chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash and itching over the torso, arms, and neck. Appeared about 60 hours after the second vaccination.  There was no reaction to the first dose.  No treatment. There is a possibility that this rash indicates a new allergy to Tylenol. Tylenol is not the usual pain reliever, so had not been used for years. Tylenol was used after the vaccination to relieve chills and headache, as per instructions at the time of vaccination. This rash is similar to rashes seen as allergic responses to other drugs and also similar to rashes resulting from viral infections such as flu. Thus, the uncertainly about the cause of the rash.
dead suddenly and unexpectedly; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp via social media.  This case involves a 42 year old and unknown gender patient who died suddenly and unexpectedly while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient died suddenly and unexpectedly (sudden death) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant and was leading to death. The cause of death was unknown. It is unknown if an autopsy was done. Final diagnosis was (fatal) dead suddenly and unexpectedly.  Action taken with influenza vaccine was not applicable.  At time of reporting, the outcome was Fatal for the event dead suddenly and unexpectedly.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 42 year old patient of unknown gender who died suddenly and unexpectedly after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants and autopsy report would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: dead suddenly and unexpected
Starting at around midnight I was feeling unwell. I got a fever by 12:45ish and had extreme chills. I took a Tylenol went to bed at 1:30am. I kept waking up in my sleep I had very strange dreams of the same dream all night. I woke up delirious. I was still experiencing chills, full body pain, pain in my genitals, fever, hallucinations, hearing voices, like being a dreamlike state without being asleep, headache, arm soreness and loss of appetite. I took more Tylenol throughout the day to help with symptoms. Next day I woke up feeling better but still very lethargic and I seem to now have this rash that keeps popping up and going away on different parts of my body. It?s like itchy little white bumps. I no longer have a fever or chills on day 2, just the rash, sore arm, muscle pains and like I have no energy at all. Still no appetite as well.
suspected vaccination failure; I've had shingles 2 times.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles 2 times. The patient received Shingles vaccine after the 1st case of shingles. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
can not lift left arm over his head and right of thigh and leg is numb can't feel the difference of hot and cold, buckle at the knees sometimes when walking
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Additional Details: PATIENT REPORTS SHE HAD NECK BRUISING AND THROAT /UNDERARM SWELLING WHICH STARTED THIS MORNING ON 11/23/21. SHE CONFIRMED THAT SHE HAD NOT TAKEN ANY MEDS YET. RECOMMENDED TAKING OTC PAIN MEDICATION FOR PAIN AND SWELLING
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date a patient received her second dose of GARDASIL 0.5 mL IM, 9 months after she received her first dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted while receiving vaccine, 911 was called, pt was all right after sitting for awhile. did not leave by ambluance.
I had Bells Palsy in 1997 and again in 2000. I don't remember if the same side was affected.  I started to develop symptoms of Bells Palsy again on Sunday May 16 in the evening. It got progressively worse so I went to my primary care provider on Wednesday, May 19, 2021. PA-C ran a variety of tests and prescribed prednisone. She also made a referral to a neurologist. I have not gotten an appointment set for the neurologist. My symptoms have continued to worsen and I will contact my primary care provider later today about that. She ran Lyme's disease and other tick borne illness tests. We live in a high Lyme disease area. I had a large tick on me (not sure if was actually attached) a few days prior.
no additional AE was reported by patient.; PNEUMOVAX23 was inadvertently administered on 10/6/2021 with a labeled expiry of 10/3/2021; This spontaneous report was received from a Licensed Practical Nurse, who was also the practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 06-OCT-2021, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at a dose 0.5 milliliter (mL), lot # T021329, expiration date: 03-OCT-2021 (formulation not reported, but upon internal validation established as vial; strength, dose number and route of administration were not reported) for prophylaxis (expired product administered).  There were no known temperature excursions. The reporter stated that no additional adverse event (AE) was reported by patient (no adverse event).  The outcome of medication error was unknown.
6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced OFF LABEL USE (6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial). At the time of the report, OFF LABEL USE (6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that no signs of adverse events were noted after administration. No treatment information was provided.
Approx. 24 hrs. following administration of vaccines given on both 2/17/04 and 5/4/04. child developed fever 101F-102F accompanied by vomiting and diarrhea. Next day she was seen by MD (2/04) in ER (5/0) and admitted to hospital where she was an inpatient for 2 days each time. Was at 2 different hospitals 2/04 and 5/04. Was placed on IV antibiotics. 8/7/06 Received medical records from 2nd hospital which reveal patient brought to ER 2/04 due to cough, vomiting & diarrhea & pulling at ears.  Temp on admit was 102.  Given IVF bolus but did not improve so was admitted for continued w/u & observation overnight.  Patient lives w/3 other siblings & grandparents who have POA.  Diarrhea was noted to be green, watery & foul smelling.  Patient had been hospitalized for 3 days at 3 mos of age for gastroenteritis.  Has developmental delays. Dx w/ URI, mild dehydration.  D/C home later same day on oral antibiotics/ss 8/11/06 Received medical records from 1st hospital which reveal patient brought to ER on 1/29 for vomiting & diarrhea.  Dx: viral gastroenteritis.  Improved on IVF & d/c to home 1/30/04./ss
This case was reported by a other health professional via call center representative and described the occurrence of rash in a adult female patient who received FLUARIX QUADRIVALENT (batch number 397A7, expiry date 18th June 2016). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In October 2015, 30 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the rash to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a other healthcare professional, who herself was the patient. In October 2015, approximately 1 month after vaccination, the patient broke out in rash over face, arms and torso. The patient was not sure if it came from one of the GlaxoSmithKline Flu vaccines. She did not know if it was the FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT vaccine. In December, the patient underwent an allergy patch test that determined she was allergic to thimerosal. The reporter would call Medical Information after she verifies which flu vaccine was administered.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 23-JUL-2010, the patient was vaccinated with  improperly stored (Oka/Merck) VARIVAX dose 2, (dose unknown) from lot # 666851/0280Z with expiry date: 12-FEB-2012.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
A FEW MINUTES AFTER VACCINE, PATIENT STOOD UP AND FAINTED HITTING HIS HEAD ON FLOOR ON THE WAY DOWN.
administered an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa-IPV (Kinrix) (batch number H99J7) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Kinrix). 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: 14-Jun-2023 A registered nurse called in to report that medical assistant accidentally administered an expired dose of Kinrix and wished to know how to proceed further. The patient was administered with expired vaccine of Kinrix, which led to expired vaccine used. The reporter consented to follow up.
Patient reported with red, warm skin rash on arm vaccine was administered in. Said rash extended from around the elbow up to around the shoulder area. Rash was limited to that area only. Patient did not report any other adverse effects. Patient said rash appeared approximately 8 days after receiving second dose of Moderna.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: syncope episode, did not pass out, pale,sweating,visual changes-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: vaccine 2:40pm, CC@ 2:55pm, sweating, visual changes, sweating, feeling of going to pass out, cold compress, vitals BP 93/55 pulse 81. slight tingling feeling in hands, pale, laid on floor/feet elevated, monitored and after 30+ additional minutes felt better,sipped some water& walked out of store, advise lots of water/rest/come back or ER if further issues
pt recv vax 27AUG96 & starting itching @ inj site & quickly spread all over body;sx resolved p/med;
Pt cried 2 days post 1st immun; t102 examined by MD rx delete Pertussis;
Immediate itching all over arm and body and dizziness  within 10 minutes of flu vaccine. Within 1 hour of vaccine ,bilateral leg weakness and numbness . Next day , left arm is swollen and red. There is left arm pain radiating to left axilla. Lymph node in neck is hugely swollen and tender. The itching of the arm lasted for several days. Bilateral leg numbness disappeared. Tylenol  was taken for the pain. I still feel much weaker and exhausted ever since flu shot.
Tingling in lower legs, weakness in lower extremities, unable to walk, elevated blood pressure, paralaysis, patient intubated and received plasmapheresis.
Report obtained from telephone conversation, from doctor that pt was referred to after 2nd adverse event on 9/18/00. Within 2 hours of vax, pt had a generalized fine rash, swelling hands and feet, followed by wheezing. Pt was given Benadryl and symptoms resolved within 2 days.
Approx 3-4 weeks after vaccine, headaches, extreme fatigue, muscle weakness, tremors, felt shaky internally, mottled skin, severe nausea, decreased appetite, mood swings, light headed/feeling faint. On going, worsened over time. Never improved.
Hives; rashes on her back of her neck,rash on arm and tights; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (rashes on her back of her neck,rash on arm and tights) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced URTICARIA (Hives) and RASH (rashes on her back of her neck,rash on arm and tights). At the time of the report, URTICARIA (Hives) and RASH (rashes on her back of her neck,rash on arm and tights) 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 details included Benadryl and Zyrtec + concomitant.
