chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 64 year old patient who in fall 2008, in approximately September 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The physician reported that in July 2010 the patient had a current shingles outbreak and he was treating the patient's shingles (Treatment unspecified). At the time of the report, the patient had not recovered from shingles. The patient sought medical attention (spoke to physician). Follow-up information has been received from a completed questionnaire from a physician concerning a retired female patient with no illness at time of vaccination, a history of chicken pox when childhood and no recent exposure to chickenpox or herpes zoster, who on 18-NOV-2008 (previously reported as September 2008) was vaccinated subcutaneously into her left arm with a dose of ZOSTAVAX (Merck) (Lot 659759/1873U). The physician stated that on 20-JUL-2010 the patient had a zoster outbreak. The lesions were in the left upper arm C5. The patient had a pain value 3 in scale 0 to 10. There was not a direct fluorescent antibody, no specimen was collected for PCR and no photos were taken of the lesion. In September 2010, the patient recovered. There were no laboratories diagnostics studies performed. No further information is available.
chills; a light fever; light headache; This is a spontaneous report from a contactable consumer or other non hcp.  A 9-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter is scheduled to receive the second dose and asked if she experiences side effects, should she drink hot or cold stuff. Reporter stated her friend (Patient) received the Pfizer Covid-19 vaccine and on an unspecified date experienced chills, a light fever, and a light headache that lasted for a day. The outcome of the events was recovered.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Patient stated she has a large bump at injection site, rash, fever, dramatic change in blood sugar, flu like symptoms, body aches/unable to get out of bed.
"Moderna COVID19 Vaccine EUA" patient had nonintractable episodic headache from time of vaccine 01/04/2021 through the time of visit 01/15/2021.
After receiving his COVID-19  moderna vaccine,  patient sat in waiting area for his 15 minutes. Before his 15 minutes were up, patient felt light-headed and passed out to the floor. Patient hit head on floor.
Bells Palsy - left side of face  Treated with prednisone and anti viral medication
no adverse effects; a patient was administered a dose of PROQUAD that did not dissolve completely following reconstitution; the color of the reconstituted product was CLEAR.; office manager reported she thought this ocurred because the medical assisstant did not agitate the vial enough following reconstitution; This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 23-MAY-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot # R008203 with an expiration date in 16-SEP-2019), subcutaneously, for prophylaxis (dose, strength and frequency were not provided), that was reconstituted with sterile diluent injection (lot # R008203 with an expiration date in 29-AUG-2020) (strength, dose, frequency, route and indication were not provided).     On the same date, it was noted that the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not dissolve completely following reconstitution (product reconstitution quality issue). Additionally, it was also stated that the reporter thought that this occurred because the medical assistant did not agitate the vial enough following reconstitution, and it was also mentioned that the color of the reconstituted product was clear (product colour issue). No adverse effects were reported.    At the time of reporting, the outcome of product reconstitution quality issue and product colour issue was unknown.     The causality assessment between the reported suspect therapies and the reported events was not provided.
Patient received a COVID-19 vaccine at the COVID vaccination clinic. The vaccines were shipped addressed to 2 Soldiers who were hosting the vaccination clinic. The vaccination were alarming in transport and both Pfizer and USAMMA both told the Soldiers that the vaccines were no longer viable and should not be given to the patients. Due to a lack of and miscommunication, 5 patients received the vaccines.
3 complete doses were drawn out of a 6 dose vial of Pfizer vaccine. Reconstitution error expected and found after a dose was given to patient. Attempts to notify client 5/24/2021 x2 and 5/25/2021 x1. Will continue to attempt to notify to discuss vaccine, possibility of slightly larger dose, and possible side effects to expect.
Increased heart rate, dizziness, pale coloring around lips. No treatment. BP 129/81, resp 20, pulse 95 T. 97.7, SPO2 99%.
Bright red 2x2in rash in left arm, exact location of injection site. Warm to touch, non tender, non-itching.
an unusually large red and bumpy rash on the left side of my hip; an unusually large red and bumpy rash on the left side of my hip; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiry Date were not reported), via an unspecified route of administration, administered in Arm Right on 10Mar2021 10:30 (at the age of 31-year-old) as dose 1, single for covid-19 immunisation at School Gym Building. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks or any other medications in two weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient has no known allergies. On 13Mar2021 07:45, the patient experienced an unusually large, red, and bumpy rash on the left side of her hip. Does not itch or hurt. The patient did not receive any treatment for the adverse event. Outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
tested positive again for covid; tested positive again for covid; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Arm Right on 19Dec2020 13:00 (Batch/Lot Number: EK5730) as 2nd dose, single and dose 1 intramuscular, administered in Arm Right on 07Jan2021 16:00 (Batch/Lot Number: EL3302) as 1st dose single for covid-19 immunisation. Medical history included covid-19 in Nov2020 to an unknown date. The patient is not pregnant. Concomitant medications included levothyroxine and propranolol both taken for an unspecified indication, start and stop date were not reported. The patient reported having tested positive again for covid on unspecified date in May2021. The patient underwent lab test and procedures which includes a nasal swab in Nov2020 and May2021 both resulted positive. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The outcome of the events was unknown.  Follow up needed, further information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid 19. The case will be reassessed once new information is available.
