chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2016) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Severe itching starting on neck region, developing into full body hives on both arms, hands and ears, lower stomach and back areas, both legs front and back.  Took 2 Antihistanine Diphenhydamine HCL 25mg which helped with symptoms.  Next evening, same symptoms began to appear and took 2 more antihistamine which seems to keep hives at bay.
A spontaneous report was received from a health care professional concerning a non-identifiable patient, who was received COVID-19 Vaccine and there was a drop that was not administered. The patient's medical history was not provided. No relevant concomitant medications were reported. At an unknown date, the patient received his/her 1st dose of two planned doses for prophylaxis of COVID-19 infection. On 02 Feb 2021 15:15 EST, a call came from a health care professional saying that "there was a drop that was not administered at the full vaccine". HCP had a question whether this was considered a full dose or had to re vaccinate. Attempted to contact the reporter for additional info, but no response at this time of report. Action taken with the first dose in response to the event was not reported. The outcome of the event there was a drop that was not administered (accidental under dose) was considered as resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses (Lot unknown), reporting Accidental under dose without any associated adverse events.
The patient received the vaccine, but uses the other pharmacy in town for his medications. The pharmacist called me to relay the info he got from the patient's family. He said that the patient had a headache and body aches on Saturday 05/22/2021 and went to bed but did not wake up the next morning.
During patient observation period, patient passed out. She stood up to notify someone that she wasn?t feeling well then fell and hit her head on a shelf . Duration of unconsciousness was about 10 sec.  She regained consciousness and was shaken but appeared recovered. Called paramedics to evaluate any possible head injury due to the fall. She was cleared and was allowed to go home. She called someone to drive her home
I had cold symptoms the week before and tested negative. Then my symptoms progressed and I tested positive with symptoms of body aches, nauseous, low energy and tired, and a cough. My symptoms lasted 7 days intensely and then 7 days of cold symptoms.
Patient reported that on 12-22-2021 at around 10am her right side felt "funny" and lower lip was numb. At around 3pm she proceeded to go to the hospital to get checked. she was admitted to the hospital and was diagnose with Bells Palsy and TIA.
7APR92 t103, vomited x 1 in noc; mom gave APAP x 24 hrs x/when sleeping; 8APR92 mom called @ 1600 stating pt had temp of 105; instructed mom to go to ER, telling MD recvd DTP;
Screamed for 3 hrs after receiving Pediarix, Hib and Prevnar on 10/1/03.
This spontaneous report as received from a healthcare worker (office manager) refers to a 65 year old female patient with no drug reactions or allergies and no pertinent medical history. On 01-NOV-2013, the patient was vaccinated with the first dose of PNEUMOVAX 23, lot # J005071, expiration date: 19-JAN-2015, intramuscular in the left deltoid (dose not reported). Concomitant therapies included AMBIEN CR. Over the next 2 days after receiving her first dose of PNEUMOVAX 23, in November 2013, the patient developed injection site reaction described as swelling and redness in her left deltoid where she was vaccinated. There was no treatment given for adverse events. No laboratory tests were performed. The outcome of swelling and redness in her left deltoid was unknown. The patient sought medical attention, was seen in office. This is one of two reports received from the same source. Additional information has been requested.
Fever of 101.2 about 9 to 10 hours after the vaccination with headache, flu like symptoms and dizziness
Eyes were better,he can read without his old glasses; Little tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (Eyes were better,he can read without his old glasses) and VACCINATION SITE PAIN (Little tenderness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Eyeglasses wearer. Concurrent medical conditions included Type 2 diabetes mellitus.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Little tenderness). On 08-Mar-2021, the patient experienced PRE-EXISTING CONDITION IMPROVED (Eyes were better,he can read without his old glasses). At the time of the report, PRE-EXISTING CONDITION IMPROVED (Eyes were better,he can read without his old glasses) and VACCINATION SITE PAIN (Little tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medication to treat diabetes type 2. Treatment medications were unknown.
Child broke out with less than 50 pox 2 days after 2 siblings. He was not taken to physician, but siblings did and diagnosed with possible chickenpox. Treatment with Caladryl and Benadryl.
Nurse states 2 doses were given to minors; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Nurse states 2 doses were given to minors) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Nurse states 2 doses were given to minors). On 13-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Nurse states 2 doses were given to minors) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant mediations were not provided.  Treatment information was not provided.  Patient is scheduled for 2nd dose on 10jun2021.   This case was linked to MOD-2021-211661 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional follow up information contains reporter details.
