chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 2 month old infant who on 11-NOV-2008 was vaccinated with PNEUMOVAX 23, polyval, 0.5 ml via subcutaneous (lot # 9733401). The medical assistant stated that the office person that ordered the PREVNAR ordered PNEUMOVAX 23, polyval in error. The vaccine that was delivered to the office was PNEUMOVAX 23, polyval. The medical assistant stated that the PNEUMOVAX 23, polyval was originally placed where the office stored the PREVNAR. The medical assistant stated that the PNEUMOVAX 23, polyval was no longer stored where the PREVNAR was stored. The medical assistant stated that there was a sign to the PNEUMOVAX 23, polyval which stated that the vaccine was not to be used. No adverse effect was reported. No additional information was provided. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
County Public Health Nurses make visits to the County Detention Center to inmates who request STD/TB/Pregnancy testing and/or immunizations. 9/6/19: Patient seen at County Detention for testing and desired immunizations. Hep B virus panel drawn, Hep A vaccine (LDIM) and Tdap (RDIM) given. 9/9/19: Negative Hep B virus panel, not immune. 9/17/19 PM:  Heplisav given at County Detention Center by Public Health Nurse. 9/19/19 approx 1530:  Call from detention center staff nurse, reports pt c/o redness, swelling, warmth, and itching in area of Heplisav injection. Red raised area marked with a sharpie, topical hydrocortisone applied to area at approx 1540. 9/20/19 AM: Visit with patient at County Detention Center by Public Health Nurse, redness is slightly larger than marked area, area of raised, warm, redness measures 3" from top to bottom and 4" across with a 1-1.5" area in the center that is not red, raised, or warm. Pt reports slight itch today, better than yesterday, no pain unless touched, pain level 3 of 10 when touched. No blister(s) or pustule(s) noted, no other complaints. Reports no problems with Hep A or Tdap vaccines given 9/6/2019.
giving an expired / dose to a patient /  Vaccination date: 12th July 2021 / Expiration date of the vaccine: July 2nd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HBV (Engerix B) (batch number KC4OF, expiry date 2nd July 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The reporter wanted to know how to proceed after patient was given an expired Engerix-B dose, which led to expired vaccine used. The reporter consented to follow-up.
Right posterior arm rash - 16 x 7 cm red area with central denuded area approximately 3 cm - edges appear to be deflated blisters. Pt reports fever x 2D T-100.5, feeling ill, blistery rash to arm - still new blisters as of yesterday.
PATIENT CALLED ON 11/15/23 STATED THAT HE MIGHT HAD A DELAYED ALLERGIC REACTION TO THE MODERNA VACCINE AS HE GOT HIS DOSE 11/06/23 ALONG WITH OTHER 2 VACCINES WHICH HE HAD BEFORE AND NEVER CAUSED HIM A PROBLEM ( 2ND DOSE OF SHINGLES AND A FLU SHOT )  I ASKED HIM IF  HE HAD ANY REACTIONS RIGHT AFTER THEM HE SAID HE FELT LITTLE TIRED THE DAY AFTER AND THAT WAS IT SO I ADVISED HIM TO GO TO THE DR THEN I FOLLOWED UP WITH HIM TODAY 11/19/23 AND HE STATED THAT HE USED BENADRYL AND THE RASH DISAPPEARD SO HE CANCELED HIS OPP WITH THE DR AND HE STATED THAT HE DOESN'T THINK THAT WAS BECAUSE OF THE VACCINE
first dose was in June 2022 and 2nd dose in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In July 2022, the patient received the 2nd dose of Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The pharmacist reported that the patient he/she received 2nd dose of shingrix less than the minimal interval.  The patient not immunocompromised, first dose was in June 2022 and 2nd dose in July 2022. No other information available The reporter consent to follow-up. Additional Supportive information: The patient received 2nd dose of shingrix less than the minimal interval, first dose was in June 2022 and 2nd dose in July 2022, which led to shortening of vaccinations schedule.
have experienced intense muscle pain.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 16:00 (Lot number: EW0183) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: HYZAAR; PREVACID. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EW0183,administration date= 25Jun2021, administration time=03:00 PM, Dose Number: 1, vaccine location=Left arm), administration date: 25Jun2021, when the patient was 59 years old, for Covid-19 immunisation, reaction(s): "Facial Spasm". The following information was reported: MYALGIA (non-serious) with onset 24Jul2021 07:00, outcome "recovering", described as "have experienced intense muscle pain.". Therapeutic measures were not taken as a result of myalgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included stool softner, multiple vitamin.  No follow-up attempts are possible. No further information is expected.
1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (The patient had a heart attack 11 years ago prior to receiving the 1st dose of the moderna vaccine). Concurrent medical conditions included Heart disease, unspecified (The patient was a high-risk patient as he had a heart condition and heart attack 11 years ago prior to receiving the 1st dose of the moderna vaccine) and Hearing impaired (he had trouble hearing but stated that it was not due the vaccine.).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose received on 21Jan2021 and 2nd dose received on 01Mar2021) had resolved.            No concomitant medications reported. No treatment information was provided. The patient seemed upset and stated that he is confused with lack of information and so much confusion surrounding the 3rd dose and booster vaccine.
