chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain and shortness of breath. Constricted deep breathing.  Began mid November of 2021, approximately 2 weeks after second vaccine.  Extreme changes in menstrual cycle? delayed period, extremely heavy bleeding, weakness, light headedness, fatigue and painful cramping. Began during full first cycle after the second vaccine. Date of expected period 12/04/2021. Actual start date of delayed period 12/08/2021.
Pediarix dose was 4th dose of hep b/ Interchangeability Pentacel and Pediarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a male patient who received DTPa-HBV-IPV (Pediarix) (batch number 47cx9, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Pentacel for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and Pentacel at an unknown dose and frequency. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 27-Jul-2022 Reporter's Comments: Nurse had a male patient that received Pediarix as a 5th dose after 4 doses of Pentacel.  This Pediarix dose was the patient's 5th dose of dtap and ipv and 4th dose of hep b. The reporter consented to follow up. Additional Supportive Information: The patient was administered with Pediarix vaccine after Pentacel, which led to interchange of vaccine products.
Arm pain; headache; body aches; nausea; vomiting; low grade fever; chills; night sweats; Metallic taste in my mouth immediately after injection.; This is a spontaneous report from a contactable nurse. This 54-year-old female Nurse reported for herself that she received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:15 (Batch/Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation (54 years at the age of vaccination).  Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 150 unk daily taken for an unspecified indication, start and stop date were not reported; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported; estriol (ESTRIOL) taken for an unspecified indication, start and stop date were not reported.  If covid prior vaccination was yes and If covid tested post vaccination was no. The patient experienced Arm pain, headache, body aches, nausea, vomiting, low grade fever, chills , night sweats and Metallic taste in my mouth immediately after injection on 23Aug2021 16:00. The patient underwent lab tests and procedures which included body temperature: low grade fever fahrenheit on 23Aug2021 low grade fever.  Therapeutic measures were taken as a result of all events (Zofran). The outcome of the events was resolving.   Follow-up attempts are completed. No further information is expected.
Patient had a headache and vision changes, went to ER.  They ran tests and found it was "stroke."
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects 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-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491:
Three weeks later my last vaccine 07MAR2023 I began to feel ill with unusual pain everywhere.  My ankles feet legs and everywhere swelled up, I had pains everywhere, all over my body with real bad headasches.  Sometime in April I was unable to walk, in the middle of the night during this time I would wake up at night crying so bad due to the pain all over my body particularly in my hips.  I am still not well and I being tetsed to determine what is wrong with my bgody.  I have seen a kidney, blood, and lung  doctor, blood doctor.  I have had a CT scan.  I am scheduled to have a lung biopsy on 05JUL2023.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 11-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided) per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines for Children (VFC) program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
itchy in the body; body was really hot/ feeling the heat; started breaking out in hives; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy in the body), FEELING HOT (body was really hot/ feeling the heat), URTICARIA (started breaking out in hives) and RASH (rash) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No other vaccine was administered to the patient 1 month prior to Moderna COVID-19 vaccination. The patient had no allergies to medications, food and other products.  The patient's past medical history included COVID-19 in January 2021.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy in the body), FEELING HOT (body was really hot/ feeling the heat), URTICARIA (started breaking out in hives) and RASH (rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy in the body), FEELING HOT (body was really hot/ feeling the heat), URTICARIA (started breaking out in hives) and RASH (rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  The patient experienced the adverse events after 3 days of receiving the first booster dose/third dose of the vaccine.
