chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He started walking more slow and he became very weak; He started walking more slow and he became very weak; They looked for flu like things; He fell a couple times; This is a spontaneous report from a contactable consumer. A 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 23Jan2021 (86-year-old at the time of vaccination) (Batch/Lot number: EL8982,  number/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history included diabetes for about 25 years and hypertension. Concomitant medication: Reporter stated, "He was on 3 pills one was for blood pressure, he took one for sugar, and one for potassium correct, he take these 3." Reporter stated: "he was calling to report the side effects that happened to the patient, after he get the Pfizer vaccine." Reporter stated, "He had his first injection and after that injection, it was noticed that he started walking more slow and he became very weak. He always had been a walker. And that was not normal for him, he was very healthy. All events were reported yesterday, first was an ER visit, the doctor said they had no explanation, they asked what is causing that, the weakness, he used to drive, he did daily walks, was active, it all started after the first injection, but at the time, no one knew to look for fatigue, they looked for flu like things, and he fell a couple times. Reporter stated, "Yes, he had both diabetes and hypertension, but doctor was absent because he had diabetes for about 25 years and when aunt told them that she thought that it was related to the vaccines then they just said they have no idea." Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
I had the shot at 1:17pm, I was extremely fatigued and fell asleep until 12:10am. I woke up because I needed to use the restroom but as I attempted to move, I felt a great deal of pain along the length of my spine. As if someone wrap a cloth around it and tighten it beyond any I?ve ever felt; it brought me to tears. After about a minute it stopped and I gingerly went to the restroom. My head was heavy and I had chills but the fever at that time was only 97.5 degrees.  The only other reaction at that time was that my left side of the neck felt achy but that happened with the first shot as well.
10-15 min. after vaccination developed cough, stayed 20 more min. Pt. claimed she felt funny, but was not having difficulty breathing and left at closing time. Next day called me and related some redness and rash.
Swelling in pain in arm, pt seen 02/21/17 by Dr and given prednisone and asked to monitor for s/s infection.
Blood Glucose went up to 300 mg/dL; shaking; bed for hours; knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine; knot (Swelling the Size of palm of hand) on the injection site; Sore Injection Site; Pain all over her body; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL), TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine) and VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE), LISINOPRIL DIHYDRATE (LISINOPRIL ACCORD), ROSUVASTATIN CALCIUM (ROSUVASTATIN +PHARMA) and LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL), TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine), VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site), VACCINATION SITE PAIN (Sore Injection Site), MYALGIA (Pain all over her body) and VOMITING (vomiting). On 04-Apr-2021, BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL) had resolved. On 05-Apr-2021, TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine), VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore Injection Site) and MYALGIA (Pain all over her body) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 300 (High) 300 mg/dL.         Concomitant products included Humulin N Insulin, Humulin R Insulin.  Action taken with mRNA-1273 in response to events was not applicable.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional details were provided as follows: The case was reported by relative of the patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient experienced Guillain-Barre receiving SHINGRIX. The reporter did not have any other details, other than what was reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II for prophylaxis. On an unknown date the patient experienced drug dose omission, product supply issue, product expiration date issue and circumstance or information capable of leading to medication error. The outcome of drug dose omission, product supply issue, product expiration date issue and circumstance or information capable of leading to medication error is unknown. The reporter considered drug dose omission, product supply issue, product expiration date issue and circumstance or information capable of leading to medication error to be not related to M-M-R II. Additional information has been requested.
Urticarial rash with some mild respiratory symptoms within 24 hours of vaccine. Hospitalized overnight, received Benadryl and Solumedrol, recovered within 24 hrs. Dgx of: allergic anaphylactic reaction to immunizations.
A physician reported that he received an injection of TD absorbed (manufacturer unknown) on 05-FEB-1999 and , one week later, developed polyneuropachies 0f 7-9 nerves, and an inability to taste sweets.
Shingles outbreak, right shoulder, mild 3-4 lesions Outbreak started  3 days after immunization.  Started Valacyclovir and continued 7 day treatment course.
sideeffect after my second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sideeffect after my second dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sideeffect after my second dose). At the time of the report, VACCINATION COMPLICATION (sideeffect after my second dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was considered to be not applicable.
Developed fever, chills, headache, nausea, fatigue, and severe pain at the injection sight. The fever developed about 8 hours after taking the vaccine. I had previously had COVID back in August and this is what it felt like for me.
muscle pain; low grade fever; flu like symptoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 60's received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ6369), in arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns Disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6201), administration date: 11Feb2021, for Covid-19 immunization, reaction(s): "Covid-19", "muscle pain", "low grade fever", "flu like symptoms", "tiredness"; BNT162b2 (Dose: 2nd, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6206), administration date: 04Mar2021, for Covid-19 Immunization, reaction(s): "Covid-19", "muscle pain", "low grade fever", "flu like symptoms", "tiredness"; BNT162b2 (Dose: 3rd, Date (dd-Mmm-yyyy): 24Sep2021, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FF2587), administration date: 24Sep2021, for COVID-19 Immunization, reaction(s): "Covid-19", "muscle pain", "low grade fever", "flu like symptoms", "tiredness". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 23Apr2022, outcome "recovered", described as "flu like symptoms"; PYREXIA (non-serious) with onset 23Apr2022, outcome "recovered", described as "low grade fever"; MYALGIA (non-serious) with onset 23Apr2022, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 23Apr2022, outcome "recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, influenza like illness, fatigue.
Macular rash, koplick spots, fever 104 duration of illness 8 days-recovered;
Parked car after injection which was painless.  Pain at wrist and tingling in hand. Right arm from wrist to scapula swollen and in pain. Pain at neck and couldn't tell if swollen. Lasted through the next day.  Persistent right hand tingling lasted over 24 hours.  Had to use left hand to type for work.
Quarter sized, raised red bump, sore to touch, itchy. Writer referred ct to her PCP.
He experienced extreme dizziness and a fever.  Tylenol brought the fever down and the dizziness is beginning to lessen on it's own.
DEVELOPED SHINGLES INFECTION THE NEXT DAY PER HUSBAND WHO IS DDS. PT IS IN EXTREME BACK PAIN AS OF TODAY 10/01/2018.
The patient's grandfather notified me 3-5 min after vaccine was given that he was having trouble breathing, was dizzy, and blurred vision. The manager called 911 while I tried to locate a blood pressure cuff. Temp 97.6 F, pulse 52 bpm. Within a few minutes he was feeling better and sitting up alert, no symptoms. see back -->
Pt was given vaccine at 12:10 pm. At 1400 patient ambulatory up to vaccine clinic stating she felt SOB, nausea, chills, back abd thigh aches, clammy, and sweaty. Vitals were stable at 1405 BP 126/71, 97.8, 99% O2, HR 81, RR 20.  IV started. At 1413 30 mg hydrocortisone IV and Tylenol 650 mg po given per protocol.  Patient left vaccine clinic at 1530 and felt better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-MAR-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-FEB-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. On or about 19-FEB-2015, the patient sought subsequent treatment for a facial paralysis resulting from damage to the facial nerves diagnosed as Bell's palsy. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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. Upon internal review, facial paralysis/Bell's palsy was determined to be medically significant. Additional information has been requested.
1hr p/vax severe violent vomiting-stomach pain-diarrhea-for approx 3 hrs;
S: Employee received Covid vaccination on 12/28/20. Employee reported noticing "itching all over my body". The following day she experienced nausea and moderate joint pain. She then also experienced redness on forehead, ears and "felt like they were on fire." B: Covid vaccination on 12/28/20. Employee contacted advice nurse and was instructed to report to specified authority A: Employee reported to specified authority on 12/29/20 and received solumedrol shot R: Reporting for tracking purposes
A nurse reported the occurrence of an injection site reaction in a 4 year old female who was vaccinated with DTAP (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to VAERS.  The pt had no medical history, adverse experiences following receipt of previous immunizations, or concurrent medications. The pt had a cold at the time of immunization. The pt received her fifth injection of Infanrix (Lot # DTPA592A9) on 04/15/03 into her left arm. She also received injections of IPV and MMRII into her right arm. On 04/16/03, 1 day post-immunization, she developed an injection site reaction characterized by redness and swelling that extended from the injection site to the elbow. The events resolved. The nurse considered the events to be related to Infanrix administration.
New onset bladder irritation, pain, spasm, urgency, frequency with no UTI. Symptoms wax and wane.  No prior history of any bladder issues. No history of UTIs. No history of lower urinary tract symptoms.
Right Arm reddened, swollen and painful some itchy. Mother stated notice swelling last evening 6/16/09 at about 8.00pm. Mother did not massage arm after shot.
spots in his tongue; Diarrhea; itching at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (itching at the injection site) and TONGUE DISORDER (spots in his tongue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PRURITUS (itching at the injection site). On 11-Jan-2021, the patient experienced TONGUE DISORDER (spots in his tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 09-Jan-2021, DIARRHOEA (Diarrhea) and VACCINATION SITE PRURITUS (itching at the injection site) had resolved. At the time of the report, TONGUE DISORDER (spots in his tongue) 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.   No concomitant product use was reported.; Sender's Comments: This case concerns a 46-year-old male who had nonserious events of unexpected diarrhea and tongue disorder and expected vaccination site pruritus.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment with diphenhydramine. Pruritus and diarrhea resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
right hand edema and pain, right forearm pain, right shoulder and neck pain, edema of supraclavicular region; pt given motrin 800 mg and t#3 prn.  PPD placed as well, Sanofi-Pasteur, lot C2670AA, right forearm.
Extreme pain in joints and muscles; vomiting, fever, swollen and painful lymph node in injection arm, headache  Treatment: Advil - not effective.     Tylenol- not effective.   Hot showers and hot baths.
Graves Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "Graves Disease".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Tinnitus - a whooshing sound in my ears - started within a day of the 1st dose. I saw an audiologist who tested me and said that my hearing was fine, and gave me information on dealing with tinnitus. It was never really bad, and by later in August, it started fading, and seemed to have mostly gone away. I received a COVID booster on. Nov 10, and within a day, the same tinnitus returned. I'm hoping that it follows a similar path to what I experienced after the initial vaccines and fades away after a few months. It seems fairly clear that the COVID vaccine has caused my tinnitus.
20OCT95 redness size of quarter started by 22OCT95 area 15cm x 18cm red, hard hot put ice on it 23OCT95; no change from 22OCT;kept ice on;24OCT95 called ofc, area less red, warm to touch & hardness is almost gone will cont w/ice
Two hours after receiving 2nd Moderna booster had severe chills.  "I shook so hard my teeth were chattering and even wrapped in a down comforter could not get warm."  Two hours after this had severe headache and got hot.  Had low grade fever (99.4 F).  Headache lasted until late at night despite taking Tylenol.  Next day complains of "foggy head" and fatigue.  3rd day felt better but still had fatigue.  No significant side effects with first 3 Moderna injections.
Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender not reported) who had expired imovax dose that was inadvertently administered for a pre-exposure immunization, while he/she received vaccine IMOVAX RABIES. 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 0.5 ml once dose of suspect RABIES (HDC) VACCINE lot M13911M, expiration date- 24-Jul-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient experienced any adverse event. 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 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. Documents held by sender: None.
Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; Extreme Moodiness. 12 hrs after shot anger and 2 days later sadness and crying out of no where.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:00 (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included omeprazole and thrive lifestyle supplements taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient experienced extreme moodiness. 12 hrs after shot anger (10Mar2021 23:00) and 2 days later (12Mar2021) sadness and crying out of nowhere. Patient was not received any treatment for adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Information has been received from the father of a now 6 year old male who in 12/95 was vaccinated with the 1st dose (0.5ml) of MMRII, at less than 1 month of age. There was no concomitant medication. In approx. 12/95, the pt developed ear difficulties (details unknown). At the age of 2 (in 1997), the pt experienced difficulty in his speech. The reporter stated that the pt was not dx'd with autism but was dx'd as having pragmatic language. The pt did seek medical attention. Upon medical review, the pt's difficult speech and pragmatic language were considered "Other Important Medical Events". Additional information has been requested.
This spontaneous report as received from a registered pharmacist refers to a 61 year old female patient with no known drug allergies. On 14-FEB-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously in the back of left arm. The pharmacist reported that on 16-FEB-2013, "36 hours post vaccination", the patient developed adverse event. The patient complained of redness at the injection site of left arm. The redness spread across the arm, around the arm and under the left arm. The arm was so sore that patient could not lift her seat belt to put it on. The patient did not receive treatment for the adverse event. The patient's symptoms were subsiding. Additional information has been requested.