chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; Arm soreness from COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Arm soreness from COVID-19 vaccine). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and PAIN IN EXTREMITY (Arm soreness from COVID-19 vaccine) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  company comment  This spontaneous case reported by a consumer, concerns a 62 year old  female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 62 year old  female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Started as pain at the injection site then a red, bulgy rash appeared around, measuring about 3inch in diameter. Rash went away after 4-5 days.
Severe pain at injection site starting 24 hrs after vaccine administration and last approx 12-18 hrs. Redness, swelling.
1st 24 hours-very sore arm-still persists especially stiffness instable.  2nd or 3rd day-trouble swallowing pills, not food, has persisted within 7-10 days noted shakiness of arm when trying to use arm to fix hair-this has resolved.
pt received a COVID vaccine of moderna and within 15 minutes pt c/o throat feellng itchy and tight down low. Also, c/o of tingling in fingers and toes. Pt noticeably shaking. Pt has a hx of fainting with needles. Pt become more anxious and requested and ambulance to be called.  Color was flushed. B/P 169/99 P146 SPO2 99%. For pts comfort gave O2 at 2L/min via NC. Pt remained alert and oriented and talking. EMT administered Benadryl 50mg IM.  Ambulance escorted pt to ER where only observation was done. F/U with pt about 2 hours later. Pt states she believes she panicked and was doing fine right now. No other issues.
Right arm red, swollen about the size of two quarters.  Treat with cold compress and Tylenol for pain.
No adverse effects were reported; HCP called to report a TE with PNEUMOVAX 23 PFS.; This spontaneous report was received from a consumer and refers to a 68-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, expiration date: 25-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger recorded a 46.7F temp on 03-MAR-2023, and did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours. No additional adverse event was reported.  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002667: US-009507513-2304USA002750: US-009507513-2304USA002694: US-009507513-2304USA002746:
Covid Arm- one week after shot got big red spot on same arm as shot was administered. Did not itch, warm to touch, also hard knot. About a 3 x 3 spot. Lasted two days.
18-month-old child received line nasal H1N1. Mother reported that there was no wheezing or other adverse reactions after vaccinating.
Fatigue, pain at injection sight, left cervical and axillary lymphadenopathy, muscle aches
about 2 weeks after receiving 2nd dose of Pfizer COVID vaccine, started noticing memory loss, dropping things, sleeping pattern is off, mood swings, headaches, cough for about last 3 weeks (mid-july), can't get anything done.  Received 2 doses of Pfizer COVID vaccine:  4/6/2021 lot #EN6206, 4/27/2021 lot #EW0170  Advised to contact Med clinic (phone number given) for check-up; patient stated he does not have a doctor.  Also advised to call 911 or go to ER if trouble breathing, or other life threatening issues.
Site: Pain at Injection Site-Medium, Additional Details: Patient's spouse called the pharmacy on 1/28/2023 and said that he and his wife had been experiencing pain in their arm since their vaccinations. He stated that the pain comes and goes. Neither one of them has seen a Dr. about this yet. They would like someone to reach out to them about this.
No adverse event; administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered after the 30 day beyond use date).    No concomitant drug were reported.   It was reported that HCP was transferred to excursions line to discussed HCP mentioned that 5 patients were administered the vaccine after the 30-day beyond use date. It is the same lot number as the previous case however the date of thaw and administration are different.    5 patients were administered the vaccine after 30-day BUD. vial was opened individual vials  Vial size was reported as 2.5ml  On 20-Sep-2022, the vial was initially stored in the refrigerator.   The vial did not undergo any temperature excursion.   Vaccines administered were first boosters for some and second booster for other patients.
I experienced sleeplessness for two days following the shot.   As a side note, I have difficulties sleeping in general.  Secondly, my left arm is still sore 16 days after the shot.
hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
Employee was vaccinated on 9/22/2022 with vaccine that had been left over from a vaccination clinic on 9/20/2022.  The vaccine should have been discarded at the end of the day on 9/20/2022 but was not.
Patient was supposed to receive Meningococcal B but Meningococcal A was given by mistake. The patient did not develop any adverse effects from the incorrect vaccine given and was notified of the mistake so he could receive the correct vaccine.
Approx 12 hours after injection I became very ill. Chills, fever, severe muscle aches, severe nausea - it was a sleepless night and I was very sick. This lasted approx 10 hours although nausea persisted for several hours longer. It left me very weak for a couple of days.
Hives all over the body; Itching; Red; Rash; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red), RASH (Rash) and CHILLS (Chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Ovarian cyst, Hymenectomy and Wisdom teeth removal. Concurrent medical conditions included Drug allergy (Codeine phosphate allergy).   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red), RASH (Rash), CHILLS (Chills) and NAUSEA (Nausea). On 26-Feb-2021, URTICARIA (Hives all over the body), PRURITUS (Itching), ERYTHEMA (Red) and RASH (Rash) had resolved and CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement (120-80 mmHg): 124/70 mmHg (Inconclusive) Inconclusive. On 26-Feb-2021, Body temperature: inconclusive (Inconclusive) 97.8 degree Fahrenheit. On 26-Feb-2021, Heart rate: inconclusive (Inconclusive) 74 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  Treatment details included triamcinolone acetonide ointment 0.5% and diphenhydramine 50mg.  General examination included no acute distress and clear auscultation bilaterally.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-101914 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021,new events added and event outcome updated.
