chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012 the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated in the Emergency Department (ED) for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
20 min after the injection, patient started to develop itchness on his arms  and back.  for the next 48 hours the itchness came and went. small rash (raised red pimps) around the injection spot.  I have treated the itch with allergy meds and the rash with hydrocodone cream 4 days later, he still complains of sore arm, periodic metalic taste when he eats,  sore joints and arm muscles. Saturday evening he had brief chills, and sunday  reported sore throat.
pt recv vax;exp liver enzymes,a petechial rash,& a high fever;rash&high fever occurred twice over a 2 wk,period&have resolved;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, from 12Sep2023 to 17Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 days after the vaccine was given the patient reported redness and swelling at the injection site.  She went to see her doctor who informed her that she had cellulitis. She was treated with antibiotics and pain medication.
Redness and rash at injection site; Redness and rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 16:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 19Apr2021 at 07:00, the patient experienced redness and rash at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of events redness and rash at injection site was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the felt faint post vaccination. The patient sought unspecified medical attention. At the time of this report, it was unknown if the patient had recovered from the event. Additional information has been requested.
Pt. received Tdap at appx 11:45 am-At approx 11:50am Pt. was in lobby with his father. He said he was "quizy" and fainted. He hit his (l) elbow on counter also struck head on employee who was standing next to him. Pt. was out about 1 minute. When he came to he had no c/o pain and stated he "didn't do needles well." He (Pt) was examined by Dr. BP 118/42- P60 at 12 noon.
Pt became dizzy after she was given flu shot. Her blood pressure increased and her blood sugar was 80. She was placed in shock position and dr called.
Injection site swelling, injection site erythema-  Information has been received from a health care professional concerning a 5 year old male patient with cystic fibrosis who on 03-May-2000 was vaccinated SC in the right arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #634038/1713J).  Concomitant therapy on 03-May-2000 included a fourth dose SC in the left arm of poliovirus vaccine (IPOL) and a fifth dose IM in the left arm of aluminum potassium sulfate (+) diphtheris toxoid (+) pertussis vaccine (+) tetanus toxoid (tripedia).  Other concomitant therapy included vitamine A.D.E.K. albuterol and bedesonide (Nasocort)>  It was noted that the patient had an upper respiratory infection at the time of vaccination but that he was afebrile.  On 04-May-2000 the patient experienced swelling and redness to the upper arm where the injection was administered.  It was reported that the patient recovered from his experience.
Admitted on 6/26/22 for alcohol abuse, cough, fever, diarrhea. Pt was not hypoxic. No steroids or other treatments. D/C home on 6/28/22
No additional AEs reported; Product storage error; This spontaneous report was received from a medical assistant referring to a 7-month-old male patient.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 16-FEB-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742467, expiration date 05-OCT-2022, orally for prophylaxis (dose and vaccination scheme frequency were not reported) (product storage error). The patient had received two previous doses of the vaccine.        Information regarding the temperature and time frame of the excursion were not provided. No additional adverse events reported.   This is one of three reports received from the same reporter.
resp arrest w/larynigial edeam as described by mom; nauseated; throat swelling; Had 45 sec period of resp arrest; adm to hosp for observation for 2 days;
not received 2nd dose yet; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   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 incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2023 The reporter enquired that what was the efficacy with Shingrix with only a one dose immunization as the patient did not receive a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Significant right buttock bruising (covering whole cheek)with induration, swelling, and tenderness at site of injection noted one day after MMR given per Mom.   No other bruising at sites of DTaP and IPV.  No trauma.  Seen in office 10/21/02 with above signs but with improvement per Mom.  Placed on 4 day course of oral steroid.
-August 26, 2021 - We made a 10:00 AM appointment for the vaccine. It's about 10:30 AM when he actually gets the injection.We're told to wait in the waiting room for 15 minutes to make sure there are no severe reactions.  -We sit in the waiting room. 5 minutes in he says his throat is hurting badly and he's super light headed. He feels like he's high. I'm a little worried.   -We wait the 15 minutes, nothing else presents itself, and nothing worsens, so we go home.   -He doesn't feel well. He lies on the couch all day resting because he's feeling tired. I make him hydrate. He rests. CONTINUED ON OTHER PAGE
Little sick; Felt stiff; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Little sick), MUSCULOSKELETAL STIFFNESS (Felt stiff) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ILLNESS (Little sick), MUSCULOSKELETAL STIFFNESS (Felt stiff) and FATIGUE (Tiredness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 21-Apr-2021, ILLNESS (Little sick), MUSCULOSKELETAL STIFFNESS (Felt stiff) and FATIGUE (Tiredness) had resolved.            Concomitant product information was not provided.   This case was linked to MOD-2021-143386 (Patient Link).
