chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 1/14/05 from the patient regarding an adverse event occurring in the USA, it was reported that the 71 year old female received a fifth dose of RABIES VACCINE on 2/4/04. The lot number, route and site of administration were not reported. Four months later, in June of 2004, the patient started to feel sick, dizzy and weak. She has reportedly felt these symptoms for a year and has not recovered from the events. From additional information received on 3/1/05 from a health care professional, it was reported that there is no more information for this case. From additional information received on 3/3/05 from a health care professional, it was reported that the reporter was neither a vaccine administrator nor a health care provider for this case. The reporter also did not have any more information for this case. From additional information received on 4/1/05 from the patient, it was reported that the fifth dose of RABIES vaccine was administered in the arm. No lot numbers were reported and the patient reported that she was advised that the lot numbers had not been recorded. She stated that she has felt dizzy and has had an unsteady gait and fatigue since receiving the vaccines. On 6/1/04, the patient developed nausea and vomiting. She was hospitalized due to the vomiting from 9/21/04 to 9/24/04 and was treated with Cipro and Flagyl. Following discharge, she continued the Cipro and Flagyl for four days. She reported that numerous tests were done, but the cause of her symptoms was not found. Since being discharged from the hospital, she has been extremely tired, dizzy and has been staggering. She stated that she is unable to do her housework and live like she did before the shots. At the time of this report, she continues to have dizziness and staggers. Based upon the additional information received on 4/1/05 from the patient, this case has been upgraded to serious based upon the patient's hospitalization. This report has not been medically confirmed.
Pt given vaccine in am, reaction started same eve shot given. Ppt came in 8/5/2017. Rph gave oral benadryl caps to take, and also told pt to ice area. Sent pt home with extra benadry caps if needed. Rph told pt to seek medical advice if reaction worsens or diffulcty breathing. Rph to follow up with pt 8/6/2017. Also before shot given, got okay from md to proceed with ZOSTAVAX even though possible reaction cause pt on methotrexate.
Muscle soreness, chills, joint pain for first 24-36 hours.  Joint pain continued for 60 hours.  Residual joint pain in formerly broken toe has continued for 3 days, though has gradually lessened.
Flu vaccine 6-35mo preservative free IM (Quadrivalent) ordered in EPIC software for 9 mo infant. No dose was included in provider order. CMA retrieved FLUARIX QUADRIVALENT from refrigerator and adminsitered 0.5 mls. Error was recognized when she was unable to document dose given on patient chart.
Tired, feverish, stomach issues, pain at site of injection. Started to feel better 24 hours after onset of symptoms.
2nd dose of Moderna Wednesday 4/7.  Severe Migraine-like headache with nausea Thursday evening through current.  Was seen at Urgent Care Saturday 4/10 at 5 pm for headache and nausea.  Urgent care sent him to ER for bloodwork. Sodium levels were at 122.  Admitted to  Hospital Sunday 4/11 for low sodium levels and sever headache. Sodium levels continued to drop to 117 on Monday morning 4/12.
The area was larger, hot; Swelling; Redness; Itchiness in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (The area was larger, hot), SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itchiness in arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Jan-2021, the patient experienced FEELING HOT (The area was larger, hot), SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itchiness in arm). At the time of the report, FEELING HOT (The area was larger, hot), SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itchiness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information includes Cortisone Cream and ice packs  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
My temperature yesterday all day was 101.8 F; I have achy and a horrible headache; I have achy and a horrible headache; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 67-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6205) via an unspecified route of administration, in left arm on 06Mar2021 as dose 1, single (at the age of 67-years-old) for COVID-19 immunization. Patient medical history included liver disorder, autoimmune disorder, blood cholesterol increased all from an unknown date and unknown if ongoing and COVID-19, thyroid. Patient stated he was asked us get vaccine and he has had Covid. The concomitant medications included obeticholic acid taken for liver disorder, pitavastatin calcium (LIVALO) at a dose of 1 mg every alternate day taken for blood cholesterol, pantoprazole 40 mg once a day, levothyroxine at a dose of 100 mcg (100 ug) start and stop date were not reported taken for thyroid. The patient experienced temperature yesterday all day was 101.8 F on 07Mar2021, patient had achy and a horrible headache on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit. Patient had the shot on Saturday (06Mar2021) and her temperature yesterday (07Mar2021) all day was 101.8 F. This was her first shot not the second. Patient took Levothyroxine for her thyroid but she did not have thyroid, 100 mcg. Therapeutic measures were taken for adverse events. Patient had been taking Tylenol 325 mg as a treatment. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
2 days (saturday) after shot the location is red with elevation, no pain, taking tyenol and ibprofen , zrtec and chewable diphenhydramine 12.5 mg in intervals (not all as once) .
