chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of Varivax. Subsequently the patient developed a "less severe" case of chicken pox. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
During initial immunization, there was tremendous pain in the shoulder joint. About 10 days out was the height of my decreased range of motion and supraspinatus tendon function.
Nausea, fever, diarrhea, chills, vomiting, body aches, head aches that lasted for a week.
Parents stated that she was "sort of out of it, like not as responsive on that day" and then she was uncharacteristically irritable for a few weeks".  They did not report this until the 4 month visit when considering the next vaccines.  They said she was "back to her normal self, but that it was gradual and they couldn't say when the irritability was completely gone".
Pt's mom calls 9/13/05 c/o she thinks pt has a low dose of measles. Started 9/07/05 low grade temp, HA, dizzy. 9/8/05 - 9/9/05 very tired, fever 103.0 rash on torso, light sensitive. 9/13/05 lips swollen, rash in mouth, rash on torso and face gone, no fever, using Benadryl for lips seems to be improving.
Approx. 24 hours after vaccines, child became "wobbly", lost balance and fell to floor (slight head bump) and had a 2 min. tonic-clonic seizure with no cyanosis. Take to ER via ambulance and sx. resolved within 15-20 min. No fever.
Approximately 01:00am Friday morning (2/21/14) she began experiencing right sided neck pain progressing throughout the day to headache; initally the discomfort was localized to her arm, but progressed to right side of neck, then to headache.  Patient went to the ER on Monday (02/24/14) and was diagnosed "tetanus side effect".
So within about 5 minutes of getting the injection, the women who injected me looked at me and said what's going on. I felt very hot and had a lot of tightness in my chest. I took my inhaler and then they said I could go. So just walking from the parking lot to my vehicle I had really bad short of breath. I contacted my DR the day I got it and then the following Monday after my vaccine. I have had chest x-rays, echocardiogram, renal artery studies, been to the neurologist, CT of my head and the allergy DR and they did looked at my sinuses and all that and nobody really knows why I am short of breath. I don't know why, or if it is because I have so many allergies or maybe a chemical that was mixed in. I still get shortness of breath but DRs have not found anything.
Inflamed area where vaccines were injected, swollen 3-4 cm diam. with 2 papules in center vaccines admin. date 2/20/04. Date inflammation was noted 3/02/04.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 04-JAN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Narrative: Symptoms: UrticariaPruritus & PRURITUS; ERYTHEMA
Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date; The patient administered the vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027121A) for COVID-19 prophylaxis.     The patient had no known allergy. The patient did not had chronic or long-standing health conditions.     On 16-May-2022 at 11:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 16-May-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date). At the time of the report, PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination were reported as none.  The patient had not ever tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and up to 1 month before.  Six (6) vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.  The vials did not undergo any temperature excursions.  The patients had not reported symptoms.  No additional doses, medications or treatments had been administered.   This case was linked to MOD-2022-583062 (Patient Link).
3 minutes later tongue tingling and back of throat, lighthead, followed by heart palpitations, elevated pulse and blood pressure
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 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 and treatment information were reported by the reporter Date of Refrigeration was 06-Aug-2021   This case was linked to MOD-2021-363730, MOD-2021-364245, MOD-2021-364699 (Patient Link).
A report was received from a health care professional on 11/22/02, concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/02 onwards. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/10/02: A follow up report was received from a health care professional indicating that a 19 month old male vaccine was inadvertently administered Fluvirin intramuscularly on 11/20/02. Cross reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200805, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876 and PJP200200877.
pt recv vax 24OCT95 & exp bouts of abd pain, backache, diarrhea, vomiting, & fatigue;CAT scan revealed calcifications of liver & gall bladder disease;UA showed inc bilirubinuria & hematuria;pt attributed problem to vax;pt recovered;
Patient elected to receive the first dose of Pfizer COVID19 vaccine. While medic was prepping the vaccine for administration she did not realize the vaccine had to be diluted with saline. A full vial of Pfizer vaccine (6 doses) was drawn up and administered to the patient. The patient was advised of the incident and will be monitored over the next 72 hours to check for any adverse events.
