chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 06-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA008695: US-009507513-1906USA010324: US-009507513-1906USA010325: US-009507513-1906USA010331: US-009507513-1906USA010326: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
Initial blurry vision (March 25, 2021) that then became doubled (July, 2021) and diagnosed with a 4th Cranial Nerve Palsy (August 16, 2021).
Redness to left thigh and warm to touch. Benadryl to be given prn. Parent called to state decreased redness, no swelling, warmth to area.
Client was given the yellow fever vaccine in a clinical office setting. She left the building and 40 minutes later her mother called to report that this minor had difficulty breathing. Traveled to E. Tx - Pepcid and BENADRYL via IV Albuterol breathing Tx. D/C to home.
shot #1 on 2018, yet to receive #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included vaccination with live shingles vaccine (Zostavax) in 2014 (received zostavax in 2014) and Shingrix (received 1st dose of shingrix on 18th November 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 14th Apr 2022 Reporter's Comments: The reporter was the patient. The patient received Shingrix shot 1 but had yet to receive Shingrix shot 2. The reporter did not have the lot number of the shot which was administered. The reporter provided limited information. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The case has been linked with the case US2022065243 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065243:Same reporter
Approximately 2 cm from the vaccine site there was a 2x2 cm raised red round area with central white area consistent with looking like a urticaria or bug bite.
1)  My left ear began feel very stopped up 3 days after my first vaccine on 8-9-2021.  I went to my PCP on 8-19-2021 to have my ears checked.  No indication of infection, ordered steroids for 5 days.  No change in my ear after the 5 days.   2) Had routine follow up and blood work with my Hematologist on 8-26-2021.  His office called me a few days later to report that my iron level had dropped dramatically and he was going to schedule an IV of   3) Second visit to PCP on 12-21-2021 due to continue having issue with left ear, feeling of fullness and seemed to be stopped up.  He  ordered another round of steroids and antibiotics even though there was no indication of an infection.  Meds did not do anything for my ear.  iron to be administered.  I have not had to have IV iron in almost 5 years and my blood work in June did not indicate any problems with my iron. 4) Made appointment and saw the ENT on 1-6-2022.  He examined both ears and performed a hearing test.  It was determined that I do not have any pressure in my ear even though it has felt like I do since August 12th of 2021, 3 days after receiving my first COVID vaccine.  The ENT advised that this damage is permanent and this hearing loss will not return. 5) The different doctors have advised that I do not receive any further COVID vaccines as the extreme adverse events could have been caused from the vaccine.
Patient had anaphylactic reaction after receiving Kinrix and Proquad; This spontaneous report was received from an epidemiologist and refers to a 4 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot #, expiration date, dose, frequency, route of administration, anatomical location not provided) and with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) both as prophylaxis. After receiving the vaccines, the patient had an anaphylactic reaction; in consequence, she went to the emergency room (ER) where she was treated (unspecified). On an unknown date, the patient recovered from the event.   Causality assessment between anaphylactic reaction and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was not reported.  Upon internal review, anaphylactic reaction was determined to be medically significant.
LOSS OF TASTE; LOSS OF SMELL; CONSTANT SNEEZING; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 19-NOV-2021 and 22-NOV-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 1 in total, dose was not reported (dose number in series was 1) for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient received additional non-company suspect vaccine mRNA1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination(dose number in series was 2). No concomitant medications were reported. On an unspecified date, following vaccination with mRNA 1273 and covid-19 vaccine ad26.cov2.s, the patient experienced loss of taste, loss of smell, and constant sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, loss of smell, and constant sneezing. This report was associated with a product quality complaint (PQC): 90000203117. The suspected product quality complaint has been confirmed to be void this record due to no PQC identified based on the PQC evaluation/investigation performed. This report was non-serious.
achiness, low grade temperature, nausea, started on day of shot and continued for two more days
On 01/02/2018 the patient reported loss of vision after leaving the pharmacy after receiving a high-dose flu vaccine on 12/8/17. Her and her husband went to gamble then left because she couldn't see. They arrived at their home roughly 90-120 minutes after receiving the vaccine and by that time her vision had fully returned. She has had no further problems with her vision since the date of the vaccine.