Redness, tenderness, warmth at shot over approximately 4 x 5cm ?
Shoulder and arm pain 7 days. Fever, Temperature max 101, 2 days. Flu like symptoms 5 days.
soreness and swelling in her arm; body aches; soreness and swelling in her arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix, the patient experienced general body pain and pain in arm. In March 2020, the patient experienced swelling arm. On an unknown date, the outcome of the general body pain, pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in arm and swelling arm to be related to Shingrix.  Additional details were received as follows: The patient reported that she received the first dose of Shingrix about 1 month ago. She had some body aches, and soreness and swelling in her arm starting the evening of the injection. The reporter consented to follow up.
Patient reports vomiting, diarrhea and abdominal cramping which started 2 weeks ago; also was having cough, fever, mild shortness of breath, nasal congestion; started on remdesivir, empiric antibiotics, and dexamethasone, vit c, zinc.  Patient started improving.  Eventually antibiotics were discontinued.  Patient's symptoms improved.  However, patient was having generalized weakness and debility.  Family requested placement.
Began experiencing cold sweats, felt awful, a bit sick to my stomach, slight headache.  It lasted about 30 to 45 seconds.
Information has been received from a registered nurse concerning a 12 year old white female with no pre-existing allergies, birth defects, or medical conditions who on 10/05/2004 at 10:45AM was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  There was no concomitant medication.  On 10/06/2004 at 2:30PM the patient developed a generalized rash and malaise.  She was also tired and woozy.  The outcome was reported as not recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a registered nurse indicated that on 10/06/2004, one day post vaccination, the patient developed a red, raised rash on her back, abdomen, and arms.  No fever was noted.  On 10/07/2004, the patient complained of feeling tired and woozy for 1 day duration.  The generalized rash lasted approximately 2 weeks, then the patient had developed 2-3 spots at a time over a course of 2-3 weeks.  The last episode of having the itchy spots appear was approximately 11/07/2004.  The outcome was reported as recovered on 11/07/2004.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations of the patient or her siblings.  No additional information is expected.
Information has been received on 03/18/2002 concerning a 47 year old female who was vaccinated with Imovax Rabies post exposure series 4 years ago for a rabid dog bite. The pt now has nerve damage and spasms. The pt has been diagnosed with Guillain Barre syndrome by a neurologist. From follow up e-mail correspondence received at manufacturer on 5/8/02 it was made aware that correction needed to be made to the latest received date. The initial info was received on 3/18/02, not 3/19/02 as previously reported.
Per child's mother (Gillian Ritscher), the event lasted fifteen-twenty sec. Arms flew over head, face become bright red, some body shaking and stiffening. Eyes watered and some drooling from mouth. No fever.
Mild pain and redness at injection site; Mild pain and redness at injection site; mild headache x 24 hours; mild achiness x 24 hrs; tiredness x 24 hrs; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: E13247), via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:45 AM (age at vaccination was 61-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included obesity, vitamin d deficiency, Reactive Airway -all from an unknown date and unknown if ongoing. The patient did not have any known allergies. Patient was not pregnant at the time of 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. Concomitant medications included montelukast (MONTELUKAST), cetirizine hydrochloride (ZYRTEC ALLERGY) biotin, cyanocobalamin, folic acid (MVI 3) ergocalciferol (VIT D) all from taken for an unspecified indication, start and stop date was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild pain and redness at injection site, mild headache x 24 hours, mild achiness x 24 hrs and tiredness x 24 hrs on 22Feb2021 15:00. No treatment received for the events reported. The clinical outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
expired vaccine administered, with no reported adverse event; Initial information received on 20-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves male patient with an unknown age who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Sep-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported, expiry date- 17-Sep-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day).  It was reported "It is unknown if the patient experienced any additional symptoms/events."  At time of reporting, no adverse event was reported.   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 the 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.  There will be no information available on the batch number for this case.
