chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doctor had confirmed patient had shingles; This is a spontaneous report from a contactable consumer (patient).  A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0217) via an unspecified route of administration, administered in arm left on 08Sep2021 12:00 (Age at vaccination 35 years-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type Vaccine was workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had not known allergies. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0186) via an unspecified route of administration, administered in arm left on 18Aug2021 12:00 (age at vaccination 34-years-old) as DOSE 1, SINGLE for covid-19 immunization. There was no COVID prior vaccination. There was no COVID tested post vaccination. On 05Oct2021 after second dose of vaccination, the patient experienced doctor had confirmed patient had shingles. This event was considered as medically significant. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment of valacyclovir for adverse event. The outcome of event was unknown.
Significant onset of pain localized to injection site. Pain began 1 hour after vaccination and became severe 5-6 hours after vaccination with chills, body aches, rigors, inability to move arm. He was sent to ER and admitted overnight for observation. Temperature in ER peaked at 39.5. Overnight pain was improved with prn regimen, by am he was able to move arm better. No redness, warmth, swelling at any time during hospitalization. During reassessment today 11/25/19 by provider PA-C exam showing decreased range of motion left shoulder due to pain. No redness, warmth or swelling of shoulder, left hand slightly more swollen than right.  He had tenderness at left bursa at area of injection per patient.
Was diagnosed with early on set of Parkinson's disease; patient began to move slower; started to stumble; developing tremors; numbing on right side; Has difficulty with concentration; anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). No other comorbidities. Very healthy individual prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EJ1685), administration date: 30Dec2020, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Feb2021, outcome "not recovered", described as "Has difficulty with concentration"; PARKINSON'S DISEASE (medically significant) with onset Feb2021, outcome "not recovered", described as "Was diagnosed with early on set of Parkinson's disease"; ANXIETY (non-serious) with onset Feb2021, outcome "not recovered"; TREMOR (non-serious) with onset Feb2021, outcome "not recovered", described as "developing tremors"; HYPOAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "numbing on right side"; HYPOKINESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "patient began to move slower"; GAIT DISTURBANCE (non-serious) with onset Feb2021, outcome "not recovered", described as "started to stumble". The events "was diagnosed with early on set of parkinson's disease", "patient began to move slower", "started to stumble", "developing tremors", "numbing on right side", "has difficulty with concentration" and "anxiety" required physician office visit. Facility type vaccine reported as hospital. In Feb2021 patient began to move slower, started to stumble started developing tremors and numbing on right side. Had difficulty with concentration and anxiety. Was diagnosed with early onset of Parkinson's disease. Therapeutic measures were taken as a result of parkinson's disease, hypokinesia, gait disturbance, tremor, hypoaesthesia, disturbance in attention, anxiety included prescribed Carbidopa/levodopa.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), SPLENOMEGALY (spleen was enlarged), LYMPHADENOPATHY (lymph nodes are swollen) and PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5) 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 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and LYMPHADENOPATHY (lymph nodes are swollen). On 10-Aug-2021, the patient experienced PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5). On an unknown date, the patient experienced SPLENOMEGALY (spleen was enlarged). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), SPLENOMEGALY (spleen was enlarged), LYMPHADENOPATHY (lymph nodes are swollen) and PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Body temperature: 103.5 (High) Ranges from 101.8 to 103.5. On 10-Aug-2021, Liver function test: elevated (High) Elevated. On 10-Aug-2021, Mononucleosis heterophile test: positive (Positive) positive. On 10-Aug-2021, Red blood cell count: low (Low) Down a little bit. On 10-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Body temperature: 101.8 (High) 101.8. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Mono test was done which came back as positive and immune system was down. No Concomitant medication information was reported. The patient started to run a low grad e fever, mother said she also had the same low grade, fever got the fever and had the fever since, 10-Aug-2021.The fever ranges from 101.8 to 103.5. The patient took Tylenol for treatment. The patient had a stiff neck and her lymph nodes was swollen, that started around 09-AUG-2021 and was scheduled for the second on 31-AUG-2021. The red blood count was down a little bit. Three Covid tests within a week and all were negative. This case was linked to MOD-2021-293008. Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received on 20-AUG-2021 include reporter details, patient Lab details, treatment medications updated.
swelling of the arm; Back side on the right part of the head goes numb; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the arm) and HYPOAESTHESIA (Back side on the right part of the head goes numb) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (swelling of the arm) and HYPOAESTHESIA (Back side on the right part of the head goes numb). In November 2021, PERIPHERAL SWELLING (swelling of the arm) and HYPOAESTHESIA (Back side on the right part of the head goes numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  medications were reported. No treatment medications were reported. Patient had no allergies. Patient had the first shot and was not sure if it was on 01 Nov 2021 or 05 Nov 2021. The events only lasted for few hours.   This case was linked to MOD-2021-405026 (Patient Link).
