chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st Covid shot had extreme pain in left arm and  couldn't sleep, had to take tylenol. Experienced short dizziness episodes but on March 18 and 19 had nausea.  After the 2nd covid vaccine my left arm hurt but pain went away after third day but periods of dizziness continued for a couple of weeks. During month of April had increase of pain in pelvic area and lower back. In May spasms in pelvic area which  got worse. couldn't sleep by May 24 and called 911 togotothe Emergency Room
Information has been received from a registered nurse concerning a several patients placed on dialysis who on an unknown date, were vaccinated with a complete series of RECOMBIVAX HB (route and lot number not reported). On an unknown date, the patients had "positive" titers when the titers were checked one month after the final dose. It was reported that when these same patients were retested 2 months after the first dose, most of them then had negative titers for hepatitis B. At the time of the report the outcome of the patients was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient received a high dose fluzone instead of the regular dose.  Reports having chills that evening and tired the next day.  Resolved within 24 hours.
Swelling, redness, area was warm and itchy (4 days). Very tired for 2 days.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 12:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 12:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.22  On 14 Feb 2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 03 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09 Feb 2021, vial was moved to clinic on 13 Jan 2021. 30 vials were sent to clinic. Vaccine BUD date was 10 Mar 2021.  On 14 Feb 2021, no hourly temperature recordings available  The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Concomitant product was not provided by the reporter Treatment medications were not reported.
Waited two days instead of one after a dose; Spontaneous report received on 20DEC2019.  A non-healthcare professional reported that a female consumer who "waited two days instead of one after a dose" (PT: Inappropriate schedule of product administration), following immunization with Vivotif. She took four doses of Vivotif from 30NOV2019 to 07DEC2019, but she skipped two days instead of one day after taking one of her doses of Vivotif. Thus, she completed the course over eight days. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer waited two days instead of one after a Vivotif dose (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer waited two days instead of one after a Vivotif dose (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
Baby brought to ER for lethargy 8 days after MMR vaccination.  Lab work revealed hypoglycemia and elevated liver enzymes. 5/15/08-records received for DOS 4/11/08-Admitted with acute hepatitis, symptoms began 2 days ago with cough and rhinorrhea, decreased oral intake. this morning woke with lethargy difficult to keep awake, refused all oral intake. Admitted for observation.  Possible EBV.
Vertigo during the night when turning over from one side to another. I have never in my life had vertigo, so i did not know what it was. It is now 11/15/15 and I still have it at night, albeit not as intense as initial, AND I have it during the day when I turn my head side to side or up/down - affecting my work (presentations and meetings).
The dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30-day use by date) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter.  No treatment medications were reported.
Information has been received from a registered nurse concerning a 7 year old female with no known history who on 28-MAR-2000 was vaccinated SC with a first dose of Varivax (lot # 632371/1464J). There was no illness at the time of vaccination. On 23-MAY-2006 the patient developed a chickenpox like rash. On 24-MAY-2006 the patient's mother called the physician's office. The patient had <50 lesions on her body and no fever was noted. On 26-MAY-2006 the patient recovered. No further information is expected.
Three hours after shot, I developed tightening in throat and chest, difficult to swallow, some mild restriction of breathing - alleviated after taking  benadryl. (If the breathing and throat constriction had not improved, I would have called 911). Continued "headiness" somewhat like a head cold but without sinus drainage. Headache, joint pain and chills overnight. Low grade fever of 99.6 Symptons somewhat alleviated by taking aspirin. Next morning still some "headiness" with very little sinus drainage. Continued low grade fever, headache and joint pain. The area of the shot shows NO redness, tenderness or swelling and never has exhibited the expected reactions. I've not experienced a sore throat or coughing. Am continuing bed rest, fluids and aspirin.
Information has been received from a licensed practical nurse (L.P.N) concerning a pediatric patient with no allergies, who on 06-Jun-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of ProQuad (lot# 656312/0297U). Concomitant vaccinations included a dose of DTaP (unspecified) and a dose of poliovirus vaccine which were given in an alternate site. Subsequently, on an unspecified date following vaccination, the patient experienced nausea, fever and injection site swelling with redness and warmth, possibly cellulitis. Unspecified medical treatment was sought. It is reported that it is possible that the patient was treated with antibiotics. No laboratory or diagnostic tests were performed. The outcome is reported as recovering. No product quality complaint was involved. The reporter considered the patient's adverse experience to be important medical events. Additional information has been requested.