Patient ran high fever 104.8 rectally with last immunizations.  Mother had difficulty bringing fever down.  Gave Tylenol and Motrin.  Took to ER-was given anti-fever medication there.
Severe pain in left shoulder, (near location of the injection).  Pain and range of mobility decreased as time went on.  On scale from 1-10 pain rated 3 normally with periods of 8 when using left arm.
I received the shingles vaccine on Thursday night and by started having chills fever intense pain in the arm I had the injection. I was in bed all Friday Saturday I was still feeling like I had the flu but u set my eyes was swollen and my face felt right. By Sunday most of the flu like symptoms were gone and my eyes looked like I hadn't in weeks because the swelling went down and now there were bags. My arm still has radiating pain down it and I have a severe headache.
-brain fog starting about an hr since vaccine administered -random spurts of dizziness/lightheadedness with varying lengths of time
5cm erythema, warmth, pruritus at injection site left deltoid 24 hours after injection. Afebrile. Cold packs, Tylenol, Benadryl prn for itch.
2hr p/vax devel fever of 102-104 & vomiting;sx cont to present time (1 1/2 days late);fever reduced by pain reliever med;recommended to take child to pvt md;
Onset of seasonal allergies: sneezing, watery eyes, sinus congestion etc. Continued treatment with OTC and natural remedies
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unknown dates the patients received doses of improperly stored (being exposed to temperatures outside of the recommended range) ROTATEQ (dose not reported, lot # L008578 with expiration date 14-DEC-2016) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever; felt achey; chilled; exhausted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 13:15 (Lot number: EWER8134) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergy: penicillin" (unspecified if ongoing), notes: Known Allergy: penicillin. Concomitant medication(s) included: IRBESARTAN. Past drug history included: Irbesartan 75mg for blood presure, notes: blood pressure being treated with, Irbesartan 75mg. Vaccination history included: Bnt162b2 (DOSE NUMBER: 1st, lot number=EW0170, location=Right arm), administration date: 07May2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "felt achey"; CHILLS (non-serious), outcome "unknown", described as "chilled"; FATIGUE (non-serious), outcome "unknown", described as "exhausted". Therapeutic measures were not taken as a result of pyrexia, pain, chills, fatigue.  Follow-up attempts are completed. No further information is expected.
The patient had reported itching to his arms and legs, ears were swollen, lumps on his chest. and was getting lightheaded 6 to 7 minutes after he had received the covid-19 vaccine. The patient reported his cousin had an epi-pen, which he used and felt better afterward.
Day 1 - 02/03/21 - sore arm Day 2 - sore arm, slight redness at injection site Day 3 - sore arm, more redness and hard lump at injection site Day 4 - in the morning, more redness and a few small red spots near the site - by the afternoon slight rash on torso and at injection site Day 5 - Rash all over - mainly on torso, but also arms - very light on legs and feet and only a few on face - Very itchy and tingly -  Day 6 - 02/08/2021 (today)  I have an appointment with primary care doctor today
Information has been received from an ID specialist as part of a marketing research program conducted, referring to unknown patients  of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dosage, strength, route and lot # not reported). There was no concomitant medication reported. The reporter stated that the patients experienced rash type reaction in site area of vaccine, red area/ cellulitis a few days after vaccination (saw it maybe once every few years), fever and achiness. The outcome of the events was unknown. Additional information has been requested.
Janssen COVID-19 Vaccine  On 4/12 I started having a lot of pain overnight, especially the left side of my body. My left hip is hurting really bad, my left arm sometimes hurts. My back is also now hurting. Nothing I take alleviates the pain, I have tried Aleve, Tylenol and Ibuprofen. I am extremely fatigued both day and night now. My bones feel very painful even sometimes down to my feet. While most of my body hurts, the left side seems to hurt more than my right side. When I got the vaccine I felt very "out of body" if that makes any sense, but now I feel very off. I also seem to be bruising easier than I used to before as well.
Patient presented to ED on 11/15/21 with SOB, found to have acute hypoxic respiratory failure due to Covid 19 infection. Patient is fully vaccinated. Patient completed 5 days of remdesivir and 10 days of dexamethasone course. Patient was appropriately treated and was discharged on 11/25/21.
This spontaneous report was received from a pharmacist refers to a male patient in his 70's. No medical history was reported. On an unknown date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry, route not reported) from an unspecified pharmacy. The pharmacist reported that this patient came to the pharmacy today complaining of radiating pain in the arm he received his ZOSTAVAX. Pharmacist reported this patient stated he has had this pain for the last week (since May 2013). No treatment was given. Patient sought medical attention (asked pharmacy). The outcome of radiating pain in the arm was unknown. Additional information has been requested.