She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported 7/10/2023 1968385 5/22/2024; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 10-JUL-2023, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968385 and expiration date 22-MAY-2024, 2 milliliters for prophylaxis (dose number and route of administration were not provided) (product storage error). Temperature excursion was 34.9 degrees Fahrenheit (F) for 6 hours 34 minutes 0 seconds; 51.4 F for 7 hours 33 minutes 0 seconds; 51.1F for 24 hours 0 minutes 0 seconds; 50.7F for 9 hours 27 minutes 0 seconds. No previous excursion was provided.; Sender's Comments:  US-009507513-2307USA009885:
Covid19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error. Patient received diluted dose
swelling of the face; tingling face and tongue; tingling in hands and feet,same sensation in her hands and feet; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of the face), PARAESTHESIA ORAL (tingling face and tongue), PARAESTHESIA (tingling in hands and feet,same sensation in her hands and feet) and DYSPNOEA (trouble breathing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M204) for COVID-19 vaccination.     Concurrent medical conditions included COPD (since 20 years). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced SWELLING FACE (swelling of the face), PARAESTHESIA ORAL (tingling face and tongue), PARAESTHESIA (tingling in hands and feet,same sensation in her hands and feet) and DYSPNOEA (trouble breathing). At the time of the report, SWELLING FACE (swelling of the face), PARAESTHESIA ORAL (tingling face and tongue), PARAESTHESIA (tingling in hands and feet,same sensation in her hands and feet) and DYSPNOEA (trouble breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-214883 (Patient Link).
Rash covering body, including palm of hand and bottom of feet.  Very itchy.  With even small scratching turned to welts/hives. Took allergy medicine to help these symptoms.  ADVISED NOT TO GET SECOND DOSE. Rash increased in severity over 1st week.  Lasted almost 4 weeks.
p/vax pt devel swelling of eyes, generalized redness of skin & itching, throat closing, cough, bloody sputum & diarrhea;pt went to ER told allergic rxn to hep b vax;recv DPH inj & nebulizer tx;
there were a lot of little bumps all over my torso. Only some of them were reddish.; extreme fatigue; aching joints; headache; chills; skin feel really textured; This is a spontaneous report from a contactable consumer. This 26-year female consumer (patient) reported for herself that.  A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:15 as (At the age of 26-years) dose 1, single for covid-19 immunisation. Medical history included covid prior vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. Patient did not test covid post vaccination. No known allergies ware reported. Patient was not pregnant at the time of vaccination. The patient experienced there were a lot of little bumps all over my torso. only some of them were reddish, extreme fatigue, aching joints, headache, chills, and skin feel really textured on 13Feb2021 11:30. It was reported that the following day, for about 6 hours, patient experienced extreme fatigue, aching joints, headache, and chills. Patient then noticed 2 days later, there were a lot of little bumps all over his torso. Only some of them were reddish. Overall, it made his skin feel really textured. Patient did not receive any treatment for the events. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
About  10 minutes after receiving the vaccine , while seated in the pharmacy waiting area, the patient started experiencing visual disturbance. His Father was him and he alerted the pharmacist. The patient described feeling like vomiting  and the pharmacist handed him a bucket. He started  hyperventilating and his face turned pale. He was sweating  but in a few minutes he said he he felt cold. No hives were observed. 911 was called and the EMS  examined the patient. His heartrate, blood pressure and blood sugar were all reported normal. The patient was calm and said he felt better after the EMS assured him that his vitals were normal. They told him he is ok to go home but to call if anything unusual happens.
Tingling / numbness in arm after leaving store and came back. Went away by later that evening when we checked on patient.
Arm swollen, red, and painful and pt reported not feeling well. Pt got antibiotics for cellulitis.
This spontaneous report was received from a nurse referring to 8 unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD for prophylaxis, lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) (dose, route, lot# and expiration date were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6 F to 14 F (degrees Fahrenheit) for 135 days. No previous temperature excursion was performed. The call was not because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested. Sender's Comments: US-009507513-1705USA014052: US-009507513-1705USA014053.
approximately 24 hours (1/4/20) after vaccine patient developed large red, raised rash  starting on legs that over the next 24-36 hours spread to trunk, upper extremities and face. Rash was red, raised, and itchy. Rash had begun to resolve on 3rd day and on day of presentation (1/6/20) had only few scattered raised red targetoid lesions on face and hands.
