chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided.; the patient was administered an improperly stored dose of Pneumovax; Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies, and concomitant therapies were not reported.  On 26-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (therapy type: digital data logger) (strength, dose, frequency, route of administration, or anatomical location was reported) with lot # S004548 which was confirmed to be valid for pneumococcal vaccine, polyvalent (23-valent) with an expiration date reported and established as 12-AUG-2020, for prophylaxis.  Temperature excursion (product storage error) was reported as follows: temperature 47.3 degrees Fahrenheit and the timeframe was 20 minutes. No previous temperature excursion was reported. The product storage error was identified via a data logger. No additional adverse event information provided. No product quality complaint was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302: US-009507513-2005USA000310: US-009507513-2005USA000352: US-009507513-2005USA000356: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000415: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000614: US-009507513-2005USA000624: US-009507513-2005USA000735:
Guillan Barre- May 2021 Myositis DVT/PE cardiac arrest  NSTEMI with 100% LAD occlusion EF 10-15%
2 hours after vaccine patient had confusion, got lost while driving in familiar area, belted into parked car, green diarrhea, nausea, vomiting, feeling weak and run down. Patient came to pharmacy on 11/1/15 to report reaction. At this time he was feeling better. No longer had diarrhea or confusion.
This spontaneous report has been received from a 65 year old male consumer who was allergic to penicillin referring to himself. In 2017, the patient received a dose of flu vaccine and PREVNAR and nothing happened. Concomitant medication included unspecified cholesterol medicine and metoprolol. On 11-OCT-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 in left arm to avoid pneumonia (strength, route of administration, frequency, batch/lot # and expiration date were not reported). The patient was also vaccinated with an unspecified influenza vaccination in the same arm. On 12-OCT-2018 (reported as next day after vaccination), the patient had a fuzzy head, fever and chills and the injection site was red and hot. The patient said that the head symptoms, fever and chills were resolved two days later but he still had a big red hive at the injection site and a big red band that started at the injection site and ran across his arm, which was gradually fading but still hurt. On 13-OCT-2018 (reported as Saturday), the patient began to experience insomnia and he lied awake both Saturday and Sunday night and UNISOM did not help his insomnia. The patient had not spoken to a physician about his side effects. No lab diagnostics/studies were performed. No causality assessment was provided.
Started at 5-6 pm on same day 7-6-11. Joint pain, fever (101 degrees), chills, aching muscles, very scared, all-over sick feeling, pain from waist down to feet, tiredness, weakness, confusion, maybe skin reaction (told it was poison ivy). Called doctor - told to give ADVIL. The next morning she was better but very weak.
FLU LIKE SYMPTOMS; SWEATING; BODY ACHE; MIGRAINE/HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stent in heart, and stent in leg, and concurrent conditions included migraine, high blood pressure, gastroesophageal reflux disease, and irritable bowel, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gastroesophageal reflux disease, and irritable bowel, hydrochlorothiazide for high blood pressure, lisinopril for high blood pressure, metoprolol succinate for high blood pressure, pantoprazole for irritable bowel, and gastroesophageal reflux disease, butalbital/caffeine/paracetamol for migraine, acetylsalicylic acid for stent placed in heart, and clopidogrel bisulfate for stent placed in heart, and stent in leg. On 05-APR-2021, the subject experienced flu like symptoms. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, sweating, body ache, and migraine/headache on 09-APR-2021, and nausea on 07-APR-2021, and was recovering from fatigue. This report was non-serious.
Area where injection happened was sore the next day; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 25Jan2021, at 10:30 as single dose for covid-19 immunization.  Medical history was reported as none. The patient's concomitant medications were not reported. No allergies to medications, food, or other products were noted.  The patient experienced area where injection happened was sore the next day on 26Jan2021, which was non-serious.  No other vaccines were received within 4 weeks prior to the COVID vaccine. The outcome of event was recovering without treatment. Prior to vaccination, the patient was not  diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of area where injection happened was sore the next day was recovering.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Menstrual cycle started a week early. Extremely fatigued and unusually heavy flow.
Low fever and chills 24 hrs after innoculation.  Lasted about 4 hrs. Then OK.
Raised erythematous papular rash on face arms legs, worse over area of injection on left anterior thigh.
4/15 day of vaccine:  intense headache 4/16-4/18:  bouts of intense pain across face and jaw and sinuses...preceded and followed by tingling and numbness in face 4/19. Symptoms went away
Later that same day injection site area became painful and red rash developed 4x6 inches, in the following days pain increased and black and blue mark developed at injection site a little larger than a half dollar. Red rash went away in 3 to 4 days. Six days later still has some pain and tenderness and black and blue mark still there.
