chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brain hemorrhage; general comprehension has gone downhill; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 75-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, administered in the right arm on 17Mar2021 at 14:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 1 diabetes mellitus from an unknown date and unknown if ongoing (not controlled). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication) included insulin for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Mar2021 at 14:30, the patient experienced brain hemorrhage, and general comprehension has gone downhill; both considered to be disabilities for which the patient was hospitalized for 2 days. Clinical course: One week after immunization, on 30Mar2021 at 14:30, the patient started screaming his head hurt. They had to medicate him to get him into ambulance because he was confused. A brain scan was performed on 30Mar2021 which revealed a small brain hemorrhage. They then transferred patient. His general comprehension has gone downhill. No treatment for the event was given. The patient had not recovered from the events, brain hemorrhage, and general comprehension has gone downhill.   Information on the lot/batch number has been requested.
I received my 4th booster on May 4, 2022.  I had COVID-19 in June 2022.  I had pneumonia in both lungs.  I now have fatigue every day.  I continue to have itchy burning skin with whelps, like pimples, that come and go.  My skin burns and itches at the same time.  My back turns beet red and broken out from my middle back all the way up to my neck.  I went to urgent care.  An hour later the redness was gone.  I feel like I have a crawling feeling, like bugs, under my skin.  I have memory problems now and cannot organize my thoughts.  I have abdominal pain so severe that once I went to urgent care for it.  I have chest pain and I have been to the urgent care for this.  My taste and smell has not returned completely.  My hair started to fall out in clumps last week.  My eyes began to itch before my upper body and skin began to itch.  I am seeing an allergist tomorrow, November 8, 2022.  I have seen my primary doctor.  I have seen my oncology doctor for my regular, routine blood draw, also.  I am in remission with CLL ? Chronic Lymphocytic Leukemia.
No adverse event; Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant medications were reported.  Reported that patient did not report any AEs after the vaccine was administered.  No treatment medications were reported.
Pt. states that approximately 20 minutes after receiving vaccine she noted pain radiating up to left wrist. This sensation has continued more intermittent at the present, no inflammation at site.
Leg pain calf area starting 11-6-21, reduced leg pain 11-7-21. Leg swelling calf area starting 11-7-21
SORENESS IN UPPER LEFT ARM FOLLOWING INJECTION AND BECOMING WORSE AND GRADUALLY MORE PAINFUL OVER MONTHS  PAIN IS SO SEVERE THAT DRIVING, DRESSING AND LIFTING ARE RESTRICTED DUE TO PAIN.
4/7/03 This morning, noted rash over most of body after shower. Sore throat one week ago but better now. Lymph node post cervical chain. Temp 99.2.
Palpable 1-2 inch hardened lump in deltoid region of arm where vaccine was administered (left). Site is tender and painful. Noticed approximately 4 weeks following final dose in the 3-dose Gardasil-9 vaccination series.
Per Patient:"  left arm exactly where the 2nd injection was done has developed a pretty consistent muscle spasm. The spasm is  in the EXACT location as the covid injection."   Patient reported this on 5/28/2021.  Vaccination was given 4/13/2021
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 29-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Seen for WBV today (1/29/2020) and mom mentioned that when he had the flu vaccine in October, he had a rash on his abdomen that started approximately 2 hours after vaccine administration. Rash was itchy. No respiratory distress, oral swelling or vomiting.  Rash resolved on own the following day with no other symptoms.  Described rash as large red bumps.  Did not appear on other parts of body. Showed her photos of rashes on line and she pointed to urticarial rash.  She did not seek medical care at the time of the event.
The evening after the shot could not sleep and was nauseous. The next day had body aches, fatigue and chills. Back really hurt. The next day felt lots better.
Cellulitis at Injection site, redness, swollen-red line traveling up arm, prescribed Bactrim DS
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants drugs were reported. No treatment drug was reported The vial was initially stored in the refrigerator on 24Sept2021 No temperature excursions.
Low grade fever with mild urticarial rash on day 3, with more dispersed urticaria on day 5 after vaccine administration.
