chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of the palate; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 60-year-old) as a single dose and also received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 13:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to penicillin. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021, the patient had experienced swelling of the palate. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling of the palate was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Had anxiety panic attack; Had anxiety panic attack; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable consumer(Patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included used to have panic attacks and has been many years. The patient's concomitant medications were not reported. The patient had 1st dose of covid vaccine yesterday on 20Apr2021. Said was fine yesterday but woke up this morning on 21Apr2021 and had anxiety panic attack. Patient was concerned. Used to have panic attacks and has been many years, patient was not taking any other medication so thinking it has to do with vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 8/14, experience extreme itching on my right antecubital area and when I scratched it, I noted a vesicle with clear fluid that popped with scratching.  I then noted two other 1 mm fluid filled lesions on my right forearm that were also itching.  Several hours later, I had the sensation of stinging (as if I was being bitten by an insect)  on my right upper back and three more lesions similar to the ones on my forearm appeared.  There was also another one on the base of my neck on the right side.  The lesions on my right forearm continued to itch for the next week.
Patient on 11/15/15 reported to store manager for the first time he was experiencing pain in the arm that he got the vaccine. It continued for more than 3-4 days. Visited family MD.
Recommendations if missed the second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-Apr-2022 Reporter's comments: This case was received from Shingrix. The reporter asked if someone missed the window 2-6 months for the second dose of Shingrix after receiving the first dose, what was the recommendation. If the patient could restart the series or receive the second dose regardless of time elapsed from the first dose. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient received 2nd dose of vaccine too early. First dose was administered on 5/28/2021. No adverse reactions to vaccine noted. Patient to receive repeat dose of vaccine since 6 months has passed since invalid dose given.
The patient fainted after vaccine administration.    The patient was fine after about 30 minutes of sitting.
This spontaneous report was received  from an other health professional regarding a patient of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
The pt experienced a systemic onset of JRA approximately 2 months post vax. the pt was hospitalized. The pt is currently on steroids and NSAIDS.
11 by 16 indurated erythematous warm area right upper thigh on 12/15/2001.
admitted to Medical Center on 2.2.2023 expired 2.14.2023 covid-19 positive 1.20.2023
Blood pressure elevated higher than it is ever been (144/101); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism; TRIAMTERENE taken for hypertension. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 10Nov2023, outcome "unknown", described as "Blood pressure elevated higher than it is ever been (144/101)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was 83-years-and-6-months old. The vaccination site was reported as the patient's left. The patient reported that she had the Pfizer COVID-19 Vaccine (clarified as Comirnaty 2023-2024) two days ago. On the morning of 10Nov2023, her blood pressure was elevated higher than it is ever been to 144/101. The patient had no other lab work or treatment done for the event (as reported). The patient had no other vaccines administered on same date or previous immunizations within 4 weeks with the Pfizer vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
My 16 year old son was given the wrong vaccine-HPV instead of meningitis booster
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-NOV-2015, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles on or about 05-JAN-2017. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Pain, swelling, heat at site of injection, followed by fever, chills, fatiguea and muscle aches. Symptoms  reached zenith about 24 hours and then began to lessen. On +4 day as this is written, arm still sore, persistent fatigue abut flu-like symptoms, while present are milder.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's current condition included liver cirrhosis, BIAXIN allergy, meperidine allergy, morphine allergy, VICODIN allergy, DARVOCET allergy, codeine allergy, opioid allergy, iodine allergy, naloxone allergy, TYLENOL allergy and iodinated contrast media allergy. On 17-MAY-2012, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, strength, route of administration and the site of administration were not reported) dose 1 and received PNEUMOVAX 23 (lot number, expiration date, strength, route of administration and the site of administration were not reported) second dose on 09-JAN-2013. Concomitant therapies included PROTONIX, ibuprofen, XANAX and levothyroxine sodium (manufacturer unknown). On an unknown date the patient developed redness and swelling at the injection site after receiving the second dose of PNEUMOVAX 23. The patient was treated with ice for the event. There were no lab diagnostic studies performed. It was reported that the patient had sought medical attention for the event. There was no product quality complaint (PQC) involved. The outcome of developed redness and swelling at the injection site was reported as recovered on an unknown date. The causality of the event was not provided. Additional information has been requested.
