chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad headaches; right  arm swelling/side of injection/Right arm is swollen up, has a knot and is painful; feverish/Fever; chills; nauseous; Feels awful; Feels like her kidneys are gone because she is hurting back there; feeling cold; sore neck; This is a spontaneous report received from a contactable consumer (patient). A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no: not reported/lot number: EN6200) via an unspecified route of administration, in right arm on 04Mar2021at 13:30-14:00 (at the age of 66-years-old) as dose 2, single for covid-19 immunization. Medical history including diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity and respiratory illness. Concomitant medications included Levothyroxine at 50 mg every day from on an unknown date (taking it so long, forever). Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/lot number: EL9261) injection to left arm on 11Feb2021 at about maybe 13:30-14:00 (at the age of 66-years-old) as dose 1, single for covid-19 immunization and had bad headaches. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Patient was administered the second dose of Pfizer-BioNTech COVID-19 on 04Mar2021. She sat for monitoring after being administered the second dose of the vaccine and had nothing, no reaction. When she woke up on 05Mar2021 morning she has bad headaches again; chills; fever; feels awful; nauseous; right arm is swollen up, has a knot and is painful; Feels like her kidneys are gone because she is hurting back there. The events after the second dose of the vaccine are worse than they were after the first dose of the vaccine. Bad headaches as she cannot stand the headaches; she gets migraines, but she cannot take a headache, it kills her. Her head hurting was bad. Fever feels feverish, hot all over. When she first checked her temperature, it was 98 degrees Fahrenheit, then when she checked her temperature again it was 99.4 degrees Fahrenheit. She has been drinking water and everything. She has chills and feels cold, her feet are cold, hands are cold. received second shot of pfizer covid vaccine yesterday and woke up with bad headaches, right arm swelling/side of injection, sore neck, feverish, in Mar2021 feeling cold. chills. states with the first injection, he woke up next day with headache only but now after the second dose he has extra side effects. The patient underwent lab tests and procedures which included body temperature was 98 fahrenheit on and body temperature: 99.4 fahrenheit, both on an unknown date in Mar2021, mammogram test was performed on Feb2021 and results were came out great, they did not find anything. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient has moderate hair loss since a few days after vaccine administration.  This was not an issue prior and now she has thin and bald spots to the scalp.  Patient is educated to look into minoxidil type shampoos and to avoid pulling of the hair.
This is in follow-up to report(s) previously submitted on 4/6/2007. Initial and follow up information has been received from an office receptionist and a nurse practitioner(N.P.) concerning her 17 year old step daughter who on 28-FEB-2007, at 2:30 PM was vaccinated in the left arm with a first dose of GARDASIL lot #654535/0960F. The patient experienced extreme nausea, diarrhea and dizziness after the injection. "Patient was vomiting so hard, that the blood vessels in her eyes broke." The patient's outcome was unknown. In follow-up it was indicated that patient started vomiting on 01-MAR-2007 at 03:00 AM and vomited 8 times. She broke blood vessels in both eyes. Her diarrhea continued for 24 hours and she was very tired, slept a lot and missed 2 days of school. On 03-MAR-2007 patient recovered. Additional information is not expected.
Father reported that at approx 4:30-4:40 pm on 1-18-17 after receiving the vaccines, client experienced swelling of the face as well as a general feeling of "itchiness" all over his body. Father reported that client had no breathing issues or wheezing.
Chills started at 6 pm, fever and chills spiked through the night and next day until about 7 pm on April 15. Also, during this time I had intense body aches and headache. The fever spiked several times at 100.9. My normal temp runs 97.5. When I have fever I wake up long enough to take ibuprofen/Tylenol and go right back to sleep. No eating or drinking during that time. Only enough to get the Tylenol/Ibuprofen down.
26JAN93 & 4MAR93 pt recvd vax & 10FEB93  hive like rxn vax & 8APR93 hive like reaction, fatigue, hive like rxn over trunk, face, legs and arms; referred to pvt MD for treatment;
The shot felt like it took forever, I walked away to the next building, started sweating profusely and couldn't see straight and could barely hear, Waited about 5 minutes till I could walk again and went back to the clinic, they told me I was very pale and that I was sweating and gave me a juice box and crackers and M and Ms. Then they let me leave, however I felt out of it for the rest of the day.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer-sponsored program. The reporter is the parent.  A 24-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, and administration date 13 May 2021 (Lot number: EW0185) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
tingling on the lips; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling on the lips) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and GI upset.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling on the lips). On 05-Feb-2021, PARAESTHESIA ORAL (tingling on the lips) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included medications to treat high blood pressure and GI problems.  Treatment medication included Tylenol.
