chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/23/21 Pt developed productive cough, chills, diarrhea, chest discomfort with coughing, nausea, some shortness of breath and bilateral ear aches.  Presented to emergency department for evaluation.
She developed the fluttering heart 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, lot number: EK4176), administration date: 15Jan2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Allergic reaction of numbness and swelling of her lips", "numbness and swelling of her lips", "Allergic reaction of numbness and swelling of her lips"; bnt162b2 (DOSE 2, lot number: E8982/ K8982, ), administration date: 10Feb2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3, lot number: 301US8A), administration date: 29Sep2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "fluttering heart"; bnt162b2 (DOSE 4, lot number: FJ9943), administration date: 01Apr2022, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "fluttering heart". The following information was reported: CARDIAC FLUTTER (medically significant) with onset Sep2022, outcome "unknown", described as "She developed the fluttering heart 2 weeks later". Therapeutic measures were not taken as a result of cardiac flutter. Clinical course: The patient develops fluttering of the heart two weeks later. She developed a fluttering heart two weeks later, on all of three of her last doses.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321100 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321099 same patient/vaccine, different dose number/event;US-PFIZER INC-202300321098 same patient/vaccine, different dose number/event;
This spontaneous report as received from a consumer, wife of the patient, refers to a 78 year old male patient with blood pressure issues, who was diabetic and had a triple bypass in 2012. The patient had no drug reactions or allergies. On an unknown date, reported as approximately two to three years ago, the patient was vaccinated with a single dose of ZOSTAVAX, 0.65 ml, subcutaneous  (lot number was not reported). Concomitant medications included an unspecified blood pressure medicine on an unspecified diabetic medicine. At the end of August 2014, the patient got a case of shingles: the patient's back started hurting and on 09-SEP-2014, reported as this past Tuesday, the patient got shingles rash from his back around to his belly button. The patient sought medical attention via contacting the primary physician. The patient was treated with Valacyclovir hydrochloride (28 pill, 1000 mg) and Acetaminophen (+) hydrocodone bitartrate (reported as HYDORCO-ACETA) pain killer. No laboratory diagnostics studies were performed. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Sore arm; headache; chills; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) (at the age of 24-years-old), via an unspecified route of administration, administration on left arm on 16Feb2021 16.00 as dose 2, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1, on 26Jan2021 for covid-19 immunization. The patient was not pregnant. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experiencing sore arm, headache, chills and fatigue on 17Feb2021. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected.
Received Pfizer vaccines on  3/17, 4/7/21 COVID-19 positive by PCR on  1/10/22 admitted to hospital 1/10-1/12/22 for pneumonia d/t COVID 19
TINNITUS; HEADACHE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and headache. This report was non-serious.
Fever 101 Rash (itchy raised red bumps on left arm, left upper leg, both breasts, neck, and stomach) Tylenol and benadryl.  Not resolved yet.  Missed work today 4/19/21
MMRV (Proquad ) was given to a 16 year old boy.  Proquad should only be given to children up to age 13.  No adverse reactions or treatments.
sore arm  Narrative:  employee states: first dose- 12/23/2020 she experienced tiredness and sore arm second dose- 1/20/21 she  experienced a sore arm
itchy, burning bumps began on my left hand and then my right; itchy, burning bumps began on my left hand and then my right; The rash is only on my hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy, burning bumps began on my left hand and then my right), BURNING SENSATION (itchy, burning bumps began on my left hand and then my right) and RASH (The rash is only on my hands) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030701) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 27-Oct-2023, the patient experienced PRURITUS (itchy, burning bumps began on my left hand and then my right), BURNING SENSATION (itchy, burning bumps began on my left hand and then my right) and RASH (The rash is only on my hands). At the time of the report, PRURITUS (itchy, burning bumps began on my left hand and then my right), BURNING SENSATION (itchy, burning bumps began on my left hand and then my right) and RASH (The rash is only on my hands) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant and treatment medications were reported.   The next day after vaccination, raised, itchy, burning bumps began on my left hand and then my right. The rash was only on her hands. A week later the rash continued with small improvement on her left hand.
Presented with fatigue, upset stomach, loss of appetite, crying out in discomfort, PRN tylenol admin.
suspected vaccination failure; Shingles on Sept. 6; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11th April 2021, the patient received COVID 19 VACCINE. On 6th September 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingrix 4 years ago from the date of reporting. Less than 2 months after receiving Covid-19 vaccine, the patient got shingles. It was unknown if the reporter considered the shingles to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided. This case had been linked with case US2021AMR266501, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266501:same patient - 2nd outbreak
Information has been received from a health professional concerning a patient who sometime in January 2008, was vaccinated with a dose of Gardasil which was stored at 33F for 1 to 1 and 1/2 hours.  Medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Possible late 2nd dose; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix. On 24-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-APR-2023 The reporter reported about a possible late 2nd dose of Shingrix.  The vaccine administration facility was the same as primary reporter. No adverse event details were available at that time. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
miscarriage after receiving both doses of COVID19 vaccine; This is a spontaneous report received from Pfizer sponsored program from a contactable consumer reported for self. A female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient is pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient had a miscarriage after receiving both doses of COVID-19 vaccines. The patient received no treatment. The outcome of event was unknown.   Information about lot/batch number has been requested.