She has had and continues to have the tightness in her legs and pain, terrible pain in her calves; She has had and continues to have the tightness in her legs and pain, terrible pain in her calves; Has difficulty sleeping, she can't sleep well; very tired all the time; She has had and continues to have the tightness in her legs and pain, terrible pain in her calves; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Mar2021 (Batch/Lot number: ER8730, Expiration Date: 31Jul2021) as DOSE 2 single for covid-19 immunisation. Medical history included Guillain Barre syndrome on an unspecified date in 2014. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/Lot number: EN6203) on 08Mar2021 for covid-19 immunization. On an unspecified date in 2021, patient experienced getting hard to sleep, very tired all the time, tightness in her legs, terrible pain in her calves. Patient stated she had the same symptoms as with GBS and asking if it is vaccine related or not. She reported that she has had and continues to have the tightness in her legs and pain, terrible pain in her calves, has difficulty sleeping, she can't sleep well. Lot number of Covid vaccine dose 1 and dose 2 was not provided. Patient also stated when she had the vaccine and called in and no one has gotten back to her regarding what happened when she had the vaccine. Caller states she may still be experiencing but she is not sure. She had the vaccine a couple of months ago and in 2014 had been treated with IVIG for Guillain-Barre Syndrome and since she had Guillen Barre Syndrome and was treated then she naturally had the Covid vaccine for comorbidities. Caller states that since the vaccine she has had and continues to have the tightness in her legs and pain, terrible pain in her calves. Caller states her symptoms are mimicking when she had Guillen Barre Syndrome but she doesn't have it. States she has difficulty sleeping, she can't sleep well, and is very tired all the time and doesn't know if this is part of the vaccine or not. States these are symptoms she had when she had Guillen Barre Syndrome but she doesn't have it now. States she doesn't want an EMG as it's very painful and she is not going for a spinal tap and that was how it was diagnosed in 2014. Outcome of events pain, muscle spasms, difficulty sleeping, fatigue was updated as unknown, for stiffness updated as not recovered.  Follow-up (08Jul2021): New follow-up information received from a contactable consumer (patient) included: Dose 1, 2 start date, lot number, expiration date, relevant history, event added.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
HEAVY JOINT PAIN , RASH ,. KNOT ON ARM WHERE  I GOT SHOT.
Shot made her sick; Second shingles shot  / body aches; Second shingles shot  / fever for about 24 hours; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hysterectomy (at the age of 42). Previously administered products included Shingrix (1st dose received on an unknown date and was fine). Concurrent medical conditions included irritable bowel syndrome.   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 2 months after receiving Shingrix, the patient experienced sickness, general body pain and fever. On an unknown date, the outcome of the sickness, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the sickness, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years old.  The family of the patient had been all died for a long time. There were no relevants tests available. The patient did not have periods because the patient had hysterectomy. The patient received the Shingles vaccination 5 weeks before the COVID-19 vaccine. The batch number or expiry date of Shingles vaccine was unknown.  The patient received the second shingles shot and that made her sick, she had body aches and fever for about 24 hours. The patient did not receive any prior vaccinations within 4 weeks of COVID-19 vaccine. The patient had received 1st dose of COVID-19 Vaccine (manufacturer unknown) with batch number EJ1685, expiry date March 2021 on 18th December 2020 15:00 at the right arm. The patient experienced headache immediately, within about 20 minutes after the injection on 18th December 2020 which was still there till the time of reporting. On 19th December 2020, the patient experienced strange lower abdominal pain which was different than IBS. Shortly after abdominal pain, the patient started having waves of nausea which began 24 hours after the COVID-19 vaccine. The abdominal pain lasted for a minute and a half. The reporter did not know if abdominal pain was coincidental. The reporter wanted to know how long the side effects would last. The reporter consented to follow-up via mail address.
Case number PHEH2015US000949 is an initial spontaneous report from a consumer received on 09 Jan 2015. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1414101, expiry date: Jun 2015) on an unknown date. On 31 Dec 2014, after vaccination she experienced an allergic reaction (unspecified). The outcome, seriousness and causality of the event were not reported.
12/18/2020 Moderna Covid Vaccination  025J20-2A 01/22/2021 Moderna  Covid Vaccination 030L20A 7/20/2021 Exposure to patent in Home care, took vitals, catheter change (approx 30 min) EE wore surgical mask 7/23/2021 asymptomatic 7/28/21 Tested positive with Covid PCR test, cough 8/3/2021 EE potential to return to work
I noticed an itching sensation on the backs of my hands, mostly localized between the thumb and index finger; a very small blister(s); resulting in a tiny scab; very light discoloration on my left hand; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 19Feb2021 11:00 (at the age of 49-years-old) as dose 1, single for COVID-19 immunisation. Medical history included migraine, drug hypersensitivity (Penicillin) from an unknown date and unknown if ongoing. Concomitant medications included sumatriptan succinate (IMITREX), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fenofibrate (FENOFIBRATE), magnesium (MAGNESIUM) and ubidecarenone (COQ-10). He did not take any other vaccine in four weeks prior COVID -19 vaccine. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Within a few days of receiving the first dose, on 20Feb2021, the patient noticed an itching sensation on the backs of his hands, mostly localized between the thumb and index finger. He believed it was worse on my left hand than on my right and there was a very small blister that he inadvertently scratched and opened, resulting in a tiny scab. The itchy sensation persisted at a low grade for a week or two after and the patient was left with very light discoloration on his left hand three weeks later. Initially, he thought it was due to the extreme cold weather, but recently he read about a rash related to the Moderna vaccine. The patient did not received any treatment for all the events. The outcome of events was recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
AFTER RECEIVING TDAP IMMUNIZATION PATIENT REMAINED IN ROOM FOR 10 MINUTES THEN PROCEEDED TO LEAVE.  AS SHE REACHED DESK, PATIENT STATED SHE GOT DIZZY AND EVERYTHING WENT BLACK AND SHE PASSED OUT.
Lost of balance when standing, feel her balance go; she fell; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost of balance when standing, feel her balance go) and FALL (she fell) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Lost of balance when standing, feel her balance go) and FALL (she fell). At the time of the report, BALANCE DISORDER (Lost of balance when standing, feel her balance go) and FALL (she fell) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-373853 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant follow-up- Event (fall) added. On 04-Nov-2021: Non-significant follow up appended.
Information has been received from a physician concerning a 57 year old female with an allergy to penicillin and a history of mitral valve prolapse who was vaccinated with three doses of RECOMBIVAX HB over five years ago. There was no concomitant medication. The patient now has a positive hepatitis B core antibody test. The results of her hepatitis B surface antibody test indeterminate. The patient was asymptomatic. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Within 3-5 minutes after my injection, my heart rate increased and my blood pressure increased.  I became very dizzy and my hands were tingling.  I felt like I had tunnel vision, couldn't catch my breath.  The nurse monitored my heart rate and then notified the rapid response team.  While monitoring my blood pressure, they made the call to get ENT's to get me to the ER.  I was in the ER for 5 hours for monitoring, iv fluids and testing.
starting sunday he felt achy, on monday he had headache and swelling in armpit, then progressed to marble size bump on lymph node on armpit and now is swelling down rib cage, patient has been to doctor today and was put on keflex antibiotic
she began experiencing herpes zoster outbreaks again; Herpes zoster; she got really sick after the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included liver transplant (had in 2002) and herpes zoster (Chronic outbreaks).   On an unknown date, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In February 2020, unknown after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the patient experienced malaise. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown and the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix. It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received both doses of Shingrix and she got really sick but it passed within 48 hours. The patient also had outbreak of herpes zoster. The reporter consented for follow up.
shingles; This 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 medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a nurse practitioner for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Small pimple-like sore at the injection site. Itching at the injection site.
HEART PALPITATION; PANIC ATTACKS; This spontaneous report received from a patient concerned a female of unspecified age. 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, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced panic attacks. On 05-NOV-2021, the patient experienced heart palpitation. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitation, and panic attacks. This report was non-serious.
She received vaccine on thursday afternoon and woke up friday morning feeling awful. she has redness and pain at the injection site. she also expierenced headache, muscle aches, muscle soreness, and fatigue.
Felt very hot & flushed (according to mom) approx 1AM infant had sz then began vomiting. Rescue squad called-infant felt much cooler when they arrived, temp 101 infant observed in ER x 4 hrs after problems; Sent home w/tylenol.
This spontaneous report as received from a registered nurse refers to one of twin female patients of unknown age. The twin patients were vaccinated with VARIVAX (Merck) (lot number and injection site were not reported) (0.5 ml, subcutaneous) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date one of the twins "had a seizure, the other did not" but it was unspecified by the reporter as to which one of the twins referenced experienced the adverse event. The patient who had the seizure "had to go to a Neurologist". The outcome of the patient was unknown. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
It was reported that a female pt received a series of Imogam Heat Treated and Rabies Imovax IM vaccinations on August 5th, 8th, 12th, 19th and received last dose of Rabies Imovax IM on September 2, 1999. Reportedly approximately 1 1/2 weeks after the last dose of vaccine the pt developed severe headaches with nausea, which last several days or several hours - never ending.
Pt recv vax on unspecified date; subsequently pt exp generalized, raised, red rash.