chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding a 22 year old male patient. The patient's relevant medical history, concurrent condition, and relevant past drug history were unknown. On 18-APR-2015, 22 year old patient was accidentally vaccinated with ZOSTAVAX, .65 ml (The lot number and expiration date - unknown). The pharmacist was concerned because ZOSTAVAX was not indicated for patients under the age of 50. It was also reported that the pharmacist was 99% certain that the patient did not receive ZOSTAVAX. There is no relevant lab data. As of 19-APR-2015, the patient was not on ZOSTAVAX. The outcome of a 22 year old possible being administered ZOSTAVAX accidentally was unknown. Additional information has been requested.
Bell?s Palsy treated with prednisone steroid and Valacyclovir anti-viral prescription
Developed a fever 104. Had febrile seizure 02/25/202. Seen at hospital 02/25/2003. Diagnosed with pneumonia and released. Started Augmentin po
About 15 minutes after the injection patient had throat tightness and tingling in face that lasted about 1.5 hours.  It felt similar to an allergic reaction she experienced 4 weeks earlier when given cefazolin.  Patient seen by physician and given Epipen and instructed to hold on receiving second COVID vaccine dose at this time and follow-up with allergy provider.
Received vaccine on 1/4. Started menstrual cycle on 1/16 which was 1 week early. 3 days into the cycle, heavy vaginal bleeding with large blot clots (golf ball size) starting on 1/20/201 and continuing until now 1/31, bleeding still going on.
During the observation period, pt was seen trying to take off his jacket, and proceeded to pass out and fall out of his chair. Pharmacist rushed to help him up and he complained of feeling very hot and sweating profusely. He did not have any swelling/itching of throat/facial area. Patient was provided cold water, and told to remain seated. Pt was asked questions such as name, what day it is, to establish if patient was alert and oriented. Patient complained of experiencing tunnel vision while passing out. He proceeded to pass out once more, while seated, this time the pharmacist was able to support him in his chair.  After the water and rest, patient said he felt much better and his girlfriend came to escort him home. He stayed for about 30 minutes before leaving and staff made sure he was feeling alright.
10 on pain scale experienced upper L arm is raised above head, abducted, adducted, flexed, or crossed in front of body. Pain is sharp. Area where injection given is also tender to touch.
Fever of 103.1, chills, shaking, muscle/ joints ache, fatigue, injection site redness and pain. Hard knot still on injection site 15 days post injection. All Symptoms lasted 48 hours.
"Moderna COVID-19 Vaccine EUA", 8 hours after shot - muscle aches all over body and chills,  24 hours after shot through today - headache, eye pain when moving eyes, chills, cough, head congestion .
This spontaneous report was received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent condition, medical history and concomitant medications were not provided. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # K010797, expiry 04-FEB-2016). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt experienced SOB and swelling of her throat approx. 25 minutes after her injection- she had already left the clinic, called to report sx, and was instructed to return.  She was given epinephrine IM and PO Benadryl and sx resolved
Patient was given MCV4, flu and HPV with consent and after vaccine initially given was asked if he was feeling alright. Patient's response was "yes". Patient was sent to office waiting room to wait 15 minutes. Around 4 minutes into waiting office staff and providers were called into waiting room to find pt unresponsive on floor and bleeding from his nose. Within about 30 seconds pt became responsive. Pt's pulse was 40 which then slowly came up to 68 within 2-3 minutes. Pt sat slowly and stood up was returned to exam room to rest. Provider did neurological work up which was WNL. Pt sent to local ER to eval if nose was fractured. X-ray revealed fracture.
The day after administration left arm was red, tender, enlarged node left axilla. Very tender axilla. By 8/26/13 enlarged anterior cervical nodes tender enlarged bilaterally sore throat headache, diarrhea. Strep test negative taken (8/22/13). Nodes palpated anterior cervical bilateral left axilla afebrile. Will monitor symptoms. Encouraged patient to return to our clinic or PCP if symptoms not improving or worse. Will consider labs at that time.
