chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Phone call from parent after patient left office reporting patient was having acute allergic reaction with rash, facial swelling, lip swelling, tongue swelling, difficulty breathing, and wheezing. Parent reported facial rash started at doctor's office but she did not report it to anyone. Parent was advised to administer EpiPen patient had on hand for known food allergies and call 911 for emergancy medical attention. Parent gave EpiPen, Xopenex inhaler and oral Benadryl but did not seek emergancy medical attenntion as instructed.
230PM mom noticed pt's rt leg had swollen to 2 times it's nl size; pt was fussy w/fever of 100 ax; mom called MD office & pt was seen & given APAP, DPH & ice pack to the site;
Left upper arm: red, swollen, hard, warm to touch.  Per mom pt complained of "itching". Cool compresses, Benadryl advised.
8/2/99 febrile sz, rash, sz 2min followed by 30min period rt arm paralysis;CT Brain nl;rx APAP, advil, chloral hydrate;
On April 13, 2019 patient came to the pharmacy and reported that her arm felt hot and warm to the touch. Patient showed pharmacist her arm over the weekend. Patient's arm was red, hot to the touch and swollen length wise along her arm. Patient was instructed to take an anti-inflammatory for the swelling and to contact her physician if it had gotten worse. Patient came back to the pharmacy Monday evening at 6:30pm and reported that she had to go to the ER to be seen. The patient was in excruciating pain Saturday night through Sunday morning. Her arm continued to swell. The patient reported to the pharmacist the ER physician wasn't sure the cause but determined it could have been cellulitis due to a reaction from the vaccination. The patient was prescribed keflex to take for 10 days along with tramadol for pain. On Monday evening, the swelling was noticeably down compared to Saturday but still prominent, hot to the touch and painful. Patient was instructed to continue taking the antibiotic and if the swelling continued to get worse to go back to the ER for evaluation.
worked up in ED at Medical Center (location where vaccine was administered) for fatigue, dizziness, tachycardia. Received IVF. Elevated WBC, possibly sepsis & UTI rather than vaccine reaction. Patient transferred to another Hospital for admission.
2mo old had DPT/OPV/HIB the morning of 7JAN92; pt exp 20 mins high pitched crying; had a localized erythematous reaction @ site of immun & extending almost to the knee;
gastrointestinal issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 20-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal issues".  Additional information: Reporter wanted to verify if gastrointestinal issues are symptoms from getting the Pfizer-BioNTech COVID-19 Vaccine. Reporter confirmed this would be for the 2nd dose of a 20 year old woman.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 6 hours, I developed a fever, all over body aches (from neck to toes), headache, inability to think clearly, difficulty speaking.  This lasted for approximately 48 hours until the fever broke.  Fogginess and headache lasted for another 48 hours.
I started running a low grade fever. I had chills and a headache and nausea. It lasted for several days. My body felt like someone had beat me. Every joint and muscle ached. Several months later I started feeling weird. I went to the bathroom and I fainted and hit my head as a result. I had a CT scan completed on March 15th and I was advised I may have had a stroke. Then an MRI was completed to check for the possibility of blood clots. There were no blood clots detected at that time. I also contracted COVID-19, I started feelin a little off on 8/17/2021 and tested positive on 8/20/2021. I lost my taste and smell I also had a headache. I also was put on antibiotics for 10 days because I developed a sty on my left eye. I went to the eye doctor and was prescribed an additional 14 days and was still taking them at the time I contracted COVID-19.
BROKE OUT WITH A RASH..STARTED WITH ONE SPOT ON BOTTOM THEN ONE ON RIGHT THIGH WHERE INJECTION WAS GIVEN. RASH IS CURRENTLY SPREADING ONTO BACK. RASH BEGAN 9-25-09. TREATMENT IS TO LIMIT EXPOSURE TO OTHERS, MONITOR RASH AND ADMINISTER ZYRTEC FOR ITCH IF ITCH DEVELOPS.
I thought that I had a cold at first. This lasted for weeks, and it got to the point I thought I had a bad ear infection. I contacted a doctor, and she recommended a nasal spray and a decongestant. My cold symptoms went away but the ear pain didn't. On 1/10/23, I had an episode of Vertigo, and this went on through 1/15/23. I went to urgent care, and they gave me meclizine. I have been taking this medication and been dealing with this since January. I have been doing rehabilitation and they told me that I have lost 50% hearing in my left ear. I am still dealing with this at this time. I am having a hard time with my balance right now.
