chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nerve Pain; Dart like pain/ pain throughout body; Pain in leg and arm; pain in breast; pain in scalp; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax on an unknown date, prior to Shingrix) and Shingrix (received 1st dose on an unknown date).   On 20th June 2018, the patient received Shingrix (intramuscular) .5 ml. On 20th June 2018, less than a day after receiving Shingrix, the patient experienced nerve pain, prick pain feeling, pain in extremity, breast pain and scalp pain. On an unknown date, the outcome of the nerve pain, prick pain feeling, pain in extremity, breast pain and scalp pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, prick pain feeling, pain in extremity, breast pain and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she did fine with her first dose but has had a reaction to the 2nd dose of Shingrix. She received the injection in her left deltoid.  The patient reported that she experienced sharp dart-like pains throughout her body.  It was mostly in her legs but had occurred in arms, breast and scalp as well. The patient continued to experience these pains presently. She also stated that she had had the Zostivax shot prior to the Shingrix being released and did not have any reaction to that.  The patient had given permission to contact her physician. There was consent to follow up. There was a discrepancy in outcome of the events. The outcome of events were taken as per narrative.
States that a day after the injection started to have left shoulder pain around the  injection site  and especially when lifting arm overhead. Pain has been ongoing for almost a month without changes
Persistent, uncontrollable itching all over. Not relieved by BENADRYL. Stated 20 min after and has been continued for 1 wk.
Body aches, fatigue, headache, dry cough, chest tightness, sore throat.
Upper left arm and shoulder pain sufficient to limit mobility of the arm and prevent sleep. Treated with 650 mg acetaminophen once, and later with 75/325 mg hydrocodone/acetaminophen once. Pain and stiffness ongoing at this report (10:30 am 12/29/2018), but enough less to get by without medication. I consider this clinically significant because I am the sole caregiver for a bed-bound person, and the event is hampering my duties.
Patient received J&J vaccine at a college  03/31/2021. 12-16 hours after vaccination patient developed dizziness with 1 syncopal episode. Patient also experiencing moderate to severe headache, chills, fatigue and pleuritic pain. Patient described BLL pleural pain on inspiration. patient said breathing unrelieved with APAP/IBU or albuterol inhaler. at time of examination, patient had ill appearance but was not in any acute/emergent distress.
Split family - biological mother brought child to local medical clinic - FLUMIST given 10/27/11. Biological father signed school flu consent form FLUMIST administered at school on 10/27/11. Both parents contacted. No adverse side effects from receiving 2 doses. Error found when trying to enter data into state immun registry.
The pt presented on 12/15/01 with a temperature of 103F (rectal). No source of temperature. Dx'd with viral illness vs reaction to immunizations.
Information has been received from a pharmacist concerning a female in her 20's with no pertinent medical history and no drug reactions/allergeis who on 06-MAR-2010 was vaccinated with a dose of VARIVAX (Merck). On 06-MAR-2010, within hours of vaccination the patient developed a stiff neck. Later she developed a fever, malaise, chills, achiness and redness the size of a palm at the injection site. The patient also developed 3 bumps on her right arm and shoulder. Bumps are not fluid filled. The patient talked to pharmacist and would call physician today. At the time of report the patient's status was not recovered. Additional information has been requested.
Dizziness, Headache, Myalgia, "foggy", "tremors", fatigue Narrative:
a small lump on at injection site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00580956).  This case involves a 45-year-old male patient who had a small lump on at injection site (vaccination site mass) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In August 2020 (date not reported), the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AA and expiry date: 30-Jun-2021) via an intramuscular route in the arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious a small lump on at injection site (vaccination site mass) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient recently presented to pharmacy with a small lump on his right upper arm. He stated that this bump developed at the FLUZONE injection site and has not gone away for 8 months. When providing template information, pharmacist stated that their documentation indicates that patient received vaccine in his left arm. Pharmacist states that he may have switched arms after the information was keyed into the computer. Pharmacist reported that bump was about as small as "the circle part" of a ball-point pen- definitely smaller than a dime. It was hard and painless and feels like scar tissue.  The details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the patient had not recovered from the event.