Weakness; shaking; numbness of tongue and face mostly right side; numbness of tongue and face mostly right side; This is a spontaneous report from a contactable consumer, the patient. This 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration in the left arm (at the age of 29 years-old) on 20Mar2021 at 01:30 PM for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant. Concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 20Mar2021 at 02:00 PM, the patient experienced weakness, shaking and numbness of tongue and face mostly right side and was hospitalized for the events. Treatment was received for weakness, shaking and numbness of tongue and face mostly right side. The clinical outcome of weakness, shaking and numbness of tongue and face mostly right side was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.                     Field Name: NO days hospitalization Field Value: 1  Field Name: Hospital name Field Value: Name  Field Name: Hospital city Field Value: Name Field Name: Hospital state Field Value: Name  Field Name: if patient recovered Field Value: Recovering  Field Name: if treatment ae Field Value: Yes Field Name: Ae treatment  Field Value: Tylenol and fluids with Benadryl  Field Name: if covid prior vaccination Field Value: No   Field Name: If covid tested post vaccination Field Value: No  Field Name Known allergies Field Value: No  Field Name Other medical history Field Value: No  Information about lot and batch number was requested.
Headache, Fever, chills, sore throat Narrative:  Headache, fever 101.2, chills, sore throat; treating with ibuprofen and tylenol.
RASH FROM BUTTOCKS TO THE POPLITEAL SPACE. HEADACHE, WITH BLURRED VISION. "FELT AS THOUGH HEART WOULD SKIP A BEAT". COLD SWEATS.
Chills, body aches, high fever over 100F . Currently using ibuprofen and Tylenol to minimize the fever along with cold compress. Pain and weakness in the arm of the injection site. Also using Tylenol and cold compress.
By the night of the shot, my arm was swollen, bright red from shot site and wrapped around inside my left arm. The nerve endings were alive and well near injection site. That was the worst.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 83-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 24-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable Tdap vaccine after a temperature excursion, which led to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
This case was reported by a healthcare professional and described the occurrence of loss of consciousness in a 54-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included hypercholesterolemia. previous vaccination included Engerix B (GlaxoSmithKline) given on 3 October 2006 and 3 November 2006. Concurrent medications included Zetia. On 7 April 2007 the subject received 3rd dose of Engerix B at 1.0 ml in the left arm. On 9 April 2007, 2 days after vaccination with Engerix B, the subject experienced loss of consciousness for about 3 minutes and was vomiting. The subject was taken to the emergency room and released. Within two weeks, the subject developed a fever, an all over body rash, chills, swollen lymph nodes and extreme generalized fatigue. The subject reported that she was seen by multiple physicians and underwent many blood tests and Ct scans without any clear diagnosis. She was also treated with high dose Penicillin without benefit. The subject was unable to work starting 18 July 2007 due to her symptoms. It was documented that the subject was hospitalised at some point and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject stated that she began to notice improved functioning on 28 December 2007, when she noticed that she was not as fatigued when she climbed the stairs or when she would go to the store. Her fever was also resolving. She was diagnosed 11 January 2008 as having a reaction to hepatitis B vaccine. The reaction was described as systemic. Improvement was specifically reported for vomiting, rash and fever. All of these events with the addition of loss of consciousness were considered probably related to treatment with Engerix B.
Random itching in the back of my neck and behind my ears. Then I notice I start to feel itchy on random parts of my body (arms, legs, chest, neck, butt) and when I itch it big welts start to form (hives). I also have noticed that the palms of my hands turn red and hot. This happens mostly in the morning and at night. Believed to happen more after I eat or go inside my apartment after being outside.
