chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minutes after vaccination, experienced a tingling in the brain that increased until it spread causing a tingling sensation all over the "brain" leading to cognitive difficulties such as impaired thinking, memory loss, trouble with memory recall, personality changes, depression, and anxiety, and physical difficulties such as lack of energy, chronic headache, trouble breathing, bone pain/loss, hair loss, extreme food sensitivities, chronic fatigue, excessive sleeping, unrestful sleep, dark gums (oral), aged skin, joint pain, etc. The tinkling in the brain felt like my brain was frying until eventually my brain felt numb and no longer noticeably tingly simply because the entire brain was damaged.
Patient was administered Prevnar-13 and Zostavax and experienced a vaso-vagal reaction about 30 seconds to 1 minute following administration.  He became unresponsive briefly. He was lightheaded. He did not fall to the floor, but remained upright in the chair. He was alert and talking after about 3 minutes.  911 was called and EMS treated at the pharmacy. He was not transported to the hospital.
Initial solicited report received from a consumer (online market research respondent) in the study on 09 September 2015. The subject (gender and age were not reported) received a dose of Influenza vaccine (Manufacturer unknown) on an unspecified date (site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported a bad experience with last flu shot. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none
Redness and swelling to (R) deltoid-child taken to urgent care-dx Cellulitis and Allergic Reaction. Given BACTRIM 200mg/5ml-9 ml po BID for 10 days. Area not measured by urgent care-resolved by 3/5/08 when mom came in to report it.
The order of symptoms in the order they occurred starting at 7:00pm on 9/30/21:  very cold - entire body; tremors in legs and arms; worse in legs; couldn't stand, very nauseous, brain fog, couldn't see clearly, throwing up everything she ate an drank
Up all night post shot screaming in pain. The next morning woke up with SEVERE allergic reaction rashes from head to toe. Took many weeks/months for the reaction rashes to heal, and then was replaced with eczema.
PATIENT COMPLAINED OF HEMATOMA ON LEFT ARM BELOW DELTOID, ABOUT SIZE OF 2.5 INCH DIAMETER.  AFFECTED AREA APPEARED BRUISED AND UGLY BUT SUFFERING NO OTHER ADVERSE EFFECTS.
? injection site pain - continue as of 9:30AM 04/14/2021 ? tiredness - continue as of 9:30AM 04/14/2021 injection hand (left), knees, legs. ? headache - continue as of 9:30AM 04/14/2021 ? muscle pain - continue as of 9:30AM 04/14/2021 ? chills - continue as of 9:30AM 04/14/2021 ? joint pain - continue as of 9:30AM 04/14/2021 ? fever - was present on 04/13/2021. Gone as of 9:30AM 04/14/2021 ? injection site swelling - continue as of 9:30AM 04/14/2021 ? injection site redness -  none. ? nausea - was present 04/13/2021. Gone as of 9:30AM 04/14/2021 ? feeling unwell - continue as of 9:30AM 04/14/2021 ? swollen lymph nodes (lymphadenopathy) - none ? diarrhea - continue as of 9:30AM 04/14/2021 ? dizziness - continue as of 9:30AM 04/14/2021
pt recv vax 20APR98 & 24APR98 pt reportedly exp an inj site rxn;
Red spots on face, puffy face (L) eye, watery, headache. Pt's 1st flu vaccine.
Generalized varicella-form rash. 40-50 lesions at 24 hours of symptoms. Fussy poor sleep restless on day 9 s/p vaccine, low grade temp on day 6 s/p vaccine.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Information has been received from a nurse concerning a female child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced a normal case of chicken pox. It was reported that the child recovered and had no complications. There was no hospitalization. Unspecified medical attention was sought and no product quality complaint was involved. No other information is available. Additional information has been requested.