Employee tested positive greter that 14 days past vaccination, asympomatic was previously positive 11/13/2020  Narrative: employee tested positive greater than 14 days post vaccination of dose #2. Employee was previously positive outside of our institution
This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support, received from a contactable consumer (patient). A male patient with age of 81 (unit unknown) received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number not reported), on unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history included quadruple bypass and diabetic. The patient was taking unspecified concomitant medication, it was reported that he took a pill not insulin. The reporter stated that he got his second dose 2 hours before the present report (20Feb2021) and he wanted to know when he will be protected because he wanted to go the restaurant and eat. He had no side effects after this dose, and after the first dose he only had tingling in his arm for a few hours. It was very mild. He got his shot before lunch and midafternoon his symptoms were gone. He had had a quadruple bypass and he was a diabetic. He took a pill not insulin. The event was reported as non-serious. The outcome of the event was resolved.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Lots of pain in upper arm near shot location that resonates down and up the arm; Lots of pain in upper arm near shot location that resonates down and up the arm; Tired; This is a spontaneous report from a contactable consumer(patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EL3247) via an unspecified route of administration, administered in arm right on 09Feb2021 at 11:15 (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Allergies to medications, food, or other products were reported as not applicable. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. On 09Feb2021 (reported as 9 hours 45 mins after the vaccination), the patient experienced lots of pain in upper arm near shot location that resonates down and up the arm and as well as a bit tired. The patient did not receive treatment for the adverse event. Since the vaccination the patient was not tested for COVID-19. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Spot that was running down from the injection site towards my elbow; Redness in the arm at the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Spot that was running down from the injection site towards my elbow) and VACCINATION SITE ERYTHEMA (Redness in the arm at the site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced RASH MACULAR (Spot that was running down from the injection site towards my elbow) and VACCINATION SITE ERYTHEMA (Redness in the arm at the site). At the time of the report, RASH MACULAR (Spot that was running down from the injection site towards my elbow) was resolving and VACCINATION SITE ERYTHEMA (Redness in the arm at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller confirmed that she got the Moderna vaccine on 14-Jan-2021. she stated that she had no initial side effects. On 29-Jan-2021, I noticed a spot that was running down from the injection site towards my elbow. On the 30th the shape of the spot changed into a rectangle 2 by 4 inches. The patient indicated that the spot is lighter in color today and will continue to monitor it. The patient received the Moderna vaccine in the upper left arm on 14-Jan-2021, just before 4:00 PM. The vaccine was given to prevent COVID-19. The lot number an expiration date were unavailable at this time.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Report received: Initiative recieved; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
felt like I had the flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's daughter just had Shingles at age 30 and she was miserable). Previously administered products included shingles vaccine with an associated reaction of pain (received first dose on an unknown date and experienced pain, refer case US2021AMR188159) and Flu shot with an associated reaction of pain (received dose of Flu shot on an unknown date and experienced pain, refer case US2021AMR188157).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the second Shingles shot and felt like he/ she had the flu for a day. The patient stated that it was still better than getting shingles and strongly advise the shot. This case is one of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188159:same reporter, same patient US-GLAXOSMITHKLINE-US2021AMR188158:same reporter, same patient
redness on Saturday AM, bump, seen AM cranky & T103 came down w/APAP;now non tender rt leg 3.5 x 4cm sl red w/a knot/lump under center;probably traumatic secondary to needle;
Sore, red around injection site reported about 24 hours after injection. Called pt's family doctor - no treatment, unless symptoms worsen.
REAL BACK PAIN; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced real back pain. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and real back pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421426.
This case was reported by a healthcare professional and described the occurrence of joint pain in arms in a 44-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 3 June 2011 at 09:00 the subject received unspecified dose of BOOSTRIX at 0.5 ml in the right arm. At an unspecified time after vaccination with BOOSTRIX, the subject experienced joint pain in the right arm and a little in the left arm. The subject also reported no strength in the right hand and wrist (decreased hand strength and decreased strength in wrists). At the time of reporting the outcome of the events was unspecified. Attribution of events to treatment with BOOSTRIX was not reported.
Arm pain started about 12 hours after shot Fever, aches, chills, headache started 15 hours after shot and lasted 24 hours
50-249 maculo papular lesions that lasted 5 days assoc with strep infection.
Patient had a negative serum HCG immediately before (same day) receiving immunizations.  Patient found out 7 days later she was pregnant (serum HCG on 18 Jun 2019).
50 Days past 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 Days past 1st dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 Days past 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 Days past 1st dose) outcome was unknown.        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.   The reporter had a patient at 50 days after her 1st dose of the Moderna vaccine and the reporter needs to know that how long a patient can go after the first dose of vaccine.  No concomitant products reported.  No treatment products reported.    This case was linked to MOD-2021-227886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Followup received on 18 Jun 2021 contains no significant information
Patient had several visits to the ED within 6 weeks of receiving COVID vaccination. on 3/17/2021 and 3/25/2021 he presented to the ED for chronic left shoulder pain. On 3/27/2021 he presented to the ED for alcohol dependence without complication. On 4/8/2021 patient presented to the ED for alcoholic intoxication without complication. On 4/10/2021 patient presented to the ED for left leg cellulitis. On 4/11/2021 patient presented to the ED and was subsequently hospitalized for alcoholic intoxication without complication, cellulitis.
redness; soreness; first dose of Shingrix in January 2020; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema, pain and incomplete course of vaccination. On an unknown date, the outcome of the erythema and pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient was vaccinated with 1st dose of Shingrix and experienced soreness and redness for 5 to 7 days after vaccination. Till the time of reporting patient did not received 2nd dose which led to incomplete course of vaccination. On 6th October 2020 patient was on doctor's office was told, he should get the 2nd shot at this time. The patient was hesitant to receive the second shot due to he experinced events after 1st dose. The patient was also concerned it may not be as effective since he was getting it after the 6 month window.   The patient  planned to get 2nd shot in reporting week. The reporter did not consent to follow up.
Redness, swelling at injection site and painful, fever 101 9/6/06 only. Gave Atarax 3/4 - 1tsp Q 4-6 hours PRN.
A mother reported that her 15 month old son received Prevnar and other immunizations (unknown by mother) in the morning on 05/20/2002 and that afternoon, began vomiting. His vomiting abated within approximately 16 hours; he then developed fever and diarrhea and experienced lethargy. The pt was taken to the emergency room and treated with intravenous fluids. His fever, lethargy and diarrhea resolved within aprproximately 2-3 days. At the date of this report, no further info was available.
Expressive aphasia and apraxia starting at 5pm on 4/18/21. She went to  Hospital and was treated with tPA.