chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 14 year old patient (gender was not specified). The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 24-SEP-2015, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot # L025204, expiration date 07-JAN-2017) (dose, route of administration and anatomical location were not reported). On 11-NOV-2015, the patient was vaccinated with a second dose of PROQUAD (Merck) (lot # L032759, expiration date 24-FEB-2017) (dose, route of administration and anatomical location were not reported). There was no concomitant medication reported and no product quality complaint was involved. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 2016, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with PNEUMOVAX 23, (dose, route and site of administration not reported) lot # H014283 and expiration date 17-APR-2014 on 05-MAY-2014. There was no adverse reaction reported. This is one of several reports from the same reporter. Additional information has been requested.
Generalized erythema rash with low grade fever. Symptomatic management of low grade fever and reassure parents.
Warm to touch; Painful / Increased pain due to her itching it; Very itchy; This spontaneous case was received on 24-Oct-2023 from other healthcare professional via Company (reference number: SEQW23-03707) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 13-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, and anatomical location: not reported) as Influenza immunization. The batch number was not reported.  On an unspecified day in Oct-2023, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient reported feeling very itchy, warm to touch, and painful. As reported, the patient had no fever, and the pain probably increased due to the patient itching it. The patient's treatment included hydrocortisone cream and Benadryl itch gel (diphenhydramine hydrochloride).   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient was vaccinated with Flucelvax Quadrivalent vaccine. Within eleven days following vaccination, the patient experienced skin warm, pain and pruritus. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine cannot be excluded, and is assessed as possible for all events, due to chronological plausibility.; Sender's Comments: The patient was vaccinated with Flucelvax Quadrivalent vaccine. Within eleven days following vaccination, the patient experienced skin warm, pain and pruritus. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine cannot be excluded, and is assessed as possible for all events, due to chronological plausibility.
At 7:00am the morning after receiving my second dose of the vaccine, I arose from bed and went to the bathroom to brush my teeth. At the sink, I immediately started feeling extremely dizzy and lightheaded and felt like I was going to throw up. I was also extremely clammy and started sweating. I tried to make my way to the kitchen to get a glass of water and blacked out and the next thing I remember is waking up on the floor of my apartment hallway covered in sweat and screaming and crying. I called my primary care physician's office and spoke with a triage nurse who advised me to go to the ER for examination due to my loss of consciousness and lingering feelings of dizziness, nauseous, and body aches.
fever began with chills/temp of 100; sore arm; didn't feel well; fatigue; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EL19581) via an unspecified route of administration in right arm on 10Feb2021 09:15 AM at single dose for COVID-19 immunization. Medical history included High blood pressure and moderate cholesterol. Patient has no known allergies. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included CRESTOR (rosuvastatin calcium) 10mg, losartan, ASA (acetyl salicylic acid) 81 mg, PROTINIX (omeprazole) 40mg (all received in two weeks). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EL3249) in right arm on 27Jan2021 at single dose at the age of 74 years for COVID-19 immunization. The patient experienced extremely sore arm, didn't feel well and fever began with chills 12 hours after 2nd injection on 10Feb2021 at 09:15 AM. All night and next day, fever and fatigue treated with Tylenol and one Aleve taken mid day. She usually run a subnormal temp, so subnormal temp so a temp of 100 (unit not provided) was bothersome to her especially with chills. The patient was not diagnosed with COVID-19 post to vaccination. The outcome of events was recovered in 2021.  Information about lot/ batch number has been updated.
VACCINE DID NOT WORK; This spontaneous report received from social media a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry date: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination  (dose number series: 1). The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, it was reported that "the vaccine doesn't work, either people die or they don't it's called the damn flu people need to realize that's all it is".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine did not work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220100090 -Covid-19 vaccine ad26.cov2.s - vaccine did not work (Drug ineffective) This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
FEELS SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feels sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels sore was not reported. This report was non-serious.