GARSASIL 9 at 14 years old in July 2109, turned 15 in May of 2020; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date in July 2019, at the age of 14 years old, the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, (route of administration, lot #and expiration date were not provided) for prophylaxis. On unspecified date in June 2020, at the age of 15 years old,  the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml (route of administration, lot #and expiration date were not provided) for prophylaxis. She wanted to know if this complete the series. The onset date of the inappropriate schedule of product administration was reported as 08-DEC-2020 and the outcome was not provided.
taking medicine (Fluticasone nasal spray) for sinus congestion in between doses; This is a spontaneous report received from a sponsored program. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Mar2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she received her 1st dose on 03Mar2021 and 2nd dose is tomorrow 24Mar2021,she is taking medicine (Fluticasone nasal spray) for sinus congestion in between doses. Therapeutic measures were taken as a result of sinus congestion. The outcome of the event was unknown.  Information on lot/batch number has been requested.
My left arm is still sore. And it went from my left arm to my whole body feeling sore and achy. The only way I know to describe how I felt was like if I had the flu. I had headaches and my body ached. And then I became so sore I could hardly move. And I'm still sore. It got to the point where my back was hurting so bad, I could hardly walk.  If I laid down, I couldn't turn over on my own. That went on for about almost a week. The chiropractor has gotten me to where I can move with ease now. But my body is still sore. The first two shots I had no problems whatsoever. I can't say that it was the shot, but these symptoms were definitely not here before. Went to the ER but went home immediately as there was a lot of people at the hospital.
it was rpt fro HCP concerning pt who was vax  & subsequently pt exp a breakthrough case of varicella. no further info avail
Patient reported shingles-like rash on left arm at injection site.  Rash covered an area about the size of her hand.  Patient also reported muscle and joint soreness in her neck, shoulders, and arms.
Patient is a 69 yo female that C/O right arm pain with some intermittent nausea that started approx. 5hrs ago. She noted pain originates from site where Pneumococcal vaccine was given this morning. Mild redness around area without appreciable swelling. No chest pain, no cough/congestion. Denies recent illness. No numbness/tingling into RUE. Afebrile. She had taken 2 doses of Ibuprofen without significant improvement. Sharp/shooting pain that she rates 10/10.
Patient became very despondent and confused she became abnormally affectionate.  She could not take direction she appeared almost unable to hear.  Her speech was limited.   She was extremely sleepy.   This started just two hours after the vaccine was administered.  She has continued to have episodes like this since this day and they last several days that have sudden onset and sudden ending. 5/19/08-records received for DOS 11/8/07-well visit.  5/21/08-ED records received for DOS 12/8/07-DX: Acute behavioral changes. presented with altered behavior. Appears despondent and distant. Began acting out at school and acting odd at home. Slept many hours.
Gonorrhea and chlamydia; Gonorrhea and chlamydia; Case reference number US-BN-2023-001123 is a spontaneous case report initially received from a other health professional (reference number: USBAV23-0781) on 20-Jun-2023 and concerns a patient of unknown demographics.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (batch number not provided), at unknown dose, route and anatomical site of administration, for an unknown indication.  On an unspecified date, an unknown amount of time after the first dose of Jynneos, the patient experienced gonorrhea and chlamydia.  On an unspecified date, an unknown amount of time after the first dose of Jynneos, the patient was coming in for the second dose of monkey pox vaccine, as reported, and also asked for sexually transmitted disease (STD) treatment for gonorrhea and chlamydia.  At the time of initial report, the outcome of the events 'gonorrhea' and 'chlamydial infection' was unknown.  The reporter assessed the events 'gonorrhea' and 'chlamydial infection' as non-serious. However, the events 'gonorrhea' and 'chlamydial infection' were assessed as serious due to the seriousness criteria of medical significance. Causality assessment was not provided for the reported events.  Additional information received from Bavarian Nordic on 21-Jun-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics received the first dose of Jynneos, via unknown route and site of administration. An unknown amount of time later, before receiving the second dose of Jynneos, the patient developed gonorrhea and chlamydial infection (serious, medically significant events). Gonorrhoea and chlamydial infection are unlisted per the insert for Jynneos. The patient's medical history and concomitant medications were not reported. Considering that gonorrhoea and chlamydia are sexually transmitted diseases, a causal relationship is deemed biologically implausible. The events are assessed as not related to Jynneos.; Sender's Comments: A patient of unknown demographics received the first dose of Jynneos, via unknown route and site of administration. An unknown amount of time later, before receiving the second dose of Jynneos, the patient developed gonorrhea and chlamydial infection (serious, medically significant events). Gonorrhoea and chlamydial infection are unlisted per the insert for Jynneos. The patient's medical history and concomitant medications were not reported. Considering that gonorrhoea and chlamydia are sexually transmitted diseases, a causal relationship is deemed biologically implausible. The events are assessed as not related to Jynneos.
