chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IMMEDIATE FLARE OF UNDERLYING AUTOIMMUNE DISEASE; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included: Underlying autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced immediate flare of underlying autoimmune disease, and was bedridden.  It was reported by patient as "I chose to receive the first J and J injection after much research and consideration. I had an immediate flare of my underlying autoimmune disease and was bedridden, on oral steroids for 3 weeks. I chose to not have further injections". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the immediate flare of underlying autoimmune disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221136694- immediate flare of underlying autoimmune disease. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Upper arm pain radiating down arm to fingertips started within two hours of receiving vaccine.  Nine hours after administration started with chills and tremors, then headache and body aches. Temperature spiked to 104 by 12-midnight. Took Tylenol. Temperature went down to normal by 2:00 pm the following day. Was lethargic throughout the following day.  Still experiencing fatigue when exerting myself.
rash over eye extending to scalp; itchy bumps; ear ache; mild discomfort; doses two years apart, first dose December of 2020; fever; headache; malaise; mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2021, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced fever, headache, malaise, rash, itchy rash, ear pain, discomfort and drug dose administration interval too long. On an unknown date, the outcome of the fever, headache, malaise, shingles, rash, itchy rash and discomfort were recovered/resolved and the outcome of the ear pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fever, headache, malaise, shingles, rash, itchy rash, ear pain and discomfort to be related to Shingrix.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The patient received first dose of Shingrix and experienced mild case of shingles Less than 2 years after first vaccination, the patient had fever, headache and malaise which lasted for 2 days. The patient reported rash over left eye extending into the scalp and rash consist of itchy bumps.  The patient experienced ear ache during shingles episode and mild discomfort. The shingles episode lasted approximately 3 weeks. The patient asked that need to get another dose of Shingrix if first and second doses were two years apart. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case US2022143290 was identified as duplicate of US2022AMR143199. The case US2022143290 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Persistent, inconsolable crying lasting > 3 hours within 24 hours of dose, lasting for 48 hours.
Extreme headache on my whole head.  Not a sharp pain.  Just a constant pain, not throbbing.  When I bent my head down it would hurt a little more for a minute.  Just a painful and very annoying headache that lasted through 12-17-2009 (today).  When I took 2 Excedrin it helped a lot.
Complained of crying on the night of vaccinations but not constantly. No swelling. Temperature was 100.1F on 3/1/01. Called on 3/5/01 and reported 3 hours of crying, non-stop in the AM with no other symptoms. No swelling or temperature.
Vaccine was given in right arm at approx. 10:00 am. Positive pain onset 1-2 hours later, in right shoulder and radiating down front of right bicep. KENALOG injections in right shoulder x4, numerous ortho appts, not resolved. Continued pain and ROM. Surgery scheduled.
Red injection site; Blistered injection site; The site is scabbed; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th August 2019, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site blisters and injection site scab. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site blisters and injection site scab were unknown.   It was unknown if the reporter considered the injection site erythema, injection site blisters and injection site scab to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. The patient experienced a red, blistered injection site. The patient stated that the site was still red and scabbed. The reporter consented to follow up. The healthcare professional consented to follow up for this adverse event.
Client returned to Clinic reporting "Tightness in the back of his throat". Denied difficulty breathing or other symptoms. Patient was clearing his throat periodically. Patient states he has anxiety, so he also believes that is adding to his symptoms. After checking vitals  administered epi and dial 911. Patient had started to clear his throat more often.  Continued to monitor patients symptoms and did not have any worsening of symptoms and after approximately 5 minutes, he stated he felt better. EMS arrived and discussed with patient and he elected to refuse transport to the hospital. He has a buddy in the parking lot who drove him here.
Patient sat down next to father after vaccines were given in the triage area. Several staff saw patient put head down and shook her head for a few seconds. Vital signs were then obtained of 10 minutes for 30 minutes. Vital signs were stable. Patient was given cold water to drink and crackers.
pt devel rash;seen by MD;T104;lethargic some vomiting;urine unremarkable maybe a little decreased;T105 tympanically;weight 23 1/2 # was 24 on 24APR;skin has erythematous lesions;dx viral exanthem consistent w/varicella;
Client called the office 3 days after vaccine regarding pain, redness and swelling at the site of injection with fever of 101.8 noted day prior to phone call. The next day client stated she went to the ER for Treatment due to symptoms not improving and arm becoming more swollen. She states that she receive IV antibodies (Vancomycin and Dablavomycin) in the ER. Client was discharged from ER and not admitted to hospital.
AFTER RECEIVING THE VACCINE, PATIENT SAT DOWN FOR 15-MINUTE OBSERVATION PERIOD AND SAID HE EXPERIENCED LIGHTHEADEDNESS. HE SAID HE FELT AS IF HE WAS GOING TO LOSE CONSCIOUSNESS, SO WE CALLED PARAMEDICS, WHO CAME TOOK THE PATIENT TO THE HOSPITAL AFTER TAKING HIS VITALS.
