chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Fever, NauseaVomiting, Fatigue Narrative:  Symptoms started day after injection, persisted for several days  Other Relevant History:
Slight soreness initially.   Itching and soreness on left arm and left back/shoulder.  Soreness in mid back left side. Lasted 3 days.  6 days later swollen and sore lymph nodes under left arm began.  1 Week later slight soreness at injection site occurred but felt like 2nd or 3rd day after receiving initial vaccine.  Slight Soreness on left side back shoulder and neck occurred on 9th day after receiving vaccine.
Information has been received from a physician concerning a 30 year old female who on 01Oct03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On the evening of 01Oct03 the pt developed erythema, swelling, and pain at the injection site. The pt was afebrile. The reporter indicated that the next day the pt was much improved. Unspecified medical attention was sought.  There was no product complaint involved. Additional information has been requested.
Pt vaccinated with TD developed muscle spasms lasting 4 hrs, aching in joints, difficulty walking x 4 hrs & some dizziness x 4 hrs; After 4 hrs period symptoms resolved.
Redness, tender, warm to touch, no fever Area of tenderness approximately 2-3 inches.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 68 years old male patient who was vaccinated with a 0.5 ml dose of ADACEL (Batch number: U6103AA, expiration date: 25-Oct-2020, site of administration: left deltoid and route was not reported) on 19-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. ADACEL was shipped to them and then they received something stating that the arrival time was longer than normal and that ADACEL is no good and the invalid ADACEL vaccine was vaccinated. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Sedation, Myalgia, UrticariaPruritus,  Decreased concentration  Narrative:  After 1st dose on 2/16/21 noted arm soreness and myalgias, and felt random prickling sensation in body. Received 2nd dose 3/16/21 and noted onset of prickling sensation with 2 hours, which lasted through 3/18/21. Noted myalgias the night after injection. Felt feverish during the night, but did not check temperature. Pt awoke the next day with hives on the non-injection arm - which resolved after 3 hours. Also noted fatigue and decreased concentration. Missed work x 1 day. No known prior covid infection.
Initial and follow-up call information has been received from a pharmacist concerning three patients who were vaccinated with PREVNAR within the past two 2 weeks. The lot numbers were not recorded at the time of the vaccination. The facility was considering revaccinating all patients with PNUEMOVAX 23. No adverse effects were reported. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status, healthcare provider name and contact information. Follow up information was received from the pharmacist who stated that the report did not involve product confusion but involved medication error. Additional information has been requested.
pt told the nurse she was allergic to penicillin so she was monitored for 30 minutes after being vaccinated.  Upon leaving the vaccination site she became light headed and very fatigued.  About 5 minutes later, while driving home, she had a black out and started having body spasms.  She was shaking and hot flashes.  She had to pull the emergency brake and stop the car.  911 was called.  When paramedics arrived her BP was elevated and she had difficulty breathing.  Since the hospital ER was packed with covid patients, she was monitored in the ambulance for about 20 minutes to watch her breathing and her BP.  She was very sleepy  so  she went home to get some sleep.  She stayed very fatigued for about a week following the vaccine.   The second vaccine only gave her dry mouth and sore arm.
the patient complain of nausea and vomiting, dizziness and sweating just after she had the covid vaccine administered to her
Red, itchy, sore, sollen, background of red becoming yellow and blue Started just before bed tie feeling sore and itchy. Put cream on and went to bed.
pneumonia; sore back maybe from coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (sore back maybe from coughing). On 03-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and BACK PAIN (sore back maybe from coughing) had not resolved. Not Provided      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.   The patient's treatment included Prednisone 20mg 2pills for 5 days, Doxycycline 100mg twice a day for 10 days and Cefuroxime 500mg twice a day for 7 days.
One week after receiving the latest Moderna Covid vaccine I started to get periodically, lasting to the present time, allergic type symptoms such as sneezing, coughing, itching, chills, light headedness, and digestive problems. I never had any such reactions like this, or any other reactions, from the five previous Moderna vaccines I received, nor from any other vaccines I've ever received.
PT screamed for 3 hrs, then slept long periods & would not eat; seen by MD 23AUG & 26AUG; MD recommends Ped. DT next visit; no fever;
A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The patient was inadvertently administered expired FLUMIST on 13-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST is unknown. The report was considered to be non-serious.
contracted Covid 19; contracted Covid 19; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient contracted Covid19 in between doses. They are asking if the patient can get the second dose, now that he shows no symptoms and has completed quarantine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Soreness of her body; Feels really weak; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness of her body), ASTHENIA (Feels really weak), FATIGUE (Tiredness) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021GZ1A and OA8A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN (Soreness of her body), ASTHENIA (Feels really weak) and FATIGUE (Tiredness). 13-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, PAIN (Soreness of her body), ASTHENIA (Feels really weak), FATIGUE (Tiredness) and PYREXIA (Fever) outcome was unknown.            Concomitant product information includes Blood Pressure medicines. Treatment information was not provided. Action taken with mRNA-1273v in response to the events was not applicable.   This case was linked to MOD21-076085 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional Information received Patient demographics were added.Dose 1 and 2 details were added.Events Fever,Tiredness,Soreness of body,Feels really weak were added; Sender's Comments:  MOD21-076085:
Patient was found by husband in respiratory distress on 3/3/21 with inability to arouse and agonal breathing. Intubated and sedated and brought to facility. Possible aspiration pneumonia, as patient vomited prior to intubation. Unknown if related to vaccine
mild injection site pain - onset at 13:00 on day of injection (90 minutes post dose), lasting several hours.
