chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After his 12 month shots, he lost all language and all eye contact and could not respond to any noise or even waving in front of his face. He still has no language and no receptive response. He has some eye contact but does not respond or react to people but is getting a little better at times. Called 911 and EMS came. Called because he was very hot with temperature of 106F and then 104F after trying warm towel and bathing in small tub of water but didn't work out. At ER he arched his head all the way back, was stiff and eyes rolled and looked very bad. The dx in ER was viral syndrome (fever of unknown origin) and possible seizure.  Diagnosed with Global Developmental Delay.
spitting out of her mouth,lot of saliva came out of her mouth; mucus came out of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (spitting out of her mouth,lot of saliva came out of her mouth) and SECRETION DISCHARGE (mucus came out of her mouth) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced SALIVARY HYPERSECRETION (spitting out of her mouth,lot of saliva came out of her mouth) and SECRETION DISCHARGE (mucus came out of her mouth). At the time of the report, SALIVARY HYPERSECRETION (spitting out of her mouth,lot of saliva came out of her mouth) and SECRETION DISCHARGE (mucus came out of her mouth) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Elevated fever 103 degree; mod. ill appearing sore throat and headache and cough almost immediately after nasal flu mist.
On 08/31/2021, muscle aches, mild headaches, temperature at its highest 100.3 within the first 2 or 3 days. On 08/30/2021 I took the COVID-19 self-test and the results were negative. I had a tele-visit with Doctor, on 09/03/2021, and I was swabbed on that same day, for the COVID-19 TEST-results were positive. By 09/05/2021, my symptoms resolved.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 13-FEB-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Blotches, nausea, dizziness, pale, no itching. BP 108/62, AO 100 reg, RR 16 - reg easy no resp distress, ringing in ears. Sent to hospital via ambulance per fire dept. Father with patient. blotches R forehead and neck. Faded prior to transport.
lt arm swollen, erythematous, ice pace-arm q 2-3hr x 20min;DPH given;erythromycin;
This case was reported by a physician from regional center of pharmacovigilance of patient and described the occurrence of macrophagic myofascitis in a female subject who was vaccinated with Engerix B for prophylaxis. The subject belonged to the EMMM association under reference 228. From 1970 to 1990, the subject received several injections of DTP vaccine (unspecified batch reference). On 01 July 1991, 01 August 1991, 30 September 1991, 12 May 1993, 10 November 1995, 14 August 1997 and 17 September 1997, the subject received seven doses of Engerix B vaccine (unspecified batch reference). On 17 September 1997, she received a firs injection of 14 August 1997 Havrix (unspecified batch reference). On 27 September 1997 and 08 January 2003, she received an injection of typhim (unspecified batch reference). On 21 February, 21 March and 21 April 1998, the subject received three doses of GenHevac B vaccine (unspecified batch reference). On 06 November 1997, the subject received the eighth dose of Engerix B (unspecified batch reference). In unspecified date, within an unspecified delay after the eighth dose of Engerix B, the subject complained of diffuse myalgia, asthenia, muscular fatigue at the upper and lower limbs, rachis pains, sensitivity, auditory and visual disorders and deglutition and sleep disorder. On 10 November 2005, a biopsy of the left deltoid revealed fibers with same diameter and with a good differenciation. No glycogenic overload was noted. A macrophagic myofascitis was then diagnosed. At the time of the report, the outcome of the events was unknown. On 10 October 2005: Biopsy of the left deltoid: Fibers with good differenciation, no glycogenic overload. Macrophagic myofascitis was diagnosed.
felt their legs were numb, for 15 seconds could not stand up, move legs; fell to floor because of numbness; weakness; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (felt their legs were numb, for 15 seconds could not stand up, move legs), FALL (fell to floor because of numbness), ASTHENIA (weakness) and FATIGUE (extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 20-Dec-2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (felt their legs were numb, for 15 seconds could not stand up, move legs), FALL (fell to floor because of numbness), ASTHENIA (weakness) and FATIGUE (extreme fatigue). At the time of the report, HYPOAESTHESIA (felt their legs were numb, for 15 seconds could not stand up, move legs), FALL (fell to floor because of numbness), ASTHENIA (weakness) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Client stated after receiving his vaccine he had shoulder pain leading from the injection site.  Vital signs O2 sat 99%, BP 137/71, HR 78.
10 minutes post vax, the pt fainted. Pt laid on floor with feet elevated; cool cloth to face, head, and neck. Oxygen started at 4 liters, pulse was slow but strong. He had a bump on left side of head. Pt sent to physician for rule out aneurysm; no aneurysm found only migraine.
