chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I awoke the morning of the 28th feeling slightly fatigued with some soreness at the injection site.  By lunchtime, I am experiencing extreme fatigue, overall body soreness, loss of appetite, and increased pain at the injection site. By 3 pm I am home and in bed, dealing with chills/sweats as well. Couldn't find any comfort to sleep thru the night. In the morning of the 29th, I'm still displaying all the issues listed above. I stay home from work and go back to bed. I awake at noon to find all the listed issues greatly reduced, but feel soreness in my jaw and feel swelling in the lymph nodes under the jawbone, more so on the right than the left.
Vaccine given after left out over 12 hours.  Patient was called and advised to get another dose as the efficacy is questionable after 12 hours
sore arm after the first shot but throat swollen and developed hives on my back after second shot. Took two Benadryl and gained symptom relief
pt recv vax; 4 hr later, inconsolable crying for 4 hr; T 100-102 for 12 hr;
I got some reaction to the vaccine the night before and during the day (cold like syntoms). But I also  got a large red rash on my torse. I have a picture if you would like to see it.
This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 16-DEC-2017. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
Information has been received from a consumer concerning her 15 month old son with no pertinent medical history and no known drug allergies or reactions who in January 2008, June 2008, and October 2008 was vaccinated with the first, second and third dose of HEP B vaccine respectively (manufacturer unknown, lot # not provided). There was no concomitant medication. In October 2008 ("the next day after receiving the third shot"), the patient experienced bad rashes and the rashes lasted for four to five months. The patient was brought to a dermatologist and the dermatologist considered the rashes were linked to HEP B vaccine. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. No further information is available.
Vaccine given at 2:30 pm, by 6:30 pm experience numbness of face, swollen lips, rapid heartbeat, throat narrowing, wheezing at ER-given EPINEPHRINE, SOLUMEDROL, 20 FRAN, ALBUTEROL, BENADRYL, PEPCID, 40 mg PREDNISONE X 3 days
1:45pm - Brought in 16 year old female to room to receive shots.  Mother and 17 year old sister, accompanied  Explained to mother the shots both the females would be receiving (Tdap, MCV4, HPV). Patient received shots thereafter. Mother asked if TB was given. I stated I would prepare the vaccine to give to the 2 patients.  i could here the patients laughing.  1:55 - When i returned, patient was sitting on the blue chair.  I told her that  she would be first, picked up her arm to place TB and she stated she wanted to vomit.  I reached over the cabinet to get the emesis bag,  patient became clammy and was unable to hold her head up.  I called LVN to assist with the patient.  The LVN began to check 02 Sats which were 97%.  2nd nurse, PHN was called to help transfer female to the ottoman. 2:05pm - We laid patient down and raised her legs, patient was responding to commands and instructions. Vitals were taken while laying down- BP 120/82 P74 R20.  Within a minute or two patient opened her eyes and stated she was feeling better, she wanted to sit up. We had her wait a couple of minutes.   2:10 - We sat patient up and retook BP which was 110/74. Patient responded to all questions  2:15pm Stood patient up to retake BP which was 10/60. completed filling out all paperwork Asked patient how she felt. She stated much better Mother stated she had done the before.  Thanked me. Patient ambulated independently denied further symptoms
1/7/21: injection site started to turn red, swell, itch and was hot ~12 pm; by 7 pm redness had extended to apx. 3 in. wide by 2 in. high; also I had extreme pain in my back between my shoulder blades and had a hard time breathing. These symptoms persisted until 1/10/21; on 1/10/21 the redness turned from swollen and smooth to not swollen and bumpy - rash like. By 1/12/21 the swelling had gone away, but the rash had turned red and spread to more area on my arm. The rash reached its full size on 1/14/21 of apx. 6 in. wide by 4 in. high making a "box" like shape with a circle (apx. 2 in dia.)inside of the rash box; I was still having a hard time breathing; I saw the Dr. on 1/13/21 and was diagnosed with respirator infection. He prescribed antibiotics and prednisone. I felt better by 1/18/21, but then started having more back pain. Went back to the Dr. and was told I was having severe muscle spasms possibly due to the respiratory infection; was prescribed a muscle relaxer. The (1st ) doctor did not feel the symptoms I experienced were due to the vaccination, but all of the symptoms started as soon as my injection site started to have a reactions. I finally felt better without medication on 1/29/21. I received my second shot on 2/2/21 and had normal symptoms the day after (body aches, fever, chills, fatigue). Thank you! :)
Redness, pain, warmth, swelling at injection site that spread to below elbow. Treated with ice. Felt to have developed into cellulitis. Started on KEFLEX 2/3/15.
