chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse events; The patient received improperly stored vaccine of Pneumovax 23; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 16-DEC-2019 the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot # S006778, expiration date 28-NOV-2020 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion above 47°F/9°C 49.8F for 43 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and chills was not reported. This report was non-serious.
Patient came to the pharmacy today requesting his second shot of the COVID-19 Pfizer vaccine. He reports that he has had a headache since getting his vaccine back in May 2022. However, he mentioned that today was the first day he did not have a headache. As a result of his recurring headaches, he has been taking Excedrin Extra Strength. The patient also reported getting a large black bruise at the site of injection. When observing his arm today, I could visually see a healing bruise located below his deltoid muscle, I assume from drainage. I asked the patient if the current bruise location was where he received his vaccine, but he was uncertain.
trouble breathing; shaking; This case was reported by a other health professional via sales rep and described the occurrence of difficulty breathing in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENACTRA for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and MENACTRA. On an unknown date, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced difficulty breathing and tremor. On an unknown date, the outcome of the difficulty breathing and tremor were unknown.   It was unknown if the reporter considered the difficulty breathing and tremor to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 reported as follows: The age at vaccination was not reported. The patient received dose of Bexsero and Menactra at the same time and experienced shaking and trouble breathing about 2 to 3 hours. It was the urgent care who told that event was from the vaccine. It was unknown if the reporter considered the difficulty breathing and tremor to be related to Menactra. It was the urgent care who told that event was from the vaccine. No further information was reported. The reporter consented to follow up.
Information has been received from an office manager concerning a 65 year old male patient who on 12-MAY-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot # not provided) instead of ZOSTAVAX (Merck). No adverse symptoms noted. This was not product confusion, it was a human error. The patient sought unspecified medical attention. Follow up information has been received from a office manager concerning an 65 year old male patient with no illness at the time of vaccination, penicillin allergy and enteric coated medication allergy who on 12-MAY-2010 at 10:15 am was inadvertently vaccinated with a first dose of VARIVAX (Merck) (lot # 665025/0992Y) subcutaneously into his left arm instead of ZOSTAVAX (Merck). No adverse events were reported. No further information is available.
Nausea; Vomiting/constant vomiting; Severe stomach and back pain; Severe stomach and back pain; Chills; Severe acid reflux; Night sweats; That feels like shooting pain and a knot; Severe ingestion; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 19Nov2021 at 18:00 (Lot number: 32030BD) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: SYNTHROID and LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL9261, Anatomical site: left arm), administration date: 23Jan2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL9266, Anatomical site: right arm), administration date: 19Feb2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 at 18:00, outcome "unknown", described as "Dose received 3/ dose number=3"; NAUSEA (non-serious) described as "Nausea"; VOMITING (non-serious) described as "Vomiting/constant vomiting"; ABDOMINAL PAIN UPPER (non-serious) and BACK PAIN (non-serious); both described as "Severe stomach and back pain"; CHILLS (non-serious) described as "Chills"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) described as "Severe acid reflux"; NIGHT SWEATS (non-serious) described as "Night sweats"; PAIN (non-serious) described as "That feels like shooting pain and a knot"; DYSPEPSIA (non-serious) described as "Severe ingestion"; all with onset 27Nov2021, outcome "recovering''. The events "Nausea", "Vomiting/constant vomiting", "Severe stomach and back pain", "Chills", "Severe acid reflux", "Night sweats", "That feels like shooting pain and a knot" and "Severe ingestion" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent SARS-COV-2 test by test type nasal swab and the result was negative.
Came in with the chief complaint of generalized fatigue nausea vomiting.  Admitted for weakness and physical deconditioning. He was diagnosed with COVID-19.  Tx w/ abx, Vit C, zinc; did not require O2.
Axillary lymph node-grape size, on side of injection site painful, movable and tender 5 days after the vaccine injection. No longer tender but still same size
10 to 15 minutes after vaccine, child complained about headaches and upset stomach (mother said she thought it was because child had not eaten).  Within a few minutes, she became rigid--was carried to bed, feet/hands were massaged--child fell asleep for 3 hours--had sweats.
Information was received from a licensed practical nurse on 15-JUN-2010. The patient received the influenza virus immunization (manufacturer unknown) in the past. The patient subsequently experienced an allergic reaction (no details were provided). Additional information has been requested. The case was originally reported to Merck & Co., Inc. (1006USA01826). Information was received from a licensed practical nurse (via a pharmaceutical company) on 06-JUL-2010. The nurse was unable to provide the patient's date of birth. The patient had experienced an anaphylactic reaction to the flu vaccine on an unknown date. It was unknown if the patient was hospitalized. The patient recovered. The nurse was unable to identify the flu vaccine manufacturer. The patient decided not be vaccinated with GARDASIL due to the flu vaccine reaction. No further information is expected. This case was considered serious due to medical significance. The company considered event unassessable in relation to AFLURIA due to lack of information regarding time to event onset. Information derived from this AE report does not change the current safety profile of the product.
