chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unspecified date, an unknown number of patients were vaccinated with an improperly stored dose of VARIVAX (lot# M048203, expiration date 07-DEC-2018) (dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at a temperature excursion of 18.6F for 22 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided.
Malaise; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise) and MYALGIA (Body aches) in a 77-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 MALAISE (Malaise) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise) and MYALGIA (Body aches) outcome was unknown.            No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-258759 (Patient Link).
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 12 year old patient who on 12 JUL 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck).  There was no adverse event.  There was no further information provided.  There was no product quality complaint involved.  Additional information is not expected.
Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported Covid symptoms returned after 14 days.  No treatment information was provided.
Pain and tenderness within first 2 days of vaccine which seemed normal. However, on day 4 after the injection, the pain had gone away, but the area around the injection site began to raise/swell, turned red, and began to itch. The area of redness and itchiness is between the size of a golf ball and baseball. It is still red and itchy 12 days after the injection. It is not painful, but is annoying because it continues to itch. Appears to be some type of delayed hypersenstivity reaction.
Nothing for the day after the injection. At night, started to have some chills, could not sleep.  I took a Paracetamol 500.  I am breastfeeding my 5 month old daughter, so sleep is already  broken up but I can normally sleep soundly between each feed.   In the middle of the night, i had a mild fever and troubles walking 5m.  In the morning (05/21/21), I took a paracetamol 500, still had fever, migraine, chills, and was generally very weak.  At 2pm, I took a paracetamol 1g and at 2.30pm, my temperature under the arm was 37.8°C.  Thanks to the paracetamol the fever went down but I still a a strong migraine.  8pm, temperature at 38.4 under the armpit, took paracetamol 1g.  Fever and chills went down,  still had the migraine and nausea.  05/22/21: 2am, chills and general pain, took a paracetamol 1g.  Could sleep 8am, no fever still headache.  Migraine and nausea all day.  10pm, no symptoms anymore except for the muscular pain in the right arm when the injection was done.  05/23/21. Only subsides the muscular pain in the right arm.
Fever; headache; fatigue; vomiting; diarrhea; extreme chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th September 2020, less than a day after receiving Shingrix, the patient experienced chills. On 27th September 2020, the patient experienced fever, headache, fatigue, vomiting and diarrhea. On 28th September 2020, the outcome of the chills, fever, headache, fatigue, vomiting and diarrhea were recovered/resolved.   The reporter considered the chills, fever, headache, fatigue, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. Later on the same night of vaccination the patient started having extreme chills. The next day on 27th September 2020, the patient developed fatigue, headache, fever, vomiting and diarrhea. The patient stated all of her symptoms lasted through 27th September 2020, but have resolved as on the day of reporting. The reporter declined to provide health care professional information and offered copy of personal information. The reporter did not consent to follow up.
fever; tiredness; muscle pain; chills/shaking in bed with blanket on; still get wet/sweat; headache; nausea; feeling unwell; Felt "very sick"; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 06Jan2021, at 76 years of age, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, 45 minutes after shot, the patient felt "very sick" and was on bed for 4 days; moreover the patient reported he had "a big reaction" as, on an unspecified date, he felt fever, tiredness, muscle pain, chills (reported as "shaking in bed with blanket on"), still get wet/sweat, headache, nausea and feeling unwell. All the reported events were assessed as non-serious. At the time of the report the events "felt very sick", "tiredness", "muscle pain", "chills/shaking in bed with blanket on" and "still get wet/sweat" had resolved on an unspecified date, the events "fever", "headache" had not resolved yet and outcome of the events "nausea" and "feeling unwell" was unknown. The patient asked whether or not to take the 2nd shot in 3 weeks.  Information on the lot/batch number has been requested.
Myalgia, Arthralgia, Fever, weakness, chills, fatigue & sweats Narrative:  2/25 20:30 Myalgia, Arthralgia, fever 101.6, weakness, chills, fatigue, sweats; took Tylenol. Hx of reaction to flu shot- swelling of arm,  rash turning to cellulitis. No recent vaccinations.
little fever; coughing; headache; he felt pressure at the injection site; injection part hurt for a good 24 to 36 hours; This is a spontaneous report from a contactable consumer (patient).   A 74-years-old male patient received second dose of PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6203 and expiry date: Jun2021) via an unspecified route of administration, in the right arm, on 19Feb2021 at 16:00 - 17:00 (at the age of 74-years-old) as a single dose for covid-19 immunisation. Patient's medical history included overweight, blood pressure, thyroid and diabetes. Concomitant medication was not reported. He reports he does not exercise. Patient did not receive other vaccine in four weeks of vaccination and no adverse effect, prior vaccination. No additional vaccines were administered. Patient had previously received first dose of vaccine on 18Jan2021 (Batch/lot number: EL3246and expiry date: Apr2021) in right arm and from 01Feb2021. On 01Feb2021, COVID-19 virus test was perform and result was positive. He started having symptoms on 01Feb2021, experienced cough, headache, sinus issues, tiredness and weak and had no fever. He was tested for the Covid 19 virus on 03Feb2021 with the swab in his nose and he received his positive results in the afternoon on 04Feb2021. His symptoms only lasted until about 05Feb2021, except for the tiredness. He was tired and weak for about 6 weeks. On 19Feb2021, patient experienced little fever, coughing, headache, injection part hurt for a good 24 to 36 hours and pressure at the injection site. Reporter seriousness for all events was unspecified. The outcome of event fever, coughing and headache was resolved on 20Feb2021 and for other events was unknown. He has routine blood work done every 6 months and was healthy.   No follow-up attempts are needed. No further information is expected.
