chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB immunization series (lot # K022265 with expiration date of 22-OCT-2016; dose and route unknown). The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worst care scenario. The temperature excursion was cumulative since last February 2016 per manual recording system. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
morning of 19th pt broke out in itchy, red rash;morning of 20th pt went to family hlth center & was put on zyrtec;that evening pt had swollen glands & temp up to 101.8;23rd pt went to clinic also had reddened areas on soft palate of mouth;
VERY LONG, CANNOT MOVE THE BODY; SWEATING LIKE CAME OUT OF A POOL; SUDDENLY STARTED FEELING VERY ILL; NUMBNESS OF BOTH LEGS AND BOTH HANDS; This spontaneous report received from a patient concerned a white male of an unspecified age and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 041A21A, expiry: unknown) dose was not reported, 1 total administered to left arm on 11-APR-2021 for prophylactic vaccination. On 11-APR-2021, 3 to 4 minutes following vaccination with covid-19 vaccine ad26.cov2.s, the patient suddenly started feeling very ill, sweating like came out of a pool, very long, could not move body and numbness of both legs and both hands for 8 weeks (2 months) (Dose number in series 1). The patient recovered from numbness of both legs and both hands on JUN-2021, and was recovering from very long, could not move the body, sweating like came out of a pool, and suddenly started feeling very ill. The patient received booster of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 12-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamin b12 nos for nerve regeneration.  On 12-JAN-2022, 3 to 4 minutes following vaccination with covid-19 vaccine ad26.cov2.s, the patient suddenly started feeling very ill, experienced sweating like came out of a pool, very long, cannot move the body and numbness of both legs and both hands for 8 weeks (2 months) (Dose number in series 2). The patient reports that he had the same reactions with both the shots. The physician is aware of the adverse events that the patient experienced and advised to not to get anymore vaccine nor booster. The patient felt much better currently. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of both legs and both hands on MAR-2022, and was recovering from very long, cannot move the body, sweating like came out of a pool, and suddenly started feeling very ill. This report was non-serious. This case, involving the same patient is linked to 20220518225 (Dose number in series 1).
Patient's mom called to report child had #2 Varicella vaccine and started to hurt right away, site become swollen with "deformed lump" on 12/22/05.  Red in color, warm to touch, low grade fever and chills.  Patient became congested with sore throat while arm better 12/23.  Patient used ice and Advil reported to family doctor.
upper arm @ inj site red, itchy 4" edema, sl tender, afeb;ice, watch T, DPH, RTO-PRN;
Employee reports with c/o excruciating pain on left should/arm after 10 days, post vax, with the Flu vaccine. Went on vacation and reports having pain during all that time. Denies tingling/numbing in upper extremities, redness, swelling, hematoma or rash on left deltoid or arm. Was taking Motrin with no relief. Denies trauma or injury to left arm. Called PHP with left arm pain. MD told her it was probably bursitis. Neurology referral by PMD. DX: Brachial neuritis. Pain control with Neurontin, Trileptal and Lamictal.
red splotches on both of his arms; He got the booster, the Pfizer booster vaccine; He got the booster, the Pfizer booster vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as a single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine dose 1, and dose 2 (lot numbers and expiry dates was unknown) via unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Reporter stated, "she called for her husband withheld (Not spelled, hence captured as UNKNOWN in the initial tab). He got the booster, the Pfizer booster vaccine and on the 26th and he has these red splotches on both of his arms that appeared after the booster, and he was wondering if you know what this was and what we should do about it?". He got the booster, the pfizer booster vaccine (extra dose administered) on an unspecified date, he got the booster, the pfizer booster vaccine. Name of the Vaccine: Pfizer COVID-19 Vaccine. Reporter was informed about the Role of Pfizer Drug Safety and Pfizer Medical Information Department. Reporter stated, "That was what they gave her, the last person she talked to said here was the number to the Pfizer Medical Department and they gave her this number. Now you are going to be sending her to a third person. All she is getting was the run around. Reporter was informed about Pfizer Medical information department and was provided with the number as withheld. As, reporter abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and further probing could not be done. Limited information available over the call. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Same with the booster dose as with the second shot Fever after 24 hours of vaccination, fever lasted about 24 hours, and soreness at injection site and down arm for about 6 inches, and warm feeling at injection site
1st incident:  Uncontrollable nose bleed for 40 minutes. Went to ER. This occurred four days after the first shot.   2nd incident: After the second shot, the same thing happened three days later, uncontrollable nose bleed.