Received DTaP and Varivax (right) arm. Noted swelling and redness a day later. No fever, pain 8 1/2cm x 7 1/2cm erythema and induration (right) arm
hives in her upper thigh, toes, eyelid; Throat closed; This is a spontaneous report from a contactable consumer (patient). A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. The patient's medical history included allergic to Penicillin. The concomitant medications were not reported. With the COVID-19 vaccine, patient had a reaction of hives in her upper thigh, toes, eyelid; went to sleep, when woke up it was pretty much gone with Benadryl. Patient have throat closed. For second dose, patient wanted to know if it be needed the EpiPen or tell ambulance just in case. Her second injection was on Sunday. As per the verbatim the patient had not administered the second dose yet. The outcome of hives in her upper thigh, toes, eyelid was recovering. The outcome of throat closed was unknown.  Information on the batch/Lot number has been requested.
Client provided the vaccine on approximately 10/13. Presented to Express clinic on 11/19 with complaints of "sore know on his left upper arm that is getting larger, red, and sore to touch after provided a flu vaccine injection one month ago" at his place of employment. A 2 cm X 2 cm abscess drained per I and D with culture sent on purulent discharge. Culture resulted growth of Mycobacterium Fortuitum Complex that was sensitive to Ciprofloxacin. Client was initially treated with doxycycline which only provided intermediate coverage and had resistance to other antibiotics. Client placed on Ciprofloxacin on 12/19 as the wound continued to be open but not draining.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a month after receiving SHINGRIX, the patient experienced tiredness and difficulty breathing. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the difficulty breathing was not recovered/not resolved. It was unknown if the reporter considered the tiredness and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The reporter has a patient that was so tired for three days after receiving the first dose of the SHINGRIX vaccine that she could not get out of bed. The symptoms resolved after three days. The patient also developed breathing issues after receiving the vaccination. She went to the Emergency room for these issues two weeks after receiving the vaccination. She was still having breathing issues. The reporter did not consent to follow up. The reporter was unable to provide additional information. She was transferred to Medical information.
Minutes after vaccination symptoms reported were "hot, dizzy, clammy". Denied difficulty breathing, did not lose consciousness. Assisted to chair to sit by myself and mother. Did not fall. Reports ate lunch, drank water today. Given juice in office. Left with mother. Denied above symptoms. To seek care if further or similar symptoms.
This is a spontaneous report received from a contactable pharmacist. A 50-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK9895), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced joint swelling (ankle swelling), with outcome of unknown. Additional information: A 50-year-old male patient, received a dose of the Pfizer COVID-19 vaccine, gray cap vial (confirmed). 5 days after receiving the vaccine, patient had swelling in his ankles. Follow-up attempts completed. No further information expected.
Pt developed localized edema, erythema and induration @ site of injection, no fever /lethergy
2 recent patients at the age of 5 years of age that have been sick and titer tests were conducted and neither patient had titers of Prevnar.; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 5-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number 4, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Hep, reaction(s): "no titer"; Prevnar 13 (dose 1), for immunization; Prevnar 13 (dose 3), for immunization; Prevnar 13 (dose 2), for immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "2 recent patients at the age of 5 years of age that have been sick and titer tests were conducted and neither patient had titers of Prevnar.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The nurse was describing 2 recent patients at the age of 5 years of age that have been sick and titer tests were conducted and neither patient had titers of Prevnar. She felt both had 4 doses as infants. Thought was strange that they had no titers. One of the patients also had no titers of Hep B. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300027122 Same reporter/ drug /AE, different patients.;
Petechial rash and itching on trunk started w/in 2 hours of vaccine - on trunk only. Platelets low normal.