Severe rash to the trunk, arms, legs, scalp, and back. Steroid shot of steroid to the hip to treat rash. Prescribed predinsone for 5 days.
On the 5th-6th day I became incredibly fatigued. Noticed that my neck was swollen and sore. I am a nurse practitioner, therefore palpated my neck, and noted very large supraclavicular lymph node present., multiple. This was on the right side, the same side I had my shot. The next day however another supraclavicular lymph node appeared on the left side as well. Fatigue was extreme for three days.
Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer.  A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
mRNA-1273 (lot/batch: 010A21A) via unknown route for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced itchiness, sensitivity at the injection site, little bit inflamed, like a lump, hard, little ring of redness, had 2 and a half inches round. Treatment details included tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe chills and extreme shaking the evening of shot and through the night. Weakness and dizziness the next morning until approximately 10 am
Symptoms started with a racing heartbeat and was very tired. By the morning of I had severe pain from the injection site, could barley lift my arm, it was red, slightly swollen and hot. Throughout the day I developed a headache, felt very achy and tired. By 8pm, everything worsened, had a fever of 100.9, was nauseated, had severe cramping and vomited.  Fever broke the next evening, but the cramping, body aches and headaches remain.
Immediately after receiving her vaccination she developed lightheadedness. She has an aversion to needles.
Received  MMR and Influenza on 10-13-11. That evening Mom reported fever to 105.0, lips blue, vomited x 1. Mild cough. Parents transported to ED. Treated/released.
Large red rash appeared on left arm at injection site 3 days after injection. Warm to the touch and sore.
angioedema to throat with wheezing  requiring Epinephrine 0.3mg and 0.5mg  IM with IV Benadryl 50mg and IV Decadron 10mg with racemic epinephrine neb.
fever of 101 F; blood vessels in her eyes were expanded and red; sore arm; muscle weakness of whole body; headache, stabbing head pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th May 2022).   On 30th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced pain in arm, generalized muscle weakness, headache and nausea. In September 2022, the patient experienced fever and eye red. On an unknown date, the outcome of the pain in arm, generalized muscle weakness, headache, nausea, fever and eye red were unknown.   It was unknown if the reporter considered the pain in arm, generalized muscle weakness, headache, nausea, fever and eye red to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-SEP-2022  Reporter's Comment: The case was self reported by the patient. The patient received second dose of Shingrix and experienced sore arm, muscle weakness of whole body, a headache and nausea. Additionally patient had a fever of 101 Fahrenheit last night (the day before reporting), stabbing head pain, and noticed that the blood vessels in her eyes were expanded and red. The reporter consented to follow up.
Initial report was received 28 February 2011 from a health care professional. A 24-year-old female patient had received a left arm injection (route not reported) of YF VAX, lot number UF802AA on 25 February 2011 and one day later, she developed a headache, body aches, fever of 100F, chills and sweating. She had no illness at the time of vaccination and no known allergies. Medical history was not reported. Concomitant medications consisted of LEXIPRO, TOPROMAX, ALTRAM and vicoprophen. She had not received any other vaccines within four weeks of YF VAX. At the time of the report, the patient's outcome was not recovered. Follow-up information received on 01 April 2011 from a health care professional who reported that the patient had additional symptoms of extreme shortness of breath and worsening symptoms. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient had received a subcutaneous injection of the YF VAX at approximately 2:30 pm on 25 February 2011. On 28 February 2011 at 11:37 AM, the patient reported Flu-like symptoms and reported she recently had the flu (dates not provided). She reported her headache had improved with TYLENOL and body aches slightly improved with two Advil tablets. At 3:37 pm on 28 February 2011 the reporter called to "check" on the patient and stated the patient sounded better and more energetic. On 01 March 2011 at 8:30 am, the patient reported to the clinic with complaints of extreme shortness of breath and worsening symptoms. The patient was transported to the hospital emergency room (ER) for evaluation and treatment. Diagnostic and laboratory tests included a portable chest x-ray which was negative, oxygen saturation of 100% on room air (RA), blood draw with results not reported and a temperature of 99.1 degrees. She was treated with ATIVAN. The patient was discharged from the ER in stable condition with instructions to drink plenty of liquids and to be off from work 01-03 March 2011. No further information was available at the time of the report. The patient's outcome was reported as recovered on 02 March 2011. Documents held by sender; None.
18 patients recieved dose from underfilled vials, 9 doses each vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (18 patients recieved dose from underfilled vials, 9 doses each vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (18 patients recieved dose from underfilled vials, 9 doses each vial). At the time of the report, INCORRECT DOSE ADMINISTERED (18 patients recieved dose from underfilled vials, 9 doses each vial) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The Pharmacist reported that one of their locations had two vials that only contained nine doses each. For both vials the lot number 014M20A and Expiration 12-Aug-2021.  The vials are not available for return and were discarded.  The nine doses in each vial were given to patients.  At that time there are no patient identifiers. Pharmacist stated that it may be possible to get identifiers for all the patient that were given that lot for that day/location but not sure if can single out the 18 patients who specifically got those does out of the two short dosed vials.