Rash on right shoulder and upper arm. Treated with Hydrocortisone 1%
pt recv vax; became pale, limp & "maybe not breathing" x 30 sec;called paramedics; to er;on f/u no problems noted 5jun95;
Itching at the injection site; area has since become hard; Redness at the injection site of 2*3 inches; smaller patches of redness and itchiness surrounding the original area; area has since become hard and swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE INDURATION (area has since become hard), VACCINATION SITE ERYTHEMA (Redness at the injection site of 2*3 inches), VACCINATION SITE RASH (smaller patches of redness and itchiness surrounding the original area) and VACCINATION SITE SWELLING (area has since become hard and swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE INDURATION (area has since become hard), VACCINATION SITE ERYTHEMA (Redness at the injection site of 2*3 inches), VACCINATION SITE RASH (smaller patches of redness and itchiness surrounding the original area) and VACCINATION SITE SWELLING (area has since become hard and swollen). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE INDURATION (area has since become hard), VACCINATION SITE ERYTHEMA (Redness at the injection site of 2*3 inches), VACCINATION SITE RASH (smaller patches of redness and itchiness surrounding the original area) and VACCINATION SITE SWELLING (area has since become hard and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information included anti-itch cream.
5-8-06 Grandmother reports, child had continuous seizure on 5/5/06, required visit to ER, due to respiratory arrest. Diagnosed with pneumonia and released home to mothers care. 5/9/06 phone call, to mom, child is on antibiotics for pneumonia doing well.
Body aches, fever (100.8 - my regular temp is 97.5, very low energy
Information has been received from a physician concerning an 80 year old male (physician's friend) who on 06-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck). A few days after the vaccine was given (also reported as 3 days later) the patient had the prodromal phase with symptoms of pain over the trigeminal nerve. Physician stated he saw his friend "last night" on 07-MAY-2012 and it looked like a case of ocular shingles. The patient sought medical attention by asking physician. At the time of report, the patient was not recovered. The patient's ocular shingles was considered to be disabling. Additional information has been requested.
PATIENT STATES THAT WITHIN 2 WEEKS OF THE FIRST VACCINE SHE NOTICED BREAST SWELLING, NIPPLE INVERSION  AND TENDER AXILA OF THE RIGHT BREAST.  SHE RECEIVED THE SECOND VACCINE AS TOLD TO DO .  SHE CAME IN FOR AN EXAM ON 4-16-21 AND WAS SENT FOR EVALUATION BY MAMMOGRAM.
Loss of vision. Could not see for 20 minutes, colors were blurred when vision began to return.
Nausea and stomach discomfort - Nausea started around June and progressively got worse. Still dealing with the nausea as of 2/1/2022.
Sinus issues; Runny nose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus issues), RHINORRHOEA (Runny nose) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Sinus issues), RHINORRHOEA (Runny nose) and PYREXIA (Fever). At the time of the report, SINUS DISORDER (Sinus issues), RHINORRHOEA (Runny nose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Updated the second dose details and updated the action taken as not applicable from unknown.
PATIENT HAD REDNESS AT INJECTION SITE AND HAD TENDER MUSCLE.  AFFECTED AREA WAS ABOUT 3 X 4 INCHES.  REACTION WAS ALMOST GONE BY TODAY (IN 4 DAYS). TOOK A PICTURE OF THE AFFECTED AREA AND ATTACHED IN PATIENT PROFILE
20 minutes after injection, there was a bad taste in the back of my throat followed by tingling around and inside my mouth.  Dizziness in waves accompanied by nausea.  Itch but no rash.  Headache started around 4:30 p.m.  Arm was sore, red and hard at the injection site for 10 days.  Next day:  Chills but no fever.  Headache.  Pains in stomach and both sides of my back.  Slept for most of  the day.  Third day:  Dizziness and nausea and stomach pain continue.  Fourth day: Congested, irritation in sinuses, eyes and throat.  Face became hot and red, cold sweat, no fever.  Upper lip on the left is still somewhat numb.
14 hours after shot - elevated temperature, chills, sweats, headache, body pain lasting 14 hours   48 hours after shot - left arm bright red, warm and uncomfortable - at times very itchy - lasting 72 hours
Pt reported she received Pneumococcal shot on 03/02/18. She had it in the left deltoid. Pt reported she felt pain right after the shot. Pt was told is a common adverse reaction. On Friday night states very painful in the left arm. She went to the doctor on Saturday and the provider looked at it and was red. Pt was instructed to come back if becomes worse. Reports over the weekend, she is getting worse. Pain and redness increased. States, "worse pain of her life' and extremely fatigued. She went into ED this morning and was diagnosed with Cellulitis of left upper arm. Pt was treated with KEFLEX 500mg. Pt is upset that she has cellulitis from the PNA shot.
who get the shot end up with the flu; Initial information received on 28-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social media via Agency.  This case involves a adult female patient who get the shot end up with the flu (influenza) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious who get the shot end up with the flu (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "That's been my experience with family as well as others. Those who get the shot end up with the flu. Those who don't, don't."  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Diarrhea, vomiting, dry heaves, dizziness, severe abdominal pain for 1-2 hrs. 2 days later severe abdominal pain, took to ER. 1 week later same symptoms. 1 more week later same symptoms went to ER again. 4 weeks later stomach hurts every day and dizziness continues. No health problems prior to contracting the flu and taking this drug.