Patient began running fever about 4am on Friday.  At about 3 pm on Friday she developed a rash that looked like "the three day measles" from head to the soles of the feet.  She was currently on a course of Prednisone 20 mg treating poison ivy.  She also noted bruising at the injection site.  She saw her physician on Monday, Feb 1 and was prescribed hydroxyzine in addition to continuing her prednisone taper.
About 5 patients miss the 2nd dose due to COVID-19 pandemic; This non-serious case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date 1st dose of Shingrix received.).   On an unknown date, the patients did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: About 5 patients miss the 2nd dose due to COVID-19 pandemic). The outcome of the social problem was unknown.   Additional Information: GSK Receipt date 14-APR-2023 The pharmacy technician stated that the pharmacy had several patients received there first dose of Shingrix and then miss the 2 to 6 month dosing window for the second dose, due to COVID-19 pandemic. At the time of reporting the reporter known about 5 patients that they know of so far. The reporter did not had any of the patient dosing information. The reporter did consent to follow up via fax, phone or mail.; Sender's Comments:  US-GSK-US2023055332:Same reporter.
fever: 101 degrees: started as 99 degrees went up as day went on, nausea: occurred at the thought of eating, dizziness: when I stood up throughout day, general body soreness/tiredness: all day
This spontaneous report as received from a vaccine coordinator refers to an 8-year-old female patient. The patient's medical history was not reported. On 23-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021315, expiration date 07-AUG-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178.
This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014-2015 season (batch number FS575, expiry date 30th June 2014). On 23rd October 2014 the patient received FLUARIX Quadrivalent 2014-2015 season .5 ml. On 23rd October 2014, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional information: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 23 October 2014.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 48-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported) which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805475 was crossed linked to original cases 201804863 due to same reporter.
Headache, nausea, fever, dizziness, congestion, sore throat, diarrhea.
This spontaneous report was received from a registered pharmacist concerning an adult patient of unknown age and gender. On an unknown date, approximately in May 2012 (approximately 6 months ago), the patient was vaccinated with a first dose of (Merck) VARIVAX (dose, route and lot number unspecified) from an unspecified provider. No concomitant medications were reported. On 20-NOV-2012 (reported as now), the patient was in the pharmacy to receive the second dose of (Merck) VARIVAX (dose, route and lot number unspecified) which was late. Additional information is not expected.
Tiny tenderness on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tiny tenderness on left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tiny tenderness on left arm). On 10-Feb-2021, VACCINATION SITE PAIN (Tiny tenderness on left arm) had 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.   No concomitant medication was reported  No treatment medication was reported  It was reported in the first follow up that the customer's symptoms resolved and requested no further follow-up   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: No specific follow-up information recorded.; Sender's Comments:
R/arm swollen (from shoulder to finger tips), small amt on 1/11/00, increased significantly on 1/12/00. Went to Med Ctr; red, hot to touch. Grandmother was told to give Tylenol  cold compresses. Also, had rash around vax site.
Patient received second dose of Moderna, shortly afterwards in observation she started reporting tingling in her face, no other symptoms. Stated this happened with her first dose and symptoms abated with a single dose of Benadryl.  Benadryl 25 mg. p.o. administered at 0845, BP 128/76 HR 66, pulse ox 97%.  Kept the patient in observation for 30 minutes after which time she reported a decrease in the face tingling and felt fine.
Migrane: Started next day around 2pm. Took extra strength Tylenol and slept.  Sore arm: started later the same day as vaccination.  Slight nausea: took promethazine as needed for nausea.   Sweaty: tried to keep cool with air conditioning and fans.
Pneumonia vacc, Tdap on 8-16-11. (R) arm injection site was swollen & red. Fever of 102 degrees F Tx'd at health clinic. Was given an injection of antibx.
A father reported that his son received his 1st dose of Prevnar and subsequently, developed a "high" fever. No further information was available at the date of this report.
Tested positive for Covid-19 on 26Dec2021.; Tested positive for Covid-19 on 26Dec2021.; Currently 37 weeks pregnant and fully vaccinated.; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 22Oct2021 (Lot number: Fh8020) as dose 2, single and intramuscular, administration date 01Oct2021 (Lot number: Ff8839) as dose 1, single for covid-19 immunisation. Date of last menstrual period: 07Apr2021. The patient was 28 weeks pregnant at the time of exposure to bnt162b2. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Jan2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (other vaccine 4weeks product=Flu vaccine). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 26Dec2021, outcome "not recovered" and all described as "Tested positive for Covid-19 on 26Dec2021."; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Currently 37 weeks pregnant and fully vaccinated.". The patient underwent the following laboratory tests and procedures: covid-19: (24Dec2021) negative, notes: Nasal Swab; sars-cov-2 test: (24Dec2021) positive; (26Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, vaccination failure, maternal exposure during pregnancy.  Additional information: The patient did not took other medications in two weeks. The patient did not have Covid prior vaccination. The patient tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
I was diagnosed with Telogen Effluvium hair loss. My dermatologist indicated that the triggering event to my episode likely occurred 3-6 months prior to it's onset. I have had no other changes in medications, lifestyle, hormones, stress, or surgeries in that time-frame. After I received the Covid vaccine I had fever, chills, headache, and fatigue for a few days. I spoke to a pharmacist who said it is possible that my reaction to the Moderna vaccine caused the Telogen Effluvium. I have now experienced extreme hair fall for four or five months. I have lost about 50% of my hair, and the hair loss continues.
4-6 weeks post vaccination, pt developed alopecia areata.  Diagnosed by family MD, confirmed by Dermatologist.