28OCT94 730-8AM flu vax; 11AM non productive cough, sl tight in chest; 12N bilateral conjunctivitis, no discharge; 1P myalgias, h/a; 630P t100.8, myalgias; 29OCT94 dec conjunctivitis, inc fatigue otherwise OK
Around early January 2023, I began to experience heart palpitations, lightheadedness, dizziness, and fatigue to the extent that it alarmed me enough to request a telehealth visit through urgent care with my healthcare provider. I had seen a PSA that mentioned that if those symptoms were present, they could be indicative of impending stroke or heart attack, so they caused me a great deal of concern. Through the telehealth visit, I was scheduled for bloodwork and an EKG, both of which I underwent on 1/27/2023. I had a follow-up video visit with my PCP on 2/6/2023 to discuss the results of the tests. I initially received a diagnosis of septal infarct, and I was referred to a cardiologist to undergo a cardiac stress test on 3/2/2023. The results of the stress test were not supportive of heart attack, but my PCP suggested that if I had another episode again, more testing and monitoring would be in order. I have begun a regular exercise regimen (rigorous walking). I have purchased a smart watch to keep track of my heart rate and activity. I have greatly reduced my intake of sodium, alcohol, and saturated fat. I have made it a point to be less sedentary, and I would say that my overall well-being is improved. I have lost about eight pounds, I sleep better, and I have better emotional and mental health.
itchy eyes; watery eyes; inability to sleep; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received Shingrix. On 29th May 2019, less than a day after receiving Shingrix, the patient experienced sleeplessness. On 30th May 2019, the patient experienced eye pruritus and watering eyes. On an unknown date, the outcome of the sleeplessness, eye pruritus and watering eyes were unknown.   It was unknown if the reporter considered the sleeplessness, eye pruritus and watering eyes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter did not consent to follow-up. The reporter did not wished to participate in safety report or provide demographics
FEELING HOT; FEVER; THROWING UP EVERY 20-30  STARTING AROUND 21.00-22.00 UNTIL AROUND 08.00 NEXT DAY, CONTINUED THROWING UP LESS FREQUENTLY ON NEXT DAY, BUT THE VOMITING GOT WORSE AGAIN AND UNABLE TO EAT AS BEGAN THROWING UP AGAIN MORE FREQUENTLY; LOW TEMPERATURE; SWEATS; SEVERE ABDOMINAL PAIN; STOMACH  SPASMING; FEELING VERY SICK AROUND 19.00-20.00; ARM HURT; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 1805081, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at around 14.00 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced low temperature. On 24-MAR-2021, the subject experienced sweats. On 24-MAR-2021, the subject experienced severe abdominal pain. On 24-MAR-2021, the subject experienced stomach spasming. On 24-MAR-2021, the subject experienced feeling very sick around 19.00-20.00. On 24-MAR-2021, the subject experienced arm hurt. Laboratory data included: Body temperature (NR: not provided) 95.7 F. On 24-MAR-2021 21:00, the subject experienced throwing up every 20-30 starting around 21.00-22.00 until around 08.00 next day, continued throwing up less frequently on next day, but the vomiting got worse again and unable to eat as began throwing up again more frequently. On 25-MAR-2021, the subject experienced feeling hot. On 25-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) over 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt on 24-MAR-2021, had not recovered from throwing up every 20-30 starting around 21.00-22.00 until around 08.00 next day, continued throwing up less frequently on next day, but the vomiting got worse again and unable to eat as began throwing up again more frequently, severe abdominal pain, and stomach spasming, and the outcome of low temperature, fever, sweats, feeling hot and feeling very sick around 19.00-20.00 was not reported. This report was non-serious.
Several incidents (so far) of Polymorphic Light Eruption primarily of both arms after cutting the grass. Have never experienced this in 62 years.
had a harsh cry entire 15 mins p/inject & couldn't be comforted; 17SEP sitter indicated pt cried alot that afternoon; 18SEP pc w/mom pt cried for >2 hrs that afternoon but improved in ER;
No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis. No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine). Concomitant product use was not provided by the reporter. The patients were administered Moderna COVID-19 vaccine with blue capped purple-bordered (Ages 6-11 MONOVALENT) instead of receiving Moderna COVID-19 vaccine, bivalent.  Treatment information was not provided.