This medically confirmed spontaneous report (initial receipt-07-Nov-2014) concerns a 53 year old female patient. The patient did not receive any concomitant vaccine in the same or other arm. She had no known allergies or any significant medical history. On 18-Oct-2014, the patient received intramuscular AFLURIA (batch number: T51708) at 0.5 ml. On 18-Oct-2014, the patient developed soreness in the arm. The patient always received a flu shot annually but had never experienced a persisting local reaction. She was treated with ibuprofen and applied compresses to help with the soreness but these measures had only worked for maximum of 24 hours and then the soreness came back. Outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious.
First a feeling of light headedness; Then jumbled thoughts not understandable but feeling of urgency; feeling disoriented; no exact memory of the thoughts i was having; Arm was sore at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021275475.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 11:30 (Lot number: EN6198) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "First a feeling of light headedness"; THINKING ABNORMAL (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "Then jumbled thoughts not understandable but feeling of urgency"; DISORIENTATION (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "feeling disoriented"; AMNESIA (non-serious) with onset 27Feb2021 10:00, outcome "recovered" (2021), described as "no exact memory of the thoughts i was having"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "Arm was sore at injection site". Therapeutic measures were not taken as a result of dizziness, thinking abnormal, disorientation, amnesia, vaccination site pain.  Additional information: The patient was not pregnant at time of vaccination. Other vaccine same date product was reported as none. Other vaccine in four weeks was reported as no. Other medications in two weeks included Cholesterol Medication. No COVID prior vaccination and no COVID tested post vaccination. It was reported that, first a feeling of light headedness. Then jumbled thoughts not understandable but feeling of urgency. Then feeling vanishes and left feeling disoriented and no exact memory of the thoughts the patient was having. Stated that, first started approximately on 27Feb2021 at 10:00 am. Stated that, this experience happened 2 to 3 times a day and lasted for about 5 days. Stated that, the last incident was on Saturday, 06Mar2021 at about 10 pm. Enquired, so far, no other occurrences but the patient was concerned about getting the 2nd dose. Would this side effect happen again or worsen.  No follow-up attempts are possible. No further information is expected.
nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea and fever. On an unknown date, the outcome of the nausea and fever were unknown.   It was unknown if the reporter considered the nausea and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient no side effects with 1st dose of Shingrix After receiving the 2nd dose of Shingrix the patient experiecced fever over 100 degrees F and nausea.  The call was hung up, could not get all details such as dates. The reporter consented to follow up.
Pt had syncope episode x1 - no treatment necessary other than monitored in office x 30 minutes. F/u pt doing well today. 1-11-11
angioedema; Hashimotos antibodies/ Chronic idiopathic hives/ abnormal thyroid levels; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 31 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 07Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history (none until Oct2022). There were no concomitant medications. Patient had no COVID prior to vaccination. She has not been tested for COVID post-vaccination. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". Vaccination history included: Covid-19 vaccine (primary immunization series and first booster dose completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant) with onset 21Oct2022, outcome "not recovered", described as "Hashimotos antibodies/ Chronic idiopathic hives/ abnormal thyroid levels"; ANGIOEDEMA (medically significant) with onset 27Oct2022, outcome "not recovered". The events "hashimotos antibodies/ chronic idiopathic hives/ abnormal thyroid levels" and "angioedema" required physician office visit. The patient underwent the following laboratory tests and procedures: follow-up tests: (unspecified date) confirmed Hashimotos antibodies; (21Oct2022) abnormal thyroid levels. Therapeutic measures were not taken as a result of autoimmune thyroiditis, angioedema. Clinical course: Chronic idiopathic hives and angioedema starting 27Oct2022 and lasting to present. Annual lab work done on 21Oct2022 showed abnormal thyroid levels. Follow-up tests confirmed Hashimotos antibodies.  No follow-up attempts are possible. No further information is expected.
