chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received concerning a 17 year old female with no medical history or allergies who on 09-APR-2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 09-MAY-2007, a month after receiving the vaccine, the patient developed small clear blisters on top of her hands. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. Initial and follow up information has been received from a mother concerning a 18 year old white female student with no medical history or allergies who on 09-APR-2007, was vaccinated in left deltoid with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On 11-APR-2007, the patient developed small clear blisters on top of her hands/small blister-like pimples on top of her hand. No medical attention was sought. No laboratory diagnostic studies were performed. On 16-APR-2007 the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information is not expected.
One month old full term infant received hep B vaccination 2/11/17. On 2/12/17 left leg, anterior thigh is mildly swollen, not red, slightly tender, slightly warm.
Weakness, fatigued, nausea, dry heaves, dizziness, lightheadedness, dyspnea with exertion, malaise, anorexia, not eating or drinking and dark runny stools.
On 2/25 he started having severe itching all over for the knees up. On Friday he had facial swelling and swelling with both hands and puffy fingers. Between his fingers he became very red and his face was red.
A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weakness, brain fog.
2nd dose 02/26/2021. tested (+)PCR 12/01.  Case not interviewed thus no other info known about them.
Peeling of the skin of both hands; This case was reported by a physician via sales rep and described the occurrence of skin peeling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR078931   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and experienced peeling of the skin in both hands. The reporter consented to follow-up. Additional supportive information: For the tolerance of 2nd dose of Shingrix, refer linked case US2022AMR078931.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR078931:Same reporter.
Body aches; Nauseated; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary incontinence (it was under control with Flomax). Concomitant products included tamsulosin hydrochloride (Flomax).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced general body pain and nausea. On an unknown date, the outcome of the general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with urinary incontinence prior to receiving the Shingrix vaccine, but it was under control on Flomax. The patient received Shingrix on left arm and experienced body aches and felt nauseated. These symptoms lasted for less than 24 hours. For tolerance to the 2nd dose of Shingrix, refer case US2019GSK086539. No additional information was reported. The reporter consented to follow up. The reporter gave permission for his physician to be contacted.
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. On 16-JAN-2014, the patient was vaccinated with GARDASIL (lot # J011272 expiry date 21-APR-2016) 0.5 ml, intramuscular for an unknown indication. It was reported that the patient received improperly stored GARDASIL. The GARDASIL was stored at a temperature of 29 F for 15 hours. No adverse event were reported. No product quality issue was noted. Additional information has been requested.
Rash all over body that lasted two days. Red cheeks that come and go since 11/24/2016 still ongoing.
Chills, lasting for 2 days, fatigue lasting for 2 days, very sore arm 4 days
After both of my vaccines about a day or 3 days after I had some trembling in my hand when I go to write. It is also accompanied by some slight arm pain. It goes away after 3-5 days.
Patient has side effects after the 2nd dose like when he had COVID in March; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Patient has side effects after the 2nd dose like when he had COVID in March) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Patient has side effects after the 2nd dose like when he had COVID in March). At the time of the report, ADVERSE REACTION (Patient has side effects after the 2nd dose like when he had COVID in March) outcome was unknown.            no concomitant medications are provided. Treatment information were not provided.
diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included constipation from an unknown date and unknown if ongoing Caller described herself as an advantage in having diarrhoea because she is normally constipated. The patient's concomitant medications were not reported.The patient experienced diarrhoea on an unspecified date. The outcome of the event diarrhoea was unknown.  Information about the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Approximately 29 hours after receiving my first dose of Covid-19, I began feeling itchy all over my body (particularly on my back). I woke up the next morning (14 Mar 2021), and noticed raised wheals on both upper legs, my upper back and lower abdomen. I did take approx 10 mg of Benadryl and it subsided a little. I became increasingly itchy once again, later in the day (14 Mar 2021) and took a second dose of Benadryl at approx 10:00 PM PST. This dose was effective and I awoke this morning (15 Mar 2021) with no symptoms.
Since A week or so after second shot I have been fatigue, feverish, brain fog, cough, achy   Have been to doctors on antibiotics   Still not feeling up to par
Rapid heart rate, Migraine (worst ever), fainting, numbness in hands and arms, chills, paleness, weakness, dizziness, hyperventilation, and low temperature.
RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 74 year old  female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The batch number was not reported and has been requested. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3mL of dose (vaccine under dose and off label use) (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209679, 20211209706, 20211209740, 20211209843, 20211209880, 20211209912, 20211209921, 20211209976, 20211210019, 20211210106, 20211210670, 20211210662, 20211210610, 20211210590, 20211210585, 20211210555, 20211210409, 20211210408, 20211210385, 20211210350, 20211210334, 20211210197, 20211210180, 20211210165, 20211210160, 20211210159, 20211210143, 20211210141, 20211210112, 20211210112, 20211209551, 20211210058, 20211209775, 20211210733, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210588, 20211209775, 20211209874, 20211209880, 20211210824 and 20211209884.
Vaccine administered on 10/4/09. Patient called pharmacy on 10/6/09 and states had black spots and red rash over body. Went to see Dr. on 4th day. Was treated with ice pack and Tylenol. Black patches was present for more than 7 days.
other zoster-related conditions; shingles; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 22-APR-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, anatomical location, lot# and expiration date unknown) by a physician at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of the use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles and other zoster-related conditions was considered as not recovered and causal relationship was assessed as related.
RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE). At the time of the report, TINNITUS (RINGING IN EARS THAT STARTED AFTER GETTING COVID VACCINE) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: found nothing wrong.         No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
30 minutes post vaccination C/O dizziness, double vision/feeling warm/nauseated/(L) arm aches from deltoid to wrist. C/O fatigue, malaise.
she broke out with the blisters on her left side of face by eye, goes up to her crown of her head on the left side.; area turned red; tingle on the left side of her face, forehead and scalp; flu like symptoms; vomiting; This case was reported by a nurse via sales rep and described the occurrence of tingling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 12th October 2021) for prophylaxis.   On 20th May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced vomiting and influenza-like symptoms. On 21st May 2020, the patient experienced tingling. On 22nd May 2020, the patient experienced erythema. On 23rd May 2020, the patient experienced blister. On an unknown date, the outcome of the tingling, erythema, blister and influenza-like symptoms were unknown and the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the tingling, erythema, blister, vomiting and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and started to had a tingle on the left side of her face, forehead and scalp and the area turned red.  The patient broke out with the blisters on her left side of face by eye, goes up to her crown of her head on the left side and had been vomiting a for two days and has flu like symptoms after the injection.
Vaccine exp 5/25/2017. Patient experienced shortness of breath, shivering, nausea, vomiting.
Within 3-4 hours of getting the vaccine I started feeling feverish. My temp was 99.8-99.9, my blood consistently. I then started experiencing this burning uncomfortable  sensation in my chest area and pain in the middle of my back. this discomfort lasted for hours. I contacted the nurse and was told to go to the ER for observation.
1046 states feels nauseated  brought to cot to monitor VS 130/74 HR 86 99 RA site cool to touch denies pain at site just states very nausea. States she had breakfast and had fluids this am.  given OJ and crackers per her request. denies any pain or other issues at this time 1056  129/75 81 100RA states feels better just needed the crackers denies any more nausea does state has a small headache starting but not bad 2/10 1110 125/68 78 100 RA denies any more nausea and headache is subsiding . She will go to ER if any more sx  released at this time.  1836 called to check on pt states she was a little tired the rest of the day denies any more nausea or HA . Instructed to go to Er if any other sx occur.
Took a 1.5 hour nap and when she awoke around 4:30 pm she was unable to move for about 10 minutes. First able to open eyes, then wiggle fingers and toes, then head and shoulders were able to move last.
Varicella-type rash (~30 lesions papulovesicular in various stages) scattered on trunk, mild lethargy.
Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
POSSIBLE TEMPERATURE EXCURSION; EXPOSED TO A TEMPERATURE OF 35 DEGREE FAHRENHEIT FOR 4 HOURS; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced possible temperature excursion, exposed to a temperature of 35 degree fahrenheit for 4 hours, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, possible temperature excursion and exposed to a temperature of 35 degree fahrenheit for 4 hours was not reported. This report was non-serious.
Pt developed a low-grade temperature, post vax and began a downhill condition after his 18 month DTAP. He lost all previous cognitive, language and pragmatic skills by the age of 27 months. Now he is dx'd with severe autistic disorder.
Left shoulder pain, itching  and swelling starting a week after vaccination. Treated with ibuprofen and diphenhydramine.  Symptoms ongoing as of today 1/6/2021
Facial paralysis/Bells palsy. Acute autonomic neuropathy. ASHD (arteriosclerotic heart disease). Demyelinating nervous system disease or syndrome.
Pt reported to clinic  with several other individuals requesting COVID vaccines. Group of patients were together in one room per their request as well as the request of the individual in charge of the boys. All individuals that day are not patients of our facility as they reside at a group home in the neighboring town.  The patient requested pfizer vaccine as the start of his series, Pfizer was drawn up and getting ready to administer when the individual suddenly changed his mind and requested Janssen since "he didn't know where he would be in 3 weeks". Other health care employee handed the J & J vaccine to administering RN and gave vaccine. Pt tolerated well.
scratchy throat; Vomited; Chills; Entire body, even fingers and toes, ached; Welt at injection site; face was bright red/breasts were cherry red; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on 21Sep2020 on the left arm at a single dose as a pneumonia shot. The patient had no medical history and there were no concomitant medications.  The patient was trying to get a list of ingredients before she even thinks about getting the COVID shot (confirmed that she has not received the COVID shot) because she had a severe reaction to the pneumonia shot. On an unspecified date in Sep2020, in the evening, it started with scratchy throat. The patient's granddaughter suffers from anaphylaxis and her reactions begin with a scratchy throat. The patient's daughter left Children's Benadryl at the patient's house in case her granddaughter had a reaction. So the patient took Children's Benadryl after throat was scratchy because that is all she had. On an unspecified date in Sep2020 (reported as 'Thursday') at 06:00 in the morning the patient vomited and had chills. Her entire body even fingers and toes ached. She looked in mirror, her face was bright red. Her breasts were cherry red. The patient had a hug welt on her left arm at the site of the injection. The patient called doctor and was advised no more shots. The outcome of the events were unknown. It was also reported that approximately six weeks later the patient got the Fluzone shot and had a similar reaction, but not quite as severe, the patient was bright red, had a welt, she kind of chilly and not her usual self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 month old received Kinrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter did not have any patient demographic details to provide at time of call. The reporter reported that administration of Kinrix to a 4-month old patient. The reporter consented to follow up. Additional Supportive Information: The 4-month old patient was administered with Kinrix, which led to inappropriate age at vaccine administration.
Extreme soreness, itching, redness, swelling, and heat on right arm at shingles vaccination site. Area of swelling approx 3 inch diameter. I am not certain which Hep B vaccine I received; my paperwork doesn't say so I just picked one.