very painful; had both shots and a small patch each time / Suspected vaccination failure; It was a small patch each time; side effects like muscle pain; headaches; general feeling of being unwell; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice, once in 2007 and again in 2010. A small patch on my midriff in the same spot). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had the old vaccine on an unknown date between outbreaks; one needle).   In JAN-2023, the patient received the 2nd dose of Shingrix. In OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had both shots and a small patch each time / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: It was a small patch each time), pain (Verbatim: very painful), muscle pain (Verbatim: side effects like muscle pain), headache (Verbatim: headaches) and feeling unwell (Verbatim: general feeling of being unwell).  The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 1 month) and the outcome of the pain was not reported and the outcome of the muscle pain, headache and feeling unwell were recovered/resolved (duration 3 days).   It was unknown if the reporter considered the vaccination failure, shingles, pain, muscle pain, headache and feeling unwell to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain, muscle pain, headache and feeling unwell to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. Recently, the patient received the first and second Shingrix shot and stated it was a small patch each time but very painful which lasted each time about a month. The patient reported that he/she was lucky that it was only a small spot each time. The second time gave him/her side effects like muscle pain, headaches and general feeling of being unwell which lasted about 3 days. The patient reported that still he/she would recommend getting the vaccine because some get a more advanced rash than others. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Irregular menstrual cycle), MENSTRUATION DELAYED (Menstrual cycle delayed), HEAVY MENSTRUAL BLEEDING (extremely heavy bleeding) and BLEEDING TIME PROLONGED (prolonged bleeding) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular menstrual cycle), MENSTRUATION DELAYED (Menstrual cycle delayed), HEAVY MENSTRUAL BLEEDING (extremely heavy bleeding) and BLEEDING TIME PROLONGED (prolonged bleeding). At the time of the report, MENSTRUATION IRREGULAR (Irregular menstrual cycle), MENSTRUATION DELAYED (Menstrual cycle delayed), HEAVY MENSTRUAL BLEEDING (extremely heavy bleeding) and BLEEDING TIME PROLONGED (prolonged bleeding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant product were reported. No treatment medication was provided.
Itching of scalp, fullness sensation to back of throat immediately after Td vaccine. Benadryl 50mg IM 11:35 AM 6/2/05. Adrenaline 0.02ml SC 6/2/05 12:05. Vital signs stable.
Severe loss of range of motion in left shoulder, SIRVA, MRI, PT. Severe, debilitating pain.
Pain 14 hours after injection in (L) deltoid where shot given followed by all night feeling chills & body aches. Feels better now with ibuprofen. 7AM SOB & dizziness. Stiffness neck 7AM.
Realized she was only 17 at time of shot,  have to be 18 with EUA.
Itchiness after her first dose of COVID-19 vaccine this afternoon. Received vaccine around 2:15 PM and may be 30 minutes later just got diffusely itchy. No rashes not swollen anywhere no nausea or vomiting or belly pain no trouble speaking or swallowing or breathing. She got some oral Benadryl 50 mg prior to ED arrival.
Patient had Ileoanal anastomosis (J-pouch) surgery in 2000 and minor corrective surgery related to the pouch in 2015.  This event required a 15 day hospital stay due to severe abdominal cramps, pain, vomiting and diarrhea.  It was a suspected Crohn's flareup with stricture or blockage complications.  Vomiting and diarrhea began late 2/24.  Patient went to emergency room next morning and was subsequently admitted.  Multiple diagnostic imaging (X-ray, MRI, CT Scans, etc) showed narrowing of the small intestines above J-pouch.  Scope was completed on day 9 of the hospital stay.  Scope showed no narrowing or blockages, root cause of vomiting, diarrhea and severe abdominal pain unknown.  Patient had been doing well for several years after 2015 surgery.
Patient was going to get three vaccinations. He started with Shingrix and then the Havrix was administered in the other arm. He had no past reactions with shots and had flu vaccinations with us in the past. After a few minutes, he was feeling light headed and dizzy. He was visibly sweating and was leaning forward. Instructed him to lean back in case of passing out. I asked him if he wanted a water or anything to eat since he was not feeling well. He said he had not eaten anything today and was just dizzy.   Told him we should probably hold off on getting any more shots today since he was not feeling well. He voiced understanding. He was asking me about shingles and why exactly they call it that. After about 2-5 minutes of talking, he started to lose awareness and his eyes were not responsive. My technician called 911 and for manage to help out if needed. Patients wife was near and I explained the situation. I suggested an epi-pen to be administered because patient was non-responsive. Breathing was visible but was shallow and sounded muffled. The pen was administered and about 5 minutes later the patient was alert and responsive. Sweating had lessened.    Medical help arrived and patient did not want to go to the hospital. They took blood pressure which was low. We gave him some water and some mints in case blood glucose was a factor. Patient did not want to leave in ambulance if though medical help recommended this in case epinepherine wore off.