Feeling very light headed / Light headed 4 hours after 2nd shingles vaccine; This case was reported by a consumer via  interactive digital media and described the occurrence of light headedness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2021, the patient received the 2nd dose of Shingrix. On 3rd May 2021, 4 hrs after receiving Shingrix, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown.   It was unknown if the reporter considered the light headedness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient felt light headed after the Shingrix vaccination. The follow-up would not possible as no contact details were available
Per incident report: received flu shot on 10/25/11. Got red rash-like reaction on both forearms and right front torso. Extreme body aches on 10/26/11. (As a side note: received vaccine in right arm). Reaction was brought to Employee Health attention on 10/27/11. Discussed reaction with EE (employee), who states redness on arms started within 1 hour of receiving vaccine, and spread to right side of torso. Red areas are non-raised or warm to touch. Areas do not itch. Red areas cover both arms and look like large blotches. On 10/26, EE states his whole body ached so bad he could hardly get out of bed. Aches lasted all day, and are better today (10/27) except his back still aches. EE took BENADRYL on 10/27 at 9:30am. Will f/u to see if redness subsides. Incident reported to "VAERS" through CDC. 10/27/11, 1:00pm: EE came to EH office stating BENADRYL did not work. Red blotches continue all over both arms and right side of torso. Mid back area continues to be achy. EE states he got the chills during lunch, and went and had temp. taken by nurse on the floor. Temp. 100.5. EH gave EE 400 mg Ibuprofen. EE also states he has been very thirsty the last 2 days, and has been drinking plenty of fluids. EE states he is going to go home and rest. EE denied need to be seen by Occ. Health at this time. He will update EH in a.m. of his status. 10/28/11: EE states feeling worse today. Reddened patches on both arms and torso are getting larger, and is now spreading to legs, neck and face. Body aches are worse today. States he continues to have fever on and off. Writer noticed EE coughing occasionally yesterday. When questioned, EE stated he had it on and off for about 2 weeks. Noticed today cough is progressively worse. EE agreed to see MD. Occ. Health MD not available. EE's primary MD is Dr. EE will be seen by Dr. at 11:30am. Will f/u after appt. 10/28/11: received RTW form. EE may RTW on 10/31/11 with no limitations. EE was supposed to be on call over the weekend. Coverage has been found. 10/31/11: EE back to work. States feeling better, but achiness has now gone from mid-back area to elbows and shoulders. Redness has diminished dramatically and fever is gone. Per EE, Dr. placed him on 5 days of abx's. Tested for Lyme disease, which per EE, came back positive. He is waiting for MD to call to confirm results. Will f/u with EE tomorrow. Submitted claim. 11/2/2011: EE states MD called, and Lyme Disease results from testing came back negative. Preliminary testing came back positive and it was sent for definitive results. EE plans to contact regarding results, and MD now confirms that EE had reaction to flu vaccine. EE continues to have achy back. He has a f/u with MD on Friday.
18 month old had 2 grand mal seizures 8 days after recieving DTAT, HIB, Prevnar vacination.
Pt recv vax on 11/10/98; on 11/11/98 pt exp rx around vax site
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 29-NOV-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 17-DEC-2015, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with ocular involvement. The patient was prescribed tramadol (ULTRAM) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, herpes zoster/shingles with ocular involvement was determined to be medically significant. Additional information has been requested.
Approximately 3" erythematous and edematous area about 3/4" to 1" medial in length at injection site. Treated with applying ice 24 hours then moist heat X 2 hours and observe.
Shortly after receiving his second dose in Mar/Apr, it spread to the rest of his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jun2021, for COVID-19 immunization, reaction(s): "Vitiligo on his hands". The following information was reported: VITILIGO (non-serious), outcome "not recovered", described as "Shortly after receiving his second dose in Mar/Apr, it spread to the rest of his body". The event "shortly after receiving his second dose in mar/apr, it spread to the rest of his body" required physician office visit. It was unknown if therapeutic measures were taken as a result of vitiligo.  Additional information: Recipient told me that he received the vaccine around Jun and by Dec, he started to experience Vitiligo on his hands. Shortly after receiving his second dose in Mar/Apr, it spread to the rest of his body. It was unknown if other vaccine taken in four weeks. It was unknown if any COVID prior to vaccination. It was unknown if COVID tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190379 Same patient/vaccine, different dose, similar event;
Raised Papular red colored rash . Very mildly itchy . Starters near bilateral arm folds ( not involving armpits) ans then spread to abdomen ,thigh, back ans neck
It was report that a 55 year old female Speech Language Pathologist working at a hospital received her Fluzone SV ;01-'02 injection on Thursday 11/01/01 at 3pm. That evening, she noticed red small dots on her abdomen which spread thru out the evening to her torso (belly, chest, back, neck, both arms, especially the anticubital area of inner arms and groin area). On Friday 11/02/01, the rash looked more like hives. On Saturday, 11/03/01, patient also felt nauseous. She denies raking anything for it. By Sunday 11/04/01, rash, hives were not as bad. Monday 11/0501 there was still a trace but fading to dots again and itchy. On Tuesday11/06/01, skiin was clear, rash gone.
Injection Tuesday, June 2 Wednesday, June 3 redness & feverish where injection was given on right arm Friday, June 5, 3:00 a.m. severe abdominal cramps, body sweats and diarrhea for 3 hours All day Friday I felt achy and diarrhea continued as did cramps.  10 a.m. I had blood in my stool and called my Dr. to talk to a nurse.  She suggested I go to ER to be checked.