Made an appointment for COVID dose 1. When I went in for dose 2 pharmacy realized they had given me a flu shot.
Patient experienced nausea, vomiting, chest pain and seizures (history of seizures but experienced it more strongly after the shot)
Developed a rash on the left side of my jaw line and lower cheek.  Initially I had paresthesia at the rash site then itching.  The rash continued to get worse so decided to go to Facility for treatment as it was a Saturday and my PCP did not have office hours.
Skin rash, Swollen glands, Itching - starting 07/28/2002, Tried to control with Benadryl - had no effect, Now on Prednisone 10 mg plus Cipro Floxacxin,HCL 500 mg, Starting to receive some relief from symptoms.
Information has been received from a pharmacist concerning a 50 year old female patient who on 24-APR-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # and route not reported). Concomitant therapy included FLONASE and JUNEL FE. The pharmacist reported that the patient got a rash in the injection site every time she went to the tanning bed. It was unknown if the patient sought medical attention. At the time of the report the patient was recovering from the event. Follow-up information has been received from a pharmacist concerning a patient with no illness at time of vaccination who on 24-APR-2012 at 15:30, was vaccinated with the first dose of ZOSTAVAX (Merck), left back arm (lot # 671144/1269AA, exp. 05-NOV-2012). The pharmacist reported that the patient stated rash around injection site was worsened and reappeared after tanning in tanning bed. The patient did not seek medical attention. The patient recovered on an unknown date. Additional information is not expected.
I was tired and exhausted for a day and a half, post vaccine. On Monday, 4 days after the vaccine, on the 11/01/2021 I woke up with hives all over my arms, legs and part of my body. Hives everywhere. I took some Lysine and 1 - Ibuprofen 200mg. It was kind of okay for a few hours and then it came back in full force. About 5PM, I took a baby Benadryl 12.5mg. At that point it was all over my body and everywhere. It itched like crazy. At 10PM, I took a Claritin. The Claritin helped. I fell asleep. I woke up the next morning of 11/02/2021, eyes were half swollen shut and itched like crazy. I took some more Benadryl and that helped some but did not solve it. Then in the evening the hives got worse. I was concerned because I felt like my throat might close up. Then took Benadryl 50mg, that helped some. The next morning of 11/03/2021, left eye was half swollen shut and was extremely exhausted. I do not have as many welts on my body. I was not totally covered in them. I called my doctor. I had a telehealth call at 2:00PM on Wednesday. She said to take Claritin and Benadryl at night in addition to. I fell asleep Wednesday night and on Thursday 11/04/2021, I still had welts under my eyes, but it wasn't closing my eyes. My eyes were not swollen shut. I had a little bit of puffiness underneath my eyes. And 11/05/2021, I am fine.
It was brought to attention of provider that clarification needed on booster vs 3rd dose. 3rd dose was documented in error. Discussed with CMA who administered and she believes that .25 dose given. Unable to reach pt to see if she had any adverse reaction. She has not called the clinic to report anything. Multiple outreach attempts made.
9 days p/receiving vax, child had another episode of sz; Child felt warm, eyes rolled bck, lips turned blue, limp body, mucous coming out of mouth;
itchy; RED; bump around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), ERYTHEMA (RED) and INJECTION SITE SWELLING (bump around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (RED) and INJECTION SITE SWELLING (bump around the injection site). At the time of the report, PRURITUS (itchy), ERYTHEMA (RED) and INJECTION SITE SWELLING (bump around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.   This case was linked to MOD21-076769 (E2B Linked Report).; Sender's Comments:  MOD21-076769:
I woke up with extreme muscle aches and joint pain.  I took 2 Ibuprofen every three to four hours.  This seems to help.
This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) which were exposed to 30 degrees Fahrenheit (F) on 19-APR-2013. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Body aches 7pm-10 am chills 7pm-10am body convulsions 9pm-8am vomiting 9pm-3pm  headache 9 pm-present (currently 10 pm next day)   Treatment-Tylenol, Motrin, fluids, ice pack for head
Received shot on 9/24/09.  Began with a migraine that afternoon that lasted 3 days.  Pain and swelling at injection site.  By 9/26 had swelling in base of neck -- which doctor advised was swelling in my lymph node. As of today 9/28/09, swelling still in base of neck.     Doctor advised that shot was "Flu Zone" and that I had a reaction to the preservative in the shot.