11/19/04 swelling, itching, redness left upper outer arm in the evening. Area hot to touch. Used Benadryl Cream. 12/1/04 symptoms resolved.
a-flutter; Itchy rash on the injection site; Rash on the lower part of upper body; rash under left nipple area; rash around shoulders; Rash around the neck; injection site swelling; redness; Itchy rash on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area) and RASH (rash around shoulders) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, POTASSIUM CHLORIDE, LISINOPRIL, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), UBIDECARENONE (COQ), Stool softner, GUAIFENESIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area), RASH (rash around shoulders), RASH (Rash around the neck), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (Itchy rash on the injection site). At the time of the report, ATRIAL FLUTTER (a-flutter), RASH PRURITIC (Itchy rash on the injection site), RASH (Rash on the lower part of upper body), RASH (rash under left nipple area), RASH (rash around shoulders), RASH (Rash around the neck), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE RASH (Itchy rash on the injection site) outcome was unknown.            The patient applied topical medication, Betamethasone to relive the symptoms. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR-events updated
Left shoulder/injection site pain. Pressure around the heart, slight difficulty breathing with exertion, fatigue, headache, joint pain and mild rash/hives.
Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient experienced seizures. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information is not expected.
2 days after receiving vaccine had developed a red rash on the left thigh. Redness and swelling also occurred at injection site. All resolved 4 day later.
Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, Tachycardia "skin feeling on fire", random pain that moved around body (ankle, knee, calf, hip neck) restlessness. left sided chest pain Narrative:  Other Relevant History:
The day after the vaccine was administered, the patient reported fever/chills and body aches.; chills; body aches; This is a spontaneous report from a contactable consumer or other non hcp.   An adult female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration, administered in right arm on 28Jan2021 14:45 as 1st dose, single for an for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.The patient's concomitant medications were not reported.   On 29Jan2021, at 08:00 AM, the patient experienced the day after the vaccine was administered, the patient reported fever/chills and body aches. the treatment reported as an unknown. The outcome of the events was recovering.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Initial reaction was a tickle in the back of throat.  I tested positive on the 10th and had multiple issues including bilateral pneumonia.  From the second vaccine, I had chills, severe headache, diarrhea, fatigue, swollen face.
Immediate shoulder pain when vaccination was injected.  Sought visit to the MD on 3/10/2014 when pain was still present and unable to lift left arm without significant pain.
Received SHINGRIX Vaccine dose 1, on 04/17/2019, and developed fever to 101.3F, severe myalgias and weakness, shivering, back pain, headache, intestinal distress for the following 24 hours. Symptoms started 17 hours after receiving vaccine.
Information has been received from a pharmacist concerning a female consumer who on 11-SEP-2007 was vaccinated SC with a 0.5 ml single dose of Zostavax (Oka/Merck) (Lot#658211/0884U). On 12-SEP-2007 the patient developed injection site redness. The pharmacist told the patient to take diphenhydramine HCl (Benadryl) 25 mg every 6 hours for the symptom, and to ice the site. At the time of this report the redness was improving, but it seemed to be "spreading" more outward from the original injection site. The patient was seen by her physician. At the time of this report the patient was recovering. No further information was provided. There was no product quality complaint involved. Follow up information from the pharmacist indicated that the patient recovered on 15-SEP-2007. Additional information is not expected.
Had nasal congestion for 2-3 days prior to imms. Then the night after the imms developed fever and rapid breathing and was assessed in the ER and X-ray indicated possible pneumonia/inflammation. Pt was admitted for abx and discharge 2 days later. Normal today (9-15-09).  10/05/09 Received hospital medical records of 9/12-9/14/2009. FINAL DX: Pneumonia Records reveal patient experienced nasal congestion, dry cough x 2-4 days.  Seen for vaccinations day prior to admit.  Developed fever & increased respiratory rate w/retractions following day.  Temp in ER 102.3 & in respiratory distress.  Tx w/IV antibiotics.  Improved & d/c to home on continued oral antibiotics. ICD9 codes: 486, 6233, 78791, 53081
Tingling in both hands and arms, likely tingling in feet too.; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included fluticasone (MANUFACTURER UNKNOWN) on an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 07:00AM the patient experienced tingling in both hands and arms, likely tingling in feet too. The patient has not received any treatment for the events tingling in both hands and arms and likely tingling in feet. The clinical outcome of event tingling in both hands and arms, likely tingling in feet too was recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.