chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US015694 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to a 12-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 06 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml. The children (age 5-11) received 0.3 ml x 41.9 mcg/ml = 12.6 mcg. Pfizer Case #: ID
pains in arm began 4 days p/flu shot; pain went down arm & lasted 1 wk; no joint pain when asked; resolved;
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Rash over body & difficult breathing; In clinic 31OCT91 rash on body had swelling of hands & face; c/o severe itching;
Chills, painful legs where child would cry to walk, nausea, blurred vision, weakness. Reported symptoms to doctor on call and was told to keep an eye on them.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions include dialysis.  Subjects had previously received Recombivax and did not respond to therapy.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis B antibodies.  At the time of reporting the outcome of the event was unspecified.  The nurse reported that this occurred in a total of eight patients.  GSK case numbers are A0638778A and A0638780A through A0638786A.
This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose as 3rd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 002A21A and 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 27-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose as 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose as 3rd dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications reported included unspecified cancer treatment medications. Patient did not report any adverse reactions to the 3 doses. Treatment information was not provided by the reporter.
rash, looked like hives; "you could see clear liquid underneath, kind of like ant bites"; A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash, looked like hives), BLISTER ("you could see clear liquid underneath, kind of like ant bites") and RASH (A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (rash, looked like hives), BLISTER ("you could see clear liquid underneath, kind of like ant bites") and RASH (A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA (rash, looked like hives), BLISTER ("you could see clear liquid underneath, kind of like ant bites") and RASH (A rash in his arm that was injected / rash, right about the elbow / rash, broke out on his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.  Consumer was vaccinated with first dose on 19APR2021 (lot: 030B21A), about 4 hours after, he developed a rash in his arm that was injected, it was right about the elbow, no pain no swelling, no itching. It looked like hives, "you could see clear liquid underneath, kind of like ant bites", he also broke out on his neck. Consumer took ibuprofen after vaccination. He has not had any guidance, from his primarily doctor, the pharmacist at the pharmacy, the CDC or the state department of health on whether or not he can get the second dose which is scheduled for today 17 MAY 2021.
Treatment of Covid-19; Treatment of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypopituitarism" (unspecified if ongoing); "stroke" (unspecified if ongoing); "blood clots" (unspecified if ongoing); "pituitary macroadenoma" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Ehlers Danlos Syndrome" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Feb2022; PREDNISONE, start date: Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive, notes: I first tested positive for Covid; (06Sep2022) Negative, notes: finally tested negative, 4 days after completing a course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Patient received Paxlovid for Treatment of COVID-19 on 29Aug2022 and stopped on 02Sep2022. Patient reported that it has been 4 days since my last dose of Paxlovid and she have developed a severe cough. She only had nasal congestion and a sore throat for 24 hours when she first tested positive for covid, and she was able to take Paxlovid within 3 hours of her positive test. Her symptoms went away almost immediately and her considered herself symptom free for the duration of her 10-day isolation. Her cough developed the same day she finally tested negative, 4 days after completing a course of Paxlovid. She would test again in the coming days to see if she has rebound covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Didn't eat much; Slept all day; Severe chills; Running a high fever; Headache; Muscle were sore/Achy; Felt weak and Trouble getting up/Felt pretty tough; Couldn't get out of bed by himself and Trouble getting up; Sweaty during the night; Seemed a little confused; Generally felt bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused) and FEELING ABNORMAL (Generally felt bad) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 739904 and 739904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy). On 30-Oct-2021, the patient experienced FEEDING DISORDER (Didn't eat much) and SOMNOLENCE (Slept all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, ASTHENIA (Felt weak and Trouble getting up/Felt pretty tough), MOBILITY DECREASED (Couldn't get out of bed by himself and Trouble getting up), NIGHT SWEATS (Sweaty during the night), CONFUSIONAL STATE (Seemed a little confused), FEELING ABNORMAL (Generally felt bad), FEEDING DISORDER (Didn't eat much), SOMNOLENCE (Slept all day), CHILLS (Severe chills), PYREXIA (Running a high fever), HEADACHE (Headache) and MYALGIA (Muscle were sore/Achy) had resolved.            No Concomitant medications were reported.
Patient stated she had first Moderna on 4/28, and felt almost "high" within 30 minutes. She had a sore arm, fatigue. Three weeks later she stated she felt like she was "hit by a bus." Was in and out of ER and hospital. Still not feeling well. Not sure if she should get second vaccine now or later. Shew stated she is getting different advice from different providers. She is 4 months psot partum as well. RN referred her to OB since. she has not spoken with her yet.
Patient experienced shortness of breath, slight chest pain, faint, felt nauseated; Left arm was swollen, red, hot to touch, painful at injection site. Injection site developed pustule, prescribed antibiotics and pain reliever for arm.
This case was reported by a consumer via call center representative and described the occurrence of burning gum in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced burning gum, burning oral sensation, pain in arm, fever and redness gum. On an unknown date, the patient experienced tingling mouth. On an unknown date, the outcome of the burning gum, burning oral sensation, pain in arm, fever, redness gum and tingling mouth were recovering/resolving. It was unknown if the reporter considered the burning gum, burning oral sensation, pain in arm, fever, redness gum and tingling mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that within 24 hours after receiving their initial dose of SHINGRIX the patient developed a sore arm, felt feverish and experienced a burning sensation in mouth with red patches on gums above teeth. At this time the patient stated the symptoms had mostly subsided and was about 98 percentage resolved, however still had a tiny bit of tingling sensation in their mouth. No further details provided regarding the event.
Pt complained of lightheadedness, dizziness, heart beating fast at 8pm the day the vaccine was adminsitered. Woke up at 12 midnight on 01/16/2002 and was aching all over. Arm became sore couple days later. Two weeks after the shot her arm got so sore she couldn't lift it. The pain was excruciating. No relief denies rash, lump, redness or fever. Ibuprofen and warm heat helped.
1 d prior to vaccination R leg became erythematous. Exam 8/29/03 with 6x6 inch erythematous area. No fever Keflex prescribed and told to f/u if worsens.
Chills after taking the 2nd shot; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program.  A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. No medical history and concomitant medication were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. On an unspecified date, the patient experienced chills after taking the second shot. The patient wanted to know if she was immune to COVID now. The outcome of the event chills was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. On an unknown date the patients were vaccinated with PEDVAXHIB lot # M036612 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB.
EMPLOYEE FELT NAUSEA'S, VOMITING, LIGHTHEADED AND WEAKNESS, SYMPTOMS ARE CURRENTLY ACTIVE.
pt recv vax 5JUN96 & 11DEC96 pt presented w/chickenpox MD reportedly described the event as a vaccine failure, but was unsure i vax had been stored or administered properly;
tiredness; not in the mood of doing anything; 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 32 year-old male patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (Lot number: EW0181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Appendix removal", start date: 2013 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "tiredness"; MOOD ALTERED (non-serious) with onset 2021, outcome "unknown", described as "not in the mood of doing anything".  Additional information: Caller reported that this all started happening after the first dose of the Covid shot, he started feeling tired, not in the mood of doing anything. The tiredness started after the first shot, and he has been tired since. Right now he is dealing with Side effects.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-MAY-2014, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 23-FEB-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 include 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. Additional information has been requested.
Sore arm; Severe headache; Chills; Fatigue/ very tired; Vomiting; Nigh sweats; severe muscle ache; wasn't feeling well; Sleeping; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Severe headache), CHILLS (Chills), FATIGUE (Fatigue/ very tired), VOMITING (Vomiting) and HYPERHIDROSIS (Nigh sweats) in a 59-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.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Severe headache), CHILLS (Chills), FATIGUE (Fatigue/ very tired), VOMITING (Vomiting), HYPERHIDROSIS (Nigh sweats), MYALGIA (severe muscle ache), VACCINATION COMPLICATION (wasn't feeling well) and SOMNOLENCE (Sleeping). On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, HEADACHE (Severe headache), CHILLS (Chills), FATIGUE (Fatigue/ very tired), VOMITING (Vomiting), HYPERHIDROSIS (Nigh sweats), MYALGIA (severe muscle ache), VACCINATION COMPLICATION (wasn't feeling well), SOMNOLENCE (Sleeping) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        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 and concomitant medications were not provided by reported.
Itchy Sensation of Arm; Itchy Sensation of Throat; Itchy Sensation of Tongue; Wheezing; Rash - Near Injection Site; Aches; pains; A spontaneous report was received from a consumer concerning a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events itchy sensation of arm. itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site. The patient sought professional guidance from her pharmacist.   Treatment included  diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events include itchy sensation of arm, itchy sensation of throat, itchy sensation of tongue, body aches, body pain, wheezing, rash - near injection site was unknown/not reported.; Reporter's Comments: This case concerns a 49-year-old female who experienced NS unexpected events of pruritus, throat irritation, tongue pruritus, wheezing and NS expected events of injection site rash, myalgia.  The events occurred the same day as the first dose of mRNA-1273. Treatment included diphenhydramine. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever of 101, body aches, chills, mild headache, tiredness, sore arm, and inflamed lymph nodes
Severe joint pain in knees at night. Woke up crying that she was in pain. This is the second time she has reported joint pain since this vaccine was given. I gave her children's Tylenol, 1 1/2 ts. and put heating pad on knees and legs. She was better within an hour or two.  She had the same pain when she had amoxicillin. THey called it serum sickness.
Severe neck pain; migraine headache; muscle aches; nausea; upper body joint pain
74-year-old gentleman received COVID19  booster dose today at dialysis appointment, sometime around 1300 hours.  Experienced rigors afterwards.  Admitted to the emergency department tonight, and subsequently to ICU in shock state requiring vasopressors.  Admission to the hospital approximately 12 hours after administration of vaccine.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot number and expiration date were not provided) for prophylaxis. On 30-MAR-2017, the patient received the second dose of GARDASIL 9 (strength, route, lot number and expiration date were not provided) for prophylaxis. On an unspecified date the patient received the third dose of GARDASIL 9 lot #: N003703, expiration date on 29-OCT-2019 (strength and route were not provided) for prophylaxis. It was reported that the patient received doses of GARDASIL 9 outside of the prescribing information, however no adverse events reported. Additional information has been requested.