Heart Palpitations, difficulty breathing, foot drop, ataxia, uncoordinated movement, blurred vision, muscles aches, cramping, flank pain in left and right flank, kidney pain in lift and right kidney area, severe tremors in left hand/arm severe tremor in right hand/arm, severe tremor in right leg. Inability to walk or stand in excess of 16 hours a day for 11 consecutive days. Experience complete muscle freezing (Frozen Man Syndrome) for 11 days. Sequel, increase in nephropathy symptoms in  arms and legs. Pain and severe muscle cramping  in back legs and neck. Painful lymph nodes in legs arm pits and neck. Patient experienced inability to walk or stand in excess of 16 hours a day.  Patient was week and uncoordinated and unable to judge distances and experienced bumping into walls and tripping on floor rugs.
arm continues to itch at the injection location.; arm continues to itch at the injection location; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev dose details, Prev dose product=COVID 19, prev dose brand unknown=True, Prev dose brand name unknown: Covid 19 vaccine, prev dose lot unknown= True, Prev dose lot  unknown reason: Misplaced/Discarded, Prev dose administration Date: 21Dec2021, prev dose dose number=1, Prev dose vaccine location: Right arm), administration date: 2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2022), described as "arm continues to itch at the injection location."; VACCINATION SITE REACTION (non-serious) with onset 2021, outcome "recovered" (2022), described as "arm continues to itch at the injection location". Therapeutic measures were not taken as a result of pruritus, vaccination site reaction.  Additional information: If other vaccine in four weeks: No.other medications in two weeks: Yes.My right hand was itchy and raised bumps appeared after first dose. It continues to itch to this date. After the second dose my arm continues to itch at the injection location.AE resulted in: None of the above.If treatment ae: No.If Covid prior vaccination: No.If Covid tested post vaccination: No. known allergies: Yes.other medical history: Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
body aches 3 days, fever over 101 5 days, fatigue 3 days, rash on arm 5 days, dizziness 2 days
DIARRHEA, FEVER, ACHING ALL OVER.   NO LOCAL REACTIONS.
This spontaneous report was received from a Certified Medical Assistant concerning a female patient of unknown age. On 04-MAR-2013, the patient was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular. On 03-SEP-2013, the patient received her second dose of GARDASIL, 0.5 ml, intramuscular, and on 03-OCT-2013 the patient received her third dose of GARDASIL, 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested.
I just was dizzy like light-headed/I got kind of light-headed; This is a spontaneous report from a contactable consumer or on health care professional (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 67 years old) as dose 1, single for COVID-19 immunization at  Health Department. No patient history and concomitant medications, other products were reported. The patient stated that she had her first dose of the Pfizer covid vaccine on 04Feb2021 and right after she had vaccine, she got kind of light-headed and it only lasted for five minutes. And also stated he do not have a headache. Patient was asked was it a serious side effect and just wondering that if she should get the second dose. No Investigation Assessment were provided. Seriousness was reported as No. Outcome of the event was resolved on 04Feb2021.  Call was transferred from Pfizer Medical Information by  Transferring agent stated, A female patient on the line who reported some light headedness more like dizziness after taking the Pfizer Vaccine. She said that she had the vaccine on 04Feb (not clarified), the first dose of the Pfizer Covid vaccine and she felt lightheaded which lasted for about five minutes and answered her questions already. When paraphrased the concern, consumer stated, just when she had the vaccine, she would say maybe five minutes after she got it and it only lasted for five minutes. Expiration Date and Dose: Consumer stated, it doesn't have an expiration date. Treatment: Consumer stated, "No." Consumer further stated, she got it at ( Health Department." Anatomical site of vaccine administration: Left Arm. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  Follow-up attempts completed. No further information expected.
