chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 03 November 2014. A 78-year-old female patient had received first dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly in left deltoid on 24 October 2014. The patient's medical history includes AVELOX and latex allergy and concomitant medication was not reported. The patient had not received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the patient had experienced itchy rash. After the rash patient experienced stiffness in the legs. Laboratory investigations and corrective treatment was not reported. It was reported that itchy rash was for 2 days but the outcome of the event was not reported. Follow-up information was received for this unsolicited case on 30 January 2015 from a consumer who is the patient's daughter. Additional information was received the same day from the pharmacist who was the original reporter. According to the patient's daughter, the patient was described as being in good shape at 78 years of age when she received the vaccine on 24 October 2014. The patient told her daughter that she had a fever and her bones were sore. The patient was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters on the back of her legs about the size of a dime and a nickel. The patient showed it to her doctor as she could not walk. She was hesitant to go back to the doctor. The patient experienced pneumonia like symptoms within the week and was put on oxygen. She could not drive because she could not move. She was treated with antibiotics two weeks later. She had swelling in her left leg. The patient was found dead in her chair on 12 January 2015. A pharmacist also reported the event on 30 January 2015 after the daughter had reported it to him. The patient had died on 12 January 2015. The patient had seen a healthcare provider for the first time after vaccination on 25 November 2014 and was treated with an antibiotic. Around this time the patient had developed pneumonia. The daughter reported that the patient had stopped taking the antibiotic because it made her itch. She returned to the healthcare practice on 8 December 2014 and was treated with another antibiotic and was placed on oxygen. The patient outcome is fatal. Documents held by sender: none.
p/vax mom returned back to clinic w/child crying  eyes puffed lower eye lid;mom states child started to cough & stated couldn't breathe good;mom sent to MD office given Decadron & DPH;
stomach bug; fever; vomiting; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Concomitant medication included tofacitinib citrate (XELJANZ XR), oral from an unspecified date at 11 mg, daily for Rheumatoid arthritis. The patient's concomitant medications were not reported. Patient was still taking xeljanx XR but missed the doses due to covid vaccine and after vaccine patient had a "stomach bug" which included fever and vomiting. The outcome of the events was resolved. PT also reports a general side effects of Xeljanz of fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a licensed practical nurse concerning a 17 year old white male who on 18 Apr 2006 was vaccinated SC with a 0.5 mL first dose of with Varivax (lot# 650389/0951R) as part of his school requirements. Concomitant vaccination on the same day included a dose of Boostrix and a dose of Menactra. On 03 May 2006, in the a.m., the patient was seen by a physician for lesions on his arms, trunks, and in his hair line. The patient recovered on an unspecified date. A product quality complaint was not involved. No further information is expected.
Baby found prone by mother at about 10:00, unresponsive and blue in color. After 1 minute, baby's color returned but remained unresponsive; temp 104.3F at outside ER. Transferred to Peds ICU, where pt was observed to have seizure; remained unresponsive; intubated. Pt remains intubated with decrease in activity. Per doc 197659: On 08/22/2000 at 16:00 call from parent, child is fully recovered; lenght of time in hospital: 10 days. Discharged on phenobarbital. No further incidence of seizure. On 09/21//2000, no reply from hospital, letter and consent form sent to parents. On 10/20/2000; second request; letter and consent form sent.
VS: BP 188/80, HR 76, RR 16, Temp 97.7 SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeated 172/89, other vitals unchanged; Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles"; Pt verbalized "I am nervous because I'm afraid of needles"; 9:00 Pt c/o abnormal feeling to throat. However pt couldn't describe feeling clearly. Denies throat itchiness/pain, tightness, or tingling.; VS: BP 188/80, HR 76, RR 16, Temp 97.7 SpO2 100% RA, Drank 1 cup water 9:06 Drank 8 oz water with swallowing difficulties Pt verbalized "I am nervous because I'm afraid of needles" 9:15 BP repeated 172/89, other vitals unchanged; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an intramuscular route of administration in the left arm on 15Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. It was unknown if patient had any known allergies to food, medicine or other products. Other medications taken within two weeks was reported as not available. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 09:00, the patient complained of abnormal feeling to throat. However the patient couldn't describe feeling clearly. She denied throat itchiness/pain, tightness, or tingling. The patient underwent tests for blood pressure and the result was 188/80 (units unspecified), heart rate was 76 (units unspecified), respiratory rate was 16 (units unspecified), body temperature was 97.7 (units unspecified) and pulse oximetry SpO2 was 100% RA.  The patient drank 1 cup water and at 09:06 Drank 8 ounce water with swallowing difficulties The patient verbalized she was nervous because she was afraid of needles. On 15Mar2021 at 09:15, the patient again underwent test for blood pressure and the result was 172/89 (units unspecified), other vitals unchanged. On 15Mar2021 at 09:18 the patient had left symptoms free. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events abnormal feeling to throat, blood pressure at 09:00 and blood pressure at 09:15, swallowing difficulty and nervousness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Lot of coughing; Back pain: "felt like my back was breaking in half"; Couldn't walk Life Threatening; Crumps that felt like came from her kidneys; Body aches; Headaches; Fever of 100.4° F; Couldn't eat because of the nausea; Flu like symptoms; Chills; Sore throat; Diarrhea; Felt achy after walking; Runny nose; Fatigue/Felt weak; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PAIN (Felt achy after walking), RHINORRHOEA (Runny nose), DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (Sore throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung disease (Lung problems + MBP). Concomitant products included VITAMINS NOS, AMLODIPINE, BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and Cilapro for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPERTENSION (High blood pressure). On 12-Jan-2021, the patient experienced FATIGUE (Fatigue/Felt weak). On 13-Jan-2021, the patient experienced PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose). On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 16-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), NAUSEA (Couldn't eat because of the nausea) and PYREXIA (Fever of 100.4° F). On 18-Jan-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys). On 11-Jan-2021, HYPERTENSION (High blood pressure) had resolved. On 12-Jan-2021, FATIGUE (Fatigue/Felt weak) had resolved. On 13-Jan-2021, PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose) had resolved. On 15-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 16-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 17-Jan-2021, CHILLS (Chills) and PYREXIA (Fever of 100.4° F) had resolved. On 18-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), NAUSEA (Couldn't eat because of the nausea) and HEADACHE (Headaches) had resolved. At the time of the report, COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, Fluticasone propionate, Alprazolam (the day of the injection for nerves)
A-FIB (ATRIAL FIBRILLATION); This spontaneous report received from a consumer via a company representative concerned a 58 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient never had problem before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced A-fib (atrial fibrillation), and was hospitalized (date unspecified) for two days (spent two nights in the hospital). It was reported that the patient heart was out of control. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a-fib (atrial fibrillation) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220542320-COVID-19 VACCINE AD26.COV2.S-A-FIB (ATRIAL FIBRILLATION). The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Inappropriate age at vaccine administration; Circumstance or information capable of leading to a medication error; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 68-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date 20th May 2021) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced inappropriate age at vaccine administration and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The patient was immunocompromised, would be receiving Soliris. The age at vaccination was not applicable for this case. At the age of 68 years, the patient was recommended to receive Bexsero from her physician, which led to off label use and if received would led to inappropriate age at vaccine administration (circumstance or information capable of leading to medication error). Till the time of reporting, Bexsero had not been administered to the patient. The batch number and expiry date provided were for the vaccine that would potentially be used. The reporter consented to follow up.
This spontaneous report as received from a health professional refers to multiple unspecified patients of unknown age and gender. Information regarding the patients medical history and concurrent conditions were not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (Lot number-L022447, expiry date-26-FEB-2017), orally. No adverse effects were reported. No laboratory tests were reported. It was also reported that the temperature was 27C for a time frame of 29 hours and that there was no previous temperature excursion. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Lateral tender (L) axilla pain radiating down distribution of brachial vein to distal bicep w/sore skin.
This is a spontaneous case (prospective) pregnancy case, initially received from other non-health professional (consumer) on 01-Nov-2018 and follow-up received on 08-Nov-2018 combinedly processed), concerning a 34-year-old, adult, female pregnant patient. The patient had 1 previous pregnancy. The patient had no history of still birth, miscarriage, birth defect and congenital anomaly in previous pregnancy. The patient had no paternal medical history (hereditary disease). The father did no take any medication prior to conception. The patient did not take any contraceptives. The patient's current condition included gestational diabetes. The patient's concomitant medication included pre-natal vitamins for an unknown indication. The patient's last menstrual period (LMP) date was 25-Mar-2018. It was reported that, it was patient's second pregnancy. There was no evidence of defect or adverse finding from prenatal test. On 30-Oct-2018, at 31 weeks gestational, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252672, expiry date: 30-Jun-2019) (explicitly coded as vaccine exposure during pregnancy). At the time of the report, the patient and foetus had not experienced any adverse events. The patient's estimated deliver date (EDD) was reported as 31-Dec-2018. The reporter assessed this case as non-serious.
Persistant congestion.  Right TM with 1/4 cloudy fluid base.  Skin (+) 3 small lesions, 2 vesicular around neck area.  Suspect chicken pox. URI.
Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was more prominent, rinsed eyes with cold water  multiple times. Swelling still exists 1/14/2021 at 1315, (time of typing this information).  Seeing slight improvement.
Patient presented to office ~24 hours after vaccines with significant, bilateral hand and foot swelling.  Feet and hands were hot to the touch, read, and edematous, but improving per parent report. Advised parent to give benadryl and monitor. No further action taken.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (rHA) status (lot # J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Stingy pain in calf; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program  A female patient of an unspecified age received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history included ongoing cancer. The patient concomitant medications included an unspecified chemotherapy medication. It was reported that the patient has a stingy pain in calf today (22Feb2021) and been going on since the first dose. It started the day after of the first dose on an unspecified date. The outcome of the event was not recovered.  Information on the lot batch number has been requested.