This report describes the occurrence of Lyme disease in an adult male of unspecified age who was vaccinated with Lyme disease vaccine recombinant. This report was received from the subject and has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Reportedly, the subject received his third injection of LYMErix in May 2000. He stated, "Shortly thereafter, I contracted full-blown Lyme and I have been dealing with symptoms of chronic Lyme ever since." He has reportedly been treated with tetracycline 1500mg daily. The subject stated that "regular cluster headaches persist." The subject reported that he was unable to work "as the result of these problems." Therefore, the events are considered persistently incapacitating.
pain in arm; headache; received 1st and 2nd dose of Pfizer; her back was bent over; had to hold on to a furniture to walk; could not stand up straight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (could not stand up straight), PAIN IN EXTREMITY (pain in arm), CAMPTOCORMIA (her back was bent over), GAIT DISTURBANCE (had to hold on to a furniture to walk) and HEADACHE (headache) in a 64-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.     The patient's past medical history included Chemotherapy (has a rare health problem since she had chemo 21 years ago when tamoxifen damaged her neurologic system.). Previously administered products included for COVID-19 vaccination: Pfizer (1st dose) in May 2021 and Pfizer (2nd dose) in June 2021; for Product used for unknown indication: TAMOXIFEN (damaged her neurologic system). Past adverse reactions to the above products included Adverse event with Pfizer and Pfizer; and Neurological disorder NOS with TAMOXIFEN. Concurrent medical conditions included Dysautonomia and Orthostatic hypertension. Concomitant products included GLUCOSAMINE, VITAMINS NOS, CLONIDINE and LISINOPRIL for an unknown indication.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced DYSSTASIA (could not stand up straight), CAMPTOCORMIA (her back was bent over) and GAIT DISTURBANCE (had to hold on to a furniture to walk). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st and 2nd dose of Pfizer). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSSTASIA (could not stand up straight), PAIN IN EXTREMITY (pain in arm), CAMPTOCORMIA (her back was bent over), GAIT DISTURBANCE (had to hold on to a furniture to walk) and HEADACHE (headache) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st and 2nd dose of Pfizer) had resolved.            Other concomitant medication included  Sleep aid.  Moderna booster was given on her left arm and her symptoms were similar to that of Pfizer vaccine including pain in arm and headache. Further the consumer mentioned that she took Tylenol and Ibuprofen as guided by a nurse.
Headache, Myalgia, Arthralgia, Fever, fatigue, injection site pain Narrative:
30 minutes after receiving the COVID 19 vaccine, the patient experienced an allergic reaction with facial and tongue swelling and difficulty swallowing.  A rapid response was called and the patient was taken to the emergency department where she had an IV placed and received IV famotidine, IV diphenhydramine, IV methylprednisone, a NS bolus, and epinephrine. Patient was then monitored in the ED. Patient has plans to discharge from the ED to home. COVID vaccine was placed as an allergy in the patient chart.
diagnosed with COVID with a 101F fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received the first dose of Pfizer's COVID vaccine on 15Mar2021 with no problems. On 24Mar2021, she was diagnosed with COVID with a 101 Fahrenheit fever. She had an appointment on 06Apr2021 for the second dose, but would have to quarantine until 08Apr2021. She was asking when she could have the second dose. The patient stated her daughter was 19 years old and had allergic reactions to Zithromax, Augmentin, and amoxicillin and was asking if it was safe for her to receive Pfizer's COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
After HPV vaccine given, pt. walked toward the waiting room and began to stagger and sway. Clinic RN stabilized her against the hallway wall as patient lost control of her bladder. Though patient did not appear to lose consciousness, she did not immediately respond to verbal commands.
redness at the injection site, tenderness, and right axillary lymphadenopathy, progressing since 2 hrs after injection
no adverse event; Dose of expired Bivalent was administered on today (19Dec2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of expired Bivalent was administered on today (19Dec2022)) and NO ADVERSE EVENT (no adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-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 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of expired Bivalent was administered on today (19Dec2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of expired Bivalent was administered on today (19Dec2022)) 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 (Dose of expired Bivalent was administered on today (19Dec2022)).    Concomitant medications were not reported.   Treatment medications were not reported.
DIED IN SLEEP; This spontaneous report received from a consumer via social media concerned a 42-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) with unknown dose, on unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up required for this case. No concomitant medications were reported. On 04-APR-2021, the patient died in his sleep and the cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This case was linked to 20210428967 (same reporter) This report was serious (Death).; Sender's Comments: V0:20210429895-COVID-19 VACCINE AD26.COV2.S- Died in sleep. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient had a low grade fever, arm and general soreness and chills. He said he has had this for the days after shot. He is feeling better as of 12/1/17 7pm and he barely has a fever.
pt exp a febrile sz w/a T101-103, fine clonic movement, cyanosis perioral area, no focality;it was confirmed that cyanosis was considered part of the sz;duration of the sz was 5min; tx motrin & lukewarm bath
fever over 100 degrees (duration: 2 days) fever under 100 degrees (duration: 2 days) severe headache (duration: 4 days) body aches (duration: 2 days) chills (duration: 4 days) back pain (duration: 2 days) sinus congestion (duration: one week +) sinus pressure (duration: one week +) cough (duration: one week +) COVID arm (duration: one week +)
Woke up 1/7/21 at 4:00 am with a temp of 102.0, Nausea, body aches, chills, arm pain, joint pain, extreme thirst and fatigue. Tylenol taken temp continued to be 102 and increased to 102.4.  All symptoms lasted until until 1/8/21 5am woke up sweating temp down to 99.8, arm pain, fatigue. 1/9/21 all symptoms resolved.