An expired booster dose was given to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment  information was provided.
By 4p on 10/19/99, pt had a raised,bright red welt approx 2" x 3" in diam;hot to the touch at inj. site,neck,shoulder, & lower back pain w/ accompying chills.The next day,sx worsened.Tx w/ Benadryl & cephalexin.
pt recvd vax;25aug95 exp herpes simplex like condition in mouth & fever of 100.7 for several days
Fever and erythema, blister. Treatment: Loratadine, cephalexin.
Information has been received from a consumer concerning his 17 year old son who on 29-APR-2011, was vaccinated with the first dose of GARDASIL (route and lot number not reported). On Saturday morning on 30-APR-2011, the son was complaining of nausea. By Saturday afternoon, approximately 24 hours after the administration the son felt better. Additional information has been requested.
I had fatigue, headache, upper respiratory problems, and fever for one day. I tested positive for COVID-19 and was prescribed PAXLOVID. I started to feel better after taking PAXLOVID. I rebounded several days later. I had upper respiratory problems, coughing, nasal drainage.
01/23 arm pain became unbearable, large bruise formed at injection site. 01/24 woke up feeling out of sorts with a nasty headache, arm pain was severe, redness around site size of half cup measure and site was hot to the touch, by afternoon a low grade fever (99.4) began; fever went to 101.1 on 01/24, felt chills alternating with sweating, severe joint pain, restless sleep. 01/25 woke up in a sweat, same symptoms as the day before, site was hot, red and very sensitive to the touch; fever, spiked to 102.2, chills, sweating, severe joint pain, nasty headache, fever broke around 2:00 PM, joint pain and chills eased. Site was red and hot and very sensitive to the touch from shoulder halfway to elbow. 01/26 site still red, hot and very sensitive to the touch; called pharmacist and began taking Zyrtec in afternoon, site somewhat less sensitive and a bit less red by bedtime. 01/27 site about 50% less sensitive than original pain, but still sensitive. Redness and heat has subsided to now being from shoulder to about 4" below shoulder - covering entire front of right arm. 01/28 will call my primary care physician. Note: Shot was recommended by my pulmonologist.
NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
baby curled up, arms & legs flexed tightly & cried inconsolably for 8-9hr;took to Er & gave codeine which calmed pt down;pt was not self for about 1wk p/vax;
This spontaneous report was received from a nurse concerning a female patient of unknown age. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with VARIVAX lot # M004326 (strength, dose, route, frequency and expiration date were not reported) for prophylaxis. On 15-SEP-2017, the patient was vaccinated with M-M-R II lot # L037356 and expiry date 28-SEP-2017 (strength, dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported and no product quality complaint was filed.
Raised area where vaccine was given, skin was warm to touch, tender, and pt was achy. Pt denied any fever or throat swelling. Pt developed Rxn on 3-30-2016/given steroid injection. 4/4/16 attempted to reach parent to check status. No answer.
(R) upper arm 8cm warm to touch. Induration, erythema, Tx BENADRYL 25 mg PO 9:15 AM. 9:45 AM mild erythema still induration antibiotics tx x 7 days.
injection site swollen, large rash sprending down from injection site measuring 3 1/2 inches wide to 4 inches long swelling  with blisters, had a fever at the site..  per the doctor cold pack increase my allergy medication  and I am not  use the Moderna vaccine. this lasted a week.
Quick onset of exhaustion, dizziness, low body temperature, loss of word retrieval ability, injection site greatly enlarged, sensitive to touch, swollen, red and expelling heat several inches away from body for 5+ days
Client came in to receive Novavax dose 2. She stated that when she received her first dose 9/6/22 , 30 minutes after she experienced a fibromyalgia flare up. She had headache, joint pain, stiffness and tingling for two days. She took Tylenol. She  didn't go to the primary care provider or seek emergency care. She was able to tolerate it at home. She states she's never had a reaction with a vaccine. Client received her second dose and was approved by Dr to receive. She will seek emergency care if needed.