Sore are both times tired after the 1st 2nd shot... 7 days out started developing extee exhaustion elevated resting vitals bp avg 150/90 heart rate 100 abg ang 02 is in low 90s and temp avg high 96s. Daily headaches, shaking cramps in legs,arms,neckb lasting up to several minutes Nausea. Dizzy blurred vsion also it appears to reduced the efficiency bof my asthma medicines. U feel at work brain fog and just panic attack.
Difficulty breathing, nausea. Oxygen placed & sent to the emergency department via wheelchair at 1430 on 9/22/22
pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed.  information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient's age and by the mentioned high blood pressure, known risk factor for  cardiovascular diseases.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain
Mom described on 8JUL91 that p/DTP on 10MAY91 pt had football sized swelling of thigh accompained by immobility lasting 10 days; Did not bring pt to MD;
felt little dizzy; little bit heart palliation for around 60 mins and then was alright.; After 1 dose soreness was gone in 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt little dizzy), PALPITATIONS (little bit heart palliation for around 60 mins and then was alright.) and MYALGIA (After 1 dose soreness was gone in 3-4 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, Vitamin D and LOVASTATIN.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (felt little dizzy), PALPITATIONS (little bit heart palliation for around 60 mins and then was alright.) and MYALGIA (After 1 dose soreness was gone in 3-4 days). On 14-Apr-2021, DIZZINESS (felt little dizzy) and PALPITATIONS (little bit heart palliation for around 60 mins and then was alright.) had resolved. On 18-Apr-2021, MYALGIA (After 1 dose soreness was gone in 3-4 days) had resolved.        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 information was not provided.
pain at injection site; bleeding at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance to the 1st dose of Shingrix, refer case US2019080707).   On 4th April 2019, the patient received the 2nd dose of Shingrix. On 4th April 2019, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage. On an unknown date, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On 4th April 2019, the outcome of the injection site hemorrhage was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced pain on his right deltoid after receiving the Shingrix vaccine into the right deltoid. The patient continued to experience the pain at the time of reporting.
Headache, Myalgia, Diarrhea, fatigue, chills Narrative:
Within 15-20 minutes of receiving hep A vax pt developed urticaria over ant. area on same arm. No systemic sx. Benadryl was given q 6-8 over five days producing temporary relief. Reaction resolved on day 5.
This case was reported by a consumer and described the occurrence of pain in a adult patient who received SHINGRIX. On 5th May 2018, the patient received SHINGRIX. On 6th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain, feeling bad, influenza like illness, shivers and gastrointestinal upset. On an unknown date, the outcome of the pain, feeling bad, influenza like illness, shivers and gastrointestinal upset were not recovered/not resolved. It was unknown if the reporter considered the pain, feeling bad, influenza like illness, shivers and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX a day before the reporting day and felt horrible on the day of reporting. The patient felt the patient was getting the flu. Ache, shivers and gastrointestinal upset all were present. The patient wanted to know that someone could tell how long the events would last.
the day after he received the vaccines, he developed swelling, erythema,  warmth and pruritus of his left arm  that lasted several days. No fever. No systemic symptoms.
Shingles vaccine gave shingles/ Suspected vaccination failure; shingles; 4 months of severe pain; 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.   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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that Shingles vaccine gave him/her shingles and had 4 months of severe pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Information has been received from a physician concerning a single female who was vaccinated on unspecified dates with three doses of GARDASIL. The patient had an abnormal PAP test since receiving the vaccination and needed a colposcopy. The patient did not have positive PAP test prior to receiving the vaccination. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information was received indicating that the patient did not receive the vaccination.  This report is related to reports WAES # 0803USA01379, 0803USA01380, 0803USA01381 with the same source.
6 year old patient inadvertently received a dose of ADACEL, with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old female patient who inadvertently received a dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-May-2023, the patient received an unknown dose once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U7665BA; expiry date: 04-Mar-2025; strength: standard) via intramuscular route in the left deltoid for Immunization.  On 25-May-2023 the patient inadvertently received a dose of adacel, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Patient is a nurse it was given influenza vaccine at her workplace.  She believes vaccine administration was done higher and deltoid then should have been.  Reported immediate pain with the injection that felt abnormal.  She continued to feel increasing pain in the shoulder later in the day.  Same day she began to have anterior biceps and deltoid tightness and was unable to raise her right arm overhead across her body or behind her back.  She sought evaluation and care from occupational medicine nearly 2 weeks later on October 25, 2019.
chills; muscle aches; fever; she was sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration on 26Feb2021 as DOSE,1 SINGLE for Covid-19 immunization. Medical history included meniscus tear, can't sleep, can't walk and knee pain. Concomitant medication included cortisone. The patient reported that she got the first vaccine on 26Feb2021 but has been having problems with her knee and it has been going on for over two months. She went to an orthopedic doctor today and got a cortisone shot and was supposed to get the second vaccine on Friday. She reported that was the first time she was receiving cortisone. She said she had meniscus tear and she got a cortisone shot to take the pain away and it worked. She wanted to know if the cortisone would affect the vaccine or if the vaccine would affect her treatment. She wanted to know if she would be able to do her daily activities without pain if she got the vaccine. She said she would rather not get the second dose of the vaccine if it changed the effectiveness of the cortisone because she could not sleep, could not walk, could not do anything when she had the knee pain. She asked if people taking cortisone get vaccinated. It was reported that first shot she was sick for 72 hours. On an unspecified day she experienced a lot of chills and muscle aches and fever and was very sick, but she called the nurse and she promised that it would be better in a day, and it was. She was hesitant to get the second vaccine anyway after these symptoms. It was like getting Covid all over again. She was taking Advil and Tylenol, and nothing was helping. It was pretty shocking, scary, and too much. Outcome of the event illness recovered on an unspecified date and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Since March 28, he has had persistent headache, myalgia, and arthralgia.