Dose #1 April 11, 2021: Exactly 14 days after the vaccination I woke in the AM and was extremly dizzy. I could not get out of bed until it stopped about 5 minutes later. I went to get a glass of water and almost fell into the refrigerator. I spent the day on the couch because I would become dizzy every time I turned my head, stood up, etc. The dizziness lasted until around 5 PM.  Dose #2 May 5, 2021: Two days after the vaccination I was slightly dizzy with a mild headache in the AM. Later that day around 6 PM I had the sudden onset of very uncomfortable pain in my neck from my ears down to my shoulders. I could not turn my head without causing extreme pain. I put an ice pack on it, took some ibuprofen and went to bed. I woke in the AM without any pain.  On May 18, 2021 I began to get headaches with dizziness in the AM when I was at work. This lasted for the reaminder of the day. The next day at work on May 19, 2021 I began to get dizzy with a migraine headache around 8:30 AM so I went to the nurse practitioner to have my vital signs checked. My blood pressure was slightly elevated but that was all. She suggested I go home but I took some ibuprofen and stayed at work because I was concerned about driving home while I was experiencing dizziness. I had a total of five consecutive days (May 18, 2021 thru May 22, 2021) with migraine headaches and dizziness that began in the AM and subsided in the PM. The following week I also had the same experience with headaches and dizziness in the AM until the PM from May 26,2021 thru May 28, 2021. The week after that I had headaches and dizziness in the AM until the PM from June 2, 2021 thru June 4, 2021 I have not had any headaches or dizziness since the last occurence in the first week of June 2021.
Refridgeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Sep-2022 at 3:04 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Sep-2022 at 3:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant information was reported. Injection site given as Deltoid. Dose/volume given as 0.5 There were excursions noted. No adverse reactions reported to reporters knowledge for patient. No treatment information was reported.
Information has been received from a health professional referring to unspecified patients. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # K007828, expiration date, route and dose unspecified). No adverse event were reported. This is one of several reports received from the same source. Additional information has been requested.
Thought I would never get over it; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient was totally agree that 2nd shot was very disrespectful. The patient thought he/she would never get over it. The follow-up could not be possible as no contact details were available.
body became very itchy and he was itchy all over; developing little red like pimples all different parts of his body; itchy bumps/ little tiny pimples on his skin and it was very uncomfortable; little tiny pimples on his skin and it was very uncomfortable; This is a spontaneous report from a contactable consumer (the patient). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiry date 31May2021), via an unspecified route of administration (injection) in the left arm on 22Jan2021 (at the age of 89-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was on unspecified concomitant medications. The patient stated he has been taking the same medications for several years, and he has had no problems with those. The patient did not receive any other vaccines on the same day. The patient had his first Pfizer COVID-19 shot on 22Jan2021. He was due for his second shot on 12Feb2021. After he had the first shot, his body got itchy all over and it was still itchy. He also had little tiny pimples on his skin, and it was very uncomfortable. He was wondering if this was a known reaction to the product. He had no idea what to do to relieve the itching. He got the vaccine on 22Jan2021, and the itching started either the next day or two days after getting the vaccine. His body became very itchy, and he was itchy all over. He was developing little red like pimples all different parts of his body; itchy bumps. The itching and pimples having continued through to now, and it seemed to get even more itchy in the evening at bedtime. Last night (unspecified date), he had it on the top of his feet down there, on the top and in between his toes. Those itchy bumps were all over, and he did not know if that was the Pfizer shot.  The patient tried different anti-itch creams on it, and that relieved it for a while, but then it came back. He used clobetasol propionate, but it had not worked. They stopped itch for a while but then it does not help. He tried some just plain anti-itch cream (clarified as Gold Bond Anti-Itch Cream) to stop the itching. It stopped itch for a while, but then it did not help. He did not have to use the cream until 3-4 days. It was some prescription from the doctor, but it was for his wife. He tried it, but it did not do anything. The patient stated the injection itself did not give him any problems. The patient was wondering whether he should take the second shot if this one gave him so much trouble. The clinical outcome of discomfort was unknown. The outcome of the other events was not recovered.
Information has been received from a consumer whose husband on an unspecified date was vaccinated with MMR II and had reactions like fever and rash. This is one of several reports from the same source. No further information is available.
No additional adverse events reported.; not followed the recommended dosing intervals for GARDASIL 9; This spontaneous report was received from an office manager referring to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.     On 20-JAN-2021, the patient was vaccinated with the fist dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route, lot # and expiration date were not reported) for prophylaxis. On 04-MAY-2021 (the second dose was noted as late on this date as recommended), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route, lot # and expiration date were not reported) for prophylaxis. On 27-JUL-2021 (the third dose was also noted as late on this date as recommended), the patient was in the office was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route, lot # and expiration date were not reported) for prophylaxis that had not followed the recommended dosing intervals for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). It was also reported that the interval from first dose to third dose was also past the 5 months as recommended. No other information was given. No additional adverse events was reported.
Breakthrough case admission after 5 vaccines Moderna 3/1/21 Lot# 015M20A;  Moderna 3/29/21 Lot# 002B21A;  Moderna 10/26/21 Lot# 077C21B;  Moderna 6/24/22 Lot# 005M21A;  Moderna 10/14/22 Lot# 030G22B
States had "itchy feeling all over" after receiving Varicella vaccine.  No c/o SOB, no visible redness/rash.