Patient received flu vaccine 11/14/16 and has ad extreme pain in her right arm for 3 weeks.
pt devel numbness lt arm followed by sweating was restless during the noc-vomited about 12-15times; taken to ER by mom 930 on 24FEB95; allergic to vax;
She got shingles.  One can only get shingles if one is exposed to the chickenpox virus.  This leads me to believe that the Varicella vaccine itself caused this.  Now she permanently has the shingles virus.  She had an ear and eye infection, which allegedly caused the shingles on her lower back to "pop out".
Pt recvd MMR vax as a child; Pt currently exhibited a lack of response to rubella; No further details were provided;
Eyes red, tongue swelling, Benadryl 50 mg, IM Left Deltoid.
Narrative: Having a reaction after 2nd Covid Moderna vaccine given on 4/25/2021 @11:03-12 hours later he started to get up and was so weak and fell. He felt paralyzed for 2 hours from waist down and loss bladder control. He is having chills. No Fever. As of today, his weakness is improving as the day goes on. He is drinking plenty of fluids. Wants to make sure his MD is aware of this so it can be reported to Moderna. Advised MD will get a copy of this note. Patient has concern for Transverse Myelitis. He was told this by his pain provider.
Pain at injection site with increased pain around the deltoid region starting 12 hours after injection and lasting for 36 hours. The deltoid was hot to the touch and throbbing during the increased pain period described above.  The pain, heat and throbbing resolved approximately 96 hours after the injection.  Tenderness and moderate pain to the touch in the area under the armpit of the same arm where the vaccine was injected. This tenderness and mild pain started approximately five days after injection.  This has not resolved yet.
Right side bottom lip became tingly and numb then swollen within a couple minutes of onset of tingling sensation. Benadryl taken.
Patient Recieved Pneumovax for pneumonia vaccine and was a little nervous because of her severe allergy to different types of nuts. 5 - 10 minutes after her vaccination she felt fine. About 20 - 25 minutes later, the patient felt a bit warm and felt like she was itching all over. She described it as wearing wool. She was a little red and felt like she had a couple of red marks on her. She otherwise felt fine. She was administerd 50 mg of oral Benadryl and rested in a chair for 30- 40 minutes. The patient felt better with the wool type itching having subsided.
Last dose was 4/5/21.  I  had 1 grandmal seizure on 6/1/21.   I had two more on 7/28/21.
Pt received his 2nd Pfizer vaccination too early.   No known adverse reactions.  1st Pfizer vaccine: 04/08/2021 2nd Pfizer vaccine: 04/23/2021
Pt was given 1st dose of Hepatitis B on 11/20/2001. Mother reported that he started having hives on 11/21/2001. Hives migrated and appeared off 1 cm for the next 6 days.
Patient stated that he had right arm redness on the lower part of his arm (not at the injection site) and had the reaction a few days later. He also has a rash on top of his hands. It does not itch/hurt.
Urticaria, puritis and dermatographia head to toe for over 4 weeks and counting
Swelling right deltoid and upper arm with erythema and induration after DTaP shot. No tenderness. Local reaction to DTaP shot.
Pt received vaccines during visit 9/15/11. Noticed arm swelling, redness, heat at vaccine site 24 hrs later (R) arm. Pt seen in ER & given KEFLEX & BACTRIM DS. Dx with cellulitis.
Left arm felt numb, tingling, ache, heavy.  Physical therapy done without benefit.
Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (non-serious) with onset Sep2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: On 26Sep2022, the patient took Paxlovid treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High blood pressure.  Was 131/83 taken mid july 2021 by home nurse  Is now 158/98 taken on sept 1st 2021 by home nurse
t103.1 ax;inconsolable crying x 3 1/2 hr;
The patient received both doses of the Pfizer vaccine at her nursing home.  Clinic team was not made aware patient was vaccinated and gave the patient 1 dose of the Moderna vaccine.  Patient had no reactions to the Moderna vaccine.  The communication process between the nursing home and the dialysis clinic was fixed post incident.
Student went to administer vaccine. An unknown quantity of vaccine leaked out of the hub of the needle and dripped down the patient's arm to the floor.  The exact amount given is unknown.  Call has been placed to Moderna and CDC for guidance in regards to redosing.
han recommended diluent added to vial.    Patient infromed of possible increased concentration and possible increased side effects.  Information regarding patient education came from Pfizer and CDC'd "Interim Clinical Considerations for use of mRNA COVID-19 vaccines.  Patient reported no increase in symptoms or other issues.
Pt recvd Hep B vax in 1984 & had seroconverted; 7MAR90 administered a booster dose of HEp B vax; Lab eval on 23JAN92 revealed that pt was anti-HBe borderline, HBe antigen neg, anti-HBs pos, core antigen neg & surface HBag neg;
About 15 min after immunization, patient presented with scratchy throat and shortness of breath.  Breathing became more labored and throat tighter. EMS was called and 1 dose of EpiPen was administered. Breathing improved. EMS transported patient to hospital.