5MAY96 goose egg size swelling @ area of inj w/redness, swelling & heat;had fever of 101 w/nausea, all joints ached;
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 56 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
I just had certain side effects and problems ever since my second shot of the vaccine and I'm really frustrated with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "I just had certain side effects and problems ever since my second shot of the vaccine and I'm really frustrated with it".  Additional information: Patient reported that they just really wanted to talk to somebody from there about, they just had certain side effects and problems ever since my second shot of the vaccine and patient really frustrated with it. The patient did not specify which vaccine they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever every noc beginning 7/14/99, h/a, nausea, low energy, diarrhea one time;feels bad;fever of 102+ this AM (1st time a.m.);
BLOOD CLOT; BILATERAL PULMONARY EMBOLISM; THROMBOCYTOPENIA; PAIN IN LEFT THIGH; EXHAUSTION; FEVER; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 37 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 02-SEP-2021, the patient started having severe headache. On 04-SEP-2021, the patient had pain in left thigh, shortness of breath, 2 episodes of fever and exhaustion. On 09-SEP-2021, the patient was admitted to the Intensive Care Unit (ICU) and according to reporter, patient was diagnosed with blood clot, bilateral pulmonary embolism and thrombocytopenia(low platelets). The reporter stated that according to the doctors the events were related to the vaccine. The patient had done genetic testing and was negative for any clotting disorder. The patient spent two days in inflammatory floor from 11-SEP-2021 to 13-SEP-2021 and was discharged on 13-SEP-2021. The reporter mentioned that the patient almost died and was told at the ICU (intensive care unit) that it was a miracle that the patient was still alive. The reporter also stated that the patient could not receive any COVID-19 vaccine or booster shot anymore. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 100.8 F. Laboratory data included: Lab test (NR: not provided) diagnosed with blood clot, bilateral pulmonary embolism with thrombocytopenia (low platelets) and Platelet count (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral pulmonary embolism, thrombocytopenia, blood clot, fever, severe headache, pain in left thigh and exhaustion was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210941148-covid-19 vaccine ad26.cov2.s-bilateral pulmonary embolism, blood clot, thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
fever of 102.6 by 1 AM. Muscle ache, headache, fatigue, diarrhea and mental confusion continued for up to a month. Arm where injection was became red, swollen and hot to the touch. About 50% of my upper arm was red. The redness finally went away by 04/19/2021 but the other symptoms lingered until approximately 05/28/2021.
A territory representative reported that a 12 month old female received an injection of Hib-Titer. Seven to Nine days post immunization she developed an injection site reaction characterized by induration and redness. She recovered. This is 1 of 2 patients from this facility who experienced this event following receipt of Hib-Titer lot # 468-488.
Platelets dropped to 1!  Petecia all over body and in the mouth.  Pt had to go to the  ER on Saturday, April 10th.  He was rushed to Doctor?s hospital .  Treatment there was not effective for the diagnosis if Immune Trombocytopenia Purpura.  He was then taken to  the hospital for infusions of Rituxinab and Promacta infusions and oral med.  He is still receiving infusions and treatment.  Platelets are still very low.
Woke up the next and every since with arm in a lot of pain, when to go to pick up something she can barely pick it up.
This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates in 2017, between 01-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored VARIVAX (lot number: M035142, expiration date: 03-AUG-2018 and lot number: M036292, expiration date: 17-AUG-2018; dose and route of administration were not reported). The vaccine was stored in a temperature between -14 and -10 degrees Celsius for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. A properly stored sterile diluent was used to reconstitute the doses of VARIVAX. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004513: US-009507513-1705USA004568: US-009507513-1705USA004569:
1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavier more painful period.; 1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavier more painful period.; 1st dose: Migraine headache with scintillating scotoma after 12 hours.Fatigue for 1 week. Much heavier more painful period.; This is a spontaneous report from a contactable consumer (patient). The 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) via an unspecified route of administration at left arm on 15Mar2021 at 5:00 PM a single dose and second dose on 10Apr2021 at 10:00 AM (lot number: EPV0150 (might be ERV0150)) for COVID-19 immunization at a hospital. The patient's concomitant medications included Levothyroxine, Bupropion and Adderall. Patient medical history included hashimotos hypothyroid. No allergies were reported. Prior to vaccination patient did not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on an unspecified date after 1st dose patient experienced migraine headache with scintillating scotoma after 12 hours. Patient experienced fatigue for 1 week and much heavier and more painful period. On an unspecified date after 2nd dose patient experienced fatigue for 24 hours and much heavier and more painful period with palm sized blood clot. It was reported that outcome of events was resolved. No treatment was received.  No follow-up attempts are possible. No further information is expected.
unknown pt called but unable to reach. Pt received the orange cap of the undiluted Covid vaccine 0.3ml
8th July early morning, pain in chest and left arm, loss of breath for 15-20 min. Advised to visit ER. Confirmed Heart Attack. Covid test given and came back negative, quickly gave IV and do not know what kind was given. Stint op.