Flu shot administered at approximately 9:30 AM, Oct 30, 2013. By 8:00PM that evening I couldn't lift my right arm.
Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; Severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache; This is a spontaneous report from a contactable pharmacist (patient). A 34-years -old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot Number: EL9262) (non-pregnant at the time of vaccination) via unspecified route of administered in arm left on 26Jan2021 at 11:00 AM as SINGLE DOSE for COVID-19 immunisation. The patient's medical history included known allergies: sulfa antibiotics. Concomitant medications (list of any other medications the patient received within 2 weeks of vaccination) included sertraline, baclofen, tylenol, pantoprazole. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot Number: EL1284) via unspecified route of administered in arm left on 05Jan2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 26Jan2021, at 12:30 PM the patient had severe nausea and strange taste in mouth, localized muscle pain in left arm, dizziness, headache. It was unknown whether the patient received treatment for the events. The outcome of the events was not recovered/ not resolved.  Follow-up attempts are completed. No further information was expected.
Back pain; Legs pain; Swelling of the lymph nodes through all her body; Extremely exhausted; Headache; Dizzy; Nausea; Felt really sick; Teeth hurts; Face swelling; Fast heartbeat rate; Freaking out; A spontaneous report was received from a consumer concerning a  67 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and patient experienced extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling.  The patient's medical history were not provided. Concomitant medications Tylenol for symptoms were reported.   On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.  On unknown date , prior to receiving mRNA-1273, the patient experienced extremely exhausted, very tired, headache and dizzy, nausea two hours after received vaccine. Patient slept for about 2 hours and then she couldn't open her eyes and had  lymph nodes were swelling every where. The patient  felt really sick. She had arm pain, tenderness not terrific. That night patient tried to sleep but she has an extraordinary pain in her back and legs. Patient could feel her nodes with the hand, teeth hurts, face swelling and fast heartbeat rate. For 3 days she was freaking out.  No Treatment for the events were reported. No Laboratory details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling were considered as unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration from an unspecified date to an unspecified date for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a local site reaction with redness, swelling and warmth on an unspecified date with outcome of not recovered. Therapeutic measures were taken as a result of the event: the patient received BENADRYL, hydrocortisone cream on the local site of reaction, but still getting worse. Follow-up (13Mar2015): Follow-up attempts completed. No further information expected.
muscle weakness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in the legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness in the legs). At the time of the report, MUSCULAR WEAKNESS (muscle weakness in the legs) outcome was unknown. Not Provided
This spontaneous report as received from a female nurse of unknown age refers to herself. Medical history and drug reactions or allergies were not specified. On an unknown date, reported as before her 26th birthday, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not specified. On an unknown date, after the vaccination, the patient had a biopsy of the cervix that was positive for human papilloma virus (HPV). The outcome of biopsy of the cervix that was positive for HPV was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected, because consent for contact was not obtained.
Itching - left hand, injection site, and upper left back. BPs 146/91 (pulse, 86), 140/89 (pulse 76). O2 sats 97%, 96%. Benadryl 25 mg PO given.
1155am Patient immediately felt dizzy after administration of the vaccine. Positioned patient comfortably in a chair. Provided water for hydration. Patient alert and oriented responding to verbal stimuli 1212 O2 sat checked satting @98% on RA HR= 104 1219  Continously checked O2 satting 99% on RA HR= 115 1221 c/o SOB  and pain @ Right shoulder currently on 99%on RA. 911 activated by the lifeguard staff. 1223  HR= 118 and o2 sat 98% on RA 1225 Pt's injection site warm and flushed to touch, with pain scale of 10/10, emergency box opened for BP machine. T= 99.1, o2 sat  97% on RA, HR 111. Patient's husband reported that patient has occassional ""nerve flare. 1230 Paramedics arrived, report given by RN. Vitals checked BP= 203/161, HR= 160 1233 Placed on a gurney by the paramedics and patient sent to the hospital @ 1234 via the ambulance.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 09-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same report. ; Sender's Comments:  US-009507513-2304USA002221: