chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second shot 05/30 I have had severe joint pains. Hands wrists ankles knees; This is a spontaneous report from a contactable other hcp (patient). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration on 27Apr2021 as, dose 1, single for covid-19 immunisation. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration on 30May2021 as dose 2, single for covid-19 immunisation. Medical history included overweight, depression, migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergy of morphine, melon and experienced hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31May2021, the patient experienced severe joint pains. hands wrists ankles knees. The patient did not receive any treatment for the events. The outcome of the event was not recovered.  Information about the Lot/batch number has been requested.
patient had the flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to case 2020SA291942 (same reporter).  This case involves female patient (age unspecified) who had the flu (influenza), while she received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing diabetic.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu (influenza) (non-serious) within 5 days following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
After second  dose of Pfizer Covid Vaccine 2 days following lymph nodes under right armpit are swollen
Localized 4.5cm x 3.5cm area of induration and erythema. No systemic reation.
Patient received one dose of Fluzone HD at approximately 12:30pm on 9/26/22. Patient called on 9/27/22 at approximately 2:45 pm to report the side effects,  including fever, extreme chilling, nausea that she states began in the evening and lasted throughout the night. Pharmacist recommended that she seek care from a physician, but the patient stated that her symptoms have now resolved.
Fever, chills, headache and rash covering entire body. Lasted 2-3 days.
Headache, Myalgia, Arthralgia, Fatigue and sore throat
This spontaneous report as received from a nurse refers to an unspecified patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR II (dose, route, lot number and expiration date not provided). On an unknown date, the patient had "severe reaction". The reporter stated that she did not had any details for the patient or the reaction except for "the patient was hospitalized for a week" at an unspecified hospital. At the time of the report, outcome of "severe reaction" was Recovered/Resolved (on an unknown date). Additional information is not expected.
Arm that had injection was sore; This is a spontaneous report from a contactable consumer. A 17-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on 23Jun2021 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had  not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jun2021, the patient's arm that had injection was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event arm that had injection was sore was recovered on unknown date in Jun2021.
Symptoms for the last 11 days:  Body aches, cough, fever - it breaks, then repeats several times a day,  very tired & lethargic, can't be up more than 30 minutes at a time.
Large localized reaction developed within 24 hours with pain, erythema, induration, gradually getting worse over the next 48 hrs to included numbness and tingling in arm that was injected with Tdap. OTC Ibuprofen and cold compresses to injection site recommended.
Pt states that approx 4 hours after the injection she had her glands in her neck start swelling and her throat became very itchy. She took 2 benadryl and it started to get better after about 20 minutes.
Local reaction, rash over bilateral tensor surface of thighs surrounding injection site. Medication prescribed by physician for reaction.
experiencing sore throat; congestion; metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (experiencing sore throat), NASAL CONGESTION (congestion) and DYSGEUSIA (metallic taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, INSULIN and METFORMIN for an unknown indication.    On 22-Dec-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 OROPHARYNGEAL PAIN (experiencing sore throat), NASAL CONGESTION (congestion) and DYSGEUSIA (metallic taste). At the time of the report, OROPHARYNGEAL PAIN (experiencing sore throat), NASAL CONGESTION (congestion) and DYSGEUSIA (metallic taste) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication Includes:Homeopathic Medicine  Concomitant  medication:Iodine IV Contrast for CT Scan  Anatomical location;left arm non dominant
pt recv vax;lab eval showed elev RA factor,f/u indicated pt's blood was drawn for the rheumatoid factor 2 days prior to vax&was revealed to be 956;
Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Patient complaining of intermittent sharp mid to low back pain since last night.  Pain occurs when getting up from laying down position and forceful exertion.
five minutes after 13 year old patient's first dose of Pfizer COVID shot, I was alerted that pt reported that her vision was "going black." when I arrived at our designated waiting area, she was sitting down with her father. parent stated that pt has never had any type of reaction to a vaccine previously, but stated that she had severe anxiety about this vaccine. pt was moved to the floor and raised her legs onto the chair. parent declined my offer to call 911 or rescue squad. her pulse was normal. parent and patient waited a total of 30 minutes before leaving the store. pt felt back to normal before leaving the store.