3 clear blisters; This spontaneous case was reported by a nurse and describes the occurrence of BLISTER (3 clear blisters) 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced BLISTER (3 clear blisters). At the time of the report, BLISTER (3 clear blisters) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications was not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021 and included details about the second dose information and outcome of the event was updated.
Extreme shoulder pain. Feels dislocated. The injection itself was very painful unlike the first dose.
Approximately 18 hours after dose I experienced a quick onset of severe fatigue (i.e. hard to get out of bed), chills & mild fever (100F). Additionally, my arm was mildly swollen, warm & very painful. Symptoms lasted for about 10 hours and then quickly disappeared. Tx: Tylenol 100mg .
Symptoms started approximately 14 hours post-vaccination.  Day 1 symptoms:   - Fever (<= 101.0 degrees F)   - Chills   - Headache   - Fatigue/tiredness   - Vomiting (one time exactly 24 hours post onset of symptoms)  Days 2 - 5 symptoms:   - Severe pain/tightness and fatigue feeling in both arms, shoulder blades, and chest.  This has slowly improved over days 2 through 5.   - Nausea associated with the pain/tightness noted above   - Coughing (no phlegm)   - Vomiting (one more time on day 2 exactly 24 hours after the first vomiting episode)   - Fever and chills (both resolved by days 2-3)  Treatments:   - 500 mg Tylenol was used to treat fever and pain during the first several days.  Fever was well controlled, but pain was only partially controlled   - On days 3+ Advil was used for pain relief and it was effective   - Alka Seltzer Gold was used to treat nausea as necessary.  It was not particularly effective as the nausea seemed linked to the severity of the pain.  When the pain eased, the nausea did as well.   Outcomes:   - Symptoms have slowly improved over the 5 days post 2nd dose vaccination.  Advil has been discontinued since the afternoon of day 4.  No fever is present and the pain is now only mild.
NECK TIGHT FEELING ON RIGHT SIDE IN GLAND AREA WHEN SWALLOWS; LEFT EYE WATERING CONSTANTLY WHILE AWAKE; NO APPETITE; PAIN AT INJECTION SITE; NAUSEA; MUSCLE ACHES; SHARP STABBING PAIN IN HEAD; HEADACHE; BODY ACHES; PAIN BACK OF LEFT LEG NEAR KNEE; FEVER; This spontaneous report received from a patient concerned a 57 year old female. 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: EL043A21A,  expiry: not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021 16:45, the subject experienced fever. On 11-APR-2021, the subject experienced pain back of left leg near knee. On 11-APR-2021 04:00, the subject experienced body aches. On 11-APR-2021 04:00, the subject experienced sharp stabbing pain in head. On 11-APR-2021 04:00, the subject experienced headache. On 12-APR-2021, the subject experienced neck tight feeling on right side in gland area when swallows. On 12-APR-2021, the subject experienced left eye watering constantly while awake. On 12-APR-2021, the subject experienced no appetite. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp stabbing pain in head on 12-APR-2021, and had not recovered from pain at injection site, neck tight feeling on right side in gland area when swallows, fever, headache, body aches, nausea, left eye watering constantly while awake, pain back of left leg near knee, muscle aches, and no appetite. This report was non-serious.
PATIENT EXPERIENCING SHORTNESS OF BREATH LATER IN THE DAY THAT EVENING.  HIVES DEVELOPED THE FOLLOWING DAY.  BENADRYL GIVEN TO PATIENT 04/09/21 FOR TREATMENT OF HIVES.  PATIENT ADVISED TO HEAD TO URGENT CARE FOR EVALUATION.
3 yr old female got PREVNAR on left arm, now with worsening redness, swelling, pain, warmth on left arm surrounding injection site.
Fever 102.3, tingling face and tongue, swelling in hands. Acheness all over body. Injection site red and size of baseball. Symptoms lasted nearly 24 hours. Treated with Tylenol, IB profrin, benderl and cold compress.
Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who experienced urticaria on both legs. At 2 months of age, the patient received the first dose on 08-Sep-2008. The patient also received a dose of DTaP on 08-Sep-2008. Additional suspect medication included ROTATEQ, IPOL, and Hib. The patient experienced urticaria on both legs on 12-Sep-2008. Prednisone was prescribed but the mother did not use the drug. The patient recovered. No additional information was available at the time of this report.