Patient was given Vaccines and 48 hours later began having fevers and resultant febrile seizure.  Had an ear infection noted at the appointment when shots were given.  5/21/09 Hospital records received DOS 5/16/09 to 5/18/09. FINAL DIAGNOSIS: Second febrile seizure following immunizations and otitis media. Post vaccination otitis media, febrile seizures, shaking, twitching, turned blue, given CPR, post-ictal state. Irritable, decreased activity, vomited.  6/10/09 ICD-9 codes received-780.31 febrile convulsions (simple)unspecified. 382.9 unspecificed otitis media.
Initially started with itchiness on skin (whole body) and then long term (potentially permanent) loss of skin pigmentation on spots of body all over but mostly on my back. The loss of skin pigmentation strongly resembles Tinea Versicolor or Vitiligo.  Itchiness has also continued on and off.  My sister have a very similar reaction to her skin with the same brand of vaccine.
FROM PATIENT WHO FILED THIS REPORT:  Beginning late evening of 3/12/21 after receiving 2nd dose of Pfizer vaccine, symptoms progressing into 3/13 and into early morning hours of 3/14 symptoms extreme nausea, headache, flu like symptoms, aches, sore arm, tired, unable to perform activities, completely bedridden.   I  stayed in bed all day on 3/13 and woke up on 3/14 at 9 am better but still nauseous, stomach achy and some aches in lower back and stomach area, although not back to normal feel much better than the previous 30 some hours...still feeling nauseous and extreme aches in lower back and stomach but joints all over not aching as previously,  slight headache now, feeling little better.    I am a previous Covid patient who was hospitalized in July for 6 days.  Symptoms similar to as when I had Covid in July.  Following guidelines from CDC and guidelines on Pfizer vaccine especially 2nd dose regarding symptoms and readings that this is a normal reaction for some people for 2 days after receiving vaccine and symptoms should subside.
Soreness; Pretty bad headache; Extremely Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), HEADACHE (Pretty bad headache) and FATIGUE (Extremely Tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Soreness) and HEADACHE (Pretty bad headache). 11-Mar-2021, the patient experienced FATIGUE (Extremely Tired). At the time of the report, PAIN (Soreness), HEADACHE (Pretty bad headache) and FATIGUE (Extremely Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  treatment medications provided by the reporter. No concomitant medications provided by the reporter.
Immediate response to swelling, redness and knot size of half dollar which lasted 4-5.  Soreness in arm for 2 days, continuous itching.  Day 10 swelling began again and continue to expand to 7" vertically and 7.5" horizontally.  Sought medical attention
0950 Post vaccination reports lower back pain and feeling flush; medical monitoring, vitals assessed: BP 142/80 P88 RR14 O2 sat 99% RA, po hydration given; 1000 FSBS checked by client=87, snack w/juice consumed, BP 133/84 P81 ; 1030 Repeat FSBS=132, reports "feeling better". Released from facility w/ husband.
This spontaneous report was received from a physician refers to a 12 year 7 month old male patient. She reported that the male patient was scheduled to receive the third dose of GARDASIL dose 3, 0.5 ml, intramuscular and also an unspecified flu vaccine (Manufacturer unknown) on 23-DEC-2013. She reported that the patient inadvertently received two doses of GARDASIL, 0.5 ml intramuscularly in two different anatomic sites. The physician stated that no adverse effects were reported. Additional information has been requested.
Patient was administered a full, diluted, multi-dose vial of the COVID-19 Pfizer vaccine instead of the .3mL single dose. Pt was notified that same day and reported no adverse events.
This case was reported by a consumer (the subject's mother) and described the occurrence of high fever in  a 6-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date in 2011 (approximately 3-4 months prior to the time of reporting) the subject received 1st dose of KINRIX (oral). The vaccine had been mixed with chocolate milk and the subject was instructed to drink all of the contents (inappropriate route of vaccination and inappropriate preparation of medication). The subject received the vaccine at a physician's office. In 2011 (approximately 3-4 months prior to the time of reporting), the same year after vaccination with KINRIX, the subject experienced high fever of 105 degrees Fahrenheit, bright red cheeks and vomited yellow bile. The subject's mother consulted a physician who asked to see the subject and instructed her to keep the subject hydrated. At the time of reporting the events were resolved. The high fever and bright red cheeks resolved 2-3 days later without intervention. The vomiting yellow bile resolved in hours without intervention.