This spontaneous report as received from a female consumer unknown age. The patient's medical history and current condition are not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (unknown strength, dosed and frequency). On an unknown date the patient experienced had side effect with PNEUMOVAX 23. The patient received treatment for the event. Product quality complaint was not involved. The outcome of the event is unknown. Additional information has been requested.
Following both first and second doses in my right arm. I received a baseball sized rash that hurt to the touch and itches. The rash lasted 8 days after the first dose and went away. The rash reappeared the day of the second dose (9/16/21)  and hasn?t responded to antihistamines.
Felt slightly dizzy within first 5minutes. Within 10minutes, started to feel numb and tingly all over left side of my body. It felt as if I had been shot with various doses of novocaine. This was still the case 8hours later when I went to sleep. This morning, I still feel this way from the left hand up to the left side of my face, lips, cheek.
Developed arm pain at the site, and body aches and head aches on 01/22/2021. Missed one day of work
A nurse reported that a child (age and gender unspecified) developed a rash described as a " few red spots" following the administration of Prevnar. No further info was available at the time of this report. The patient was one of four patients from the same facility reported to have developed a rash subsequent to Prevnar vaccination.
"knees and hands shaking"; dizziness; weakness; felt herself seek; felt like "look trough the magnifying glass"; she was scary; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR ("knees and hands shaking"), DIZZINESS (dizziness), ASTHENIA (weakness), ILLNESS (felt herself seek) and FEELING ABNORMAL (felt like "look trough the magnifying glass") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus, Hypertension and High cholesterol.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR ("knees and hands shaking"), DIZZINESS (dizziness), ASTHENIA (weakness), ILLNESS (felt herself seek), FEELING ABNORMAL (felt like "look trough the magnifying glass") and FEAR (she was scary). On 16-Mar-2021, TREMOR ("knees and hands shaking"), DIZZINESS (dizziness), ASTHENIA (weakness), ILLNESS (felt herself seek), FEELING ABNORMAL (felt like "look trough the magnifying glass") and FEAR (she was scary) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included medication for diabetes, medication for high cholesterol and medication for hypertension. No treatment information was provided.
had a 24 hours reaction to the second dose; just felt puny; rundown/lasted 24 hours and shut out  just like a clock; body aches; tired; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches), FATIGUE (tired) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION COMPLICATION (had a 24 hours reaction to the second dose), FEELING ABNORMAL (just felt puny), ASTHENIA (rundown/lasted 24 hours and shut out  just like a clock), MYALGIA (body aches), FATIGUE (tired) and PYREXIA (low grade fever) had resolved.            Patient's concomitant medication included one pill daily for asthma.    This case was linked to MOD-2021-363015 (Patient Link).
Stroke; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Mar2021 (Lot Number: EN6206) as dose 2, single for COVID-19 immunisation. The patient's medical history was reported as none (stated that patient had no previous history). Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 (LOT#: EL9266) as dose 1, single for COVID-19 immunisation. The patient experienced stroke on 04Apr2021. The patient was hospitalized for the event from 04Apr2021 to an unknown date. The outcome of the event was unknown.
Rash developed on forehead, later red splotches developed on arms and legs, itching. Patient took ZYRTEC until all typhoid capsules taken and itching and rash and itching subsided.
PT RECEIVED VACCINE 6/8 AND EXPERIENCED STANDARD INJECTION SITE SORENESS FOR 2 DAYS. SHE REPORTS BEING FINE UNTIL ONE WEEK LATER, ON 6/15, LATE IN THE DAY SHE DEVELOPED A SMALL BUMP AT THE INJECTION SITE. ON 6/16 (WED) HER ENTIRE ARM WAS SWOLLEN/INFLAMMED AND WARM TO THE TOUCH. SHE WENT TO ER AND WAS ADMITTED TO HOSPITAL AND TREATED FOR MULTIPLE BLOOD CLOTS. PATIENT REPORTED REACTION TO PHARMACY ON 6/17 AND WAS STILL IN HOSPITAL ON IV ANTICOAGULANTS. SHE IS POTENTIALLY GOING TO BE DISCHARGED ON 6/18  PER PATIENT.