Pt states that the day after receiving the vaccine she felt achy with a small fever. She states that the top of her head hurt. She states also that the skin on her face around her eye broke out similar to when she had shingles. She states that it was very mild after her first dose of SHINGRIX, but was more severe after the second dose of SHINGRIX.
Patient came to the office to get a MMR that was needed to complete her forms for school. CMA injected patient with expired vaccine. Vaccine expired 5/11/2022 and was administered 06/28/2022 on the patient.
ADACEL Tdap was given on 7/23/10 at aprox 1200. Patient reported that her joints (especially knees and ankles) were sore at about 2100 but she thought this was R/T with walking. Pt became chilled and developed a low grade (100 degree) temp at aprox 2300. Pt continued to have HA, chills, severe joint pain, and fever x2days. HA today. Feels "much better"
Diarrhea; Vomiting; Fever; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on 22Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced diarrhea, vomiting, fever, muscle pain and joint pain. On 25Apr2021, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events diarrhea, vomiting, fever, muscle pain and joint pain was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
The most painful sore throat I have ever had and chills, my throat felt like I was swallowing glass.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional was calling from her car and was not at the pharmacy to provide the patient's demographics, but she believed the male patient was around 67 years old. The patient was vaccinated with SHINGRIX about 8 days before the reporting date. The patient was reporting redness and swelling at the injection site that was still persisting at the time of reporting. The health care professional said that the patient stated the redness and swelling were mild and had began to improve.
Mom says 24 hours after immunizations given, pt has rash, hives on his face and some wheezing. Mom brought pt to ER and was given DECADRON orally which helped and advised to use BENADRYL as needed.
Multiple Sclerosis; Trigeminal Neura; This spontaneous case was reported by a patient and describes the occurrence of MULTIPLE SCLEROSIS (Multiple Sclerosis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.                                                                          On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant) and TRIGEMINAL NEURALGIA (Trigeminal Neura). At the time of the report, MULTIPLE SCLEROSIS (Multiple Sclerosis) and TRIGEMINAL NEURALGIA (Trigeminal Neura) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Case number PHEH2016US028448, is an initial spontaneous report from a nurse received on 31 Oct 2016. This report refers to a 51 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888 and expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 31 Oct 2016. On the same day after vaccination, the patient felt lightheaded, dizzy and weak, her legs felt like jelly and felt tightness in her chest. The discomfort started an hour or less after she received her vaccine. It was reported that, her vitals were monitored at the health center where she worked. The outcome of events was reported as unknown. Seriousness of the events was reported as disability by the nurse. The causality of the events was not reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.18.  Concomitant products were not provided.  On 20-Mar-2021, for excursion time 9 AM, temperature was 34, for excursion time 10 AM, temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: not provided, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
missed second dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received on 27 Jul 2021, contains updated information on second dose and added new event inappropriate schedule of vaccine administration.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020) for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and fever. On 16th July 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and fever were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and fever to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) were unsure if the SHINGRIX injection was actually administered via intramuscular route and stated there was possibility that it was administered subcutaneous route, which led to incorrect route of vaccination. No further information was reported.
1800 Red @ injection site, behind ear and on hest applied ice @ injection site gave out based Benadryl given 18:45
pt recv vax 9OCT95 & pt devel redness & warmth @ the inj site;no tx necessary;pt recovered;
C/O body itching and tingling of throat - Dr visit 2/9/19 treated with BENADRYL. Body aches, headache. Epistaxis.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route, dose, and anatomical location were not reported), (lot # J014228 expiration date 08-NOV-2015). There was no concomitant therapy reported. NO adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever; didn't feel good; nausea/Nauseated; sweating/sweating profusely; sore arm; chills/Teeth chattering; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular, Batch/Lot Number: EN6202, Expire Date: Unknown) administered in Arm Left on 25Feb2021 at 08:30 (at the age of 70-year-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19: she did have the virus, clarified as COVID-19, prior, blood pressure abnormal: take blood pressure medication, but she has taken that for years and blood cholesterol: she takes cholesterol medication. There were no concomitant medications. The Prior Vaccinations (within 4 weeks) reported as none. Reporter stated that she had her first shot about 2 weeks ago and she had what she thought was a bad reaction. She explained when she first had the shot, she had a little bit later sore arm which was fine and she was fine the rest of the day. That night, she might have had chills and her teeth were chattering a little bit. The next morning, she was feeling nauseated and then she began sweating profusely. She was sure she had a fever, but she did not take here temperature at the time. The whole day after that she didn't feel good. When probed for the outcome of these symptoms, she explains the sweatiness didn't last that long. She actually did have a fever on Friday, 26Feb2021, she did check it later on that day and it was 99. She clarifies after Friday, she was okay. On 25Feb2021 the patient experienced sore arm, chills/teeth chattering with outcome of unknown. On 26Feb2021 nausea/nauseated with, sweating/sweating profusely and didn't feel good. On an unspecified date patient experienced fever. The patient underwent lab tests and procedures which included body temperature: 99 on 26Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
From initial information received on 11/14/03 from a health care professional regarding an adverse events occurring in the USA, it was reported that a 72 year old male patient received a Fluzone SV 2003-2004 USP vaccination, lot number U1126AA, administered IM on 10/20/03 at 10:00AM. Three days later on 10/23/03 at 6:00 AM, the patient developed suspected myocarditis with congestive heart failure, atrioventricular block and cardiomegaly. The recovery status of the patient is unknown. No other information was reported.  Follow up on 09/29/04 states: "Despite continued attempts to obtain follow-up, no further information was provided. No further information is anticipated, this case is considered closed."