chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's assistant concerning a 14 year old female who was vaccinated intramuscularly with the first dose of Gardasil. It was reported that "within the same day she received the vaccine, the patient experienced "tightening of airway". The physician's assistant was unsure if this was related to the Gardasil because the patient had played softball on a hot, dusty field the same day she received Gardasil. The patient's mother had given her BENADRYL before contacting the physician. The physician's assistant prescribed for the patient 5 days worth of ALLERGAN. It was reported that after the patient took the prescribed steroids she had recovered. It was reported that the patient's sister had completed the vaccine series for Gardasil without any trouble. No further information was provided. Additional information has been requested.
-pain, erythema, swelling surrounding injection site. Rx:  antihistamine, steroid, antibiotic.
This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 23Feb2021 08:30 (at 33-year-old, not pregnant at the time of vaccination) as 1st dose, single dose for COVID-19 immunisation. Medical history included HPV infection. No known allergies. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced mild pain at injection site 5 days (1st dose) on 2021. The outcome of the event was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
The patient was ok when he received vaccine and was advised to stay around pharmacy for 15 minutes. He started to develop red dotty rash in the arms and legs and arms and legs was swollen. was seen by Dermatologist and was give prednisone for 10 days. also had biopsy and the results came back normal. There was no other symptoms other than the rash. (no itching or aches). The rash decreased over period of time and the Dermatologist said it is ok to get the 2nd dose of Moderna and was given 2nd dose on 4/18/2021.
One day after flu shot mother noted 3x2 cm swelling and redness on left thigh where injection had been given.
Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch number cannot be obtained. No further information is expected.
patient height, it provided as 160cm, while the patient is only 3 years old; temperature excursion for Pfizer Covid 19 vaccine/it was administered; temperature excursion for Pfizer Covid 19 vaccine/it was administered; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 3-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jun2023 at 15:00 as dose number unknown (maroon cap), 0.2 ml single (Lot number: GY5673, Expiration Date: 14Aug2023) at the age of 3 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 12Jun2023 at 15:00, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 12Jun2023 at 15:00, outcome "unknown" and all described as "temperature excursion for Pfizer Covid 19 vaccine/it was administered"; BODY HEIGHT ABNORMAL (non-serious), outcome "unknown", described as "patient height, it provided as 160cm, while the patient is only 3 years old".  Additional information: On 04Jun2023 the temperature reached 52.2 degrees Fahrenheit when restocking. It's not showing the total time. Just showed that day that is what it reached. went out on 3 other days. Not just for the 04Jun2023. Highest temperature reached on 17Jun2023 was 49.5 degrees Fahrenheit. Have time with no reading. It said-304 degrees Fahrenheit. Temperature provided as -304 was confirmed. Total time it was negative was at 10am and then stopped working and next reading wasn't until 2pm and was reading correctly after that. Not sure between that time what it was reading. On 19Jun2023 highest temperature she saw was 47.1 degrees Fahrenheit. Total time was about 1 hour and a half. On 20Jun2023 temperature was 47.7 degrees Fahrenheit. Thinks these are all from restocking. These 3 days had specific time. On 20Jun2023 was total of about 20 minutes. Total of about 9 patients for Pfizer Covid 19 vaccine maroon cap, bivalent. The reporter hasn't said anything so she would say not serious but isn't sure.  Follow (22Jun2023): This is a spontaneous follow-up report mail trail received in response to query sent regarding the confirmation below mentioned query. The response included: New event Body height abnormal added, response added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228860 same reporter/event, different patient/dose;US-PFIZER INC-202300228862 same reporter/event, different patient/dose;US-PFIZER INC-202300228866 same reporter/drug/event, different patient;US-PFIZER INC-202300228861 same reporter/event, different dose/patient;US-PFIZER INC-202300228962 same reporter/SD/AE, different patient;US-PFIZER INC-202300228963 same reporter/drug/event, different patient;US-PFIZER INC-202300229148 as same reporter/drug/event, different patient.;US-PFIZER INC-202300229256 Same reporter/drug/event, different patient.;
On May 14th experienced body aches, chills, and exhaustion; On May 14th experienced body aches, chills, and exhaustion; On May 14th experienced body aches, chills, and exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: EW0183) 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: PAIN (non-serious), CHILLS (non-serious), FATIGUE (non-serious) all with onset 14May2021, outcome "unknown" and all described as "On May 14th experienced body aches, chills, and exhaustion".  Additional information:Event took place after use of product.  No follow-up attempts are possible. No further information was expected.
10 day long migraine headache located behind the left eye and left temple. Throbbing, recurrent pain. Accompanied by dizziness and visual changes.
Employee came in for a flu shot. Injection site determined by best practices, and IM injection given in Left deltoid. Employee complained that shot hurt, which is sometimes the response from clients receiving injections. No bruising or swelling noticed at injection site. Employee instructed to move arm around throughout the day to help with soreness. Employee came to Occupational Health Center on 11/04/2021. She stated that her arm was still sore since injection. "I thought it would go away, but it's still sore. It feels like someone hit me." Reported full range of motion, but pain with movement. She stated that if she makes a sudden movement with her arm, she gets a sharp pain that goes into her neck. She has been.
Initial report received from literature on 28 December 2014. This case is linked to case number 2015SA000158, 2015SA000156 and 2015SA000159 (same literature report). The following is the verbatim for the article abstract: A number of medications have been associated with uveitis. This review highlights both well-established and recently reported systemic, topical, intraocular, and vaccine-associated causes of drug-induced uveitis, and assigns a quantitative score to each medication based upon criteria originally described. A 72-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of BCG VACCINE (manufacturer- unknown, batch number, route, dose number and site of administration was not reported) on an unspecified date. On an unspecified date patient had experienced bilateral granulomatous anterior uveitis after vaccination. It was reported that for a polyclonal autoimmune reaction elicited by BCG as well as amino acid sequence homology between proteins from M. tuberculosis, BCG, and retinal antigens. The patient was negative for HLA (human leukocyte antigen) -B27 but positive for HLA (human leukocyte antigen) -B8 and HLA (human leukocyte antigen) -B38. Other laboratory investigation and corrective treatment was not reported. At the time of reporting, patient outcome was unknown. Upon medical review, the case was considered as serious due to important medical event: bilateral granulomatous anterior uveitis. List of documents held by sender: none.
tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038468 and 2020SA038469.  This case involves a 10 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left deltoid for Prophylactic vaccination on 16-Jan-2020 which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
itchy at injection site; Became swollen (raised) injection site; Tender at injection site; Red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE SWELLING (Became swollen (raised) injection site) and VACCINATION SITE PAIN (Tender at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to sulpha drugs).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (Red rash on the injection site). On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE SWELLING (Became swollen (raised) injection site) and VACCINATION SITE PAIN (Tender at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE SWELLING (Became swollen (raised) injection site) and VACCINATION SITE PAIN (Tender at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took diphenhydramine (5 doses) and cortisone cream on the affected site as treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
After caller had his 2nd shot last year caller developed 2 blood clots in 1 leg; Caller's legs have been cramping since caller got the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EW0153) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (NDC number, lot number, expiration date: ER6213, Dose and route: Unknown, Dose: 1), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Cramping". The following information was reported: THROMBOSIS (medically significant) with onset 17May2021, outcome "recovered" (Nov2021), described as "After caller had his 2nd shot last year caller developed 2 blood clots in 1 leg"; MUSCLE SPASMS (non-serious) with onset 17May2021, outcome "unknown", described as "Caller's legs have been cramping since caller got the vaccine". The events "after caller had his 2nd shot last year caller developed 2 blood clots in 1 leg" and "caller's legs have been cramping since caller got the vaccine" required physician office visit. Therapeutic measures were taken as a result of thrombosis, muscle spasms.  Clinical Course : Caller is calling about the Pfizer COVID-19 vaccine. After caller had his 2nd shot last year caller developed 2 blood clots in 1 leg, which was caller's right leg. Doctor said they have never seen that before. Caller is having the same symptoms now going on in caller's left leg and caller had to go to the emergency room. Caller clarifies he did not go to the emergency room, caller went to urgent care. Just came back from urgent care and they wanted caller to go to the emergency room, but caller hasn't gone to the emergency room yet. Caller's legs have been cramping since caller got the vaccine. Caller actually went last month to urgent care and it was 7 o'clock and they sent a note for caller to go to the emergency room because the ultrasound person that checks for blood clots was gone. Caller waited a month, went back to the urgent care when the ultrasound person was supposed to be there and the ultrasound person was too busy. Don't get Healthcare. Caller has been having these symptoms for like 2 months now in both legs, now both legs are cramping and aching, but left leg is hurting more and burning more, very good burning sensation, probably where the clots are. Going to go to the emergency room later tonight. Caller is sitting up with legs in the air on pillows right now because legs are hurting so bad, has legs 4 feet up in the air, has been doing this the past 2 months, helps caller's legs. Vaccination Facility Type: Clinic set up in the mall.  No follow-up attempts are possible. No further information is expected.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild
Presented to office with (L) arm redness going from site of injection to approx 3 cm above antecubital space. Also had large bruise at site. NP looked at site and prescribed BENADRYL PO 25mg Q8 hrs for 2 days.