Information has been received from a registered nurse through the Merck pregnancy registry concerning an 21 year old female who on 06-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # not reported). A urine pregnancy test was done on 06-MAY-2009 and was negative. The patient's LMP was on 15-APR-2009 and EDD 20-JAN-2010. Additional information has been received from a physician concerning a 21 year old female with a history of 1 pregnancy and 1 live birth and a history of loop electrosurgical excision procedure for a severe cervical intraepithelial neoplasia (CIN3) on 06-APR-2009, who on 04-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot number 661952/1129X). On 15-APR-2009 the patient had her last menstrual period and on 06-MAY-2009 received her second dose of GARDASIL (Lot number 661953/1130X). On 26-JUN-2009, the patient underwent an ultrasound which revealed an 8 week old fetus. On 31-AUG-2009 a Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was done. It was reported to be within normal limits. On 14-SEP-2009 an anomaly screening was done which was also reported to be within normal limits. Follow up information has been received from a physician concerning a female patient with a history of abnormal PAP and quitting smoking in August 2009. On 29-JAN-2009 PAP smear test was performed which resulted in high grade squamous intraepithelial lesion (HGSIL). A LEEP procedure was done in April 2009. The plan was reported to do a follow up colposcopy after the patient received dose number 3 of GARDASIL. The plan was also to do cervical length checks. On 31-AUG-2009 "MSQS" was performed and was reported to be negative. On 01-FEB-2010 from 39 gestation weeks and three days the patient had a normal female baby with no congenital anomalies and no complications or abnormalities. Her weight 7 pounds and 7 ounces, length 20 inches, apgar score 8/9 and head circumference 35cm. The patient had no complications during pregnancy, there were no infections or illness during pregnancy and not complications during labor. During pregnancy the patient was taking (NATURE MADE PRENATAL VITAMINS FORMULA) once a day. No further information is available.
tachycardia; palpitations; arm pain; arm has been super irritated in the injection area; pain in the injection area and is inflamed and red; fatigue; pain in the injection area and is inflamed and red; pain in the injection area and is inflamed and red; 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 TACHYCARDIA (tachycardia), PALPITATIONS (palpitations), PAIN IN EXTREMITY (arm pain), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area) and VACCINATION SITE INFLAMMATION (pain in the injection area and is inflamed and red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Pfizer vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 TACHYCARDIA (tachycardia), PALPITATIONS (palpitations), PAIN IN EXTREMITY (arm pain), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), VACCINATION SITE INFLAMMATION (pain in the injection area and is inflamed and red), FATIGUE (fatigue), VACCINATION SITE PAIN (pain in the injection area and is inflamed and red) and VACCINATION SITE ERYTHEMA (pain in the injection area and is inflamed and red). At the time of the report, TACHYCARDIA (tachycardia), PALPITATIONS (palpitations), PAIN IN EXTREMITY (arm pain), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), VACCINATION SITE INFLAMMATION (pain in the injection area and is inflamed and red), FATIGUE (fatigue), VACCINATION SITE PAIN (pain in the injection area and is inflamed and red) and VACCINATION SITE ERYTHEMA (pain in the injection area and is inflamed and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications were reported.   No treatment information was provided.
Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:master case
Patient contacted agency on 12/22/2016 to review vaccine adverse event for VAERS (vaccine adverse event reporting system). She advised receiving her Hepatitis B vaccine (SKB lot #3P2XL) on 8/30/2016 and 20 minutes later she had a dull ache to the vaccine site. Over the next few days her pain got worse and she noticed some local site swelling and swelling to the top of her hand over the wrist and fingers. She didn't think much about this until 9/7/2016 when the pain started to radiate down her arm with right hand swelling. Pain occurs with movement. She sought medical care on 9/15/2016 for this reaction where HCP documented full ROM upper arm without redness, swelling or deformity. She did have generalized edema to the right hand. Rt shoulder exam normal with good ROM and strength. She was diagnosed with pain in right arm and treated with TYLENOL and steroid taper x 7 days. NSAIDS stopped. F/U on 9/19/2016 with Occ Health reports continued swelling to right hand/arm but was better. She still has pain along cubital nerve distribution which worsens with use of right hand. She was given Hydrocodone for pain and limited duty. F/U on 10/12/2016 reported hand swelling and pain better but continues. She C/O pain to right forearm with extension while lowering her arm which improves when arm placed over chest (flexing at elbow). Her exam showed tenderness to subacromial bursa and she was treated with steroid dose pack and sling. SM F/U with HCP doctor on 12/20/2016-1/4/2017 for MRI of shoulder and advised she went to hospital to R/O PE in arm. Results are unknown to this provider.
This case was reported by a pharmacist via call center representative and described the occurrence of low back pain in a female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 2nd dose of SHINGRIX. On 12th September 2018, immediately after receiving SHINGRIX, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was unknown. It was unknown if the reporter considered the low back pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that the patient came in on the date of reporting and had just gotten her second dose of SHINGRIX and described back pain. This case is linked with US2018166424, reported by the same reporter.
1/13/03 pt rec'd mult. vaccines. 1/16/03 return to clinic with 24 hrs of macular papular rash pruritic trunk UE and LE. Given Clarinax-res'd. 2/4/03 return to clinic with one day history of similar rash. Confluent macular papular rash trunk U and LE res'd with Clarinax.