fainting; Severe vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant) and VERTIGO (Severe vertigo). At the time of the report, SYNCOPE (fainting) and VERTIGO (Severe vertigo) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. Lab details were not provided. Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pulmonary Embolism requiring hospitalization, Heparin Drip for 2 days in hospital followed by Eloquis 5mg twice daily indefinitely, Survived
My period completely changed. I got it at the end of the month for 3 days (3/24/21-3/23/21), then again got my period at the beginning of April for 2 weeks (4/4/21 - 4/17/21).
Fever with chills at 12 hours after shot was given, severe nausea, dizziness, headache. Acting drunk from fever. Treated with ibuprofen and zofran (zofran is prescription as needed). Fever broke four hours later during the middle of the night, and all other symptoms dissipated while sleeping.
Lips swelling and tingling, pale, malaise, rapid heartbeat. No local reaction. PC Plardev Rx with Steroids, Zyrtec.
Headache, Myalgia, Fever, R axillary lymph node swelling, fatigue Narrative:  T 100, decreased to normal range with acetaminophen, r axillary lymph node swelling, headache fatigue, myalgia.
RN reported a improperly stored PROQUAD administration; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.  On 07-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S035105 which has been verified to be valid, expiration date reported and validated as 03-MAY-2021, therapy type: rHA) for prophylaxis (formulation, strength, dose and route of administration were not reported). The vaccine administered was improperly stored at a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.8 degrees Fahrenheit) for a time frame of 31 hours, as recorded by a data logger. There was no previous temperature excursion reported.
The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date; No adverse event; Patient received dose from the same lot number #015h22a administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In 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. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from the same lot number #015h22a administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from the same lot number #015h22a administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose from the same lot number #015h22a administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 01-Nov-2022 and was administered after 30 day use by date).    No concomitant medications were reported.  It was reported patient vaccinated receive any other vaccinations 4 weeks prior to the COVID-19 vaccine as unknown.  The vial did not undergo any temperature excursions.  The vial size reported as 2.5 milliliter.  No treatment medications were reported.   This case was linked to MOD-2022-692559 (E2B Linked Report).; Sender's Comments:  MOD-2022-692559:master case
A report has been received from a health professional concerning a 5 year old, male patient. No medical history, concomitant diseases and concomitant medications were reported for consumer. Patient was administered FLUMIST QUADRIVALENT (intranasal) unknown date for unknown indication. It was reported that after administration of FLUMIST in the left nostril, the patient had developed a nose bleed. The mother declined the second spray in the right nostril. The outcome of the event of nose bleed was unknown. The report was considered to be non-serious by reporter.
pt received flu vaccination and fell around 5 minutes after recieving injection. She fell to the floor on her bottom and stumbled back into the waiting room before being able to sit down. She stated she was lightheaded and had blur vision a little bit after the injection. She declined emergency services. She was conscious and alert. She rested for around 20 minutes.  After 20 minutes she stated that she felt a lot better and left.
Tested positive for covid after being fully vaccinated; Tested positive for covid after being fully vaccinated; This is a spontaneous report from a non-contactable physician via a sales representative. This Physician reported for male (Patient) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via unspecified route of administration on an unspecified date as single dose both for COVID-19 immunization. The caller stated she was a Pfizer representative, and she was having lunch in a doctor's office and she overheard one of the doctors discussing another doctor in her territory that had COVID-19 on 21Jun2021 and stated this doctor has been vaccinated. Confirmed he was fully vaccinated with the Pfizer vaccine, and she just heard this today. Caller stated the patient was not sick and had not many symptoms, but she felt like she needed to call it as she was fully vaccinated. Stated it was something that she overhead, she has not spoken with the patient about it, she was not at work. She was out for ten or fourteen days. Caller added, he was probably diagnosed on Monday of this week, because he claimed he got it at (see field) the week before. Caller did not think patient has been to the hospital or anything because (withheld) said the patient was not very sick. Caller stated he told Dr. (withheld) he had a positive COVID-19 test, and that he had both Pfizer vaccines. Caller stated (withheld) asked her if she thought the test could be negative or false, or something, and she stated she had no idea. Caller asked was there any information about a booster dose, a booster shot, or anything yet. Outcome for the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report, A meaningful medical assessment is not possible. Case will be reviewed once additional information is available