Vaccine at 0928 with Mom calling at 1230 same day  with report of not breathing , thin line of spit, big eyes, and flailing.  Pt is adopted and Mom contacted Birth Mom and she stated that breathing difficulty with Hep B in the hospital that required suctioning and immediate care.
Body Aches, Fever, Sore Throat, Horse voice/sore throat, runny nose, tiredness.
Chills, severe headache, nausea, stomach pain, pain to left arm, (unable to touch site or lie on arm). Duration 9:00pm-8:00am (11 hours).
There were no adverse effects until some 12 hours after the actual injection ... other than perhaps some mild tiredness.
This spontaneous report as received from a physician (friend of the unspecified patient) refers to a 70 years old patient of unknown gender. In approximately 2006 (also reported as on an unspecified date approximately 8 years ago), the patient was vaccinated with ZOSTAVAX vial, (dose, frequency, route of administration and indication were not provided). Concomitant medications were not reported. The ZOSTAVAX was transported from an unspecified pharmacy to an unspecified physician's office packed in dry ice. The ZOSTAVAX may have been exposed to colder than prescribed temperatures. No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was available. Additional information has been requested.
Fever, vomiting, headache, body/bone aches beginning 13 hours after vaccine, continued for 36 hours, weakness following.
I was working in the ER. At the end of my shift, I asked the OB nurse to give me my flu shot. She did and 1 - 1.5 hours after I broke out in hives all over. this has never happened prior.
Right Lower Extremity DVT confirmed on U/S Presented to our office  to rule out  hypercoaguable state, however previous work up has been negative
This spontaneous report as received from a physician refers to a 4 year old female patient. On 20-JUL-2012 the patient was vaccinated with MMR II lot # 0134AE and expiry date 10-JAN-2014, dose 0.5 milliliters, route intramuscular for prevention of mumps, measles and rubella. On an unknown date in July 2012, the patient experienced redness and swelling around injection site after receiving the vaccine. The patient was seen in office on 23-JUL-2013 and site of reaction measured 10 centimeters (cm x 11 cm. The patient was treated with BENADRYL, AUGMENTIN, ZANTAC and cool compresses. On 25-JUL-2012, redness and swelling had decreased to 6 cm x 6 cm. No other symptoms were reported. The outcome of redness and swelling around injection site was reported as recovering/resolving. Laboratory studies performed on unknown dates were complete blood count (CBC), sedimentation rate (SedRate) and C-reactive protein (CRP) with unknown results. Additional information has been requested.
Spoke with Dr. about Issue &she felt there most likely would not be any adverse effects (Grandma did not want to speak with doctor)
Syncope episode; GI bleed; Hypotension; Abdomen pain; Fracture; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 18Oct2021, this case now contains all required information to be considered valid. This is a spontaneous serious report received from a contactable pharmacist. This pharmacist reported events after the first and the second dose of vaccine. This is the first of two reports (first dose). Only this case is serious. An 84-year-old female patient received bnt162b (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), administered in arm on 12Jan2021 (at the age of 84-year-old) as dose 1, single for COVID-19 immunisation. Vaccine was not administered at  facility. The patient had not received additional vaccines on same date of the bnt162b2. The patient's medical history included Parkinson's, dementia and prior breast cancer. Patient came from an assisted living facility and was there prior to getting the first dose. The patient's concomitant medications were reported as none. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was unknown if patient had adverse event following prior vaccinations. It was reported that patient received the first dose of the vaccine 12Jan2021. She was hospitalized recently and she could not receive the second dose of the vaccine. She had been in the hospital and did not receive the full series.  Reason for hospitalization was syncope episode. The event syncope episode required emergency room visit and it was unknown if it required physician office visit. About illness/adverse event she initially stated unknown and then later stated patient came from an assisted living facility and was there prior to getting the first dose. She had Parkinson's, dementia, prior breast cancer, recent fracture on 08Oct2021, and gastrointestinal (GI) bleed, hypotension, and abdomen pain. All coincided with syncopal episode that she was admitted for on 09Oct2021. At the time of this report the patient was still hospitalized (ongoing). The outcome of the events was not resolved for syncope episode and unknown for all other events.; Sender's Comments: Considering the temporal gap between the date of vaccination and the event onset, there was not a reasonable possibility that the events syncope episode, fracture and gastrointestinal (GI) bleed were related to suspect vaccine BNT162B2. The events were most likely due to the elderly patient's underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202101393254 Same patient/drug, different dose/AE
This spontaneous report as received from a pharmacist refers to a 31 year old female patient. On 28-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not provided). Also on 28-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (route, lot # and expiration daft were not provided). On 28-OCT-2014, the pharmacist administered both ZOSTAVAX and PNEUMOVAX23 to the 31 year  old breastfeeding patient. It was unknown if the patient sought medical attention. No adverse effects were reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
rash on both thighs, extends to knees;red & warm area lt thigh;1" needle;warm compresses, DPH, Westcort cream to rash;itchy;