This case was reported by a consumer via call center representative and described the occurrence of cold in a 35-year-old male patient who received FLULAVAL quadrivalent. Concurrent medical conditions included sore throat (pre-existing). Concomitant products included DAYQUIL and ZYRTEC. On 29th September 2015, the patient received FLULAVAL quadrivalent. On 29th September 2015, 2 hrs after receiving FLULAVAL quadrivalent, the patient experienced cold, headache, runny nose and sneezing. On an unknown date, the outcome of the cold, headache, runny nose and sneezing were recovering/resolving. The reporter considered the cold, headache, runny nose and sneezing to be possibly related to FLULAVAL quadrivalent. Additional details were provided as follows: On 29th September 2015, at 9.30, the patient received FLULAVAL quadrivalent batch number and expiry date unknown in left arm. The patient experienced severe cold, headache, runny nose and sneezing.
SEVERE VOMITTING, SHAKING, TEMP 102 DEGREES APPROXIMATELY 6-8 HRS AFTER VACCINATION.  SEEN BY PHYSICIAN AND GIVEN PHENERGAN SUPPOSITORIES, PREDNISONE, AND ATARAX 25MG.
pt admitted to hospital; positive test for COVID; placed on O2; pt's condition worsened; found to have reactive lymphocytic pulmonary infiltrate s/p bronchoscopy; intubated post procedure; treated with dexamethasone for COVID; AKI worsening; vasopressors needed; family opted for comfort care, and pt died in the hospital
Fever (Tmax 102.2F), chills, fatigue, muscle ache, headache
Syringe failed and resulted in unknown, but relatively large amount of vaccine running down patient's arm
HIVES (GETTING WORSE); 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: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 23-MAR-2021, the subject experienced hives (getting worse). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives (getting worse). This report was non-serious.
INADVERTENTLY VACCINATED BEFORE THE AGE OF 12  YRS OLD. UNABLE TO REACH CONTACT FOR INFORMATION. WRONG DATA ENTRY SUSPECTED
Throat began to feel like it was tightening. Began to have trouble swallowing and breathing. Was seen in Hospital Emergency Room. No treatment. Released and symptoms were resolving.
Warm to the touch Injection Site; rash aggravated; Itching sporadically Injection Site; Rash Injection Site (1.5" X 1") Top to Bottom; Arm hurt when lifted the arm (Mild); This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm hurt when lifted the arm (Mild)), INJECTION SITE WARMTH (Warm to the touch Injection Site), RASH (rash aggravated), VACCINATION SITE PRURITUS (Itching sporadically Injection Site) and VACCINATION SITE RASH (Rash Injection Site (1.5" X 1") Top to Bottom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for an unknown indication.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt when lifted the arm (Mild)). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching sporadically Injection Site) and VACCINATION SITE RASH (Rash Injection Site (1.5" X 1") Top to Bottom). On 23-Jan-2021, the patient experienced RASH (rash aggravated). On 26-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site). At the time of the report, PAIN IN EXTREMITY (Arm hurt when lifted the arm (Mild)), INJECTION SITE WARMTH (Warm to the touch Injection Site), RASH (rash aggravated), VACCINATION SITE PRURITUS (Itching sporadically Injection Site) and VACCINATION SITE RASH (Rash Injection Site (1.5" X 1") Top to Bottom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included benadryl.  No relevant concomitant medications were reported.
Patient reported chills, rigors, malaise, weakness, and redness surrounding injection site starting approx 24 hours after administration. Patient reported the injection site was painful, swollen, and the redness was spreading. She was seen at urgent care 11/2/22 and prescribed keflex. Redness continued to spread. She was seen in PCP office 11/4/22 and prescribed bactrim.
Low grade fever since I received the first shot - 99 - 99.5.  I typically run between 97.2 -97.5.
Feverish; Felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feeling bad. On an unknown date, the outcome of the fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: This case was reported by the patient's wife via interactive digital media. The reporter stated that the patient had a reaction to his second shot. The patient was feverish and felt bad for about a day or two, which was far better than what shingles was like. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case has been linked with cases US2022AMR129222 and US2022AMR129233, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR129222:Same reporter US-GSK-US2022AMR129233:Same reporter
low grade fever 100, dizziness, starting on 26JAN (on/off) lasting for 7 days;
Hives; back, buttocks, arms, shoulders; still there as of 12/04/2014.