Injection site soreness; Slight swelling at injection site; Headache; Tiredness; Increased thrist; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP0955) via an unspecified route of administration in the left arm on 06Apr2021 at 09:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) probiotics nos (MANUFACTURER UNKNOWN) and vitamin (MANUFACTURER UNKNOWN) all taken from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 12:30 (at the age of 47-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 06:00 the patient experienced soreness and slight swelling at injection site, headache (lasted ca 8 hours), tiredness/fatigue, increased thirst. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness and slight swelling at injection site, headache (lasted ca 8 hours), tiredness/fatigue, increased thirst were recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Patient reported J&J COVID vaccine receipt on ?4/28. Symptoms of headache with visual disturbances and abdominal pain began less than 2 weeks later. She presented to the ED about 4 to 5 weeks after the vaccine with chest pain, abdominal pain, and hemoptysis.    Work up identified right sided central and bilateral segmental pulmonary emboli, with splanchnic circulation thrombosis of the upper segment of the superior mesenteric vein, splenic vein, main portal vein, and intrahepatic portal veins, as well as dural sinus thrombosis.  The patient was thrombocytopenic with elevated heparin pf4 antibody. She was initially started on heparin, but transitioned to argatroban and IVIG, with resultant increase in platelet counts over the course of her stay. She was also started on Diamox 250 BID for increased IOP.  The patient was hypoxic on room air, requiring up to 4L of oxygen during her stay, but was down to 1L at the time of discharge. She was discharged on rivaroxaban for continued anticoagulation.
No adverse reaction but vaccine given outside the recommended window of use. Primary COVID series not completed, and Booster administered..
This spontaneous report was received from a female patient of unknown age. No relevant medical history of the patient was reported. The patient was not pregnant. On 30-MAY-2014 the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not reported). No concomitant medications were reported.On 05-JUN-2014, the patient developed rash like bumpy area surrounding the injection site. The patient has no other symptoms. The patient had contacted her physician to verify if it was shingles. There was no information provided from the physicians conversation. The patient was not treated for the event. It was unspecified whether any lab diagnostic studies were performed. The patient had sought medical attention by contacting the office. There was no product quality complaint involved. The outcome of rash like bumpy area was reported as not recovered. The causality was not provided.  Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K007244, expiration date 16-MAR-2016). This specified lot number was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 176 hours with the highest recorded temperature of 48 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.
Prior to this immunization patient was a normally functioning boy.  Patient fevered and became cranky the day of the immunization.  The next day he lost most of his speech, he could not make eye regular contact, he began stimming and flapping and jargoning.  He began spitting.  He demonstrated a lack of social skills and he cried on and off throughout his days with the smallest frustration.  He was unable to keep his body still, jumping around all day in order to register sensory input and he was unable to focus.  This lasted for six months until he was brought to an herbalist and patient underwent herbal chelation and treatment to boost his immune system.  Patient has been restored to normal functioning twice and twice he has regressed directly after immunizations, even when only being given one at a time.  This was documented by his ABA therapist, his speech therapist and his teachers.  For some unknown reason, patient's immune system cannot handle immunizations.
Behavioral, mental health hospital admission within 6 weeks of receiving the COVID vaccine. Treated and released.
Client became diaphoretic, dizzy & state he could not see approx 1 min after receiving vaccine. Client use ammonia inhalant & ice packs were applied to his forehead & neck. After 10 min client's vision normalized & he was able to walk out of the clinic on his own.
I had trouble sleeping for one or more nights. I was kept awake by palpitations, so I called and they had me come in and they were trying to rule out if I was having a heart attack. They did a chest x-ray on 02/09/21, phosphate, cbc, nitrate, wbc diff,erential chem panel, troponin 1, osteoserum, EKG 12 or more leads. Those all came up just fine. That was followed up at another date. I got the Holter monitor on 02/25/21(24 hour), echo on 03/31/2021, urinalysis and hemoglobin and a1c on 05/18/21. It determined there was no damage to heart and it was functioning normally. I had high blood pressure  and started doing daily bp checks on 07/28/12 and that day it was normal 126/70 and heartbeat 158 but the subsequent days it got higher and stayed high pretty much throughout august. It went up and down through august but did gradually come down. 2-3 weeks I tested every morning and it was normal. I emailed dr asking to continue if I should do this but she didn?t respond. I think that its reasonable given this data and that probably this is anxiety. I probably am susceptible to physiological and emotional stress of any kind. I've been taking metoprolol since.
Client complained of throat tightening.  Client assessed by MD on site. Symptoms self resolved.
Received second dose of Shingrix 2 weeks apart from the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received second dose of Shingrix 2 weeks apart from the first dose).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter was a nurse from a Medical Clinic. The reporter reported that the patient received second dose of Shingrix two weeks apart from the first dose.  No other information was provided about this event. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Headache, dizziness, nausea, lightheaded, fatigue,  right side chest pain below the armpit, muscle ache, rash with redness, swelling and itchiness on the site of injection for two-three  weeks  Dizziness/lightheadedness still ongoing after three weeks despite prednisone taper 20mg