Extreme fatigue, swollen at injection side 10 days after first dose. The injection site is warm to touch, has been itching for 2 days after injection day with was 04/01/2021. Suddenly became inflamed, warm to touch, and hard 04/10/2021.
Client was given Tdap, Hep A, Menactra, and HPV.  Syncope episode 10 min after vaccine adm.  Child was assisted to the floor.  Was responsive as soon as she was placed on the floor.
Urticaria - Information has been received from a physician concerning a 15 month old patient with on known allergies, who in approximately April 2000, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  About three hours after the vaccination, the patient developed diffuse hives which were sucessfully treated with diphenhydramine HCL benadryl without complication.  The physician tested the child to see if the child had an egg sensitivity which was negative.  The physician wanted to test the child for the anti-gelatin antibody.  The patient wanted to have the patient tested for a gelatin hypersensitivity reaction.  Subsequently, the patient recovered from diffuse hives.  Additional information has been requested.
23OCT96 pt recv vax & had not immed problem, but w day later 25OCT96 till now c/o intermittent pain @ inj site;no fever/swelling/erythema/infect/bleeding or other complaint;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of VAQTA (lot # M027879, expiration date 24-JAN-2018; dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1611USA001105: US-009507513-1611USA001104: US-009507513-1610USA011275: US-009507513-1611USA001103: MERCK 1611USA001102:Mfr number.
itching of skin; bilateral hand numbness; Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other hcp. A 34-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration on an unspecified date (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was reported during her 15-minute waiting period after the injection, the patient experienced itching of skin, bilateral hand numbness, differential diagnosis: systemic reaction (hypoglycemia, hypotension, generalized rash) on an unspecified date. The patient was stable to go home and follow up with PCP. Therapeutic measures were taken as a result of events that included antihistamines and water initially with zyrtec, she was not seeing improvement. Two doses of 25 mg of benadryl of 15 minutes within each other, pt was able to see improvement. Pt aware of when she is able to take more benadryl if needed. If symptoms worsen or do not respond to benadryl, pt aware to go to ED. The follow up response to treatment was reported as good. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Body aches, fever, chills, headache, weakness, no appetite, nausea . Thus started in the middle of the 1st night till the middle of the night the 2nd night
Two days after the vaccines the patient was evaluated for suspected seizure at the ER (9/14). The following day (9/15)-office visit for lethargy and ER follow-up. Patient was lethargic and hypotonic, referred to the ER and hospitalized (9/15-9/23/17). Patient became areflexic and diagnosed with Guillain-Barre Syndrome. She was treated with IVIG and improved. Discharged home with physical therapy. Tone improved but not back to normal.
Covid arm, red circular shape 4-5 inches in diameter around injection site of arm.  Looks to be a rash.
This case was reported by a pharmacist via call center representative and described the occurrence of spasms in a 47-year-old male patient who received FLUARIX (batch number 2F5P4, expiry date 30th June 2016). On 15th October 2015, the patient received FLUARIX .5 ml. On 15th October 2015, 5 min after receiving FLUARIX, the patient experienced spasms and injection site pain. On 15th October 2015, the outcome of the spasms and injection site pain were recovered/resolved. It was unknown if the reporter considered the spasms and injection site pain to be related to FLUARIX. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a pharmacist, who himself was the patient. No concomitant medications were reported. The healthcare professional stated that 5 minutes after receiving the vaccine, the patient experiences spasms in the other arm (not the vaccinated arm) above the elbow which was about a 2 inch section. The spasm resolved soon after it occurred. On 15th October 2015, less than a day, after receiving the vaccine, the patient also experienced pain at the injection site that lasted for a minute.
Patient experienced joint pain, upset stomach, diarrhea, pain and swelling at the injection site which has progressively gotten worse since the injection was given. Patient felt like he has the flu the day after the immunization was given and is feeling marginally better on day 2 after the injection was given.
Pt experienced fatigue, migraine, and soreness in arm where injected the day after administering the vaccine.  2 days after administration, pt stated experiencing redness all over body from shoulder downs (spoke to pt over the phone)
On the 29th, I had an intense pain in my lower left calf that lasted the weekend. I have a history of blood clots, but this pain was more intense and lasted longer than usual. My calf pulsated for 3-4 days. I called my doctor who administered an ultrasound of my leg. No new clots were found and an older clot had decreased in size.
Client returned to provider with complaint of itchy skin. Hives were present on her extremities. Benadryl 50mg orally prescribed, hives and itching resolved approx. 2 hours after single 50mg oral dose of Benadryl tablets.