Information has been received from a physician concerning a 62 year old female who was vaccinated with ZOSTAVAX (Merck) (therapy dose, route and site unknown). The physician reported that the patient experienced anaphylaxis 24 hours after shingles vaccine and new with cellulitis. The patient sought medical attention. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from the physician. The physician reported the patient's name and the patient was 68 year old (previously reported as 62 year old) female. She received the ZOSTAVAX (Merck) on 09-JUL-2010 and had experienced difficulty breathing and swelling at the injection site. She used her albuterol inhaler twice to control her breathing. By the time the physician saw the patient on 13-JUL-2010, the patient's breathing had resolved and only slight redness remained at the injection site. At the time of reporting, the patient's outcome of swelling at the injection site and slight redness remained at the injection site were unknown. Additional information has been requested.
Persistent headache. Mental grogginess. Pressure in the back of the head. Headache symptoms for 3 weeks without relief.  Delayed period by 9 days. Otherwise normal, healthy predictable mensuration cycle. 4 negative pregnancy test to rule out pregnancy.
received both shingles vaccines but i am still getting shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she received both the shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Heart flutters, chest pain, shortness of breath rapid onset 3 days post-injection. Present for almost an hour- current anecdote.
4 hrs after injection I had severe pain in shoulder and unable to move 1/2 inch without severe pain. The pain compares to post op shoulder surgery or an injury and radiates thru arm into fingers. 24 hrs after injection. I spiked a fever of  101 degrees after taking ibuprofen 3 hrs prior.  Also have severe fever and aches and pains accompanying the fever.
Cl given HPV & Tdap vaccine & fainted in hallway 5-10 minutes later.  Mother eased her to floor & no apparent injury.
Left arm pain, redness and swelling, progressing since 7/12/2018. Ice, analgesics.
Received vaccine at on 5/24/2021. Patient is a 40 y/o male with no significant PMH who initially presented to the hospital after being found down at a restaurant. Was found to have ST segment changes on EKG, somnolent, and hypotensive requiring pressors. Taken to the cath lab where he had equalization of diastolic pressures and subsequently received pericardiocentesis due to concern for tamponade from pericardial effusion. 350 ccs of fluid was drained and his hemodynamics immediately improved and he came off vasopressors. Pericardial drain was placed. Over the next several days he had ongoing workup for the etiology of his pericardial effusion. His pericardial drain output dropped off, was clamped 5/31 and repeat echocardiogram 6/1 did not show significant effusion. Unfortunately, patient went into PEA arrest in the afternoon and was coded for ~40 minutes without return of ROSC. Unclear etiology at this time, no evidence of significant effusion on echocardiogram
Severe Muscle pain over entire body unrelieved by Tylenol fatigue and anorexia and headache for 36 hours.  NO fever.
16 years old was accidentally given Moderna Covid-19 Vaccine; A spontaneous report was received from a health care professional concerning a 16-year-old patient who received Moderna's Covid 19 vaccine(mRNA1273) at an inappropriate age (dosing error-pediatric use)  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On an unknown date, the patient received first of two planned doses of mRNA-1273 (batch number-Unknown) intramuscularly on a n unknown day for prophylaxis of Covid-19 infection.  A 16 year old patient was accidentally given the Moderna Covid-19 vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event, inappropriate age at vaccine administration were considered as recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
The patient had an appointment on September 29, 2020 for administration of the rotavirus vaccine and the flu vaccine. We accidentally performed a full 6-month physical exam that included the administration of the following vaccines: Pediarix, Prevnar, Influenza, and Rotavirus.  The patient, however, had already had his 6 month old physical examination on 08/04/2020 and had also received the Pediarix and Prevnar13 vaccines on that date. Rotavirus and flu vaccines were still pending at that time.  Immediately after the error was discovered (same day - 09/29/2020)  the office manager, proceeded to call the vaccine manufacturers (Pfizer and GSK) to report the incident and ask for recommendations and advice to see what steps to take following the incident. After they received the case, they called back and indicated that they had no reported cases of adverse reactions to a vaccine when an extra dose was accidentally administered. Mother and I have been in contact to discuss possible side effects of the vaccines.  MD VFC and and Health Department were also contacted to report the incident. Patient has been and is currently doing well. No high fever and patient's behavior is normal. There is only a small lump on the injection site.  A formal office incident report has been filed, as well as proactive training measures to ensure incidents such as these do not happen again in the future.
Crippling and swelling of hands and feet, post vax, 2nd vaccine shot.
3/30/09 physical with immunization 4/3/09 fever to 101 X 24 hrs, then 4/6/09 developed no fever.  Developed cough, cranky, not sleeping seen by Dr. with diagnosis fever.  Then 4/10/09 seen again with fever increase 102 cough congestion dx fever next day rash small papular rash over torso
Patient just received 4th dose, upon last im injection (HPV) immediately passed out, and Had tonic-clonic movement lasting 5 sec. Responded well to one Ammonia inhalant, Alert x3 patient placed in supine position with legs elevated monitored For additional 30 min and released w/o Any Additional sequelae noted!