chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date and refer case US2022AMR118356.).   On 9th August 2022, the patient received the 2nd dose of Shingles vaccine. On 9th August 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR118356   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received second dose of Shingles vaccine on the reporting day. The patient had no side effects. The patient experienced just arm was a little sore but same as the first dose. Additional supportive information:  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR118356:First dose case/Same reporter
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ACID REFLUX; PANIC; ANXIETY; STOMACH PAIN; LONG TERM BREATHING ISSUES; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 41 year old adult male. The patient's height, and weight were not reported. The patient's past medical history included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left arm on 14-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. The batch number was not reported and has been requested.  The patient received non-company co-suspect drug Paxlovid (nirmatrelvir, ritonavir) (form of admin and route of admin not reported) therapy started on 17-APR-2022 and therapy ended on 22-APR-2022 for covid-19 treatment. Concomitant medications included prednisone for drug used for unknown indication.  On an unspecified date, the patient had suspected covid-19 infection (suspected clinical vaccination failure). On 18-APR-2022, the patient experienced acid reflux, panic, and anxiety diarrhea, long term breathing issues, stomach pain, joint pain The patient also had reoccurrence of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, acid reflux, panic, anxiety, suspected clinical vaccination failure, stomach pain and long term breathing issues was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220548473-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Two weeks after my second injection, I had sever muscle inflammation, stiffness and pain.  The pain made it difficult to walk or stand.  I went to the emergency room and was given a steroid that cleared up the pain, but three days later the symptoms returned,  A week later I went to an urgent care clinic and was prescribed Prednisone.  I was using 20mg daily for 16 days this finally cleared up all symptoms and I no longer need the medication.
This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 18-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included latex allergy. On 3rd January 2019, the patient received the 1st dose of BEXSERO. On 3rd January 2019, less than a day after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb and injection site burning. The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site burning was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site burning to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO was 1st dose of series. After leaving office the patients arm burned and was swollen from shoulder to elbow (extensive swelling of vaccinated limb). The reaction occurred in time between the patient received the vaccine and got in the car to go home. The patient was treated at home with BENADRYL. The office followed up with the patient in 24 hours and the patient reported that the burning and swelling was gone but there was still a little pain. The reporter stated that, there were no respiratory symptoms and symptoms were localized to the injection arm only. The reporter did not agreed to follow up from GlaxoSmithKline. No further medical follow up required.
Resident had facial swelling this morning along with uncontrolled muscle movements and tremors. Residents blood pressure was elevated as well and she complained of nausea. Resident was fine this morning and the past several days with no complaints. This resident has a history of muscle spasms and tremors as well as some catatonic states in the past.
Mother reports seizures that started one day post vaccine, gradually lessened in frequency, last seizure 2/25/01. EEG normal.
Resident was given a covid second booster 6/22/22 approx 11:15 am.  On 6/23/22, Resident developed fever 101.2 approx 1:40 am.  Tylenol 325mg 2 tabs given po, temp went down to 97.1.  For the rest of the shift, resident's temp 97 -98.4, until approx 6:55 AM, temp was 103, and developed seizure.  O2 administered, was sent ER via 911
Patient received primary doses out of country but had no documentation and was to start over primary series with a dose of monovalent Pfizer. Patient was administered bivalent Pfizer instead. No adverse effects were noted during 15 minute observation; patient was advised to come back and get monovalent Pfizer as a second dose per CDC guidelines.
The patient had already received a dose of Moderna vaccine on 01/28/21- Lot #030L20A The patient tolerated vaccine well during observation period. No signs/symptoms of adverse reaction. Assisted Living Facility reported on 4/9/21 that the patient was seen at ER the night of immunization with increased shortness of breath and was diagnosed with COVID-19 and released back to facility
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 65-year-old female patient who received TWINRIX adult. Co-suspect products included TWINRIX adult and TWINRIX adult (batch number AHABB253BC, expiry date 13th July 2014). On an unknown date, the patient received the 1st dose of TWINRIX adult and the 2nd dose of TWINRIX adult. On 23rd July 2013, the patient received the 3rd dose of TWINRIX adult (intramuscular) 1 ml. On an unknown date, several years after receiving TWINRIX adult and TWINRIX adult and 3 years after receiving TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details were provided as follows: The first two doses were administered at another facility. The patient received 3rd dose of TWINRIX adult on left arm. The reporter got the information from the patient's husband that the patient had a negative titer after receiving the TWINRIX series. It was not specified if it was for Hepatitis A, Hepatitis B or both. In 2016 (very recently), approximately several years after receiving the first two doses and approximately 3 years after receiving 3rd dose of TWINRIX series the negative titer was found, though the reporter did not know when specifically it was drawn. This case has been linked with US2016150946, reported by same reporter.
Adverse Events: Palpitations, throat swelling up,  SOB, burning up, thirsty (symptoms occurred 3 minutes after administration and resolve after EpiPen dose) Treatment:  Benadryl, EpiPen Outcome: Patient stabilized after EpiPen administration and went with ambulance
Swelling in face, lips, eyes, heat-felt like worse sun burn over face.  Now peeling, saw physician 10/28/2003.  Prescribed prednisone.  No difficulty breathing, but would not blow nose.  Not debilitating, but looked terrible.  On 10/23/2003-10/25/2003: used cleaning voy suppositories.  Said reaction was not typical of antibiotic or flu, felt it was more like food.  Felt food, first, then eleocin, lost flu vaccine.
No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 26-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660151, has been verified to be a valid lot number; expiration date 17-SEP-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a temperature excursion below 36 Fahrenheit degrees  to 35.2 Fahrenheit degrees for 10 minutes and below 36 Fahrenheit degrees to 35 Fahrenheit degrees  for 1 hour and 20 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.
Noted redness and swelling of RT deltoid 10-13-15 later in the afternoon. Redness and swelling increased this mornng from yesterday. Soreness under arm as well area very to touch. Area redness 2"6" wide and 3 1/2" long.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/16/2022 SYNCOPE I82.4Z2 ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN 7/4/2022 SYNCOPE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2022 SYNCOPE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/16/2022 ALTERED MENTAL STATUS, UNSPECIFIED I82.4Z2 ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN 7/4/2022 ALTERED MENTAL STATUS, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/4/2022 ALTERED MENTAL STATUS, UNSPECIFIED
Upper left arm pain (around injection site); mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD and mild mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 18Mar2021, reaction(s): "covid-19 immunization"; BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM, Route of Administration: Intramuscular), administration date: 25Feb2021, reaction(s): "Covid-19 immunization". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Apr2022 at 15:00, outcome "not recovered", described as "Upper left arm pain (around injection site)"; HEADACHE (non-serious) with onset 14Apr2022 at 15:00, outcome "not recovered", described as "mild headache". Therapeutic measures were not taken as a result of vaccination site pain, headache.  Additional Information: Patient current age is 55. Gender Female. Dose received 3. Administration date 14Apr2022, route Intramuscular, time 11:30 AM, Vaccine location Left Arm. Previous dose details product COVID 19, administration date 18Mar2021, administration time 02:30 PM, dose number 2, vaccine location Left arm. Previous dose details product COVID 19. dose number 1, administrator route Intramuscular, date 25Feb2021, time 01:45 PM. vaccine location Left arm. No other vaccine in four weeks. Other medications in twoweeks Vitamin D. Adverse event Upper left arm pain (around injection site), mild headache. start date 14Apr2022. start time 03:00 PM. patient not recovered. No treatment ae. Yes Covid-19 prior vaccination. No Covid-19 tested post vaccination. Other medical history GERD and mild mitral valve prolapse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
As I have taken boosters the legs have become more bigger; As I have taken boosters the legs have become more bigger; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in arm, on 23Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in arm and as dose 5 (booster), single (Lot number: GH9497) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26Jan2021, Time (24hrs): Am, Site and route of injection:, Anatomical site of injection: Arm, Batch/Lot number: Pfizer EN5318, (name-withheld) came to facility), administration date: 26Jan2021, for COVID-19 immunization, reaction(s): "legs began to get bigger at a greater rate and itch and hot to the touch", "legs began to get bigger at a greater rate and itch and hot to the touch", "legs began to get bigger at a greater rate and itch and hot to the touch"; BNT162b2 (Dose: 2nd , Date: 16Feb2021, Time (24hrs): Am, Site and route of injection:, Anatomical site of injection: Arm, Batch/Lot number: Pfizer EN5318, (name-withheld) came to facility), administration date: 16Feb2021, for COVID-19 immunization, reaction(s): "the right began to swell, itching, hot to touch happened noticeable about 3 months  after second shot", "the right began to swell, itching, hot to touch happened noticeable about 3 months  after second shot", "the right began to swell, itching, hot to touch happened noticeable about 3 months  after second shot". The following information was reported: PERIPHERAL SWELLING (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "As I have taken boosters the legs have become more bigger".  Additional information: As I have taken boosters the legs have become more bigger. It caused by rebound to become worse. Prior vaccinations (within 4 weeks): None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st Dose vaccine administered IM. Pt stated she felt dizzy within 15min, Pt had water. BP checked #189/85                                                                                             #2 163/79                                                                                             #3 136/77 No longer felt dizzy She called friend and was driven home by friend
My sister has developed multiple Blood Clots in both of her lungs. She is now currently hospitalized. No history or family history of Blood Clots. No damages.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 09-MAR-2015, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (dose, route and lot# were not reported) instead of ZOSTAVAX. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient presents at the clinic with left deltoid pain and left hand swelling that he has been having for about 3 weeks  on and off . Patient states that it had started shortly after receiving his Moderna Booster vaccine .
His friend was vaccinated and tested positive last week; His friend was vaccinated and tested positive last week; coughing; runny nose; This is a spontaneous report from a contactable consumer. This consumer (patient's friend) reported for a male patient that the male patient of an unspecified age received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced his friend was vaccinated and tested positive last week in Oct2021 with outcome of unknown, coughing on 2021 with outcome of recovered in 2021, runny nose on 2021 with outcome of recovered in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2021. The clinical course was reported as follows: Narrative case summary and further information: The caller wanted to know if someone were get Covid after being vaccinated would they only have mild symptoms? Will the vaccine protect against variants especially the delta variant? After asking if I could put him on hold to provide him with the most updated information on this the caller stated he did not need an answer to this anymore. The caller wanted to know if he was safe with 2 doses or if he needed to get a booster dose? The caller stated he got two vaccines of the Pfizer BioNTech Covid-19 vaccine. The first one was the first of May and the second was 22May, 3 weeks after. He stated the last one was 5 months ago, Pfizer EW0191 on 22May.  With the first dose he only got some pain on his arm where he got the injection and it was a little red but disappeared within 1-2 days and he did not feel weak. When he got his second dose, it was just the same, a little pain at the injection site, nothing, nothing, nothing, no fever. He stated he went to withheld and tested negative 3 times and people were saying that means nothing, it could still be positive. He tested negative last week. He is 56 years old, a smoker, and has COPD. He stated everyone is dying, even vaccinated people. So many people are dying that have the vaccination but he does not know what vaccination. People are getting really sick, 50% of the people in the ICU are vaccinated who are lying there in bad condition. He stated he sees a lot of people dying,10 people, dying around him. People say they get a bad heart or get really sick from your vaccination. People say they destroy your cells, destroy your brain and they kill you. His brother's boss died and is he is not sure if he was vaccinated. His friend was vaccinated and tested positive last week (and then corrected it saying, I mean 2 weeks before. Based on how he described this I believe he meant 2 weeks ago or two weeks before that) and he only got mild symptoms and it is gone out of his body now. He just had some coughing, a runny nose, no fever and in 5 days everything was gone.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
PT recvd vax 830AM awakened from nap @ 1PM c/o h/a, afebrile; given APAP for head ache then seizured; taken to hosp ER; family are poor historians; mom denied hx of sz;
received 1st dose of vaccine on 25Mar2021 and then contracted COVID-19; received 1st dose of vaccine on 25Mar2021 and then contracted COVID-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 25Mar2021 and then contracted COVID-19 on an unspecified date in 2021. She was taken out of ICU the day before her second dose was due to be given on 15Apr2021 and she was released from the hospital shortly after. She was hospitalized from an unspecified date in 2021 to Apr2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
H/A, Nausea, achy in shoulder where the shot was give (#4).  DX H/A. se 2 Anthrax.
Too many side effect; This case was reported by a consumer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. It was reported that the patient would never get the Shingrix shot again too many side effect started the moment the patient received the Shingrix shot 1.
Rt. deltoid within 6 h redness noted around injection site. Extended to 4.8 X 5.8 cm.
developed a rash 6 days after injection.  red, warm, itchy. Taking Zyrtec
There was an order entry error, patient received both VARIVAX and PROQUAD. Patient received 2 doses of chickenpox by mistake. Patient is not yet showing any type of adverse reaction.
General body rash began approximately 9 hrs after MMR immunization given. Went to PCP for evaluation; told reaction to medication. Rash never blistered. Resolving 7-9-14.
Left arm has area 2 cm x 2 cm of erythema and warm to touch. Low grade fever. Recommended cool compresses Tylenol or Motrin.
Immediate metallic taste in mouth. Tightness in throat and back of neck that started 5 minutes after shot. Has persisted for 1 week and still going. Symptoms come in waves but not has peaked higher than initial reaction.
Low oxygen and tightness in chest.  Had 5 days in hospital for testing and nothing showed up.  Got 2 vaccination and same reaction.  My brother got his first vaccination, he had identical side effect and was advised not to get second shot.  All were Moderna serum.  My second shot was Lot#002A21A
Sore back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset 04Dec2021, outcome "recovered" (04Dec2021), described as "Sore back". Additional information: Reporter stated that, my daughter (patient) received the Pfizer vaccine 5 to 11 year old yesterday and for the second shot. Patient was fine and reporter just want to report that side effect. Patient didn't have pain in her arm normal, no fever, nothing she was fine.  QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.