chrisvoncsefalvay/vaers-outcomes huggingface dataset:
You will feel bad for a day or two after the shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: You will feel bad for a day or two after the shots). The outcome of the feeling bad was recovered/resolved.  It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  It was unknown if the company considered the feeling bad to be related to Shingles vaccine.  Additional Information: GSK receipt date: 09-MAR-2023  This case was reported by a patient via interactive digital media. The patient stated that, he/she did not know, how well the Shingles shots works, but if there was a chance it would help prevent them, he/she had made sure that, he/she would got it after he/she would become eligible when he/she had turned 50. It requires two shots about 3 months apart.  The patient stated you would feel bad for a day or two after the shots, but it sounded like it was a lot better than getting shingles. The follow up would not possible as no contact details were available.
p/vax pt exp tachycardia, as well as pain, redness & swelling @ inj site;pt was eval in ER;
Immediately after the patient received the vaccine, the patient turned pale and said, "I feel a little dizzy and my vision is blurry."  The patient fainted and ended up having a seizure.  Once the patient regained consciousness, the patient was nauseated and vomited.  Minutes later she had another seizure but immediately came out of it.  We asked the patient if this happen to her during the first dose and she said it did not.  The patient does not have a history of epilepsy.  The patient's mother did say she had the exact same reaction when she had braces put on.  The patient sat in the waiting room for 30 minutes while drinking water.  Before the patient left, we had check up on her and she said she felt completely fine.  I (the pharmacist) called the mother a couple of hours later to check up on the patient.  The mother said she felt fine as if nothing ever happened.  I did recommend to her that her daughter  gets checked up at urgent care today just to be on the safe side.  The mother said she has an appointment with her primary care next week.
a few hours after getting vaccine pt developed swelling and tenderness along L lateral scapula and extended under L arm.  Along latissimus dorsi.  I saw patient on 7/19/21 and pt was still complaining of mild swelling and tenderness.  No redness or induration.  No signs of infection.
5/9/21 - Pain on right toe, noticeable when walking and tender to touch. Gait affected. 5/11/21 - Pain worsened to the point of being unable to sleep. Right toe pain sensitive to slightest touch and flex, impairing normal walking. 5/11 - 5/19 - Pain and swelling to right foot persisting, necessitating MD visit. Unable to bear weight to foot. 5/20 - Improvement of symptoms
This spontaneous report as received from a registered nurse refers to a 19-month old child of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015 the patient was inadvertently vaccinated with a dose of ZOSTAVAX subcutaneously (dose volume, lot number were not reported) instead of the intended dose of PROQUAD (Merck). The nurse confirmed that the administration error occurred because the pharmacy dispensed ZOSTAVAX instead of PROQUAD (Merck) in error and the unspecified healthcare worker who administered ZOSTAVAX did not notice the error before she administered the dose to the patient. No product confusion was reported. No adverse effect was reported. Additional information has been requested.
Developed cold, sore throat and diagnosed with Strep throat. Not sure that this is COVID related. My husband is a teacher, and he had  Strep throat and then I was diagnosed with Strep throat.
Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA177371 and 2018SA174785. This case involves a 51 years old female patient who experienced redness of the site, tender to touch, right arm swollen, pea size knot under injection site and fever 101, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA via intramuscular route in the right deltoid. The patient developed a non-serious redness of the site 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious tender to touch 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious right arm swollen 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious pea size knot under injection site 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious fever 101 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included no lab tests). Final diagnosis was fever 101, pea size knot under injection site, right arm swollen, tender to touch and redness of the site. The patient was treated with KEFLEX. The patient outcome is reported as Unknown for redness of the site, as Unknown for tender to touch, as Unknown for right arm swollen, as Unknown for pea size knot under injection site and as Unknown for fever 101.
Patient received Janssen COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine.
Narrative:  Following receipt of second dose of COVID vaccine, patient reported mild headache/nausea that were not documented as being present following first dose.