Fussiness in the hours after vaccine. Mother reports patient has typical reaction similar to other vaccination in past.
expired vaccine administered to the patient, no AE; Initial information was received on 25-Feb-2020 regarding an unsolicited valid non-serious case from other healthcare professional.  This case is linked to case 2020SA052438 (same reporter).  This case involves a 2 months old male patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Expired product administered).  Medical history, medical treatments, vaccinations and family history were not provided.  On 25-Feb-2020, the patient received a dose of concomitant medications HIB VACCINE CONJ (TET TOX) (ACTHIB), POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) via an unknown route at an unknown administration site for prophylactic vaccination.  On 25-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA, expiry date-30-Jan-2020),  via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report 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 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.
36 to 48hr p/vax devel sx of intense myalgias specially @ abd region & also noted RUQ pains & mult ecchymotic lesions thighs, buttocks, legs w/localized soreness;no fever;
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever with the 1st dose of SHINGRIX vaccine dose. The patient asked, for the 2nd one. What's the chance the same thing would happen? Do you have an answer to the likelihood of a second fever episode?
Pain and very swollen lymph nodes under left armpit and towards left breast. Lasted two full weeks.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatigue, malaise, and anorexia. Patient was hypoxemic (oxygen saturation 90%) and tachycardic (pulse 108 beats per minute). Diagnosed with COVID-19 and acute hypoxemic respiratory failure, admitted to hospital, received remdesivir, steroids, anticoagulation, and oxygen. Patient improved and was discharged two days later medically stable.
severe allergic reaction to it/and went into anaphylactic shock/started choking; severe allergic reaction to it/her arm swelled up; This spontaneous report was received from a 56 years old female patient, who was referring to herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. It was reported that she did not have any drug reactions or allergies in her life.  On 20-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) lot # J014566, expiration date was not reported but upon internal validation process it was established as 18-FEB-2015 (formulation, dose, route of administration and anatomical location were not reported) for prophylaxis.  On the same date, the patient experienced severe allergic reaction to zoster vaccine live (ZOSTAVAX). Her arm swelled up, she started choking, and went into anaphylactic shock. She was sent to an emergency room (ER) and they were waiting. They "pumped her with shot after shot", it was really bad, and finally was able to pull out. They told her if she received another vaccine they may not be able to save her. No laboratory diagnostics or studies were performed. She did not take any vaccines since then. The outcome of the events was reported as recovered.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of anaphylactic shock was determined to be medically significant.
Cytokines storm with muscle pain, malaise, wheezing, loss of appetite, low grade fever   All lasted 10 days
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid after receiving his Pfizer Covid 19 Vaccine/has already had his first, and second shots and first booster of the Covid vaccine, before he tested positive for the Covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The caller has just completed his last dose of Paxlovid today. Caller was asking once he has tested negative for Covid if there's a recommended time frame that he should receive his second Pfizer Covid 19 Booster. Caller states he has already had his first, and second shots and first booster of the Covid vaccine, before he tested positive for the Covid virus. Caller states he took his last dose of Paxlovid this morning. Caller states in the last 6 days he had tested positive for the Covid virus. Caller states that after he had symptoms, he was prescribed Paxlovid. Caller states that he has taken Paxlovid for 5 days. Caller states Paxlovid did a great job. Caller states that he was previously scheduled for his second Covid booster shot next Thursday. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had immediate swelling at injection site in the left arm where prevnar was given. We gave an ice pack and monitored her off and on for about 30 minutes. The swelling went down, and she stated that she felt fine, then left. Also, we offered her some benadryl in case she needed it at home, and she took it in case she needed it later.
I am experiencing a severe case of Cholecystitis and can barely move or inhale deeply without sharp, stabbing pain.  It is severe enough to go to the emergency room, but I don't have health insurance and cannot afford to go to the hospital.
Pt vaccinated with DTP developed rash which was very red at the site of injection, temp of 100 rectal, infant was seen in office 72 hrs later, presented with a vesicular papular rash which covered the outer lateral thigh with various spots
On the night of vaccine admin, patient developed increase fever, irritability and Bulging Fontanel. His exam was concerning for nuchal rigidity. Patient was evaluated in the ER and treated (inpatient) x 2 days for presumed meningitis. All cultures were negative. He improved by the following day. In addition, the patient became anemic during treatment (initially 10.1 ----> 8.5 at discharge).  04/16/2007 MR received for a 2 night ER admission 03/6-8/2007 for fever, irritability, and bulging fontanel.  Seen first by PCP who refered to hospital ER to r/o meningitis. PE in ER revealed an alert but listless infant. Anterior Fontanel very full but soft.  othewise WNL. Txd with antibiotics. DX:  presumed viral meningitis.
Information has been received from a registered pharmacists concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported) subcutaneously.  After three days post vaccination the patient developed injection site welts that was 1x1 1/2 inches.  As of 07-JAN-2009 the present patient's outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Pt. c/o lightheadness, denies nausea 09:56 AM BP 138/76, SPO2 97%, HR 90 Monitored pt. for 30 min.  Pt stated she was feeling better.  Pt left the building: oriented, alert and talking.
Patient received Meningococcal conjugate vaccine on 7/11/18. Patient woke up the following morning with right arm redness, induration, and itching. Patient presented to MD office with measured redness 10 x 10cm. Patient denied any other symptoms. Patient with no previous reaction to any other vaccine. Patient instructed to take cetirizine in AM and BENADRYL in evening as needed for itching and to use ice packs for about 20min several times a day. Patient discharged home with instructions to return if symptoms worsen. Meningococcal vaccine added to patient's allergy.
fever 103 w/in 6 hr;rash w/in 24 hr;
Shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient had contracted shingles. The outcome of the event, shingles, was unknown. The patient would like to know if she should receive the second dose of vaccination.  Information about batch/lot number has been requested.
This spontaneous report was received from medical assistant regarding unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042836, expiry date 24-AUG-2018) dosing details unknown. It was reported that the vaccines administered were subjected to temperature excursion of 31.4 Fahrenheit (F) for a time frame of 84 hours. The vaccines were not subjected to any previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756484A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA  and AFLUA320BA): AFLUCA320, AFLUA320A and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
received an expired dose /expired on 31Mar2021/administered on 25Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA266A, expiry date 31st March 2021) for prophylaxis.   On 25th June 2021, the patient received Menveo. On 25th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 25th June 2021,  patient received Menveo, which was expired on 31st March 2021. The reporter consented to follow up.
Rash/hives currently localized on left forearm, but itchiness in other areas. No hospitalization.
Cough  Fatigue  Muscle or body aches  Headache  Suspected COVID-19 virus infection  Contact with and (suspected) exposure to covid-19
2nd dose shingles vaccine was given 26 days after first shingles dose was given
t103-104 treated w/APAP; temp goes down then goes back up;sz hosp pneumonia
This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on 20-MAR-2017, the patients was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M026306, expiration date 30-APR-2018; dose and frequency were not reported) intramuscularly, for prophylaxis. This information was discovered as a digital data logger measured temperatures 47.5 °F, 47°F to 77°F for a total time frame of 30 hours. There was no previous temperature excursion. No adverse side effects were reported, and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013287: US-009507513-1703USA013286:
Complaint of axillary pain, chills, sore arm,burning sensation with axillary lymphadenopathy Treatment includes nonsedating antihistamine, quinolone antibiotic and recheck in 1 week
Patient was described to have allergic reaction (swelling and pain) visit on 4/2/07 with F.N.P. dx: cellulitis, Rx: Keflex 250mg/ 5ml 1 tsp QID x 5 days.
Information has been received from a physician concerning a 15 year old female patient with a history of drug reaction/allergy while on prior therapy with GARDASIL (WAES # 1101USA02692 who in August 2003, was vaccinated with a first 0.5 ml dose of VARIVAX (Merck) (Lot# not reported) SQ, and on 01-JUL-2009 was vaccinated with a second 0.5ml dose of VARIVAX (Merck) (Lot# 664021/0502Y, Exp date 09-APR-2011), SQ. On an unspecified date, the patient went to the office for a routine physical and said that she had rash on her leg. The physician stated that on approximately 27-DEC-2010, 1 week prior to January 3rd, diagnosed her with shingles. The physician thought it was too late to provide treatment for the shingles. Patient had treated the lesion herself with CALADRYL, ELIDEL and NEOSPORIN for the lesion. There were no laboratories diagnostics performed. The physician reported that on unspecified date the patient had recovered. Additional information has been requested.