Serious pain in right leg from the groin to the thigh for 2 days can?t walk at all
I am the epidemiologist reporting on behalf of patient. The patient received two doses of the Pfizer vaccine on 03/09 and 03/30. The patient was initially hospitalized on 07/19 with an initial diagnosis of pneumonia. The patient tested COVID + on 07/20 and again on 07/28 via a PCR test (vaccination breakthrough). The patient was reported as having died on 08/15. Cause of death is listed as acute, hypoxic, respiratory failure; pneumonia/ARDS; COVID 19; Acute on Chronic Renal Failure. Underlying health conditions include chronic lung disease (asthma/emphysema/copd), chronic renal disease.
1st vaccine administered on 1/21/2021  2nd vaccine administered on  2/19/2021 Booster vaccine administered on 10/31/2021  Approximately 2 months after 2nd vaccine, my hair began to fall out when I comb it after my shower.  Approximately 2 months after booster , my hair is falling out again when I comb it after my shower.   It is very thin now prior to the COVID vaccine.  I have been told that other individuals are experiencing the same thing.
Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 657758/0642U). On an unspecified date the patient experienced cellulitis. There were six cases of cellulitis with the same lot number. 2 cases were bad enough that they needed antibiotics. It was unknown whether medical attention was sought. The patient's outcome was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
I tend to have bad allergies around this time of year, and I started feeling those on the 15th- sneezing, congestion, runny nose. Sunday morning, I woke up feeling worse I had a bad headache, and I was very warm. I took my temperature, and I did have a fever, so I did an at home COVID-19 test. I ended up doing an E-visit with my doctor that same day. I have since then tested negative but have a lingering headache that really only feels better if I nap.
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis  sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days,  self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler,  later Prednisone course by medical professional symptoms completely resolved after 5 days
Patient's body temperature went up to 104 and she couldn't walk. She was is a lot of pain and was admitted to the hospital.
Left arm - pain from finger tips - shoulder - fever chills - aches everywhere. Fri 23rd 2015 shot was given Monday 26 had to be seen in medical clinic. Arm wont move still very painful. Recheck 28th. Friday January 23, 2015 at 8:00 am I met with Dr, I was given a pneumococcal 23 shot. By 11:00 am I was starting to get sick to my stomach and my arm felt like it was on fire and radiating to my finger tips and up my neck. After the 1 1/2 drive home I was beginning to get feverish and was extremely chilled. The pain in my arm was unbearable. Saturday I call ask a nurse who told me to watch it and if my fever went over 101 to go and get it checked out. Sunday I called back to dr office they told me to go the local hospital and get it looked at. Monday morning, January 26, 2015 I made an appointment to see my local dt. I am unable to abduct my left arm. I was prescribed hydrocodone apar 5-325. Because of the severe pain and inability to move my arm. I returned to the dr for a follow up at January 29. 2015. There was little to NO improvement since the first visit. This visit they prescribed: cyclobenzaprine 10 mg, nabumetone 750 mg and methylprednisolone 4 mg. I have a follow up appointment on Feb 2, 2015 to be revaluated. As of today January 29, 2015 my arm is still immoveable.
Within a few minutes of injection had tingling sensation in tongue, followed by a couple days of increased stomach gas, tons of burping, some reflux, took Prevacid. Tongue seemed to affected during the first several days, especially along the sides, red. Didn't get concerned at first.  The common sore arm, cleared up within a few days. On about day 10 noticed large area on arm where injection given, warm red area about 4 inches by 3 inches, itchy, resolved on own by day 14 or 15.  The next week (third week) mouth seemed to be getting more sore, swallowing harder, took prevacid. Today, day 27, mouth is sore, especially noticeable along sides where there are circle looking ulcerations where surface tissue seems to be missing. Very discouraged. Doubt I feel able to receive second dose which has been postponed, by myself, until day 30. Seeing primary doctor on day 30.
Joint pain in left shoulder starting on Thursday May 9, Joint Pain and mild swelling in right knee, right elbow and right shoulder as of Friday May 10th. Worsening left shoulder pain,  Headache, anorexia  and facial flushing Friday May 10th.
PT has Gardasil injection IM right hip upper outer quadrant on 6/8/07. On 6/13/07 pt was seen for painful swollen lymph node R inguinal area and tenderness from area of injection to lymph node. WBC count was not elevated.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and flu vaccine, both via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient's arm popped up a little bit. The event was non-serious with outcome of unknown. Follow-up (15FEB2015): Follow-up attempts complete. No further information expected.
RAPID COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to over 35 medications, allergic to eggs, no alcohol use, non-smoker and tooth infection. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported,1 total administered to the left arm on 18-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: UNKNOWN) dose was not reported,1 total administered to the left arm on 17-NOV-2021 for prophylactic vaccination. It was reported that on 03-JAN-2022 the patient had taken a rapid covid-19 test after contact with her Covid-19 positive grandson and that the rapid test showed positive although the patient had no symptoms. The patient stated that during the time that she tested positive she was being treated with azithromycin and prednisone for a tooth infection and mentioned perhaps these medications were the reason she had no symptoms (dose number in series 2). On 03-JAN-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive. On 03-JAN-2022, the patient experienced rapid covid-19 test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rapid covid-19 test positive was not reported. This report was non-serious.
Parents observed shoulder and arm jerking movements, beginning on evening of May 5, increasing to about a dozen a day for 2-4 days, then gradually decreasing. Pt had normal EEG on 5/10/03.
Less that two days after receiving the Menveo, Patient developed hives on her arms and legs.  They subsided and returned over the next 4 days.  She was treated with over-the-counter Benadryl.  She was not exposed to any new irritants or medications.  She has never had a reaction like this in the past but mom believes that Patient's cousin once had a similar reaction to the Meningitis vaccine
chills, body aches, headache, congestion, chest tightness, injection site tenderness Narrative:  Took OTC Motrin, migraine medications  Other Relevant History:
10 cm x 8 cm erythematous warm, indurated, non-tender right upper arm developed in the 48 hours after DTaP immunization treated with Keflex for possible cellulitis.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of VARIVAX lot # M046005 with an expiration date of 05-NOV-2018 (also reported as 18-NOV-2018) (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown) were inadvertently administered to the patients. No adverse effects were reported. The vaccines were exposed to a temperature of 6 degrees Fahrenheit for 5 hours (supported) before administration to the patients. There was no previous temperature excursion reported. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent for further contact.; Sender's Comments: US-009507513-1706USA004159: US-009507513-1706USA009733:
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Chest Tightness/Heaviness/Pain-Severe, Additional Details: Patient stated they developed chest tightness and now has a bit of hard time breathing. Also, there was an onset of rash. Patient applied hydrocortisone topically for rash; however, the rash is now sensitive to the touch.
Two days after the COVID vaccine I developed throat pain and difficulty swallowing. I monitored it and went to see my family NP on day 8 after no improvement with OTC tx. It progressively worsened and I had to puree my food to be able to swallow it. My NP felt crepitus in my neck during her exam and sent me for labs and ENT referral. Suspecting Thyroiditis.  I had severe throat pain and was unable to swallow any solid food. This lasted for over a week.  5/4- Still with altered swallowing.
p/vax pt dx w/varicella 9/24/99-vaccine failure;
CDC reports: 2 mo infant had fever to 100.4, two convuls episodes, screaming for more than 3 hrs, lethargy & hyporesponsive episode following immunization. Hospitalized for 1 day.
no adverse event on patient; temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old female patient. The patient had none pre-existing physician-diagnosed allergies, birth defects and medical conditions. Information of concomitant medications was not reported.  On 13-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form (1 dose); strength, route and anatomical location were unknown) (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; it was not specified which one was received by the patient) for prophylaxis at private doctor's office/hospital by the ordering physician. The vaccine was purchased with public funds and the vaccine-device was purchased with private funds. The vaccine experienced temperature excursion on 09-SEP-2022, and the time of the temperature excursion was 8 mins (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. This medication error occurred in the process of storage in clinical practice. This report was called because of a data logger.  No adverse event and no issues were on patient (no adverse event). The patient had no illness at time of vaccination. The patient did not die.   This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Parent states baby became extremely fussy and developed fever later in night on day of vaccine administration. Mom also noted baby to have a bulging fontanel. Baby evaluated in office and sent to ER. In office temp 100.4 O2 sat 100%.
slight pain in her left shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had episode of Chickenpox.).   On 25th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that she received first dose of Shingrix on 25th-December-2020 on her left arm and developed slight pain in her left shoulder, it lasted for 2days. The reporter had episode of Chickenpox. The reporter did not consent to follow up. This case has been linked to case US2021AMR053770  (had same patient for 2nd dose).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053271:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR053770:same patient, same reporter , 2nd dose US-GLAXOSMITHKLINE-US2021AMR053866:same reporter (husband´s case)
Myalgia, Arthralgia, Fever, Rash, Fatigue Narrative: