove all vaccines that were received because they were stored at the wrong temperature on distributor's end. The nurse was instructed to return it to the distributor and contact Dynavax. The nurse reported that six patients received HEPLISAV-B from the same lot number. The nurse also reported that all six patients were contacted on this day. No adverse events were reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the events of product storage error and extra dose administered as non-serious. The event of product storage error and extra dose administered are unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the events of product storage error and extra dose administered as non-serious. The events of product storage error and extra dose administered are unlisted per HEPLISAV-B USPI.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On 19th October 2018, the outcome of the injection site warmth and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on an unknown arm. Within 24 hours of receiving the dose of SHINGRIX, the patient noticed that the area around the injection site was very red, hot, and swollen. These symptoms persisted for at least 2 weeks before they started going away. The redness had improved, but continued till the reporting time. The healthcare professional stated that the reddened area was 2.5 inches long by 1.5 inches wide around the site of injection. The reporter gave consent to follow up.
Contracted covid 12/10/2022; prescribed paxlovid 5 day; z-pack antibiotc; negative covid test. Cough sinus congestion prescribed bactreom;  presidone was prescribed for infection.
This is NOT related to getting the Covid vaccine.  On June 19 I developed head cold-like symptoms. I took a home test and it was positive for the Covid virus. I consulted my PCP by phone and was given a prescription for Paxlovid that I took for 5 days. On the 6th day I had a PCR test taken and it came back negative for the Covid virus. Five days later I developed head cold-like symptoms again. I took a home Covid test the following day and it came back with a positive Covid result. Based on what I read on the CDC website this recurrence of a positive test for Covid can happen in about 25% of people who took Paxlovid. It recommended no treatment but isolating for 5 days. The symptoms went away in a couple of days. I home tested on the 6th day with a negative Covid virus result.
Within 30 minutes of the injection I had a lot of nausea and a weird taste in my mouth. This went on for a few hours. Then I had fever, body aches, bone and joint pain, headache, eye pain for about 36 hours. I continued to have a headache with eye pain following this for a day.
received her 1st two GARDASIL 9 vaccinations but will be out of the country when the 3rd dose is due and will not be returning until December; No additional AEs reported; This spontaneous report has been received from an unspecified reporter referring to a female patient of unknown age. The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On unknown dates, the patient received her first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date unknown) for prophylaxis. The patient would be out of country when the third dose was due and would not be returned until December (Inappropriate schedule of product administration). No additional adverse event reported.
Developed Tinnitus or ringing in ears.  24/7.  Hard to determine if ringing is in both ears or predominately in right ear.
A non-serious, spontaneous report of administration to a one-year-old child was received from a health professional concerning a one-year-old male. There were no adverse events reported in association with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Arm was sore at the injection site; This is spontaneous report from a contactable consumer (patient). A 65-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 at 10:30 A.M (lot number: EK5730) and second dose on 08Jan2021 at 10:15 (lot number: EL0140); both taken via unspecified routes of administration, in the left arm, at single doses, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medication included rosuvastatin calcium (SUVASTATIN). The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the facility. On 18Dec2020, at 15:00, the patient's arm was sore at the injection site. On 08Jan2021, at 16:00, the patient's arm was sore at the injection site. The patient did not receive treatment for the event. Outcome of the event was recovered.
PT given ProQuad 9/27/06 expiration date on injection 8/8/06, no problems noted.
Bad chest pain all over, next day pain continued to get worse, diarrhea, headaches, sore throat, slight cough.
Bell's Palsy; A spontaneous report was received from a consumer concerning a 64-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy (facial paralysis).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, at 13:00, four hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient had had Bell's palsy and had to go to the emergency room (ER). They went to the emergency room (ER) because they though the patient was having a stroke. Treatment details included IV (intravenous) medication.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event of Bell's palsy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.