Ten days after Proquad vaccination given, patient suffered a prolonged generalized seizure of 40-45 minutes in length that occurred 3-4 hours after development of fever to 101. Fever in ED while seizure was in progress was noted to be 103. He was given 3 doses of IV Ativan after which the seizure stopped. He was considered to have status epilepticus and started on phospenytoin. He also had URI symptoms with clear nasal discharge 2-3 days prior to this febrile episode. Subsequently was noted to have otitis media and cough. MRI of the brain was unremarkable. He is no longer on seizure medication and is back to normal.  04/12/2007 MR received for a 1 night hospitalization 03/8-9/2007 for report of new onset seizure activity and continued seizure activity during ER visit. Total seizure time 40-45 minutes. Temp in the ER was 103.6'F Rectal.   Txd with Ativan, Tylenol, and phosphenytoin with resolution of seizures.  Discharged home the next day. Discharge DX:  Status Epilepticus, presumed due to complex febrile seizure. 2' DX: Febrile illness, possibly a consequence of recent ProQuad Vaccination vs. acute viral URI.  Suspected viral URI.
Patient experienced pain, swelling, and redness the evening the shot was given. She said it hurt so much she had to go to the doctor the next morning. The doctor diagnosed cellulitis and supposed the shot was given with too short of a needle (a 1 inch needle was used). He prescribed doxycycline and gave a steroid injection.
nose is running; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Left upper arm: Deltoid injection site (DTAP) is surrounded by approx 3-4cm of faint erythema and swelling, extending more than below. Non tender normal ROM of arm. Less injected/swollen in are that was under the Band-Aid.
Information has been received from a physician concerning a 32 month old male with no medical history or allergies who on 08-SEP-1998 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In September 1998, within days of vaccination the patient developed a severe case of chickenpox. It was reported that the patient was vaccinated by another physician. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. At the time of report the patient had recovered. A product quality complaint was not involved. Additional information has been requested.
Pt had a large local reaction. This included a 10 cm red indurated area with warmth and firmness at injection site. Patient improving with BENADRYL.
After given hep B injection-red swollen area noted and continued 2 weeks after administration, itch, red papule (not purulent) at site of injection-present at 2 weeks post immunization.
Had seizure (for about 30 secs) / felt light headed about 2 minutes after influenza vaccination
This case was reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; unknown given in 2012. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). In 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out into a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX and KINRIX and that subject still broke out with a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product"; there were six doses remaining to be returned to GSK for investigation. This is 2 of 4 subjects reported by the physician, for the other cases please see A1004132A, A1004136A and A1004137A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA (and similar batches: AC20B235). There is as of today, no report linked to that batch other than the ones linked to this complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information, it is unlikely that the reported events are related to manufacturing problem.
Patient received 2 doses of the Pfizer covid vaccine about 6 months ago. They also got covid infection; Patient received 2 doses of the Pfizer covid vaccine about 6 months ago. They also got covid infection; This is a spontaneous report from a contactable Pharmacist. An adult female patient (over age 18) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on unspecified date in 2021 (about 6 months ago) as single dose, first dose via an unspecified route of administration on unspecified date in 2021 (about 6 months ago) as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Pharmacist would like to know if there was a timeframe or interval between receiving monoclonal antibodies and a booster dose of the Pfizer covid vaccine. Pharmacist reported that a female patient of unknown age but over age 18, wished to receive a booster dose of the Pfizer covid vaccine due to health conditions. Patient received 2 doses of the Pfizer covid vaccine about 6 months ago. She also got covid infection and received monoclonal antibodies as treatment on unspecified date in 2021. The time the antibodies were received was unknown. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 the suspect drug BNT162B2.
Swelling and Hive type allergy after shot given on skin of left arm in shoulder area.
diarrhea; felt "a strike on her chest like being shocked in the heart"; This is a spontaneous report received from a Pfizer -sponsored Program. A contactable consumer reported a 70-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included cancer came back 1.5 years ago (as of 2021), losing her hair, bald spots on her head, lungs filling up with fluid, hard for her to breathe, and gone to the hospital twice to have her lungs drained over the last 1.5 years. Concomitant medications included palbociclib (IBRANCE) from an unspecified date for an unspecified indication. On an unspecified date after dose 1 of BNT162B2 the patient felt a strike on her chest like being shocked in the heart and diarrhea. The outcomes of felt a strike on her chest like being shocked in the heart and diarrhea were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. Since an excursion in February 2015, unspecified number of patients, on unspecified date, were vaccinated with doses of GARDASIL (lot # J006850, expiration date 31-MAR-2015) (route not reported), which have been exposed to temperatures outside of recommended range allso reported as improperly stored vaccines. No concomitant medications were reported. No adverse effect (AE) had been observed or reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid for treatment of Covid-19 from 27Dec2022 to 28Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely