chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, refer case US2019AMR167659).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, her friend's husband received dose of Shingrix and next day after vaccination experienced nausea. The nausea recovered in 1 days. The reporter did not provide additional details. This was 4th of 4 reports described by the reporter.
Lip swelling, left 4th digit swelling, pruritic palms, headache
baby received Havrix adult dose by error; baby received Havrix adult dose by error; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) (batch number 299X2, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Nurse supervisor called to report that a baby received Havrix adult dose by error as his Havrix dose which led to adult product administered to child and accidental overdose. The reporter consented to follow up via email.
I experienced a sore throat and extreme fatigue and body aches and headaches. I was given PAXLOVID for my symptoms. I took at home COVID-19 test on 09/20/2022. I have recovered from my symptoms.
2 days p/vax pt had local rxn to DTP; arm had a large red knot w/swelling & warm to touch;
Pt reports probable seizure during sleep on night of 5/26/21-woke up in morning in "wet bed" due to urinary incontinence, one of the signs that she has had a seizure.  States seizures usually only occur about once a year and can't remember when last seizure was but probably over a year ago.  Also had right foot pain, possibly due to trying to get out of bed during night, no other sx.
Three days after the first shot my tongue felt like I had burned it. A fewspots at the tip of my tongue were very painful. The reaction lasted about a week.   It took my a couple of days to connect the reaction to the shot because of the delay. When the pain started again three days after the second shot I realized it could be a reaction.  After the second shot, in addition to the burned feeling and tongue pain, my mough has a slight tingling sensation. Not painful, but certainly there. So far, I am three days into reactions after the 2nd shot.
Patient came for her Pfizer vaccine. Immediately after her vaccine she developed nausea and vomiting. She was given an ice pack. She was seen by Dr. Patient was observed and recovered after 30 minutes and went home.
Pink discharge/spotting in between menstrual  cycle, began 05Jan2022.   Last menstrual cycle ended on 03Jan2022.
He had his 2nd HPV vaccine 05/20/2022 and shortly thereafter began to note mouth pain, sore throat and has not been able to eat for the past 4 days,  feeling "funny", fatigue.  Notes that for the past couple of days he has slept all day and stayed awake all night, today he has not taken any naps.  Denies fever, shortness of breath, cough.  Is taking ibuprofen and Tylenol dose per manufacture recommendations, cough drops, warm salt water gargles.  Feels that symptoms are resolving.  Has never had reaction to vaccine prior.
Pt here with social worker for shots. Pt left clinic and returned with social worker in about 1 hour later with complaint of itching, swelling at eye and face. Social worker reports voice became raspy. Pt assessed by PA and given Benadryl (IM). Symptoms then resolved. Rx'd Benadryl X 24 hours.
Patient broke out in total body hive like rash. Approximately 24 hours after vaccine administered. Has persisted until patient seen 11-14-05. Shot given by U.S. Post Office approx 11/7/05.
Patient got Menactra, Tdap, influenza around 3:30 pm 11-15-07, 12 hours later 11-16-07 3am had high fever 102, nausea,and vomiting, unable to hold Tylenol down. To Emergency that am, got IV's, nausea medication.
I have an intrauterine device (IUD) and because of this have not have a period for years. Since the COVID-19 vaccines were administered, I have again started regular periods and am also experience spotting in between periods. My period started up again 24 days after my first dose of Moderna.
pt states she woke up during the night after the vax and her armpit was sore under the left arm and noticed lymph node swollen.  Pt called and made apt w/ PCP on 1/26/21.  She noticed two 3x3  red spots on left arm just below the injection site on the day of her appt.  Pt states today the left armpit and injection site is swollen.  Her PCP told her to keep her on it and keep her next scheduled apt for FU.
Muscle aches / pains, shakiness, sweaty, feverish, passed out, large swollen erythemic area.
area of injection with delayed reaction 8 days after vaccine, red, swollen, itchy.  Resolved without treatment
A report was received from a health  professional on 17Oct02, concerning 8 adult vaccinees who inadvertently received last years Fluvirin vaccine formulation on 16Oct02. Eight vaccinees inadvertently received last years Fluvirin vaccine formulation. The vaccinees have not developed or reported any untoward or adverse reactions. There was insufficient information to determine the reporter's causality assessment.
Nausea and diarrhea started 3:30 PM. Diarrhea ended 2:30 In AM next day. Slight nausea continues into next day
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2/A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitants medications were not reported no treatment medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-048097 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048097:Reporter case: wife
Coughing; COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs; This spontaneous case was reported by a non-health professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs) and COUGH (Coughing) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs). On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs) and COUGH (Coughing) had not resolved.            No concomitant medications were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 and contains non-significant information. On 01-Jul-2021: Non-Significant follow-up received On 01-Jul-2021: Non significant follow up received
* had vaccination 11/16/20 at about 4:30pm * Patient said she didn't feel good at about 7:30-8pm on 11/17/20 * head, knees, back, neck and arm are all in pain * has fever between 99.8 and 100.9 * threw up 2 times early this morning 11/18/20 * called doctor and was told if she throws up again to go to urgent care *** waiting to see what the doctor would like to do next and monitoring daughter
24 hours, post vax, pt developed headache, fever and chills, generalized achiness and malaise. Also, had pain and swelling at injection site. She took Advil and stayed in bed. Symptoms resolved within 24 hours, except for pain at injection site.
Severe muscle spasms throughout my body and extremities, which lasted for 20-30 minutes
This spontaneous report was received from a female consumer of currently 70 years old referring to herself. The patient had none pertinent medical history, drug reactions/allergies.  Concomitant therapies included unspecified medication for high cholesterol. On an unspecified date in October 2011, the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml (route, lot number and expiration date was not reported) for prophylaxis. Two weeks after the vaccination date, in October 2011, the patient experienced swelling in the hands and as per the patient, they looked like sausages and by Christmas in 2011 t(reported as by Christmas) he patient's hands were in carpal tunnel brace. In January (unspecified year), the patient went to a walking care facility and from there was sent to a rheumatologist after that to a neurologist, she had a carpal tunnel (carpal tunnel syndrome) but they could not figure out why there was swelling and the patient was treated for rheumatoid arthritis. At the time of the report, the patient had an autoimmune disease, and she was diagnosed with scleroderma when her hands started curling, she was treated with an anti-rejection treatment (unspecified). The patient was hospitalized for scleroderma on an unspecified date in 2016 for 3 or 4 days. The patient had a blood test done (unspecified date). The outcome of scleroderma,  autoimmune disease, rheumatoid arthritis and carpal tunnel syndrome was reported as not recovered.  The causality between the events and the therapy with ZOSTAVAX was not reported. Upon internal review, the events scleroderma, rheumatoid arthritis and autoimmune disease were determined to be medically significant.
PATIENT'S ARM APPEARED TO BE INFECTED AT INJECTION SITE OR TO HAVE AN INJECTION SITE REACTION THAT CAUSED SKIN TO BECOME RED AND PEEL. IT WAS ABOUT THE SIZE OF A SILVER DOLLAR AND HAD BEEN BLEEDING AT ONE POINT. PATIENT STATES IT STARTED THE DAY AFTER THE VACCINE AND DID NOT APPEAR TO GO AWAY. SHE FINALLY WENT TO THE DOCTOR TODAY (10/5) AND THE DOCTOR IS TREATING IT WITH AN ANTIBIOTIC. I ASKED HER TO LET ME KNOW IF IT DID NOT END UP BEING AN INFECTION. SHE STATED THAT IT HURT TO TOUCH
a few min. after receiving Moderna vaccine, pt got a few red bumps on his arm, got nauseous, very pale and dizzy. The pt. then sneezed (strongly) twice and his whole body shook after which he slid off the chair and laid on the floor. I administered EPIPEN and w/in seconds pt. was better. Was able to stand and sit on the chair. 911 was called. Pt. left with the paramedics for observation.
I am on the bipolar spectrum. With taking medication I have not had a manic episode in 7 years. After getting the vaccine shot within 20 minutes I felt the inside of my head shift and I did not feel like myself. That night I did not sleep at all which triggered my manic episode. Despite taking my regular medications to sleep I could not sleep and did not get a full solid night's sleep for 34 days. My doctor has been trying different combinations of my medicines to get me to sleep. My brain chemistry is all messed up and I have not felt like I did before receiving the shot for 2 months now. As stated I was in remission for 7 years and fine the day of the shot until 3:15 when I received the vaccination. Everything changed from that point on. I have been out of work as a  teacher for 2 months now.
Three days after my fourth dose I felt a small itching spot on my leg and thought it was an insect bite.  The next day I noticed that it was a pattern and was shingles.  I contacted my doctor and by the time she got back to me I was out of the window to use medication but she did give me a prescription of Valtrex incase it comes back again. On June 22, 2022 I had another outbreak and started taking the Valtrex medication.  I took the whole course of medication and also have taken the Shingrex vaccine.
Flu like symptoms the day after; lethargy and fever; passed by second day. Redness and itching of extremities and trunk starting about the third day. Now have significant rash on both arms from wrists to just above elbows at five and one half weeks; dense raised rash with acute itching at times. Have done a course of Prednisone and been sporadically taking antihistamines OTC. Now using a cream but nothing seems to help.
Pt vaccinated with 1st DTP/OPV on 27Jul89, developed loss of head control, screaming & vomiting, had sleep loss, limbs tense and developed seizures. Hospitalized many times between Sep-Dec89, received DT, condition worsened; Died 18APR90.
after taking 2 dose of shingrix patient experienced shingles; Shingles with no rash; Tingling on top on left side of head; First dose of Shingix in 2017, then second dose 18 months ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: after taking 2 dose of shingrix patient experienced shingles) (serious criteria GSK medically significant), shingles (Verbatim: Shingles with no rash), tingling sensation (Verbatim: Tingling on top on left side of head) and drug dose administration interval too long (Verbatim: First dose of Shingix in 2017, then second dose 18 months ago). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and tingling sensation were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and tingling sensation to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and tingling sensation to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 07-JUN-2023 A reporter reported about her self she received her first dose of Shingix in 2017, then second dose 18 months ago. The reporter stated that she was feeling tingling on top on left side of head, went to her doctor who diagnosed shingles with no rash.  The reporter did not consent to followup. The patient received 2nd dose late which led to lengthening of the vaccine schedule. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not reported.
This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 22 hrs after receiving SHINGRIX, the patient experienced headache, burning in eyes, fever, general body pain and sleep excessive. On an unknown date, the outcome of the headache, burning in eyes, fever, general body pain and sleep excessive were recovered/resolved. It was unknown if the reporter considered the headache, burning in eyes, fever, general body pain and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient had a horrific headache, burning of eyes, and the body temperature was recorded 100 degree F, along with all over pain and slept a lot. The patient was much better in 30 hours. The patient asked that, if is it safe for to her to have the next shot. The reporter wanted to know would the reaction be worse. Lab Comments: On an unknown date, patient's body temperature was noted as 100 degree F.
area of erythema and induration at site of second varicella immunization. 9 by 4 cm. no fever
Approximately 10 to 15 minutes following administration of immunizations (listed below) patient reported having hives on arms and chest and itchy eyes, and that her left arm felt like it was "burning" similar to the feeling of a sunburn. Patient stated she had similar reaction (hives from head to toe) after receiving flu shot last year. Pt denied trouble breathing or SOB. Advised pt to follow up with doctor as soon as possible for possible steroid or other treatment for allergic rxn. Spoke with pt on Sun. 12/20/15 pt reports some relief of symptoms w/2 tabs of BENADRYL approximately 30 minutes after rxn started.
Pt recvd vax & exp hlt/cold sensations & pain/tenderness lt radius to deltoid; pt raised poss of this last sx being arthritis;
Pt recvd Hep B vax on 5JUN92; pt devel generalized hives; 7JUN92 pt sx resolved;
they gave 1st doses of the Moderna Covid-19 Vaccine from 2 different lots to two adolescents; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in an adolescent patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that they gave 1st dose of the Moderna Covid-19 Vaccine from 2 different lots to two adolescents and they request any information on this situation.
Information has been received from an advanced registered nurse practitioner concerning a 23 year old female diagnosed with epilepsy 2 years ago who on 24-FEB-2009 was vaccinated with the first dose of GARDASIL (lot # not available). Concomitant therapy included Lamictal. The next day after receiving the first dose of GARDASIL (on 25-FEB-2009) the patient experienced epileptic seizures. Subsequently, the patient recovered from epileptic seizures. The patient sought medical attention to the nurse practitioner. Upon internal review, epileptic seizures was determined to be an other important medical event. Additional information has been requested. 3/19/09-records received-office visit 12/23/08 C/O darker old bleeding with menses. Gyn exam and pap. Visit on 2/24/09- received 1st HPV4 vaccine left deltoid.  On 2/26/09-parent called indicating had a full gran mal seizure day after receiving Gardasil.
After I got home, I took MOTRIN 800 mg. That night I started with shivers and fever and by morning could not get out of bed due to dehydration and dizziness and lightheadedness. My whole body ached. I couldn't go to work or do anything but stay in bed with the flu like symptoms. I got out of bed 30 hours later. Today I am just still aching in my back and sides but able to be at work.
This spontaneous report was received from an attorney via company representative refers to his son, a male patient of unknown age. Pertinent medical history and drug allergies were unknown by the reporter. On an unknown date the patient was vaccinated with (not specified MMR or MMR II) M-M-R II (lot and expiry date were not provided by the reporter). Concomitant medications were unknown by the reporter. On an unknown date the patient experienced autism spectrum disorder (medically significant). It was unknown whether the event diagnosed before or after the unspecified MMR vaccine. The outcome of autism spectrum disorder is unknown. The reporter considered autism spectrum disorder to be related to M-M-R II. No PQC filed. Upon internal review the event autism spectrum disorder was considered to be medically significant. Additional information has been requested.
had a fever after received Gardasil second dose; This spontaneous report was received from a pharmacist via company representative refers to an adult female (early 20's) patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot number, expiry date unspecified).  On an unknown date, in her early 20's the patient had fever after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) second dose of HPV vaccination series. The outcome of pyrexia was resolved. Reporter's causality was not provided.
Information has been received from an office manager concerning a 12 year old female who on an unspecified date was vaccinated with the first dose of Gardasil, injection. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a rash over body and legs that caused severe itching after Gardasil was administered. On an unspecified date, the patient sought unspecified medical attention. The patient's rash over body and legs that caused severe itching persisted. Additional information has been requested. Information received 04/03/2009. The patient's rash over body and legs that caused sever itching was gone within 4-5 days. Additional informaiton is not expected.