chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 days after first dose I had a very severe head pain. Right side of my head only. Occipital and trigeminal locations and back of neck.  Mostly behind my eye, to my ear, and below my jaw.  Had the pain 24/7 from 4/6/2021 through today 7/16/21 with no letup. On gabapenten and oxycodone and nortriptaline.  Horrible pain that doesn?t stop.  Never had headache type pain before in my life.
Next day arm swollen and red. Heated left arm. 3 days after, muscle tightness/tensed up to point of not being able to control muscles.
This spontaneous report was received from a registered nurse and refers to a 42 year old female, non pregnant patient, with no drug reactions or allergies and no pertinent medical history. On 18-MAY-2010 the patient was vaccinated with the first dose of M-M-R II, 0.5 ml, subcutaneous. There was no concomitant medication. In November 2012 the patient found to be not immune to measles at 0.9 which is equivocal, immune to rubella and had unknown status for mumps since it was not tested. In May 2013 the patient process and IgG (Immunoglobulin G) was done for measles and mumps, but not for rubella. The patient was found to have 1 which is equivocal for measles and immune for mumps. The patient sought medical attention. The outcome of adverse event is unknown. The relatedness between adverse event and M-M-R II is unknown. Additional information has been assistant.
Chills, fever, malaise, myalgia, weakness X 24 hours. Treated with ibuprofen and acetaminophen. Resulted in loss of 1 work day.
Nausea and vomiting; (fatigue; achiness; headache; and sore arm too)
After  shot was received went to have breakfast and then to grocery store. Came home and put a few things away and began to feel nauseous and a little dizzy so laid down. Needed to use bathroom so went into bathroom and became very dizzy. Attempted to make it back to bed and called for husband. Husband heard me yell and when he came to bedroom I was laying in floor passed out. He called paramedics and they came immediately. When I came to I had a feeling of extreme heat over my entire body and then broke out into a bad sweat (I was still lying in floor). After that I had a feeling of extreme heat (like fire) in my feet that rushed up to my calves. Paramedics checked me out and during that time I had I believe 2 more episodes of the heat and sweat.  Paramedics stayed for maybe 20 minutes and I seemed to be okay. I did not go to ER. Remainder of Thursday I was dizzy when I got out of bed. Dizziness improved on Friday and was better by Friday evening. Still some dizziness today (Saturday 4/3) when I move around but not bad. Blood pressure has sometimes been a little low (105/68) but sometimes more normal (118/70).
fatigue; sleppness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cold agglutinins and hepatitis c.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue and sleepiness. On an unknown date, the outcome of the fatigue and sleepiness were recovered/resolved.   It was unknown if the reporter considered the fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The patient receives Vitamins concomitantly. The patient had the vaccine 2 months ago and experienced severe fatigue for several days following the vaccination. The patient felt very tired, like she was coming down with something and slept for 5-6 days. The follow up consent was not granted. This case has been linked with case US2019232407 and US2019232409, reported by same reporter
I am not even sure if there is a connection.  But starting around March I noticed my foot fell asleep when driving more that 45 minutes.  After the third time this happened I decided to see my dr. because it was a safety hazard.  We talked about whether this might be a reaction to the medication I started taking for my CLL condition but there was no record of such a side effect of this medication.  Then I thought perhaps it might have been caused as a reaction to my covid vaccinations.  I asked my dr. and he was not aware of any cases reported.  my wife then found a medical article on line where someone did a report so I thought it would be best if I reported it.
NO ADVERSE EVENT.  VACCINE GIVEN. PATIENT STATED THAT SHE HAD NOT HAD ANOTHER COVID VACCINE ON HER FORM AND CONFIRMED TO ME AT THE TIME THAT THE INFORMATION WAS CORRECT.  HOWEVER,   WHEN WE ENTERED THE VACCINE DATA INTO  DATABASE WE NOTED THAT SHE RECIEVED P
I received the shot on 3-25-16 - shortly afterwards - heart started to race- arm started to get stiff- Joint pain became extremely painful all over my body.
CT C/O THAT AFTER RECEIVING VACCINES ON 9/6/2017 CT HAD STOMACH ACHE AND DIARRHEA 9/8/17 TO 9/10/17. THEN ON 9/11/2017 CT C/O OF FEVER AND HEADACHE- FEVER AND HEADACHE STILL ONGOING. CT RECEIVED TYPHOID AND MCV4 VACCINES ON THE SAME DATE ALSO.
ON DECEMBER 29 2021 PT WOKE UP AROUND 9:00 AM TO WASH HER FACE LIKE NORMAL . AND SHE NOTICE A LUMP ON HER RIGHT LOWER NECK . AFTER A COUPLE WEEKS HAS PASS SHE NOTICE THAT THE LUMP WAS NOW INFLAMED. SO AT TAT TIME I PURCHASE AND ALEVE TO ASSIST HER WITH THE INFLAMTION ,THEN A COUPLE OF DAYS LATER WE TOOK HER TO THE CLINIC AND CALL CLINICAL FAMILIAR, THEY PROVIDE WITH A TREAT FOR 7 DAYS MEDICATION AMOX-CLAV 875 MG. AND ON FEB 26 2022 SHE RETURN AND RECIEVED VARIES TREATMENT RADIALOGIES ALSO A SPECILIST FOR ULTRA SOUND AND VAERIES ANTIBIOTEC FOR EACH FROM 7-10 DAYS ,AND SHE ALSO MEET WITH HER PRIMARY DOC AND HE STATED THIS LUMP WAS CAUSE BY BOOSTER
Left shoulder with erythema extending about 10 cm up to clavicle and 3cm distal region. Posterior arm with 3cm area of erythema. Adverse effect began within 24 hrs of receiving vaccine.
Continued pain and soreness in left arm and shoulder where vaccine was administered. Pain lifting and moving both arms, reduced ability to grasp objects. "Allergy Shiners" in both eyes. General aches and pains in under arm area and in back of knees. Have visited family physician, neurologist and rhinologist to date with no improvement in conditions.
April 18th woke with headache and minor nausea that lasted most of the day. Left ankle (that has prior arthritis/bone bruise and recent cortisone injections within last 2-3 months) began hurting. April 19th nausea/headache were gone ankle pain increased a bit. April 20th Ankle pain was significant and minor/moderate swelling presented. Also low grade fever presented with chills and night sweats. April 21st. low grade fever/chills seem to have broke but ankle pain/swelling is still persistent.
Patient presented with a cough, fevers, and weakness. Patient is fully vaccinated and resulted positive for COVID-19.
The pt experienced a coughing spell with slight choking sensation for about 2 minutes post vax. No reaction was noted at the injection site. She became lightheaded and a red rash appeared on pt's neck, face and upper chest. MD was called in to assess the pt. Vitals were taken. Pt began to feel better within 5 minutes.
13 days p/inject pt devel fever, h/a, diarrhea which persisted x 5 days;
COVID-19 Vaccine  Sweats and chills, joint aches. headache, no appetite
Developed Covid symptoms and tested positive for Covid after completing Paxlovid treatment; Developed Covid symptoms and tested positive for Covid after completing Paxlovid treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202) intramuscular, in right arm, as dose 2, single (Lot number: ER8732) intramuscular, in right arm, on 23Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FJ1620) intramuscular, in right arm, as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Developed Covid symptoms and tested positive for Covid after completing Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment: Paxlovid; Positive, notes: After six days of feeling well, she developed Covid symptoms, and tested positive for the Covid virus after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female.  Neither medical history nor concomitant medications were reported.  On 12-Jan2009, the patient received expired FLUMISt vaccine.  The vaccine had an expiration date of 11-Jan-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.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographics were received.  Additional information was received on 12-May-2009:  product complaint investigation results.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
SUSPECTED COVID-19 INFECTION; This spontaneous report received via other company (Pfizer) from a patient concerned a 32 year old of an male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes and allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 1, 1 in total administered in right arm for covid-19 prophylaxis. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 2 administered in right arm for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series: 2).  On 07-JUL-2022, the patient received non-company co suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered for treatment of covid-19. Paxlovid last drug administration was 12-JUL-2022. On 24-JUL-2022 after 12 days of finishing Paxlovid, the patient again had COVID symptoms (covid-19 symptoms) (Dose number in series: 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran (Moderna Covid-19 vaccine) was not applicable and with paxlovid was withdrawn. The patient was recovering from suspected covid-19 infection. This report was non-serious.
NO REACTION PATIENT GIVEN EXPIRED VACCINE. EXP: 3/12/18 GIVEN 3/13/18.