RASH AND FACIAL SWELLING WITHIN 24 HOURS OF VACCINE ADMINISTRATION
fever of 99 degrees; rash at her injection site; nowthe rash is occurring all over her body (feet, lower legs, and arms) the size of dime and nickel.; This spontaneous report was received from a 65 year old female patient, who was reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot # S036495, expiration date 13-SEP-2021 (strength, dose and route of administration), as preventative vaccine. On 01-JUL-2020, the patient experienced fever of 99 degrees and a rash at her injection site. On an unknown date in 2020, the rash expanded and at the time of the report was occurring all over her body (feet, lower legs and arms) the size of dime and nickel. The patient's rash was treated with clobetasol propionate cream. She had tried contacting her doctor but the office administrator said that they do not had the information of her getting the vaccine administered and when she requested the visit summary the caller said that there was also inaccurate information. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient fainted within 2 minutes of VARIVAX vaccine being given. She then appeared to have seizure activity. She shook for 1-2 minutes. Very pale and appeared to have a green hue to skin. O2 sat 92% Pulse 40. Pt sweating profusely. Transferred to hosp ER.
Pt developed allergic rxn (tightening of throat) d/t Tdap.
5ml syringes that had been provided by Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.3ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Tested Positive for COVID-19; Sick with COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick with COVID-19 symptoms) and SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (Sick with COVID-19 symptoms). On 22-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19). On 22-Mar-2021, SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) had resolved. On 01-Apr-2021, ILLNESS (Sick with COVID-19 symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: Negative. On 22-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    This case was linked to MOD-2021-090442 (Patient Link).
Information regarding PREVNAR 13 was received from a physician regarding a 6-month-old female patient who experienced swelling at injection site, fever and redness at injection site. At 6 months of age, the patient received a dose on 03-Jul-2010. The patient also received a dose of DAPTACEL (Aventis-Pasteur), a dose of ROTATEQ (Merck & Co Inc) and a dose of HIB (manufacturer unknown) on 03-Jul-2010. The patient experienced swelling at injection site, fever and redness at injection site in Jul-2010. Outcomes for events are unknown. No additional information was available at the time of this report.
Information has been received from a pediatric medical record and a physician concerning a 10 week old female who on 28-APR-2008 was vaccinated with a dose of ROTATEQ. Concomitant suspect vaccinations included a first dose of PREVANAR. Other concomitant vaccinations included Pertussis vaccine (unspecified), HIB conj vaccine (unspecified carrier), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (manufacturer unknown), and poliovirus vaccine. On 13-MAY-2008 the patient's cytomegalovirus antibody. IgG was positive. On 25-JUN-2008 the patient was seen at the office for her four month visit. At that time the patient was vaccinated with DTap, poliovirus vaccine, PREVNAR and HIB (unspecified carrier). On 27-AUG-2008 the patient was seen at the office for her 6 month visit. The patient was vaccinated with PREVNAR, (unspecified) and hepatitis B virus vaccine (unspecified) (manufacturer unknown). Laboratory diagnostics were performed and the results can be found in the laboratory section. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
For the SECOND SHOT: Extreme soreness at vaccination site for 3 days: fully resolved in 6 days. Substantial shivering and chills at night for the first night; less the next night. Strange dreams the first two nights. Flu-like symptoms - light fever, nausea, overall body aches, stomach upset for first two days. Cold sores on lip for 7 days, beginning 3 days after vaccination. Off from work 2 days; full recovery in five days. NOTE: The first vaccine shot had only modest effects, mostly soreness.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unspecified date in July 2015, the patient was vaccinated with PNEUMOVAX23, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 21-APR-2017, the patient was vaccinated with a second dose of PNEUMOVAX23 lot # M027552 dose 2 for prophylaxis (dose and route of administration) (inappropriate schedule of drug administration). The pharmacist was informed about the patient's first dose vaccine administered, until 21-APR-2017. No adverse effect reported. No additional information was provided. Additional information has been requested.