Influenza shot was received at 3:25 pm.  Around 5:30, a cough began.  Around 6:30 hoarseness and a "funny feeling" began in the throat.  By 7:30 was thinking of going to the hospital.  Call Hospital at 8:00 and was instructed to take benadryl.  Took 2-25 ml pills around 8:10.  Call hospital again around 8:30 to report difficulty swallowing.  Arrived at hospital around 8:50.  Elevated blood pressure and shaking on arrival.  Admitted to ER and received a breathing treatment and steroid shot.  Dismissed from hospital around 10:15.
AS REPORTED BY PATIENT:  Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG.  I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on.  She suggested I download the app for CDC and report those items as well.  The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
Got the 2 shots / Each time was very ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional events were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received 1st dose of Shingles vaccine and was ill. For tolerance of 2nd dose, refer case US2021AMR027665.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027665:Same reporter.
Extremely hot, then feeling weak, then fainted, threw up, all in a short period of time. Headache for about 2 hours afterwards. Bed rest.
This case was reported by a physician and described the occurrence of hypoglycemia in a adult female patient who received FLUVIRAL (batch number G44A3, expiry date 30th April 2015). This case was associated with a product complaint. On 26th September 2014, the patient received FLUVIRAL. On 26th September 2014, less than a day after receiving FLUVIRAL, the patient experienced hypoglycemia (serious criteria clinically significant/intervention required), lightheaded, nausea, sweating and shaky. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the hypoglycemia, lightheaded, nausea, sweating, shaky and product complaint were unknown. The reporter considered the hypoglycemia, lightheaded, nausea, sweating and shaky to be probably related to FLUVIRAL. Additional details received: The only information received about this subject was that she had had lunch before the vaccination. The reporter mentioned that the nurse who administered the vaccine also had HUMALOG in the refrigerator. However, it was reported that the vial for HUMALOG was significantly bigger than that for FLULAVAL, and was located in a different location in the refrigerator. The administrating nurse also was almost positive that she did not administer HUMALOG. A total of 6 patients were vaccinated at the same school and all 6 experienced hypoglycemia symptoms. All of them were vaccinated with the same lot of FLULAVAL (2 different vials). These cases have been linked in the GSK database (see case US2014GSK000221). At the time of reporting, investigations were pending. Follow up information received from an electronic newspaper on 06October 2014: a lawsuit has been filed by two of concerned patients against the school district alleging that they were given shots of insulin instead of the GSK flu vaccine shots they believed they were receiving. Investigations were still ongoing.
abnormal ekg, azothemia, out of range CBC, SOB, loss of kidney function
Patient had episode of syncope which involved short term loss of consciousness, low B/P, low pulse rate, hands cold and clammy. Patient was moved from a chair to lie on a blanket on the floor, with his head on a small pillow, his feet elevated approximately 10", and we covered him with a blanket.  With permission of the mother and the patient called EMS to transport to ED for assessment.  Diagnosis at ED vasovagal syncope.
Severe Muscle and joint paint started at around 2am, on 2/18.  Followed by severe fatigue and trouble standing.  Fever of 101.2 noted at 6pm, 2/18.   Additional a high heart rate ha been noted since about 4pm, 2/18.
my wound was bleeding and was in moderate to severe pain for the first time; Sore arm; tingling in the hand in the same arm after letting go of the steering wheel; I began to have pain in that wound for the first time; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 at 15:00 as dose 1, single for COVID-19 immunization (at the age of 19-year-old) at Pharmacy or Drug Store. Medical history included ADHD, bipolar, anxiety disorder and neoplasm removal on foot of the pain (patient had a mole shaved off a one week ago from the vaccination on his foot) all from an unspecified date and unknown if was ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), bupropion hydrochloride (WELLBUTRIN), isotretinoin (ACCUTANE), propranolol and lamotrigine (LAMICTAL) all from were taken from an unspecified indication from an unknown date and unknown if was ongoing. No other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 07Apr2021 at 15:00, the patient experienced sore arm, tingling in the hand in the same arm after letting go of the steering wheel. He had a mole shaved off a one week ago from the vaccination on his foot. No bleeding or pain at first while applying Aquaphor and band-aid twice a day. The day of the vaccination 7 days after in the morning, he began to have pain in that wound for the first time. After he got the vaccine the pain in the foot was not as bad. When he woke up the next day, his wound was bleeding and was in moderate to severe pain for the first time. The patient did not received any treatment for adverse events. On an unspecified date in Apr2021, the patient recovered from all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
approx 2 yrs p/ vax pt exp a rash w/about 12 lesions.
Brain fog, fatigue, cold sweats, chills, nausea, headache, dizzy/disoriented
The patient fainted after about 10 minutes after vaccination was administered. Patient was aware and alert and did not loose consciousness at any time during the process. Patient stood up and approach the pharmacy counter and at that time fainted. patient did not want any medical attention . Patient left 30 minutes later with a parent.
In duration, bruise, touches, scratches that site, noted several months before Sept 2021
COVID-19 Treatment/COVID test: Positive; COVID-19 Treatment/COVID test: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 56 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment/COVID test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The event was assessed as non-serious by the reporter.