Fever, sweats. Body soreness and aches. Migraines for two days.
did not feel like eating; fatigue; low energy; This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced appetite absent, fatigue and energy decreased. On an unknown date, the outcome of the appetite absent, fatigue and energy decreased were unknown.   It was unknown if the reporter considered the appetite absent, fatigue and energy decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's mother. The patient received Shingrix and experienced fatigue, low energy, and did not feel like eating.  The reporter consented to follow up. This case was 2 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021063952:same reporter US-GLAXOSMITHKLINE-US2021063955:same reporter
I was being monitored for 30 minutes. At 20 minutes after the vaccination, I began having difficulty swallowing and within minutes of that began experiencing numbness around my mouth, including my lips, with minimal swelling wound my lips and mouth. Then I had a tingling sensation as if pins were sticking me in my face, especially around my eyes and forehead. I immediately ported my symptoms to the nurse standing next to me for observation. My entire body felt as if it was on fire, with a burning and itching sensation.  I was administered 25 mg of Benadryl IM and was transported to the Emergency Department, where I was given oral prednisone. I left the Emergency Department is about 2 hours. At 24 hours after the, I still have itching around my scalp, back and lips.
Patient complains of blistering rash along back 4 weeks after receiving SHINGRIX vaccine.
1 day after vaccination: fever/chills; 2 days after: felt fine but had cankersore; 3 days after: bottom lip numb and swollen; 4 days after: upper lip numb and swollen; 5 days after: both lips numb and swollen with white blisters; after that started taking Benadryl and started feeling better
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 22-AUG-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Sudden and continuous heartburn on 12/20/2020 which lasted all day.  Took Lansoprazole on 12/20 and 12/21.  Symptom resolved on 12/21.
Excessive chills, nightmares chills excessive urination, arm very sore stayed in bed for 2 days.
This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 13-FEB-2017, the patients were vaccinated with a dose of improperly stored PROQUAD (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. The vaccines experienced the following temperature excursions during 6 hours of more than -10 degree Celsius (C) but less than 8 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001135: US-009507513-1703USA001136: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001139.
Beginning about 2 days after the vaccine, patient began reporting headaches. The headaches were severe enough to require medication, ice, rest, removal from her classroom at school, and then medical intervention. Various treatments have been attempted but she continues to report frequent headaches and migraines, which occur with any or all of the following: noise and light sensitivity, nausea, neck pain and tension, fatigue. Patient saw PCP and was referred to neurology. Patient has follow up with neurology as symptoms persist and interfere with her daily activities.
The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022; no adverse event; Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-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 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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 (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022).    No concomitant medications were provided. The vial size was 2.5ml. The vial was initially stored in the refrigerator on 18-Oct-2022 The vial did not  undergo any temperature excursions. No treatment medication was provided. This case contains information for the 2nd of 14 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 4 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675259:Patient 3 US-MODERNATX, INC.-MOD-2022-675268:Patient 11 US-MODERNATX, INC.-MOD-2022-675269:Patient 12 US-MODERNATX, INC.-MOD-2022-675270:
Short of breath; Slightly elevated heart rate if I am at rest like talking to you it is normal but if I get up and do anything slightly elevate heart rate; I am on oxygen; Fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Jul2021 (Lot Number: IFA7485, expiration date: Oct2021) as a single dose for COVID-19 immunization. Medical history included diabetes and COVID-19- hospitalized from 06Jul2021 to 19Jul2021. Concomitant medication included metformin taken for diabetes. The patient had COVID-19 and was in the hospital from 06Jul2021 to 19Jul2021. He was not given plasma in hospital. He waited 2 weeks (further not clarified) and then got the first BNT162b2 dose. Within 3 days after he got the shot he started getting really short of breath. He wanted to know if he needed to see a doctor about it or if it would go away. He had slightly elevated heart rate. When at rest, it was normal but if he got up and did anything, slightly elevated heart rate. He feels short of breath. Recently he had fever and that went away. When probed for any treatment for the event, the patient stated, "No, I am on oxygen, oxygen concentrator from hospital not from home, that's the only treatment." The outcome of short of breath, elevated heart rate and fever was unknown.  Follow-up attempts are completed. No further information is expected.
extreme toothache; jaw pressure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure). At the time of the report, TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) outcome was unknown.            No concomitant medication was provided.   No treatment medication were provided.   This case was linked to MOD-2021-240132 (Patient Link).