Received vaccine at school flu clinic. Within 2 hours begin coughing, felt like chest full. "Bronchitis", coughed, increased phlegm, face, cheeks and jaw felt weird. "Lump in throat". Fever, chills, tingling and non stop headaches. Went to clinic to receive shot of BENADRYL and prescription of ZANTAC/BENADRYL.
Pt did not exhibit any adverse events. Pt was given vaccine at 4.30 he is fine until 4.45PM. I did check with the PT after 2 hours, he is doing fine and no side effects.
I am not sure if the below is an adverse reaction from the  Moderna booster my sister received on Dec 6th  but the timing of it in relation to her rapid onset of the below symptoms on Dec 12th I feel warrants review.... My sister woke up  Dec 12th confused and disoriented, She was taken to ED where head Cat Scan was negative but a mass was seen at top of scan in left chest area, She had 3 seizures in the ED. Her neurological  status  worsened, she was unable to respond appropriately only occasionally saying random words , rarely opening eyes  and when did unable to focus, and thrashing about in bed. She was transported by air to a city hospital. By Dec 14th, her neurological status continued to deteriorate where she no longer says words, and only opens eyes briefly if moved but is not focused , and is not responsive. She continues to this day to be in this state.  Once in the city hospital, she was diagnosed Hodgkins Lymphoma with a paraneoplastic response, no cancer in brain or CSF. No symptoms of lymphoma or paraneoplastic syndrome prior to diagnosis. Is it possible that the paraneoplastic syndrome was unknowingly present but the rapid onset of symptoms was escalated by the booster received 6 days earlier?
Narrative:  87yo male pt died in hospice care at home on 12/25/2021. Pt with hx of Parkinson's dementia, CKD, T2DM,  COPD admitted to the inpatient hospice until 12/3/2021 due to recurrent falls and spouse concern about her ability to care for him. Pt was then discharged to home hospice on 12/6/2021. Pt had received covid vaccines on 1/29/21, 2/26/21, & 11/29/21. Vaccines not related to this death.
Patient began to vomit uncontrollably. She then aspirated. She had a droopy face on the left side. She was hospitalized. While there they said she had a new heart problem and arrhythmia. She's now on a permanent feeding tube. She can no longer use her legs. There is undetermined neurological damage.
23-month-old child received H1N1 live nasal vaccine licensed for age 24 months and older. Contact mother 2-11-10 who reported no wheezing on other adverse event after vaccination.
sore arm; Allergies; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), MULTIPLE ALLERGIES (Allergies) and HEADACHE (Headache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Mar-2021, the patient experienced AXILLARY PAIN (sore arm), MULTIPLE ALLERGIES (Allergies) and HEADACHE (Headache).   On 03-Mar-2021, AXILLARY PAIN (sore arm) and HEADACHE (Headache) had resolved. At the time of the report, MULTIPLE ALLERGIES (Allergies) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment information provided.
On 11/17/21 I started having pain at the injection site. On 11/18/21 I started having very serious chills and whole body aches in addition to more painful and tender injection site area. Pains in lower extremities started to increase. On 12/8/21 I started having pain above and behind my left eye - stabbing, piercing like pain with tearing. This pain continued until Wednesday 12/14 and only was reduced due to steroid therapy started the day before. On 12/12/21 I started experiencing double vision which lasted through 12/15/21.
2 days after each shot I live  and it isn't that cold. But I was drinking a smoothie and I developed Raynaud's Phenomenon. I had never had it before - I had it about 20 hours about the first shot and 20 hours after the second shot. And intermittently since then.  Burning and excrutiating pain in right foot/toes/heel and could not longer walk or do participate in daily activities.  Used alternative medicine and pain has gone away.
fainted; I have no memory of the circumstances preceding that; had a small abrasion; fallen on the carpet; This case was reported by a consumer via interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 hr after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), memory loss, skin abrasion and fall. On an unknown date, the outcome of the faint, memory loss, skin abrasion and fall were unknown.   It was unknown if the reporter considered the faint, memory loss, skin abrasion and fall to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix shot and fainted about an hour later. The patient had no memory of the circumstances preceding after that. The patient had a few sips of alcohol, as it was 5:30 pm in the afternoon.  The patient stated that he/she must had fallen on the carpet because the patient had a small abrasion. The follow-up would not possible as no contact details were available.
Patient states that approximately 2 hours after receiving his Janssen booster vaccine for Covid 19, it was noticed that his left cheek was slightly swollen and area firm to touch..  states he has  a mild numbness of left cheek. with  uneven smile.  No other symptoms.  States symptoms are decreasng 12 hours later.