Client developed pimple like bumps 3-4 weeks after varicella vaccine administered.  lasted 3 days then dried up.
Varicella vaccine breakthrough. Diagnosed with Varicella on 5-26-09. Had over 200 lesions. No fever.
W/in week of 1st RABAVERT shot there were swollen patches of red skin in a circular pattern on my neck. Patches would reappear post workout. After flu vaccine 10/22 rash spread down torso and was more pronounced during workouts. Skin would sting and turn red during sweating.
Ice today, heat tomorrow.  Ibuprofen.  R leg swollen, red, warm to touch 3cm red, 8cm pink.
Sore arm after initial shot on 3/15.  Pain in groins started 3/17 making walking painful and slow.  Getting on and off commode I sometimes need help.   Pains in muscle area of arms  has subsided.  Called PCP to document how I felt on 3/19.  They returned call on 3/22 - said to take B12,Zinc,and Vit. C because I had questions about 2nd. shot.  Got 2nd. shot on 4/12 - seems like I'm back to  square 1.  Taking  Tylenol - 2 tabs every 6 hours. Helps  but I need to get back to normal.
HAIR FALL; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported 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 hair fall after last booster (dose number in series 2). It was reported that, "After my last booster my hair is falling out." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair fall was not reported. This report was non-serious. This case is a duplicate of 20221241559.
Initial case received from a health care professional on 11 October 2012. The female patient, age 42, with no pre-existing allergies or medical conditions had received a dose of FLUZONE vaccine intramuscularly on 08 October 2012 (lot number UH717AC, expiry 30 June 2013) into the left deltoid. Concomitant medications were not reported. It was reported that the patient received yearly flu vaccinations in the past. The patient developed hives and generalized body rash with redness, swelling and itching at the injection site and generalized malaise at an unspecified time. The patient was self treated with BENADRYL 50 mg every 6 hours, duration not specified. The patient was administered an unspecified steroid shot by their physician on an unreported date. No further information was available at the time of report. The symptoms were reported as beginning to resolve on 09 October 2012. Documents held by sender: None.
Recurring chills; Back muscular aches; The patient received booster dose; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Oct2021 at 13:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to yeast, sulfa and air borne allergens. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 19:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 19:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient had received other vaccines within four weeks prior to the vaccination and included influenza vaccine (MANUFACTURER UNKNOWN) (reported as senior flu) via unspecified route of administration in the left arm on 23Sep2021 for immunisation. On 08Oct2021 at 09:00, the patient experienced recurring chills and back muscular aches. 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 the events recurring chills and back muscular aches were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
PM of same day, fever 104; By 21JUL fever still inc severe h/a, vomiting, couldn't stand up; went to ER given Phenergan supp & ATB, ran many blood tests
Rash that looks like hives, size of a silver doller; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE URTICARIA (Rash that looks like hives, size of a silver doller) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 31-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Rash that looks like hives, size of a silver doller). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE URTICARIA (Rash that looks like hives, size of a silver doller) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient did not take anything to alleviate her symptoms
Patient was 17 years old at the time she received the COVID-19 booster. The patient should have received the Pfizer booster instead received the Moderna booster. No symptoms reported.
Blood in stools twice on same day, two days after vaccine administered. No fever or other symptoms.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-NOV-2011, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 06-OCT-2016, the patient was treated by a healthcare provider for Shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was unknown. Causality assessment was related.
Child received PPD and Flu vaccine 4-15-09.Next day he developed fever.Red rashes developed on forehead.Mom gave a dose of benadryl elixir 1 tsp and rash seem to come down a little.That same morning he bumped his head on the bed railing and sustained a little hematoma on forehead.
Vaccine was given as per usual protocol in the left deltoid. We received a phone call ~1 month later stating that since the time of the vaccine, he had ongoing left shoulder pain for which he had been treating with OTC remedies without improvement, and the pain was starting to affect his sleep. He was then seen in the office the following day, 10/25/18, and diagnosed with deltoid tendinitis and biceps tendinitis of the left shoulder. He was sent to physical therapy without resolution of his symptoms. He was seen by orthopedics, diagnosed with impingement syndrome of the left shoulder and received a cortisone injection. His sx improved somewhat, but didn't resolve. An MRI was performed 3/1/19 showing a "Massive rotator cuff tear, severe long head biceps tendinopathy with low-grade interstitial tear of the intra-articular portion, diffuse labral degeneration and near circumferential tear, and advanced acromioclavicular joint osteoarthritis, moderate volume glenohumeral joint effusion, decompressing into the subacromial/subdeltoid bursa via the full-thickness rotator cuff tear defect."
