chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; administration of MMR II outside the recommendation in the prescribing information. the 2nd and 3rd doses were administered 1 week apart on 07JUN2022 and on 14JUN2022; This spontaneous report was received from a pharmacist, concerning a 71-year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On 07-JUN-2022, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, lot #, expiry date, route of administration, and anatomical location were not provided); on 14-JUN-2022, the patient received the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, lot #, expiry date, route of administration, and anatomical location were not provided). Both vaccines were administered 1 week apart, for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-MAR-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 30-MAY-2012, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Headache, fever, severe body aches, and hot, swollen and red injection site with tenderness from 24 hours after the vaccination until approx. 36 hours later. Injection site remained red and sensitive for two more days.
Received second covid vaccine and one month later, developed chest pain, shortness of breath and was admitted to hospital for concern of myocarditis.
Case number PHEH2013US010204, is an initial spontaneous report received from a nurse on 02 May 2013 with a follow up information received on 24 May 2013: This case refers to a 31-years-old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A11042 / M11042) reconstituted with sterile diluent instead of MenCYW-135 liquid conjugate intramuscularly on 02 May 2013. She also concomitantly received hepatitis A vaccine (manufacturer and batch number: not reported) and hepatitis B vaccine (manufacturer and batch number: not reported) on the same date. No adverse reaction reported following the administration error. It was reported that she returned to the clinic and was revaccinated with correct liquid conjugate. She left without any complaints or events. Follow up information received on 24 May 2013: Concomitant vaccine and re-vaccination details updated.
Information has been received from a health professional concerning a 5 year old female with no known allergies and a history of otitis and no other pertinent medical history who on 2/1/99 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 628248/1659H). On 1/27/04 the patient developed breakthrough chicken pox. She presented to the clinic with fever and 300 chicken pox. It was noted that the chicken pox were on both legs and torso. Treatment was recommended with calamine (+) camphor (+) pramoxine hydrochloride, diphenhydramine hydrochloride, and calamine lotion. It was reported that the patient had not yet recovered from the chicken pox. There was no product quality complaint involved. Additional information has been requested.    Follow up information indicated that on Jan 26 2004, the patient developed a fever and vesicles all over her body. On 01/27/2004, the patient was diagnosed with varicella and over 100 lesions were noted throughout. The patient was treated with calamine (-) camphor (+) pramoxine hydrochloride (Aveeno), diphenhydramine hydrochloride (Benadryl) and calamine lotion. No ASA and Isolate. There were no lab test performed. On 02/03/2004 the patient recovered. No further information is expected.
This spontaneous report was received from a licensed practical nurse concerning a 75 year old patient of unknown gender. On 18-JUL-2013, the patient was accidentally vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously instead of ZOSTAVAX. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Chills and Body ache for 2 days. Sore Throat for 2 days. Tenderness of injection site on the arm for 3 days. Tightness of throat/difficulty breathing.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00567200) and transmitted to Sanofi on 19-Apr-2021.  This case involves a four-year-old female patient received an expired 0.5 mL 4th dose IPV (VERO) [IPOL] (lot R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 16-Apr-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  This was a case of actual medication error case due to expired vaccine used (latency same day).  At the 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 holders 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.
Localized 6.5cm x 7.5cm area of cellulitis (erythema, edema, warmth, and tenderness to palpation) diagnosed 3 days after the immunization. Treated with PO clindamycin.
patient's right deltoid shows  red, itchy rash  with no fever or any other symptoms which started 5 days after shot. patient was advised to take Benadryl and to monitor any other possible allergic reactions including shortness of breath and to see doctor if it doesn't go away or spreads or appears in other areas
No additional adverse events reported; A pediatrician reported that a 6 year old patient was given a dose of PNEUMOVAX 23 three years after receiving the inital dose instead of the recommended six years after the initial dose.; This spontaneous report was received from a physician concerning a 6-year-old patient of unknown date. The patient medical history, drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.     On an unspecified date in 2019, subject was vaccinated with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose, route of administration, strength, vaccination scheme, anatomical site of vaccination, lot number, and expiration date were not reported) as prophylaxis. On 27-SEP-2022, the patient was vaccinated with the second dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe piston (FMF) (dose, route of administration, strength, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U025499, which had been verified to be valid, expiration date reported and validated as 07-AUG-2023), as prevention for pneumococcal infection. This vaccination happened 3 years after receiving the initial dose instead of the recommended six years after the initial dose (Product use issue). No adverse event was reported.
