chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 18-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
On evening of 6-27-21 patient started with Nausea and Vomiting.  Had approx 10 episodes of vomiting.  Went to ER in Am on 6-28-21.  Fluid noted in lower abdomen.  Sepsis.
Injection site pain; some soreness / painful; felt discomfort at the injection site; felt like she had to support her arm to lift it and it was painful; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a female patient who received Flu Seasonal QIV (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, pain, injection site discomfort and mobility decreased. On an unknown date, the outcome of the injection site pain, pain, injection site discomfort and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain, injection site discomfort and mobility decreased to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The case was reported by patient herself The age at vaccination was not reported. The patient received Fluarix vaccine in September 2020 or 1st October 2020. The patient experienced injection site pain and injection site discomfort. She felt like she had to support her arm to lift it and it was painful. The patient did not have batch lot number or expiration date of vaccine. No other information was available.
Felt like I had severe case of flu with high fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Sep2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Sep2021 at 13:00, the patient felt like she had severe case of flu with high fever. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event felt like had severe case of flu with high fever was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received from a health care professional on 30 October 2007. Cluster of 50 cases of dark grey dots appearing instantly after injection out of an unspecified number vaccinees who had received an intramuscular deltoid injection of FLUZONE, lot number U2488AA. The reporter stated that they use B-D regular syringes, 25 gauge, one inch. The injection site had been prepped with Kendall Curity alcohol wipes. The dark grey mark appeared after all doses withdrawn from the vials and appeared instantly following injection. The reporter had not checked to observe it the dots disappeared later on and did not know how long the dots remained at the injection site. The reported event had been observed by all of the health care workers providing FLUZONE immunizations this year but had not been observed in prior years. The reporter stated they used FLUZONE and the same syringes in prior years. All 50 of the reported patients had recovered from the event.
Diarrhea, lower back pain with no relief of pain with Tylenol and ibuprofen.
who reported of improvement on her HSP rashes each time she had her covid 19 booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "henoch schonlein purpura" (unspecified if ongoing), notes: I have a patient with confirmed henoch schonlein purpura. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "who reported of improvement on her HSP rashes each time she had her covid 19 booster".  Additional information: Reporter was wondering if we had encountered any reports about covid 19 vaccines helping autoimmune disease. Reporter had a patient with confirmed (Name withheld) purpura who reported of improvement on her HSP rashes each time she had her covid 19 booster.  Follow-up attempts are completed. No further information is expected.
Pt was just fine after giving shot at 5:15pm on 11/18/17. Told that we have EPIPEN if any allergic reaction that usually happens within 15 minutes. Pt also got a FLUZONE HD and told that he might be achy from it (Sunday 11/19/ 17 he was achy all over). On 11/20/17 he was very swollen below the site injection of PNEUMOVAX and it developed a rash. Pt was going to MD for something else. Pt showed arm and MD wrote for Prednisone. Pt was not upset just showed his allergic reaction.
After 24 hours, my lips started tingling. I noticed some swelling. They next day, my lips were swollen to double their size. Looked like I had gotten lip injections. My lips were extremely itchy and almost felt raw. It was painful and uncomfortable. Around my mouth was also red. Took an antihistamine before bed. Woke up and my lips were extremely dry and still painful
PATIENT RECEIVED MODERNA ON 9/2/2021 THAT EXPIRED ON 8/31/2021.
Fever or Chills  Cough  Headache WEAKNESS ED Discharged   8/22/2021 (2 hours) Hospital ED  Last attending ? Treatment team COVID-19 +1 more  Clinical impression Shortness of Breath
6/16/07 Grandmother noticed a few red spots on patients trunk. 6/18/07 other grandmother noticed red spots on hands, top of feet and buttocks. GM states was not itching, just uncomfortable, with no fever present. Instructed GM if fever rises to take her to her PCP for further eval.
pt called in to clinic 3 hrs p/vax; had syncopal episode was tx'd & released by paramedics;
Hair falling out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out) 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, the patient experienced ALOPECIA (Hair falling out). At the time of the report, ALOPECIA (Hair falling out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jul2021 (Lot number: EW0198) at the age of 15 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0198, Location of injection: Arm Left), administration date: 03Jul2021, when the patient was 15 years old, for COVID-19 immunization, reactions: "blood clots in both legs", "swelling in both legs". The following information was reported: THROMBOSIS (caused and prolonged hospitalization, life threatening) with onset 26Jul2021 12:00, outcome "recovered with sequelae", described as "Blood clots in both legs"; DEEP VEIN THROMBOSIS (caused and prolonged hospitalization, life threatening) with onset 26Jul2021 12:00, outcome "recovered with sequelae", described as "Deep vein thrombosis". The patient was hospitalized and prolonged hospitalization for thrombosis, deep vein thrombosis (hospitalization duration: 7 day(s)). The events "blood clots in both legs" and "deep vein thrombosis" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis.