Information has been  received from a nurse concerning an approximately 74 year old female patient with no drug allergies who on Oct 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). the nurse reported the symptoms began two to three hours post vaccination. The patient presented to the doctors office Oct 22 2004 with complaints of injection site swelling, soreness, and redness. The patient was treated with oral diphenhydramine (Benadryl), heat or ice pack, and acetaminophen (Tylenol). It was reported that another female had a similar experience (WAES0410USA04294). Additional information has been requested.
The morning following the vax, the pt developed a high fever, was lethargic and flu like. By that evening was much better.
10:20 AM Vaccine given - Pfizer 1st Dose 10:25 pt in BR coughing, heaving, vomiting, I went in to assist and he said his throat was itchy and he felt like he needed to cough and vomit and symptoms started right after vaccine  Moved to exam room, continued coughing   BP: 150/84 10:33 am  10:30am 50mg Benedryl 50mg given IM R deltoid, within 15 minutes coughing decreased and then stopped  Emergency services had already been called. pt advised  even though s/s decreased still needs ER evaluation as When Benedryl wears off COVID vaccine is still in his system. Pt agreeable and EMS transported pt to hospital VIA ambulance. Pt alert and oriented. L/n aware and present. Benedryl 50mg/ml Lot #080014 x 812022 1ML administered IM R deltoid
Chest pain- felt it in my chest through my back intense pain, shortness of breath  Took a Tylenol  Started at 4:00 pm and again around 7:30 pm Continued off and on from April 14 to April 16.
Onset of symptoms about 2 weeks after booster shot received. Symptoms include skin sensitivity. Very itchy, hives/rash will form wherever I itch my skin. hive/rash will persist for ~30 min before dissipating.  Feels like skin is writhing.
arm  pain; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on Jan2021 (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain on the day and on the next day of the vaccination on an unknown date in Jan2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme arm pain, nausea, shivering, muscle pain, redness, rash, very tired and weakness, swelling of right shoulder and area, headache
Reported from mother that client had a seizure. State taken to hospital and "checked out where his tests looked ok.  We are home now and he seems way better and acting more normal now".
I have a blood clot in my right arm that is very large and visible. My blood pressure is significantly higher than normal and I have tingling in my left foot. I also have a severe headache. From Saturday through Wednesday I had extreme fatigue, nausea and a splitting headache. The splitting headache lasted through Friday morning.
weak since the second dose; Received the first dose in May and the second dose in July; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak since the second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose in May and the second dose in July) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ASTHENIA (weak since the second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose in May and the second dose in July). In July 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the first dose in May and the second dose in July) had resolved. At the time of the report, ASTHENIA (weak since the second dose) had not resolved.            No concomitant medications were reported. No treatment medications were provided.
Teeth infection; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4310130-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single, intramuscular, administration date 02May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1150237) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID-19"; TOOTH INFECTION (non-serious), outcome "not recovered", described as "Teeth infection". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Teeth infection and COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Teeth infection was not reported and for COVID-19 was possible with PFIZER BIONTECH COVID-19 VACCINE.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective, Suspected COVID-19 and Tooth infection and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
No adverse effect; administered 2 doses of M-M-R II on the same day; This spontaneous report was received from a nurse referring to a patient of approximately 12 months old. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 23-DEC-2019, the patient was inadvertently vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration and anatomical location were unknown) with lot # R031680 and expiration date 01-NOV-2020 and lot # S005248 and expiration date 20-FEB-2021 for prophylaxis (extra dose administered). No adverse symptoms were reported. The reporter stated that the additional dose was administered due to user error and no product quality complaints or errors in labeling or packaging, there was no product confusion. There was no product quality complaint associated with the case.
lump @ site of inj area of patchy nodilar vessicular-urticarial like mixed lesions; some facial/nodular inganation; Keflex, DPH; recheck 2-3 days