Very sore throat and hoarse voice in the morning for four days.  Took throat lozenge.
cold sweats; arms and legs no strength; muscle aches; low grade fever 100.5F; chills; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), ASTHENIA (arms and legs no strength), MYALGIA (muscle aches), PYREXIA (low grade fever 100.5F) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00F20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (arms and legs no strength), MYALGIA (muscle aches), PYREXIA (low grade fever 100.5F) and CHILLS (chills). At the time of the report, COLD SWEAT (cold sweats), ASTHENIA (arms and legs no strength), MYALGIA (muscle aches), PYREXIA (low grade fever 100.5F) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information received on 29-Apr-2021 content no new information.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female who on 15-SEP-2011 was vaccinated with a dose of GARDASIL and VARIVAX (Merck), also a Pregnancy Registry product, while pregnant (lot# and route was not reported). The patient sought medical attention via contacting the registered nurse. Additional information received from the registered nurse on 18-OCT-2012. On an unknown date the patient gave birth to a healthy baby without any problems encountered. The nurse did not have any other information about facts surrounding the delivery or infant demographics; only that her community sources stated that the birth was a healthy outcome and the patient moved from the area. No further information is available. Additional information is not expected.
Onset, 01/09/08-nausea, vomiting, dizziness, abdominal pain. Pt. out of school 01/10-01/11/08. Returned to school 1/14/08 but "felt bad". Seen by doctor 1/16/08 and dx as "stomach virus gastroenteritis. Out of school 1/15/08-1/17/08. Mother made report on 1/16/08. Follow up call on 1/18/08 revealed no hx of fever or rash.
Chills, burning up , legs weak , barely able to walk , slept for 18 hours straight
Heart pain; Headache; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 16:00 (Lot number: FJ1614) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient experienced covid prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Jan2021, for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 18Jan2022 17:00, outcome "not recovered", described as "Heart pain"; IMMUNISATION (medically significant) with onset 17Jan2022 16:00, outcome "not recovered", described as "Booster"; HEADACHE (non-serious) with onset 18Jan2022 17:00, outcome "not recovered", described as "Headache". The events "heart pain", "booster" and "headache" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (18Jan2022) negative, notes: Nasal Swab; (20Jan2022) negative, notes: Nasal Swab; (24Jan2022) pending, notes: Nasal Swab. Therapeutic measures were not taken as a result of angina pectoris, immunisation, headache. The patient did not receive other vaccine in four weeks. There were no other medications within the past two weeks.
16Mar90 pt vax w/ hepta B, that night devel fever, chills, sweats w/ diffuse arthralgias, + severe swelling and pain at inject site of thigh.  Sx occured nightly for 8-10 days. Tx w/ APAP + ibuprofin but was unresponsive.     see worm
Two doses of Menactra were given to patient with  asplenia on day one and day three/no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult patient who received two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] who has Asplenia on day one and day three/no AE (inappropriate schedule of product administration).  This is a case of actual medication error due to inappropriate schedule of product administration.  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site and 1 other dose was administered on unknown dates (third day) for suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  The product was administered to the patient.  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 and Module VI of the 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.
Pt recv vax on 1/11/99; on 1/12/99 pt exp itching, dry mouth, nausea