From 2 hrs p/shot until 7 hrs p/shot; pt unconsolably cried, often w/peaks of high pitch;
On 2/15/21 I began to have difficulty understanding something that I was reading. I turned to tell my wife and was unable to speak clearly. Went to ER on 2/16 and was attended a neurologist. He believed that the dx was likely "recrudescence stroke" was the symptoms were very similar to the previously noted stroke from 2016. All testing (CAT scan, EEG, MRI, MRA, echo cardiogram, and blood work was all normal/negative).  I've been a licensed physical therapist for over 50 years but had never heard of a recrudescence stroke.  After reading about the signs, and symptoms I believe it was exactly what happened and was correct when he called it a recrudescence stroke
Approx 20 min after shot, began feeling faint, heart racing, nauseated, chilled. BP checked and 140-150 over 90-113. Pulse 130 range. Saw doctor propranolol given. Advised not to have another flu shot.
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. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy 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 of herpes zoster. In 2016, the patient was treated by a physician for a 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. Additional information has been requested.
PREVNAR 13 ordered, PNEUMOVAX 23 given. Pt received PNEUMOVAX in 2011.
bumps left arm; swollen left arm; redness ans warm to the touch left arm; Rash left arm; Wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bumps left arm), PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (redness ans warm to the touch left arm), RASH (Rash left arm) and ARTHRALGIA (Wrist pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ARTHRALGIA (Wrist pain). On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (bumps left arm), PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (redness ans warm to the touch left arm) and RASH (Rash left arm). At the time of the report, PERIPHERAL SWELLING (bumps left arm), PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (redness ans warm to the touch left arm), RASH (Rash left arm) and ARTHRALGIA (Wrist pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Today 2/20/09 mom saw arm swollen & red on area of DTAP vaccine area.  Mom will apply ice on edutal arm as per phone call with mom on 2/20/09
Patient was given 0.2 ml of the Pfizer Covid 19 vaccination 12 and up formulation, instead of the 5-11 year old formulation.  When realized, Provider called to check on patient 11/22/2021-mother reports no adverse reaction, only soreness in arm where vaccine was given.  No other symptoms.  Mother advised according to CDC guidelines that second dose is optional and mom elects to proceed with second dose.