On 3/15/01, vaccines were given. On 3/16/01, left thigh was warm and red. On 3/17/01 and 3/18/01, leg continued to be red, despite mom's efforts with Benadryl cream. She contacted physician. No other symptoms. On 3/17/01, brought back child to H D to show redness of approx. 5" in diameter to left thigh with slight warmth to area.
I was pumping 10-16oz in a session. After the first dose I noticed my milk decreasing within a 24hour period. By the next day I was only producing 3 or 4 oz in a single session; I was Breastfeeding when I received the covid 19 vaccine.; I was Breastfeeding when I received the covid 19 vaccine.; This is a spontaneous report from a contactable consumer(patient). A 24-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 at 15:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation at a Clinic. The patient medical history included glaucoma, aphakic, known allergies: latex, mild mold/fungial allergy. Concomitant medications within two weeks included latanoprost, dorzolamide hydrochloride, timolol maleate (COSOPT) eye drops. Patient did not receive other vaccine in four weeks. Patient had no covid prior vaccination, and patient did not tested covid post vaccination. The patient was breastfeeding when she received the covid 19 vaccine. She was pumping 10-16oz in a session. After the first dose on 31Mar2021 at 15:00, she noticed her milk decreasing within a 24hour period. By the next day she was only producing 3 or 4 oz in a single session. Patient struggled over the next few weeks to get her milk supply up to 6oz. Patient had consulted for lactation and received treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt received Td approximately 4:30 PM on 05/21/05 at approx. 12:00AM I woke with severe pain in upper stomach and chest area. Took 2 antacids to releive pain but the pain continued and just worsened. The pain felt like all muscles in area were spasms at the same time. Lasted for 45 minutes.
flu-like symptoms x 6 days. 2/23/21, 7 days later, have symptom referred to as Covid Arm. Injection site red, itchy, swollen and hard. Redness, size of a softball. Not real painful.
tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from a contactable nurse reporting for herself. This nurse reported similar events for 2 patients: this is the first of two reports. This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient tested positive after first dose. Outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021021888 same reporter/drug/AE, different patient.
Pt received immunization. Returned approximately 5 minutes later reporting symptoms of back spasms. Pt experienced chest pain radiating. Pt was instructed to sit down and rested. Pt was monitored by pharmacy staff. Pt condition improved and was instructed to contact PCP. Pt ambulatory.
Pruititus, rash on abdomen, neck, face and legs.; Pruititus, rash on abdomen, neck, face and legs.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Optional Information: Cholesterol, diabestes, blood pressure meds; "diabetes" (unspecified if ongoing), notes: Optional Information: Cholesterol, diabestes, blood pressure meds; "blood pressure" (unspecified if ongoing), notes: Optional Information: Cholesterol, diabestes, blood pressure meds. The patient took concomitant medications. The following information was reported: RASH PRURITIC (non-serious), RASH (non-serious) all with onset 20Oct2022, outcome "unknown" and all described as "Pruititus, rash on abdomen, neck, face and legs.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Confusion, Myalgia, Arthralgia, "EXCESSIVE FATIGE"; NUMBNESS IN FINGERS, Narrative:  Other Relevant History:
fainted, shortness of breath, stomach pain, weakness.tingling, hives. 911 called
A report has been received from a Health Professional concerning a 46 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST (intranasal) started on 06-Sep-2014. Physician assistant reported patient possibly only received partial dose of FLUMIST QUADRIVALENT. When administered. The outcome of the event of partial dose of FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious.
Patient states that she had a bruise that persisted for a few weeks after injection. Injection site pain seems to increase in intensity over time and has persisted for over a month. Some loss of movement has also been noted.
I am a runner and run regularly. On 3/23 I was running with friends early in the morning and got a strange cramp in my left calf. I?ve never had that happen before. It was so strong that I had to stop running and walk the last mile home. The strange cramp/pain lasted about 4 days.  Then last week my family and I were skiing and I got a sharp pain in the shin of my left calf.  Nothing brought it on, it was intense and just started out of nowhere. The pain lasted about 10 minutes and then subsided. It was very strange. That night I had a large bruise. The next morning the bruise was the size of the palm of my hand. The bruise was gone after about 4 days. I don?t know if these are related but I?ve never experienced things like these in the past without something causing them.  So after hearing reports of adverse reactions these seemed worthwhile to report.  As a side note, I also did get sick during the 24 hours after my shot. My symptoms included intense body aches, headache, sinus pain, sore throat, fatigue, nausea and a fever of 102.4. These symptoms all subsided after 48 hours of my vaccination.
Patient was given a dose of Menveo. She was due to have her second Guardasil vaccine. Patient's mother was informed on 4/4/22 when the mistake was caught and physician was consulted. Patient's mother was understanding and had no concerns, and is bringing the patient back in 2 weeks for second HPV vaccine.