9-19-12 prior to giving HPV #3 child & grandmother mentioned 2 days after receiving dose #2 of HPV child was dizzy & had tingling sensation of both legs which last 4 days. HPV #3 was not given.
Unresponsive; A spontaneous report was received from Pfizer concerning a 45-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient was found deceased at home. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 29 Dec 2020. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
It was reported post vaccine's pt experienced swelling, redness and tenderness from shoulder to elbow.
approximately 5-10" after vaccination red, flat patchy rash appeared on chest area rash lasted about 20" - by 10:55 a.m. rash fading substantially, very faint area present on area around collar bone
Headache, Fever, CoughWheeze, Diarrhea, NauseaVomiting, bodyaches Narrative:  Reported mild symptoms. Treating at home with OTC meds  Other Relevant History:
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED JANSSEN COVID 19 VACCINE DUE TO TEMPERATURE EXCURSTION; This spontaneous report received from a pharmacist concerned a 21 year old male. 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 not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the patient experienced administration of expired janssen covid 19 vaccine due to temperature excurstion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administration of expired janssen covid 19 vaccine due to temperature excurstion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915852, 20210915731, 20210916228, 20210916312, 20210916300, 20210916455, 20210916553, 20210916520, 20210916697, 20210916658, 20210915719, 20210915661, 20210916965, 20210917160, 20210915748, 20210916849, 20210916910, 20210916959, 20210915646, 20210916907, 20210916965, 20210916808, 20210916129, 20210916401, 20210916415, 20210916715, 20210916768, 20210916498, 20210916811, 20210917074, 20210917163, 20210917603, 20210916584, 20210917515, 20210917226, 20210917500, 20210913164 and 20210916465.
Elevated Sedimentation Rate - repeated blood work, symptoms: pain in joints and muscles Positive ANA
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 30 year old white and non Hispanic or Latino female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (manufacturer not specified) (suspension for injection, route of admin not reported, batch number and expiry were unknown), 1 in total, dose was not reported, for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose not reported, 1 total administered on 01-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, (dose number in series 2) booster dose, the healthcare professional injected the individual received less than 0.5 milliliter (mL) of the Janssen COVID-19 vaccine as a booster dose (captured as: vaccine underdose) and off label use (dose number in series 2). It was reported to be confirmed that the reporter "mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the individual received less than 0.5ml of the Janssen COVID-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209976, 20211210058, 20211210549, 20211210662, 20211210588, 20211210610, 20211210684, 20211209775, 20211212088, 20211212082, 20211210555, 20211210408, 20211210334, 20211210112, 20211210067, 20211210160, 20211209798, 20211210409, 20211209782, 20211209816, 20211210670, 20211210824, 20211210590, 20211210385, 20211210350, 20211210180, 20211210165, 20211210159, 20211210143, 20211210107, 20211209679, 20211209706, 20211209740, 20211209816, 20211210019, 20211210106, 20211210141, 20211209740, 20211209679, 20211210141, 20211210058, 20211210585, 20211209880 and 20211210133.
Chest tension, pressure during breathing. Symptoms are not consistent - subsiding for a few hours, then persisting for a few to several hours.
Moderna vaccine was administered outside - reported by patient ? NO LOT NUMBER WERE SUPPLIED RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/22/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/22/2022 HYPERGLYCEMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/22/2022 SEPTIC SHOCK
Dry throat, stuffy sinuses, headache from Friday evening through following Monday.  Dry throat continuing through Tuesday (today).
Patient stated that 2 hours after the immunization she broke out in a rash all over her body. The rash was large red flat rash. She also was bruised at injection site and it was also very red and hard. Pt. used cortisone and BENADRYL for the rash. On 10/18 she went to urgent care and received Prednisone 20 mg.
Warm, swollen, red left deltoid at the site of the injection. On the first day after the injection the patient reports not "feeling well" and a little achy. The second day after the immunization her arm began to swell and the third morning a significant portion of the upper arm was swollen and red. Patient did express that she had redness and swelling with the first Shingrix dose  in the fall, but did not get seen or seek medical care and it resolved at home within a few days.
