chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Half hour after shot numbness and tingling on my face Fever of 101.4 starting about 4 hours after injection along with headache body aches nausea and chills, ringing in the ears and dizziness when laying down or closing my eyes Fever remained high with Tylenol and Motrin for about 24 hours. Around 24 hours the fever broke and for 3 days had a low grade fever of 99-100 the body aches resolved but the dizziness ringing in the ears nausea Continued for 5 day after the shot
This spontaneous report as received from a registered nurse refers to a female patient of 12 years old with no reported medical history. On June 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 1 (exact date, route, dose and lot number unknown, RECOMBIVAX could not be ruled out). On July 2009 the patient was vaccinated with hepatitis B (manufacturer unknown) dose 2 (exact date, route, dose and lot number unknown). On August 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 3 (exact date, route, dose and lot number unknown). On August 2009 the patient experienced received first dose on 06/2009, 2nd dose on 07/2009 and third on 08/2009 (Inappropriate schedule of vaccine administered). The nurse also reports that this patient received an unspecified HPV vaccine, GARDASIL could not be ruled out, on June 2009, the 2nd dose on July/2009 and the third on October 2009. This case was linked to 1303USA013867 (same reporter link). Follow up was received from the same registered nurse reporting that there was no adverse effect, no adverse information updated to her. Additional information is not expected.
RRT called for numbness and tingling sensation report by patient (employee) after receiving Pfizer COVID-19 Vaccine. Vaccine administered at 10:48am and approximately 15 minutes later starting reporting numbness and tingling sensations. All VSS stable, neuro exam completed with no other findings appreciated. MDs at bedside encouraging patient to go to the emergency department but patient refused. Encouraged to go if symptoms persist and/or worsen. Patient endorses she will take Benadryl when she gets home.
This is a spontaneous report from a contactable other hcp (patient). A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 05May2021 at 09:00 (at the age of 43-years-old) as dose 1, single for covid-19 immunization. Patient had no known allergies. Medical history included covid-19. On 05May2021 at 16:30, patient experienced pain/body ache, fever, short of breath, swollen face and left arm and headache. Unknown if the patient received treatment. Patient received other medications in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recvd vax 18OCT93 & approx 25OCT93 devel flu-like sx;  Approx 2NOV93 devel numbness & paralysis of the rt leg; next day was limping & losing control of hands; hospitalized to r/o a stroke; dx GBS;
Less than 15 minutes after receiving vaccine, patient reported feeling dizzy, tingling in arm that was vaccinated, weak, heaviness of the arm that received vaccine. Patient also felt weak. Patient was given water, M&M's, and a bag of chips, as she stated she had only eaten crackers that morning and no lunch. After 30 minutes, patient began to feel nauseated and was unable to stand on her own. Patient was transported to EMS via wheelchair.
product=COVID 19 Treatment, brand=Paxlovid/if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penecillin" (unspecified if ongoing). Concomitant medication(s) included: EFFECO HEALTH, start date: 07Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Apr2022) Negative. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3/1 Febrile seizure. about 0300 -> ER had sz there -> Home 0930 - another sz -> ER -> Home.  (Dx: Otitis Media @ this ER visit & sent home w/AMOXICILLIN)
2 yr male with cellulitis 2 hr to vaccine administration of DTaP on (L) leg, (+) warmth measuring 11 1/2 cm x 8 cm x 2 day. no F/C, no seizured
Left arm swollen and red, itching, and pain at injection site since Inj. 3 days ago.
Patient is 17 years old but falsified his birth year to make it seem that he was 18. After administration of the vaccine he acknowledged that he was actually 17 years old. He was advised that he would qualify for his second dose after his 18th birthday.
Significant flare up of both Lupus and PMR symptoms. - joint pain, exhaustion, proteinuria, swelling in fingers, chest pain (on two occasions), and increased shoulder, arm, hand, and hip pain.
Information has been received from a pharmacy intern concerning an 18 year old female with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, the patient was vaccinated intramuscularly in the left arm with the first 0.5ml dose of Gardasil (lot #653736/0689F). There were no concomitant medications reported. On 05-JAN-2007, in the morning, the patient developed tingling in the fingers of her left hand with pain in the fingertips when touching anything. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a pharmacy intern concerning an 18 year old female student with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, at 4:55 PM, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 653736/0689F). There were no concomitant medications reported. There were no known illnesses at the time of vaccination. On 05-Jan-2007, at 9:30 AM, upon waking in the morning, the patient developed a tingling, burning sensation on fingers (previously reported as tingling in the fingers of her left hand with pain in fingertips when touching anything). It was reported that the events spontaneously resolved by the following morning. On 06-JAN-2007, the patient had recovered from the events. No further information is available.
Pt recv vax on 9/30/98; on same day pt exp erythema &warmth of LA; tx=Benadryl & ice.
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
horrible pain in her low back; She could not get out of the bed; Flu like symptoms; Dry hives; It is affecting her daily activities; cough; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 (at the age of vaccination of 55-year-old) as dose 2, single for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the first dose, patient experienced sore arm and then after the second dose received on 21Apr2021. She could not get out of the bed. She had horrible pain in her low back. She took Ibuprofen. She had Flu like symptoms, cough/ dry hives and it is affecting her daily activities. She thought originally it would just be initially, but this has been going on about 2 weeks. The outcome of horrible pain in her low back was not recovered and the outcome of the rest of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
administration of an expired Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Infanrix. On 12-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 12-JUL-2023 The reporter was a medical assistant. The reporter reported that a patient received an expired Infanrix dose which led to expired vaccine used. The reporter wanted to know if the patient had to be revaccinated.  The reporter did not consent to follow-up.