Patient presented to pharmacy with redness, swelling, warmth, and tenderness at injection site.
Got woken up by intense leg pain around 6:00am the day following vaccination. I took 1000mg methocarbamol, 400mg ibuprofen (split between 2 pills each containing 500mg methocarbamol and 200mg ibuprofen), and 1000mg acetaminophen before a hot bath which relieved pain enough to get back to sleep around 7am. I woke up again around 11am with similar extreme pain, took another set of  1000mg methocarbamol, 400mg ibuprofen , and 1000mg acetaminophen along with 5mg of hydrocodone left over from recent dental work. Pain subsided  until approximately 4:00pm when legs started to hurt again before getting to severe levels around 5pm (and so did the back of my neck which was the first neck pain experienced) so I took another set of 1000mg methocarbamol, 400mg ibuprofen , and 1000mg acetaminophen along with 5mg of hydrocodone  (which has helped ease discomfort again).   Leg pain is not sharp but very persistent and painful and is located behind both knees.  Neck pain was sharp and located directly at the back. I have had no arm pain or injection site swelling or pain, just leg pain and neck.   I did not experience any side-effects after my first dose, not even injection site pain.
This year, I have had heavily irregular menstrual periods requiring endometrial biopsy and Rx medicines. As I read that cases of menstrual irregularity have been reported related to covid vaccine, which I did receive this year, I wish to report as well in case there is a correlation.
Arexvy was administered to a pregnant patient 36 weeks and 2 days gestation; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a pregnant patient 36 weeks and 2 days gestation). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 30-OCT-2023 The reporter stated that, the Arexvy vaccine was administered by an NP (nurse practitioner) to a pregnant patient at 36 weeks and 2 days gestation, which led to vaccine exposure during pregnancy. The patient had not reported any ADE's (adverse events) since that time. The reporter did not agree to follow up from GSK.
Herpes Zoster diagnosis in one-dose varicella vaccine recipient. Symptoms include: unilateral painful rash, itchy. Treatment given: acyclovir
Vaccination given at 11:11 a.m. on 01/04/21.  The first dose of Moderna was given.  Within 2 hours my arm was stiff, hurting and very sore to the touch at the injection site.  This lasted approximately 4 days, each day having less soreness.  On 1-10-21 while in the shower I found that in the bottom of my arm pit area was very sore and tender to the touch.  I have taken no other medicine for the pain or discomfort.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a 15-month-old female subsequent to FLUMIST. The patient received FLUMIST on 23-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received 31-Mar-2009: added product complaint investigation results.
retinal detachment with single break of the left; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On or around 25-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  In approximately June 2017 (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered blurry vision in the left eye and was diagnosed with retinal detachment with single break of the left eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. The outcome of the event was not reported.  The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event retinal detachment with single break of the left eye was determined to be medically significant.  Additional information has been requested.
2nd dose after 4 years of 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1 st dose received more than a 4 year ago).   In DEC-2022, the patient received the 2nd dose of Shingrix. In DEC-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose after 4 years of 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 02-MAR-2023 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Redness, tender and warm to touch at injection site, redness streaking down to inner side of right arm. Noticed redness and tenderness on day 2. Day 3 has slightly more redness surrounding injection site, 2 inch in diameter circular redness, and increased redness down arm. On day 3, the red streak is approximately 1 inch in width and 3 inches in length.
Pt recvd 3 doses of Engerix-B vax & 9DEC91 found to be a non-seroconverter;
2 mo old child received first immunization 19MAR90. on 20MAR, mother reported childs temp to be 105. On exam child was fussy, but not toxic. PE was normal. Temp in office after antipyretics was 99.