i had the shots and still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
NUMBNESS, WEAKNESS, IN LEFT ARM AND LEFT ANKLE PARTICULAR WEAKNESS IN LEFT WRIST AND ANKLE RINGING IN EARS BLURRY VISION IN LEFT EYE DOUBLE VISION IN LEFT EYE WHEN TIRED WEAKNESS IN NECK
This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 76-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to patient 3 in the literature article. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). 4 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced sensorimotor axonal neuropathy, paresthesia, numbness in bilateral toes progressing to both legs and then to bilateral fingers, loss of balance, poor dexterity and dysphagia. On neurological examination, the subject had a generalized weakness (graded 4/5). Decreased pinprick, joint position and vibration in both lower extremities. She had unsteady gait and stance. Deep tendon reflexes 1+ in both upper extremities and absent patellar and ankle reflexes. The subject was hospitalised. Cerebrospinal fluid protein was 78 mg/dl. 7 weeks after vaccination with influenza vaccine (unspecified), the electrodiagnostic was highly suggestive of acute inflammatory demyelinating polyneuropathy (sural sparing, prolonged distal latencies and absent or abnormal F responses). The subject was treated with normal immunoglobulin (IVIG). At the time of discharge, the events were improved. Improved sensations, slow improvement of weakness and dysphagia in one week after the course of IVIG. Summary of the literature article: Recent epidemiological studies established extremely rare incidence of Guillain-Barre syndrome after contemporary H1N1-influenza vaccine. The authors reported five subjects with 'atypical? GBS variants that started within four weeks of 2010/2011 H1N1-influenza vaccine. There was no evidence for other etiologies of GBS. The subjects presented with sensory ataxia, areflexia, extremity and oropharyngeal paresthesias, numbness, pain, weakness, sphincteric disturbances, and dysautonomia. One subject had Miller Fisher syndrome. All had elevated cerebrospinal fluid protein, and classic electrodiagnostic finding suggestive of GBS. All received the treatment with intravenous immunoglobulin with variable response. The author's conclusion stated that this series of subjects did not necessarily establish cause-effect relationship between the vaccination and the disease. They also emphasized that they couldn't draw general conclusion concerning the types of GBS after H1N1-influenza vaccine in larger populations. Epidemiological studies with large cohort were necessary to confirm excess cases of atypical GBS after H1N1-influenza vaccination. They also speculated the possibility that more "typical" cases of GBS after H1N1-influenza vaccine did not reach their attention at tertiary-care center but were treated by community neurologists. Nevertheless, the main message that we can draw from this study is that high index of suspicion and screening for atypical variant of GBS was warranted for the H1N1-influenza vaccinees who present with neuropathic manifestations within four weeks of vaccination.
Pt c/o temp and joint aches after Influenza vaccine - Mom request report be made.
pt recvd vax; pt devel complex seizure x 5 min after vax;
My arm is got really red but it's itchy; like skin allergy; I have a trouble hearing today as I am little congested; I have a trouble hearing today as I am little congested; My arm is got really red but it's itchy; like skin allergy; My arm is got really red but it's itchy; like skin allergy/ small red spot; This is a spontaneous report from a contactable Nurse. This 56-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: 30Apr2021) at single dose for COVID-19 immunization on 07Jan2021. Relevant history included blood pressure (abnormal). Relevant concomitant drug included Lisinopril 5 mg for blood pressure.  The patient had the first BNT162B2 and she had no problems with this one. She had some side effects for this one, it's been 48 hours since she had the vaccine. On 08Jan2021, the patient had a very small red spot but its probably 6 inches long and probably 2 inches wide on 09Jan2021. Her arm was got really red, but it's itching almost like an skin allergy. Itching was much in the night. The patient want to know if it is okay to take Benadryl?  The patient also had a trouble hearing on 09Jan2021 as she was little congested. The patient was taking Tylenol (not appropriately paraphrased and clarified). Outcome of events was unknown.
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-AUG-2016, the patient was treated at a community hospital emergency department for a persistent vesicular rash, which was diagnosed as chronic herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
pt w/vesicular eruption rt arm bicep 14 hr p/vax vesicles scabbed over have been slowly resolving over 8 days
Got 1st shot 24 Mar 2021, second shot 31 June, booster shot 1 Sept.  Mom had chemo and Radiation in 2014 and again with a mascectomy in 2017 for breast cancer so she has had bloodwork and x-rays and MRIs and Echocardiograms on the regular.  The FIRST TIME she has had an issue was after her 1 Sept booster shot for Moderna.  She had an Echo on her heart on 15 sept that shows she NOW has a leaky heart valve.   The doctor was shocked.  She now has to take aspirin daily which causes bruising.  She is NOT a good patient for surgery at her age.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 24-AUG-2017 at 13:48, the patient was vaccinated with PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) intramuscularly for prophylaxis, then inadvertently administered a second dose of PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) on 30-AUG-2017 (extra dose administered). No adverse effects reported. Follow up information was received on 04-DEC-2017 from the registered nurse referring to a 70 year old female patient. Patient's historical drugs included penicillin and heparin. The patient was allergic to heparin, penicillin (PCN), proton pump inhibitor, bee stings and shellfish. Concurrent conditions included Barrett's esophagus, TIA (transient ischaemic attack), chronic kidney disease, hyperlipidemia, hypertension, cerebral degeneration, vascular dementia and thrombocytopenia. On 01-SEP-2017 at 08:05 (previously reported as 30-AUG-2017), the patient was inadvertently administered a second dose of PNEUMOVAX 23.