Information has been received from a pharmacist concerning a 72 year old female who in 2007 was vaccinated with ZOSTAVAX (Oka/Merck). In January 2008, the patient developed Shingles. The patient required Oxycodone for pain. Subsequently, the patient recovered from the Shingles. No further information is expected.
rash from her head to her thighs that itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash from her head to her thighs that itches like crazy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH PRURITIC (rash from her head to her thighs that itches like crazy). At the time of the report, RASH PRURITIC (rash from her head to her thighs that itches like crazy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Fever, sweats, headache, chills, shortness of breath, fast heartbeat, weakness, loss of appetite. The course would be on and off for 8 days.
Patient noticed pain 10/15/15-10/20/15, Then redness at the injection site on 10/20/15 about 1-2" in diameter. Pt was advised to take Benadryl+ibuprofen, and if no improvement, see her MD. The redness continued and covered most of her upper arm. She saw her MD the next day and was diagnosed as an allergic reaction and not a secondary infection.
increasingly red, warm to touch, swelling, pain, and decreased range of motion since vaccinated until patient came to pharmacy to have me look at it. I send her to urgent care for continued care. Patient stated feeling "completely fine" otherwise and stated no  anaphylaxis type symptoms
Rapid Heartrate and Atrial Fibriliation for 2+ hours on several occasions.  Prescribed Pradaxa blood thinner and metoprolol to regulate heart beat.  Taken off metoprolol five days later because heart rate was too low.  Will have an Echo Cardigram next week and appointment with the EP cardiologist for either an ablation or pace maker.
w/in 5 mins of vax lt upper arm becam red & swollen DPh given;
Dangerously low platelets on CBC (8 K/uL) on 11/7/23. It improved and normalized after 1 week. Was sent to ER for consideration of platelet transfusion and went to hematology for evaluation.
pt recv vax 6/30/98 & 2 days later pt devel an inj site rxn characterized by a 6cm by 6cm area of swelling, redness & warmth;
Per patient caregiver: patient gets a shot for macular degeneration (not sure of name). Her right eye became swollen. No longer swollen now but still red. Patient is tired, shaking and not feeling well. Patient is going to see her doctor tomorrow. Patient caregiver wondering if Shingrix shot and macular degeneration shot caused the reaction because she got them close together
Information has been received from an 81 year old male consumer with diabetes and hypertension and no known allergies who on approximately 06-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). Concomitant therapy included multiple unspecified medications. On approximately 06-APR-2011, shortly after receiving the vaccination the patient's skin began to itch and turn red, in various areas of the body, on a transient basis. The patient sought medical attention by calling unspecified pharmacy. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered. Follow-up information was received from a physician indicating that the 81 year old male's skin began to itch in various areas of the body and began to turn red as well in various areas of the body. At the time of the report, the patient had recovered. No further information is available.