Tested positive on an antigen test 5 days later; Tested positive on an antigen test 5 days later; This is a literature report for the following literature source(s).  A 43-year-old female 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 included: "cough", start date: 2022 (unspecified if ongoing); "pharyngitis", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive on an antigen test 5 days later". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug Ineffective and COVID-19 cannot be excluded.
This initial spontaneous case, was received on 11-Aug-2017, by a pharmacist and concerns a 31 years old female patient. Patient's medical history, concomitant medications were not reported. On 09-Aug-2017, while administering FLUCELVAX QIV (dose: less than (as reported), batch number: 195214, route of administration, expiry date was not reported) to the patient, the vaccine squirted on to the face of pharmacist; as she removed syringe from the patient and was trying to dispose it and she washed her face. Outcome of the event occupational exposure while administering product was not reported. The reporter assessed the event as non-serious. Non-significant follow up received on 20-Oct-2017: The PTC (product technical complaint) reference number (1025363) was updated.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298677, 2018SA298678, 2018SA298675, 2018SA300042, 2018SA300037 and 2018SA298672 (same reporter). This case involves a patient of an unknown age (ages ranging from 32-50) who received vaccine FLUZONE HIGH DOSE lot UJ039AA, expiry date: 15-May-2019 via unknown route on 25-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Overdose and Inappropriate age at vaccine administration. It was reported that inadvertently administered FLUZONE HIGH DOSE who was less than 65 years of age. None of the persons report any reaction at this time. 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. Documents held by sender: none.
Pt recvd 1 dose Engerix-B exp sensory axillary nerve neuritis w/numbness & loss of sensation in the injected arm;
Same day as vaccine, started having itching at the injection site, body ache, and headache. Missed work the following day to those symptoms being much worse.  1 week after the injection, injection site  was itchy, red, hot to the touch, and had a large knot.  Over the next few days, the symptoms increased, and  spread out into a much larger circle on my arm.  Experienced extreme fatigue, headache, and body ache.
The day after receiving his second vaccine, he became very confused and anxious. For over 3 hours he was thinking he needed to get  a bag from his "daughters sister." The following day, his confused remained and there was another period of 3 hours that he was confused and fixated at going out to the dumpster to get a bag. Resident typically doesn't have this level of confusion or anxiety.
Very bad chills, high fever (102), nausea, muscle aches, restless.  Those symptoms persisted for around 14 hours, and then the fever began to go down, and i began to feel slightly better.  I was very sick and extremely fatigued sleeping all day for about the next 48 hours.    I had no appetite for several days.  Overall I felt very sick like I had a very bad flu.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time were 23, 34 and R; The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second time were 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old male pt who experienced prolonged fussiness 3 hrs after the administration of Prevnar. At 3 months of age, the pt received the first dose on 18Jun05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 18Jun05. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The pt experienced prolonged fussiness 3 hrs after the administration of Prevnar on 18Jun05. The child was taken to the ER at 7:00PM of the night of administration. No treatment was given in the ER. Pt recovered with 24 hrs (19Jun05). No additional information was available at the time of this report.
Mild diarrhea, fussiness, irritable, appetite not normal, tired. Treatment giving extra fluids and rest.
a welt on the injection site that is warm to the touch; a welt on the injection site that is about the size of a half dollar; a welt on the injection site that is itchy; a welt on the injection site that is red; sore at the sight of injection for 3-4 days; chills; low grade temperature of 99.1; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA (a welt on the injection site that is red) and VACCINATION SITE PAIN (sore at the sight of injection for 3-4 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ACIPHEX, MULTIVITAMINS, VITAMIN D3, PROBIOTICS, VITAMIN B12, ELDERBERRY, and FLONASE ALLERGY RELIEF for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN, CHILLS, and PYREXIA. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA outcome was unknown and VACCINATION SITE PAIN, CHILLS, and PYREXIA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported by the reporter.
Excessive swelling, hardness, itching, rash and pain at the sight of injection for meningitis vaccine.
Swollen lymph nodes (axillary) and soreness on same side of Imm.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The patients were vaccinated with PNEUMOVAX 23 (dose and route were unknown, Lot # reported as H013581, expiration date 03-MAR-2014). The reporter requested a Lot # check. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced redness around injection site, rash around injection site and fever. The patients sought medical attention by an office visit. No treatment information was reported. The reporter did not have detailed individual patient information but she said 6 patients experienced redness and rash around injection site and ac couple of patients experienced fever as well (MARRS Case # 1211USA001593, same reporter link) and one patient experienced "red streak" around injection site (MARRS Case # 1211USA001593, same reporter link). The outcome of rash around injection site and redness around injection site is unknown. The related ness for redness around injection site and rash around injection site was not reported for PNEUMOVAX 23. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age. On 22-JAN-2019, the patient was vaccinated with a dose of improperly stored PROQUAD injection via subcutaneous route, lot # R017625 with expiration date on 18-DEC-2019. The dose of the vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 103 days and 47 to 77 degrees Fahrenheit for 10 minutes. The Digital Data Logger was involved in the recording of the excursions. No adverse events were reported.
I had a sore arm for a day and a half. I got a rash that looked like hives all over my body and kept getting worse and then I started having trouble breathing. I went to ER on the 25th of April due to trouble breathing. The rash lasted a month. My family care doctor switched me to Zyrtec.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in an elderly female patient (gravida 1) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
1 day p/vax had t105, 2 days p/mom reports listless, dec appetite, t99.7