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-Jan-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX "did function as intended," and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-FEB-2016 the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Rash/welt at injection site: about a 3in diameter spot at injection site was slightly itchy, slightly swollen, very firm feeling, felt hot to touch and sensitive to touch (like a bruise).
This case was reported by a consumer and described the occurrence of skin necrosis in a 42-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. Previously administered products included hepatitis B vaccine with an associated reaction of no adverse event (1st dose). On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine (unknown) and the 3rd dose of Hepatitis B vaccine (unknown). On an unknown date, 48 hours after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced skin necrosis (serious criteria GSK medically significant), skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection. On an unknown date, the outcome of the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection were not recovered/not resolved. It was unknown if the reporter considered the skin necrosis, skin eruption, granuloma, folliculitis, scar, alopecia, prurigo nodularis, acneiform eruption, skin lesion, generalized eczematous reaction and infection to be related to Hepatitis B vaccine and Hepatitis B vaccine. Additional information: The female patient was vaccinated with a HepB vaccine series received 5 years ago at age 42. Within 48 hours after the second shot of Hepatitis B vaccine, her skin began breaking out in wounds. She had scars on her shoulders in the similar pattern of the shots (double as much on the left) but her main problem was her head. She had never ending acneiform lesions from ruptured hair follicles with chronic Granulomatous Inflammation and Necrosis. She got a biopsy that confirmed the above scalp issues. She hasn't scars on legs, hands, face or stomach. She was given the 3rd of the series despite having alopecia, skin lesion (head and arms), and treatment for 3 infectious diseases between the second and 3rd shot. Additionally, she had an area in her head that went pure white too and she heard this was due to trauma. At this point, her head/scalp had white acneiform lesions, prurigo nodules, ruptured hair follicles, viscid fluid, granulomatous inflammation, and necrotic tissue. She also get ID reactions (autoeczematization) at other sites of body from it.
Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
approx 3days p/vax pt exp absence type seizures, staring off into space & decreased level of responsiveness. had several episodes over period of 8days.
Hives at injection site starting 7 days prior. Swollen lymph nodes side of injection. Red area and warm to the touch at injection site starting 7 days prior.
pediatric second dose on 12/04/2020/received a third adult dose 4/29/2020; administration of a pediatric second dose/ adult pateint; administration of a pediatric second dose/adult pateint; Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 58-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on 5th November 2020).   On 12th April 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 29th April 2021, the patient received the 3rd dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 12th April 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product, underdose and drug dose administration interval too long. On 29th April 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the adult use of a child product, underdose, drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose paediatirc of Engerix B, which led to adult use of child product and underdose. The patient received 2nd dose paediatirc of Engerix B, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient received 3rd dose of Engerix B, less than the recommended interval, which led to shortening of vaccination schedule. The reporter stated that, 2nd dose was invalid and was not given immediately afterwards. The reporter also stated that, 3rd dose was considered as valid 2nd dose. No reaction reported. The reporter did not consent to follow up.
Pt recvd 1st dose of Engerix-B vax & on 12MAR91 exp rash on arms, back & stomach; event now described as splotchy rash on both arms, chest & back;
no additional AE reported; administered the RECOMBIVAX HB to a 17 year old patient instead of the VAQTA; patient was already fully vaccinated with the RECOMBIVAX HB; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-JAN-2022, the patient was vaccinated with hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) 5 microgram (mcg)/0.5 ml, 0.5 ml, lot # U005271 with expiration date on 21-NOV-2022 (route of administration was not reported), for prophylaxis. The reporter stated that she administered the hepatitis B vaccine (recombinant) (RECOMBIVAX HB) instead of the hepatitis A vaccine, inactivated (VAQTA) (wrong product administered). The patient was already fully vaccinated with the hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (extra dose administered). On the same day, after the error was discovered, the hepatitis A vaccine, inactivated (VAQTA) (25 units (U)/0.5ml, 0.5 ml, lot # U024504 with expiration date on 15-OCT-2022, for prophylaxis; route of administration not reported) was administered in the patient's opposite arm. No additional adverse event was reported.
Since 1978 had had flu vaccine with no reactions. Pt complains of soreness, swelling, chills, weakness, body aches a bit of nausea and dizziness. It worsened towards the right so took Motrin and Vicoden. Went to bed, felt humble at night. Next day, still felt bad, malaise lessened by 6pm. Third day felt tired. No head cold sin 15 years or flu since 1978. the first day, there was no runny nose or sore throat.