Sore arm; tired; itching; This is a spontaneous report from a contactable Nurse(Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1st via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. Medical history included High cholesterol (Verbatim: High cholesterol). Concomitant medications included rosuvastatin, acetylsalicylic acid (ASPIRIN (E.C.)), zinc, alendronate sodium (FOSAMAX), Multivitamins. Patient had first Pfizer vaccine and the only thing had sore arm and got really tired and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching. Patient think she started having difficulty was the morning of 13Feb2021. Patient was not experiencing side effect anymore. Patient did not took any treatment. The outcome of the event was recovered.
DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient had no family or personal history of clots and no provoking factors.  The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 05-APR-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 18-MAY-2021, the patient presented to the emergency department with one week of leg swelling and pain. The patient work up was notable for deep vein thrombosis ultrasound positive for deep venous thrombosis in the left lower extremity in distal femoral and popliteal and PE study showing filling defect in the lobar and interlobar pulmonary arteries extending to segmental and subsegmental pulmonary arteries, right greater than left. On MAY-2021, the subject experienced deep vein thrombosis and pulmonary embolism. The action taken with covid-19 vaccine was not applicable. The outcome of deep vein thrombosis and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: COVID-19 VACCINE deep vein thrombosis, pulmonary embolism. This event(s) is considered unassessable . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Given vaccine on Wednesday 11/9/2005 and developed fever, chills, left arm ache on Thursday. Approx 3" circular area around injection site noted on Friday.
Patient  reported for second dose of Pfizer BioNTech vaccine.  Patient complained of headache during observation approximately 25 minutes after vaccination.  Vitals taken: 10:19am 157/86, HR60 Resp 20 O298, 10:24am 155/98, HR58, Resp 20 O296, 10:29am 159/92 HR59 Resp 20 O2 95, 10:34am 154/90, HR61 Resp 18 O298, 10:39am 163/91 HR 69 Resp 20 O2 97. 10:44 176/100, HR 57 Resp 20 O2 97, 10:49am 174/102 HR65 Resp 20 O2 96, 10:54 am 180/111 HR71 Resp 20 O2 96.  Patient headache increased.  EMS called and arrived at 10:54am.  EMS transported patient.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had the lot # M043731, expiration date 22-JUN-2019, lot # M040412, expiration date 30-JUN-2019, lot # N000326, expiration date 14-OCT-2019, lot # N007931, expiration date 17-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Reported by mom by phone from home at 13:45. Daughter's face and hands swollen. Denies any dyspnea or fever. Advised to take the child to the ER or MD's office. Pt was taken to the clinic. Swelling resolved by 15:00.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported. On 31-OCT-2014, the patient was vaccinated with first dose of ZOSTAVAX vial 19400 PFU (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, second dose of ZOSTAVAX was inadvertently administered. No adverse effects reported. Product quality complaint was not reported. No additional information to report. Additional information has been requested.
The HCW noted w/i 1 hr of vaccination a constellation of symptoms including dizziness, disorientation, and fatigue; and by 4 hrs she developed swelling LUE with pain and some swelling extending to the L neck.  Over the next several days she reported marked swelling and tenderness over the triceps upper arm area; persistent swelling and pain in the neck that required cold packs for a couple days.  The reaction appeared to be more pronounced and extensive akin to the Humira local reaction she would ordinarily get; the last dose of that was 4 months prior.  By history, it sounds like extensive angioedema.  At no point was there any pruritus, erythema, or hive or rash on any other part of the body; no respiratory compromise, stridor or wheeze; and no fever.  Symptoms subsided over several days and she was well on day of her presenting for her second vaccination.  The vaccinator (who is a pediatrician), an on-call allergist; and this reporter (a medical oncologist) all consulted on best approach.  The allergist recommends skin testing; Humira may have a polysorbate component; and we collectively thought a contraindication to proceeding.  Given the deliberation the HCW actually elected also not to proceed.  We informed her that early data suggests one dose of the Moderna vaccine may confer an approximate 80% protection.  She will present to EHS for further evaluation.
"Tingling" of the head. HR fluctuating 29-80. O2 99%. Placed on 10 L Oxygen. Blanket placed on pt, c/o feeling cold (Temp 97.1F). At 10:30a HR down to 30, 911 called and pt sent to ER.