The Tdap was administered first in the left deltoid IM followed by the MENVEO in the same arm IM. The HPV9 was then administered in the right deltoid IM. I then left the room and was called back in approximately 2-3 mins. later by his father who stated he was in pain and appeared to be having a reaction. His left deltoid was covered in solid hives. I got the doctor in there. We got ice, administered BENADRYL, Ibuprofen, Prednisone, TAGAMET, and CLARITIN. His breathing and oxygen saturation remained normal (O2 Sats never below 98%). After about 45 mins. his right deltoid started itching and had a couple of hives. This arm never progressed. Dr. saw this and had me wash his arms off in case this had anything to do with the alcohol used on his skin. After an hour and a half he left feeling tired but much better. I spoke to his father 2 hours later and he stated that his arms were completely normal. Of note, his twin sister had the same vaccines, from the same lot numbers, in the same locations on her arms and did not have any reaction at all. The dad, stated he had not ever had any type of reaction like this before.
Muscle Spasm (TIC) generating from Chest though to Back as described by Patient.
Pt reported to pharmacy on 11/5/20 at ~ 8:00 pm. Pt arm was red (right). This was the arm that Pneumovax 23 was injected & administered. Pt stated it was "less red" from previous day. No other adverse reactions noted from pt on 11-5-20
Severe pounding headache; Fever; Chills; Body pain; Injection site pain; This is a spontaneous report from a contactable pharmacist. An adult male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via intramuscularly in the left arm on 25Mar2021 at 14:15, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via intramuscularly in the left arm on 04Mar2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination it was unknown that whether the patient was diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 03:00, the patient experienced severe pounding headache (lasted until 27Mar2021), fever, chills, body ache and injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events which included treatment with acetaminophen (500mg) on 26Mar2021 and ibuprofen on 27Mar2021. The clinical outcomes of the events severe pounding headache, fever, chills, body ache and injection site pain were starting to resolved on late evening of 27Mar2021 and by morning of 28Mar2021 all the events were fully resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed itchy bumps on chest , shoulders and back , 6 days after receiving the vaccine . On day 11 of receiving the vaccine , April 5th , I developed a rash on left upper arm at the injection site .  I have been taking Benadryl at night to sleep through the itching .
accidentally administered Ipol instead of a TB shot/no AE; Ipol vaccination that was delivered Interdermally/no AE; she only drew up 0.1mL/no AE; she thought she was administering a TB shot/no AE; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who accidently received vaccine IPV (VERO) [IPOL] instead of TUBERCULIN TEST [TUBERCULIN PPD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were received.  On 06-May-2019, the patient received a 0.1 ml dose of suspect IPV (VERO) lot N1F931M via intradermal route.  It was of actual medication error case due to Wrong product selected, Vaccine underdose, Inappropriate route of vaccination and Wrong vaccine administered. Nurse manager states that one of her nurses accidentally administered Ipol instead of a TB shot. Because she thought she was administering a TB shot, she only drew up 0.1mL and injected it intradermally.  The patient had not reported nor shown any signs of any potential adverse effects since the time of the injection.  Information on the batch number was requested for TUBERCULIN PPD.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On 03-APR-2014 the patient was vaccinated with a does of PNEUMOVAX 23 (lot#J011714, expiration date 20-FEB-2015), 0.5 ml, intramuscular. On an unknown date, in approximately April 2014, the patient experienced welts and rash at the injection site. The patient called her office and was suggested to use ice compresses and ibuprofen. No lab tests were performed. The outcome of welts and rash at the injection site was reported as recovering/resolving. The medical assistant was requesting a lot check. This is one of several reports received from the same source. Additional information has been requested.
I got COVID I felt fatigued I was coughing no appetite for days I had muscle involvement so I got tested 2X & both test were positive.
Experiencing a slight fever/Experiencing like a fever, it is low, it is a 100.4; I am not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FH8088) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Nov2021, outcome "unknown", described as "Experiencing a slight fever/Experiencing like a fever, it is low, it is a 100.4"; MALAISE (non-serious) with onset 10Nov2021, outcome "unknown", described as "I am not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient underwent lab tests and procedures which included Body temperature: 100.4.  No follow-up attempts are possible. No further information is expected.
not reconstituted with the supplied diluent / possibly reconstituted with sterile water; patient received a dose of Hiberix that was not reconstituted with the supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4925E, expiry date 24th October 2021) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient received a dose of Hiberix that was not reconstituted with the supplied diluent which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter stated that the incorrect dose was possibly reconstituted with sterile water. No further information was provided. The reporter consented to follow up. This is1 of 4 cases linked cases reported by same reporter. Notes: All the linked cases were conservatively considered as valid as the reporter was unsure which patient received the incorrectly reconstituted dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073596:same reporter US-GLAXOSMITHKLINE-US2021AMR073598:same reporter US-GLAXOSMITHKLINE-US2021AMR073597:same reporter