Parent noted fever @ home on 20FEB91 p/immun. 21FEB91 child was brought to ER p/parent noted sz like activity @ home;  Seen by MD temp 39.4C.
30min p/vax 12NOV97 pt stated inside of throat felt itchy & chin was itchy;No SOB, no diff swallowing;no local rxn @ inj site;given DPH;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Ringing in the ears, mainly in the right ear.  This has been going on for close to 4 weeks now.  ENT can?t find a cause, other doctor says it may be the vaccine.
pt presented to ED after EMS was called for pt experiencing SOB, low O2 saturation, placed on CPAP; hx of CHF, anasarca to lower limbs; acute respiratory failure, positive COVID test, hypoxic hypercapnic respiratory failure; placed on BIPAP in ED; pt was a DNR;  pt's condition worsened and she died in the hospital
patient received a dose of Engerix-B approximately 8 years ago. Partial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (patient received a dose of Engerix-B approximately 8 years ago.).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient received a dose of Engerix-B approximately 8 years ago. Partial).  The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Aug-2023 The vaccine administration facility was the same as primary reporter, Partial information was provided for the adverse event, vaccine and patient. The provider requested to no be contacted. The patient received a dose of Engerix-B approximately 8 years ago, which led to incomplete course of vaccination.  The reporter did not consented to follow up.; Sender's Comments: GSK receipt date: 24-Aug-2023 The vaccine administration facility was the same as primary reporter, Partial information was provided for the adverse event, vaccine and patient. The provider requested to no be contacted. The patient received a dose of Engerix-B approximately 8 years ago, which led to incomplete course of vaccination.  The reporter did not consented to follow up.
Just sore arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 10Jun2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 18May2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient had just sore arm. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event just sore arm was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt developed chickenpox after older brother had them. Multiple lesions, itching and low-grade fever. Symptomatic treatment and Rx for Acyclovir Susp. X 5 days. Tylenol as needed.
Pt described extreme swelling of site to football size with swelling extending down her arm and into the chest and back areas. Patient advised to try benadryl to calm reaction and if symptoms worsen to see a physician.
Severe joint pain in neck, shoulders, elbows, wrists, hands, fingers, knees, ankles, feet, toes.  Moves around day to day to different joints.  Window from 10-11 am until 5-6 pm not as severe,  Unable to function some days due to pain and swelling.
Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 30-JUN-2023, the patient received the 2nd dose of Shingrix. On 30-JUN-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date 30 Jun 2023: The pharmacist reported an early second dose of Shingrix was administered. The patient consented to follow up via email. The patient received early second dose of Shingrix which led to shortening of vaccination schedule.
Everything hurts. Headache. Muscle aches. Everything. This is probably the worst reaction I have ever had.
slight fever,100f; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever,100f) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 043L20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure), Diabetes, Acid reflux (esophageal) and Urinary tract disorder (Urinary issues). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), RIVAROXABAN (XARELTO) for Anticoagulant therapy, PIOGLITAZONE HYDROCHLORIDE (ACTOS) for Diabetes, RAMIPRIL and TRIAMTERENE for Hypertension, DUTASTERIDE for Urinary tract disorder.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (slight fever,100f). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (slight fever,100f) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Body temperature: 100.6 (High) 100.6 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Took Motrin after receiving vaccine on 1/5/21 and felt fine until the evening of 1/6/21 felt like was freezing with temp 100.4 and body aches.  On 1/7/21 continued to have body aches, sweaty, afebrile and that evening felt nauseous requiring medication (zofran).   On 1/8 @ 1300 after waking up felt body aches and stiffness on right side of body, right side of face felt tingly, right underarm lymph node swollen.  Went to urgent care to be examined and had xray of neck that was negative for acute process and was informed to take motrin and return in 3 days if not better.
From 02/11- 2/13, 2021,  I  had low level headache in the afternoon,  On 2/14-15th, I had a noticeable headache  in the same spot I get normal migraines. There was no aurora that I normally get with migraines, the doctor recommended: ibuprofen , Tylenol, or Excedrin.  On 02/18/2021 the headaches basically stopped.
Rash starting on legs, moving to back, torso, neck and face. Low fever. Walking as if intoxicated (falling down, lethargic. Very disoriented. Followed by Extreme pain in legs (unable to stand).  Screaming and crying in what i assume was pain. Lasted around 48 hours.
Patient received wrong dose of Covid-19 vaccine. Patient was supposed to received Pfizer 12+ State Dose (0.3 mL/30 ug), but instead received Pfizer 5-11 State (0.3ml/10 ug). In process of contacting patients guardian to have patient return and administer additional 0.2/20ug to equal intended 30 ug dose.