On July 17 2017 I took my daughter to medical group for her 1st year well check and her shots..they gave her 3 shots ... Hep A, MMR and they were supposed to give her varicella but they gave her pneumococcal ..which doctor called me around 5 and said it was a mix of varicella and MMR, and doctor said that patient might get a high fever and a seizure. I'm making a report in case she has complications later on due to the injection.
rapid pulse, x 24 hr   mental disconnect issues,   x 48hrs     anxiety      sleeplessness x 2wks
received liquid portion as first dose; received liquid portion as first dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA642A, expiry date 30th June 2023) for prophylaxis.   On 28th April 2022, the patient received the 1st dose of Menveo. On 28th April 2022, unknown after receiving Menveo, 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 Information: GSK Receipt Date: 28-APR-2022  Reporter's comment: Medical assistant reported that, a patient received by error the liquid portion of Menveo. The reporter consented to follow up. Additional supportive information: A patient received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Breakthrough bleeding. I have experienced very heavy menstrual bleeding and large blood clots even though I use birth control to avoid  monthly periods.
This morning the patient received the H1N1 Vaccine with Thimerosal. 5-8 mins following vaccination, the patient complained light-headness and sensation of "blacking-out." The patient became ashen, pupils were fixed and dilated, and he lost postural control of his body. His pulse oximetry monitor decreased to 80% and the patient was having difficulty maintaining his airway. 0.3mg Epinephrine was administered into the right thigh and airway opened using jaw-thrust technique. Within 2 mins, the patient regained his mentation and pulse oximetry increased to 99% wihtout supplemental oxygen. Patient was tolerating oral fluid and given 30mg Prednisone and 50mg Benadryl by mouth. After 30-45mins of close one-to-one monitoring, patient was released with Prednisone burst and Benadryl.
Menstrual period with heavy bleeding and moderate to severe cramping began less than 24 hours after injection, despite Mirena IUD with active hormones that has stopped my regular monthly periods since 2016.
In September 2022, I began having symptoms as fatigue first. When I got up the next day, I realized I didn't feel good and stayed home from work. That afternoon I had a fever, runny nose and cough. I tested positive for COVID-19 with an at home test. I was at home and pretty much in bed for two whole weeks. I did consult with my doctor but was not prescribed any medications. As of today, I still feel like I have not gotten my energy back.
8 year old patient received Pfizer bivalent instead of monovalent. patient was observed for 15 minutes, no adverse reactions noted.
Lingering leg muscle issues; Leg pain; 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 MUSCLE SPASMS (Lingering leg muscle issues) and PAIN IN EXTREMITY (Leg pain) in a patient of an unknown age and gender 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 MUSCLE SPASMS (Lingering leg muscle issues) and PAIN IN EXTREMITY (Leg pain). At the time of the report, MUSCLE SPASMS (Lingering leg muscle issues) and PAIN IN EXTREMITY (Leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medication was reported.
Headache, cough and red ring about 14 cm diameter at injection site. Area reddened and warm and itchy.
Pt admitted on 7/10 for dyspnea and chest pain. Pt received COVID J&J vaccine on 4/6/2021. Pt was given oxygen ~1.5 days and received dexamethasone and acetazolamide. On 7/14/21, Pt currently on room air. Possible reason for AHRF multifactorial of COVID, acute on chronic anemia and HF exacerbation with severe valvular disease.
STOMACH ACHE HEADACHE ANXIETY ISSUES DUE TO STEP SISTERS EPISODE (FAINTED). RECIEVED VACCINES AT SAME TIME. BP 142/180 HR 78.  FOLLOW UP PHONE CALL 6:50 PM, MOM STATES DOING WELL.
Patient called two days after receiving the vaccine and state he was experiencing swelling in his legs and ankles (along with fatigue, nausea, and fever)
This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 15-AUG-2016, the patient was vaccinated with an expired dose of oral ROTATEQ (lot # L000434, expiry date: 10-JUL-2016 via oral route. No adverse effect was reported. Additional information has been requested.
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 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:35 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.   Age of the patient was reported as 33.34.  Concomitant medication of the patient was not reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 03-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Patient showed up to the pharmacy this Sunday morning 3/25/18 his chief complaint is diarrhea. No fever, slight headache, no body aches.
I was pregnant at the time I was given the vaccine (17 weeks pregnant). 12 hours later I experienced fever, chills, and body aches. 24 hours later I was having contractions. I then went into preterm labor, my water broke and I remained at the hospital for almost a week. I delivered my baby at the end of the week (18 weeks) which was born sleeping.
p/DTP pt exhibited a cry for >3 hr; high pitched cry; sz-like activity (approx 5 days p/vax);