Pt bent over shortly after receiving vaccine and stood up quickly and became dizzy. BP was taken to be 119/90 HR 89 BPM, after resting for 10-15 min Sx's resolved and Pt left.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: itchty throat-Medium, Systemic: Nausea-Mild, Additional Details: Patient stated self administer benadryl after arriving home
slight fever; little headache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance refer case US2022AMR122523).   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 fever, headache and general body pain. On an unknown date, the outcome of the fever, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR122523   Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had a little headache, slight fever and body aches for 12 hours with the second dose. The patient reported that's called an immune response, which means they were producing antibodies to fight off a shingles infection. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR122523:Same reporter
Fever, chills, sweats, body aches, dizziness, fatigue, nausea
Product Storage Error with Admin; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 55RY7, expiry date 17-OCT-2025) for prophylaxis.   On 26-JUN-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error with Admin). The outcome of the incorrect storage of drug 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: 26-Jun-2023 The vaccine coordinator stated that Boostrix was 15.6 degree Fahrenheit and administered to the patient which led to incorrect storage of drug. The reporter consented to follow up via email. The case is linked with US2023088674, by same reporter.; Sender's Comments:  US-GSK-US2023088674:Same reporter
Information has been received from a physician concerning a female patient who on 02-FEB-2011 was vaccinated with a dose of GARDASIL (lot number not provided). Secondary suspect therapy also included anti-seizure medication (manufacturer unspecified). Physician reported that after receiving vaccination, (also reported as "yesterday afternoon"), the patient experienced dizziness and headache. The patient believed that the GARDASIL was interacting with her anti-seizure medication. The physician advised patient to go to the Emergency Room, but at the time of the report it was unknown if the patient went or not. At the time of the report the patient's outcome was unknown. Additional information has been requested.
administered only diluent; administered only diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the nurse from nursing home administered only diluent of Shingrix and not powder component to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No other details of vaccine or patient were available. The reporter consented to follow up.
Pt developed rash on chest and underarms 3 days after first dose of COVID-19 vaccine. She was already taking hydroxyzine for itching and zyrtec for congestion before reaction. Her PCP recommended she still get the second shot but take Benadryl and Pepcid 1 hr prior to the vaccine and q6h after for 5 days.
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included acoustic neuroma (In December 2015, surgical removal of the neuroma). On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating. On an unknown date, the outcome of the influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, difficulty sleeping, back pain, scalp pain, fatigue and sweating to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's cousin. The patient was also a physician.
Within about 2 minutes of vaccine, pt lost consciousness, for btwn 30-60sec. Became rigid for 1-2 seconds. Regained consciousness, but had become very pale, and was  a bit groggy. Was a little nautious, but did not vomit. Had pt fully reclined, and about 25min later, pt was able to sit up, and just around 30min afterward was able to walk again. Pt was expecting this, as this has occured post vaccination before.
Patient broke out in a rash across forehead after getting vaccines. Rash was red & not raised Benadryl 2.5 mL was given po
PREVNAR-13, Hep A given 9/27- dev low-grade fever x 3 days. 9/30-dev high fever-rolled eyes, shook a little. T=104.9 in office. U/A negative. Fever down with Ibuprofen-sent home in good condition.
Persistent sore throat; Swollen lymph nodes (neck); This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 09:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no  known allergies to food, medications, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 24Mar2021, the patient experienced swollen lymph nodes in the neck and persistent sore throat which was there for 1 week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event persistent sore throat and swollen lymph nodes in the neck were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Instructed to give what nurse thought was Hepatitis A, however, physician apparently stated Hepatitis B, to be administered to patient. Thus, Hepatitis A was given instead of Hepatitis B. Patient female was given 0.5mL HAVRIX Lot #AHAVB492ca eXP: 09/09/13 left thigh IM without incidence. Family Practice Office.