I had a fever of 103.5 , chills, headache, very sore arm , & very tired. Monday night it was all swelled up and red I couldn?t use it I dropped everything I picked up with my left arm. I went to urgent care by my doctor? Order as they didn?t have any appointments that day after it spread more on Tuesday they thought I maybe had cellulitis from the shot. Urgent care said it was either cellulitis or I was having a reaction to the booster. Wednesday & Thursday the redness spread even more so went to see my doctor on that Friday and he felt it was just an allergic reaction to the booster, he said it was happening to a lot of people.  It was red & swollen through the next week before it went away. I still have a headache, chills per say just feel freezing cold all the time
WENT TO BED AT 9PM 6 HOURS AFTER 2ND PFIZER VACCINE. 7AM NEXT MORNING SHE WAS PRONPOUCED DECEASED AT HOME IN HER BED
received a dose of saline instead of the yellow fever vaccine with no reported adverse event; Initial information received on 11-Jul-2022 regarding an unsolicited valid non-serious case received from a physician. GMI number: 01184725  This case involves an unknown age and unknown gender patient who experienced received a dose of SALINE [SODIUM CHLORIDE] instead of the YELLOW FEVER VACCINE - [YF-VAX] vaccine with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. This case is linked to cases 2022SA279048, 2022SA276277 and 2022SA278093.    On an unknown date, the patient took Saline [Sodium Chloride] at (unknown: strength, formulation, dose, frequency, batch number and expiry date) for unknown indication. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - (with an unknown strength, formulation, frequency, batch number and expiry date) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient developed a non-serious event of received a dose of saline instead of the yellow fever vaccine with no reported adverse event (wrong product administered) (latency: unknown).   Action taken: Not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On 10-OCT-2014 the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified). No concomitant therapies were reported. On 11-OCT-2014, the patient experienced rash on her leg. The patient was referred to her unspecified physician for diagnosis and treatment (details unspecified). The outcome of rash on her leg is unknown. There was no product quality complaint (PQC) involved. Causality assessment was not provided. Additional information has been requested.
Patient with history of latex allergy. No adverse reaction to first vaccine. After 2nd dose of COVID-19 vaccine today, pt complained of rash bilaterally upper extremities and trunk and general pruritis. Denied any swelling or itching of mouth or throat. VS: HR90, BP 140/100, O2 sat 97%. 20g IV started in Left hand and 25 mg Benadryl given IV. Patient transferred to ED for observation.
01/08/22 presents to ED for "right testicle pain and swelling". PMHx of "CVA, urinary retention, constipation"
Pt recvd Engerix-B vax; Reporter is not sure how many doses were given but the pt had @ least 1 dose; 1OCT91 had elevated "ALT" & reporter indicated that pt could not donate blood;
Information has been received from a physician concerning a 67 year old male pt, who on 11/5/02 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (lot 643503-0541M). On 11/6/02 the pt developed SXs of cellulitis in the upper arm that included swelling, redness and pain. An ER/doctor visit was required and the pt was treated with Tylenol, Motrin, and Keflex. The reporter indicated that the pt's experience was an other important medical event (OMIC). Additional info has been requested.
Pneumonia due to COVID-19 virus; Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus
Tiredness; sleeping all day; Warm and hot to touch; Swollen; Rash; Itching; Pain in arm; Headache; suspects injection was not administered intramuscularly; Localized reactions; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2020, the patient received the 1st dose of Shingrix. On 9th July 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 10th July 2020, the patient experienced injection site warmth, injection site swelling, rash, pruritus, pain in arm and headache. On 11th July 2020, the patient experienced tiredness and sleepiness. In July 2020, the patient experienced local reaction. The patient was treated with non-drug therapy (Cold Compress). On 12th July 2020, the outcome of the tiredness was resolved with sequelae and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site swelling, rash, pruritus, pain in arm and local reaction were recovering/resolving and the outcome of the headache was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site warmth, injection site swelling, rash, tiredness, pruritus, pain in arm, headache, local reaction and sleepiness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but patient was over 65 years old. The next morning after receiving vaccine, the patient had a mild headache. Later on, consumer reported developing pain in left arm and then itching. The patient observed her arm in the mirror and noticed a rash 2 x 3 inches in area approximately 1 inch below the injection site. She suspected injection was not administered intramuscularly as indicated in Shingrix prescribing information, which led to intramuscular formulation administered by other route. The patient described area as swollen, both warm and hot to touch and itching increased with each day. On Saturday 11th July 2020, consumer reported extreme tiredness and sleeping all day which was resolved by Sunday morning. Headache resolved at an unspecified time. Localized reactions not resolved but becoming better. The patient's doctor recommended cold compresses. The reporter did not consent to follow up. Consumer declined to provide demographic information and health care professional follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in narrative.
Noted hives on bilateral legs below knees. Patient took CLARITIN this morning and BENADRYL PO last afternoon and evening.
Pt reported that arm started to hurt around 2000H, but she went to sleep. Pt states she woke up at around 0200H and her whole body hurt, and her skin felt on fire. Pt states that she took Motrin at 0300H, but it didn't help pain and burning subsided slowly over the next 5 hours. Pt still reports pain and burning at the injection site.
Within about half an hour after getting the vaccine I had a bobble head feeling when I was in the car. Then when I traveled on an airplane and went into another climate change I had that strange bobble head feeling again. If I shook my head it felt like my brain was rattling around in my head with fluid. That feeling in my head only lasted for about 24 hours.
The patient was vaccinated with Jynneos vaccine intradermally; The patient was vaccinated with a 0.1 milliliter dose of Jynneos vaccine; Case reference number US-BN-2022-001978 is a spontaneous case report initially received on 19-Aug-2022 from a healthcare professional via agency (reference number: USBAV22-1090), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On 17-Aug-2022, the patient received Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00013) at a dose of 0.1 milliliters, at an unknown anatomical site of administration, intradermally for monkeypox prophylaxis (explicitly coded as 'Inappropriate route of vaccination', 'Vaccine underdose').  At the time of this report, it was unknown whether the patient experienced any adverse events due to Jynneos.  Additional information received on 19-Aug-2022 from Bavarian Nordic included local BN case ID.  This case is linked with US-BN-2022-001979 (same reporter).; Reporter's Comments: A patient of unknown age and gender received a dose of Jynneos at a dose of 0.1 milliliters intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and vaccine underdose. No associated adverse events have been reported. Both inappropriate route of vaccination and vaccine underdose are listed per company convention. The patient's medical history and concomitant medication details were not reported. Both inappropriate route of vaccination and vaccine underdose are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender received a dose of Jynneos at a dose of 0.1 milliliters intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination and vaccine underdose. No associated adverse events have been reported. Both inappropriate route of vaccination and vaccine underdose are listed per company convention. The patient's medical history and concomitant medication details were not reported. Both inappropriate route of vaccination and vaccine underdose are not related to Jynneos, but to a human factor. The case is non-serious.
Severe Autism.  6/19/07 Received PCP medical records Received provider medical records which include records from hospital, school, audio/speech & labs. Language delays noted approx age 2 & was referred to early intervention which did reveal language & social delay, diminished eye contact & short attention span.  9/03 started 5-day program at special school w/ST, PT & OT. FINAL Dx: Autism Spectrum disorder; global developmental delay; pica; intellectual limitation. 1/4/10 Autism,  no speaking.
Information has been received from a registered nurse regarding a 8 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
According to provider note: "Patient complained of nasal congestion, chest tightness, and diaphoresis approximately 20 mins after 2nd COVID vaccine.  Patient has allergy to seafood and states this is what it feels like when she has an allergic reaction." Patient received Benadryl 50 mg IV x 1 dose famotidine 20 mg IV x 1 dose Solumedrol 125 mg IV x 1 dose  Zofran 4 mg IV x 1 dose---patient because nauseated after receiving Benadryl Normal saline 500ml bolus x 1 dose Patient improved after receiving  medication
Severe chills, fever, indigestion, nausea, fatigue and muscle aches. Fatigue and bad nausea still on day four after booster along with general malaise.
The night I got the shot, my arm developed a large red spot that swelled up and was very painful. On the 21st I still have the red spot . It is not longer painful but it is still hot
Heavy chills; Very weak; Could not eat; Asleep all day long, could not seem to wake up; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 19Mar2021 at 17:30  (last Friday night) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller mentioned she had the reverse problem. Caller mentioned that she fell asleep around 8 PM, and the next morning, reported to have experienced heavy chills, very weak; could not eat, asleep all day long and could not seem to wake up. Caller was asking if those were normal effects of the vaccine. Offered to transfer to Safety, but caller declined. Caller mentioned that she tried calling on Sunday but had the same recording and was not able to make it through the queue. Referred to HCP for further guidance. Patient questioned if vaccine have the virus. Caller mentioned that she did had it for a month. Patient questioned if the second dose more potent. Explained to caller that it would be the same dose, quantity and ingredients, and explained to caller that there are many factors to consider, gave disclaimer, and referred to HCP for further guidance. No PQC was present. Outcome of the events was unknown.  Information on lot/batch number has been requested.
About 10 min after vaccine, arm began to ache from shoulder to wrist. Progressed to severe pain (7/10) X 36 hours, gradually improved. Some tenderness with palpation remains at time of report.
Right deltoid with redness, induration, pain, pruritus at injection site beginning day after being vaccinated. Hydrocortisone 1% dispensed for pruritus, encouraged ice QID, TYLENOL for pain. PREVNAR 13 documented as allergy in pt's chart.
Headache, Neck pain, fever, myalgias, weakness, numbness, tingling, pain with inspiration at rib cage.
Pt. had bloody stools 17 days after receiving ROTARIX, dx with intussusception. Went to hospital 12/31/10. Dx with formula intolerance - on ELECORE.
Patient was going to or from hot tub in the backyard on 9/12/21 about 11 PM.  Found her 9/14/21 at about 7PM laying in her backyard.  Had been there about 45 hours.  Ambulance transported her to Medical Center where she was diagnosed with a large blood clot in her brain that caused a massive stroke on the right side of her brain.  Was then intubated and placed in a medical induced coma until 9/28/21 when she was transferred from ICU to Hospice and extubated.  She expired 10/2/21 at 23:15 pm.
Patient developed a raised bump. The bump is on site of injection and is warm to touch, itching, and red.Patient sought medical attention via urgent care on Sunday after noticing symptoms not going away.  She was treated with benadryl and a steroid cream. She was advised by her provider to report symptoms to pharmacy and VAERS.
This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient's mother) reported that a 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not available), via an unspecified route of administration on 16May2021 at 12:30 PM (at the age of 13 years old) as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site, vomiting and feeling tired on 16May2021. The reporter said that her son's second dose was scheduled on June 6, 2021. The outcome of events was unknown.  Information on the lot/batch number has been requested.
I felt like I had food poisoning type symptoms. It was 8 hours after the vaccine that I had extreme stomach pain, was feeling  nauseous, and throwing up. I contacted nurse and was slurring my words.  Shortly after I blacked out  for about 4 hours. I felt better after the 4 hours.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates ("a few weeks ago") the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # K015312, expiration date 17-DEC-2015) subcutaneously. No adverse effects reported. Additional information has been requested.
By late afternoon my left arm and armpit felt a little sore.   I went to bed around 8 p.m. and awoke at 11 p.m. ~12 hours after receiving my second vaccination, with chills, arthralgias, myalgias, headache, a slightly stiff neck.  I got up to take some Acetominophen and Ibuprofen.  My hands shook badly and I had trouble opening the bottles and getting out a couple of pills (APAP 500 mg, Ibuprofen 400 mg).  I returned to bed and eventually the symptoms subsided and I fell asleep.  In the morning I had extreme lethargy, felt dizzy after standing a few minutes to the point of pre-syncope as I made it back into bed.  I slept on and off most of the day (Saturday).  By Sunday, I was much improved but still had little energy and took it easy.  My left axilla still felt a little full but I could not detect any lymph nodes.  By Monday, I was pretty much back to normal including my left arm and axilla.