pt recv vax & approx 2 days p/vax pt exp swelling on one side of face;when pt recv second dose of vax, the other side of face swelled;
tender; ring around the injection site the size of an orange; red patches on arms and legs; developed welts; injection arm was red; Chest congestion; cough; stuffy; sinus symptoms in her head; full blown severe chills; headache; body aches; fever between 100-101F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), NASAL CONGESTION (stuffy), SINUS HEADACHE (sinus symptoms in her head), LOWER RESPIRATORY TRACT CONGESTION (Chest congestion) and COUGH (cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported Historical Condition.).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (body aches), NASAL CONGESTION (stuffy), SINUS HEADACHE (sinus symptoms in her head), CHILLS (full blown severe chills), HEADACHE (headache) and PYREXIA (fever between 100-101F). On 27-Jan-2021, the patient experienced LOWER RESPIRATORY TRACT CONGESTION (Chest congestion) and COUGH (cough). On 28-Jan-2021, the patient experienced RASH (red patches on arms and legs), URTICARIA (developed welts) and VACCINATION SITE ERYTHEMA (injection arm was red). On an unknown date, the patient experienced VACCINATION SITE REACTION (ring around the injection site the size of an orange) and TENDERNESS (tender). At the time of the report, PAIN (body aches), NASAL CONGESTION (stuffy), SINUS HEADACHE (sinus symptoms in her head), LOWER RESPIRATORY TRACT CONGESTION (Chest congestion), COUGH (cough), RASH (red patches on arms and legs), URTICARIA (developed welts), VACCINATION SITE REACTION (ring around the injection site the size of an orange), TENDERNESS (tender), CHILLS (full blown severe chills), HEADACHE (headache), PYREXIA (fever between 100-101F) and VACCINATION SITE ERYTHEMA (injection arm was red) 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.
25 to 35 minutes after the injection my ears started ringing. Around 5:30 p.m. my tongue stared to swell up and around 6:15 p.m. my skin feels like its on fire. The arm of the injection site continues to have blotchy/rash spots. I drove to Express care and arrived around 6:50 p.m. They gave me a shot of Solu Medrol 125mG and a prescription for Prednisone 20 mg. and told me to take over the counter Benadryl.  Upon arriving home I took the Prednisone and a short while later I took a Benadryl. I continue to have my skin feel like it is burning, tongue is less swollen, still ringing in my ears, blotches on the injected arm, and am now getting a slight headache. will continue to take medication prescribed by the doctor. Nurse took my vitals and told me that my blood pressure was elevated to the point of a heart attack. she ttok it again befor I left and it was getting back to a normal level.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX. On 5th May 2018, the patient received SHINGRIX. On 5th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th May 2018, the patient experienced injection site erythema and injection site swelling. On 9th May 2018, the patient experienced discomfort. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the discomfort was unknown. The reporter considered the injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated in the early afternoon and reported pain at injection site on Saturday. By the next day (1 day after vaccination) the area had swelling and showed redness. The pain resolved to more of discomfort (4 days after vaccination) on the date of reporting. The reporter ended the call and said that he was done and had other things to do.
Patient who was previously administered 1st GARDASIL 9 Dose on 09/07/2022 had missed 2nd GARDASIL 9 Dose/had never received 2nd GARDASIL 9 Dose.; No additional AE reported; This spontaneous report has been received from a pharmacist, referring to a 40-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions, or allergies were not reported.  On 07-SEP-2022, the patient was vaccinated the first with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, vaccination scheme, anatomical location, lot number or expiration date were not provided) for prophylaxis. The patient had missed the second hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose and had never received it (product dose omission issue). No further information provided.  No additional adverse event (AE) reported.
Patient received an expired dose of Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Medical Information (MI) (Reference number- 00794447) and transmitted to Sanofi on 01-Oct-2021.  This case involves Adult female patient who was received an expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 30-Sep-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5666BNA, expiry: 17-Sep-2021) via intramuscular route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "A Pharmacist reporting that a consumer received an expired dose of ADACEL, on 30Sep2021. The caller reported that the vaccine expired on 17Sep2021 and the dose was given on 30Sep2021 and that the consumer is between the age of 30 to 40 years old."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Information has been received from a physician via field representative referring to a 13 year old female patient. On 07-APR-2015 the patient received her first therapy shot of GARDASIL (lot number and dose were unknown, intramuscular). On the same day in the doctor's office, after the administration of GARDASIL, the patient fainted and fell. She was not injured after the fall. No lab diagnostics studies were performed and no treatment was given for the events. The patient was recovered from the events on the same day. The causality between GARDASIL and the events was unknown. Additional information has been requested.