About two hours after injection experienced heart pain. It lasted about 3 hours; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in left arm on 06Mar2021 at 09:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included no thyroid, fibrinogen in blood; and known allergies to latex and penicillin. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), liothyronine, and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). On 06Mar2021 at 11:00 AM, the patient experienced about two hours after injection experienced heart pain. It lasted about 3 hours. There was no treatment given for the event. The patient recovered from the event on 06Mar2021 at 14:00.  No follow-up attempts are possible. No further information is expected.
Immediate tingling in back of throat, tongue, roof of mouth Extremely tachycardic and elevated blood pressure Heaviness in left arm/hand
Hives, swelling of fingers and wrists, joint pain, itchiness all over, throat swelling, joints red.
Site: Redness at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: neck stiffness/pain in the morning followed by chest pain and a diagnosis of pleurisy-Medium, Additional Details: neck stiffness/pain the next morning following vaccine followed by chest pain/tightness and 2 ER visits both ending with diagnosis of pleurisy
Patient admitted to hospital with positive COVID test on 8/25/21. States he felt bad for 3 weeks with diarrhea, multiple falls. O2 on room air was 90% on arrival.
sleepy; aching all over; felt tired; Nauseated; pain in epigastric area; Dizzy; blood pressure was 128/60; head was heavy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 30Mar2021 12:50 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 30Mar2021 13:05, outcome "unknown", described as "head was heavy"; DIZZINESS (non-serious) with onset 30Mar2021 15:45, outcome "not recovered", described as "Dizzy"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 30Mar2021 15:45, outcome "unknown", described as "blood pressure was 128/60"; NAUSEA (non-serious) with onset 30Mar2021 16:36, outcome "unknown", described as "Nauseated"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Mar2021 16:36, outcome "unknown", described as "pain in epigastric area"; SOMNOLENCE (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "sleepy"; PAIN (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "aching all over"; FATIGUE (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of head discomfort, abdominal pain upper. Additional information: Clinical course: The patient received the vaccine on 30Mar2021 at 12:50 PM. Stayed for 15 minutes and reported that head was heavy. Drank water at 1 PM and at 1:35 PM, drank 100cc of water with paracetamol (TYLENOL), had another 500 and at 3 PM, had prednisone. At 3:45 PM, the patient was dizzy. Blood pressure was 128/60. Had another 500cc of water. At 4:30 PM, felt continuous dizziness. Drank 400cc of coconut water. At 4:36 PM, the patient was nauseated and had pain in epigastric area. Took 15cc of Gaviscon and at 5:30 PM, had another 200cc of water but was still dizzy. At 5:50 PM, patient was sleepy, aching all over and felt tired. Patient was still dizzy at the time of report.  No follow-up attempts are possible. No further information is expected.
Mother reports "reddish brown dots" on neck, belly, thighs, and ears. Skin feels clammy; decrease in appetite. No fever.
HEADACHE; FEVER; This spontaneous report received from a parent concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced headache. On 11-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.
A report was received from a health care professional on 2/4/04 concerning a 5 year old male vaccinee who inadvertently received half of the correct dose of Fluvirin on an unspecified date. On an unreported date, the vaccinee received 0.25ml Fluvirin. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicated that the vaccinee received half of the correct dose of Fluvirin on 12/3/03. The outcome was unknown at the time of the report. The vaccinee received a second dose of Fluvirin at the correct dose on 1/8/04. Follow up pending.
Swelling and soreness lasting 4-5 days after administration from shoulder to elbow of right arm.
Pfizer-BioNTech COVID-19 Vaccine EUA:  Allergic reaction after receiving a COVID shot. Pt reports a rush of dizziness, diaphoretic, nausea, and near syncope. Pt appears pale but alert and oriented upon arrival.  Patient was given IM epi, IV Solu-Medrol, Benadryl, and Pepcid, placed on a cardiac monitor. He was given 1 L of normal saline.  Patient observed here in the ED for almost 8 hours. He has been persistently tachycardic; Admitted as inpt. for observation.  Discharged from inpt status on 12.18.2020 @ 2152.
rash hives on scalp and neck, muscle stiffness on neck down left shoulder.... Treatment Steroids' and muscle relaxant
patient reported left arm numbness and tingling, from site of injection left deltoid down arm lateral to 3rd, 4th, and 5th fingers.  also reported palpitations.  onset shortly after vaccine given.    mild paresthesia in left forearm noted.  no other neurologic abnl.  also with erythema and warmth surrounding injection site approx. 4-5 cms.  no rashes noted.  hypertensive to 160/100 and tachycardic to 120 (sinus tach, intermittently, sometimes with heart rate 100 at rest without anyone in the room.)