Fever; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; This is a spontaneous report received from a contactable other health professional, the patient. A 53-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not provided. The patient previously took omeprazole (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19, since the vaccination. On 21Mar2021 at 14:00, the patient experienced fever, fatigue, headache, muscle pain, joint pain, chills and nausea. The patient underwent lab tests and procedures, which included PCR (nasal swab/Flu/COVID-19) on an unknown date and resulted negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive treatment for the reported event. The clinical outcome of the fever, fatigue, headache, muscle pain, joint pain, chills and nausea was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a 75 year old female consumer with high cholesterol and hypertension and no drug reactions or allergies reporting on herself. The patient's medical history included shingles. On 28-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # not reported). Concomitant therapies included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), bisoprolol and hydrochlorothiazide (manufacturer unknown). The consumer reported that on 29-JAN-2015, she experienced injection site erythema, rash, rash papular and pain in extremity reported as redness at the injection site and irregular shaped red patch four inches long and three inches wide after being administered ZOSTAVAX. There were also red pimples inside the red area. The patient stated her arm was sore as well. The patient did not seek medical attention. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
I received the flu shot of Sunday morning at pharmacy  and on Monday afternoon on the left arm to the right of and well below the injection site an initially small and later larger red area appeared. In addition, tiredness ensued all the subsequent days and today I have felt feverish and with general body malaise despite not having a temperature. The actual injection site is still bruised looking and the red area is , despite application of otc cortisone cream, still discolored. My concern is that it would appear in all I have read that the side effects should go away in 2-3 days.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 31-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 31-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
Patient is a 11 year old male. Source of patient information was mother. Source of patient information was patient. Very unusual behavior noted this am; had ADACEL shot yesterday. When mom went in to wake up as usual this am, child was very difficult to arouse, speech very slow. Noted to have torn bed apart with all covers in a ball on the floor. A couple of hours later (while at grandma's) mother call and still noted that speech was slow and patient was not acting normal - very strange for pt. ? reaction to immunization?. Called and told to come in for evaluation, no fever, no local reaction.
Patient is reporting severe pain in her left arm with the vaccination. Her arm was sore for a week and then it went away... one week later she started experiencing pain radiating down her arm and up to her neck on the left side.
A report was received from a health care professional on 1/5/03, concerning an 18 month old female vaccinee who experienced a seizure 15 minutes after, and a urinary tract infection an unspecified length of time after inadvertently receiving Fluvirin on an unspecified date. The events were considered medically significant. The vaccinee had a previous history of a seizurre, bronchitis, and mild respiratory distress. On an unspecified date the vaccinee experienced a seizure 15 minutes after receiving Fluvirin at her mother's request on an unspecified date. The vaccinee was taken to an ER for treatment and was diagnosed as having a urinary tract infection. The outcome of the event was not reported. There was insufficient info to determine the reporter's causality assessment. The reporter also commented: "doubt seizure was caused by vaccine due to history given by mother."  Follow up on 06/25/04 states: "Vaccinee had experienced a seizure prior to Fluvirin administration, was taken to ER and found to have a urinary tract infection and fever. Pt was also found to be developing a fever with the urinary tract infection after vaccination with Fluvirin. The pt is currently being investigated for a seizure disorder unrelated to the Fluvirin event. Reporter's causality-possible, but unlikely."
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 28-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Onset of tinnitus left ear next day followed by light headache off and on only on left side Onset about 5:30 pm, tinnitus remains constant in the left ear, high pitched
Joint pain; swollen lymph nodes; headache; tiredness; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jan2021 at 14:00 hours (Batch/Lot Number: EL9262) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. The patient's medical history included HIV on treatment from an unknown date and unknown if ongoing. The patient's concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY). The patient had known allergies with acetaminophen, dipyrone, and aspirin. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jan2021 at 12:00 PM (Batch/Lot Number: PAA156051) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. On 23Jan2021 at 23:00 hours, the patient experienced joint pain, headache, tiredness, fever, swollen lymph nodes, and nausea. Therapeutic measures were taken as a result of the adverse events. The patient underwent lab tests and procedures which included body temperature: fever on 23Jan2021. The patient received treatment with Piroxicam 20 mg, one dose for the adverse events. The patient did not have any other vaccine in four weeks. The patient did not have COVID prior vaccination and had not got COVID tested post vaccination. The patient recovered from the events on an unspecified date in 2021.  Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.
Pt was found cynotic in bed 15MAY92; pt was taken to hosp; asphyxial death consistent w/SIDS;
hives all over body that started night after the shots were given. were on and off for a weeks time after. also had temp to 100 that night right after the vaccines child also experienced an ALTE/BRUE episode 1 week after shots but it's unclear if it's related to that or reflux
Pt had a positive COVID test on 6/2/22; per our records, pt passed away at home; we do not know the pt's PCP; we have no medical records
Generalized weakness, fatigue, malaise, paresthesia, arm pain x 3 weeks