chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 2nd dose of Hep B vax on 8FEB91 & 8 hrs later pt went to ER w/SOB & generalized rash; tx DPH; following day exp flu-like sx that lasted for 9 days; pt recovered;
Patient states she started feeling nauseated on the night of 12/01/2014 after getting her first dose of Imovax earlier that day.  States she also had bad cramping in her abdomen on and off throughout the day and nausea that continued on until Sunday 12/07/2014. Patient in clinic on 12/08/2014 to receive second dose of Imovax and stated no nausea or abdomen pain since afternoon of 12/07/2014. States she is feeling much better today, 12/08/2014.
Pulmonary embolism.  Developed extreme pain in my upper left side of my chest/shoulder area radiating from front to back.  Constant steady pain.  Pain was worse when lying flat.  Shortness of breath.
Extensive blood clots in left leg. Doctor prescribed XARELTO 15MG 2 times a day for 21 days, then 20 MG once a day for 21 days.
This spontaneous report has been received from a licensed vocational nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications, was not reported. On 08-JAN-2019 (also reported as 08-JAN-2018), the patient was vaccinated with an expired dose of VARIVAX and with the sterile diluent, subcutaneously, lot # M042858 and expiration date 21-OCT-2018, (dose and frequency were not provided), for prophylaxis. No adverse effects were reported.
Fever after 1st dose; soreness after 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) at a dose of 50 mg four times per day; FAMOTIDINE (FAMOTIDINE TEVA) at a dose of 40 mg once a day; PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) at a dose of 10 mg and ONDANSETRON at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data reported blood tests and EKG with inconclusive results. No Concomitant Medication was provided.   This case was linked to MOD-2021-339162 (Patient Link).
Non-Responder to 7 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021    In a case series by, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 41-years-old and a second hepatitis B series at 42-years-old.   A total of 7 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 55-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Aug2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from  04Oct2023 to 09Oct2023.   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.
This case was reported by a healthcare professional and described the occurrence of fever in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 at 07:00 the subject received a dose of FLULAVAL (unknown route, right arm). On 4 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced fever (101.6), chills and body pain. The events were reported as a systemic reaction. The subjects symptoms required her to leave work 2 hours early. Healthcare professional considered the events were disabling. At the time of reporting the events were improved. The healthcare professional also reported 7 additional subjects who had experienced adverse events of injection site tenderness, injection site redness and hotness at injection site following vaccination with FLULAVAL (see case IDs A0885121A, A0885268A - A0885273A for more information).
PATIENT REPORTED BEING LIGHT HEADED AND WARM AFTER RECIVING SHOT. PT DRANK SOME ORANGE JUICE AND WAS RECOVERED BEFORE LEAVING THE PAHRMACY. PT DECLINDED MEDICAL ATTACNTION.
she unusually broke out with flushed skin for 10 minutes.; i broke out red like heat rash; still get fever; light headache; still get fever and chills; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (i broke out red like heat rash), FLUSHING (she unusually broke out with flushed skin for 10 minutes.), PYREXIA (still get fever), HEADACHE (light headache) and CHILLS (still get fever and chills) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], VITAMIN C [ASCORBIC ACID] and PROGESTERONE for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced PYREXIA (still get fever), HEADACHE (light headache) and CHILLS (still get fever and chills). On 11-Sep-2021, the patient experienced MILIARIA (i broke out red like heat rash) and FLUSHING (she unusually broke out with flushed skin for 10 minutes.). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Sep-2021, MILIARIA (i broke out red like heat rash) and FLUSHING (she unusually broke out with flushed skin for 10 minutes.) had resolved. At the time of the report, PYREXIA (still get fever), HEADACHE (light headache) and CHILLS (still get fever and chills) 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.   Patient went to the doctor and blood work up done and Still waiting for the result   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received with event outcome recovered /resolved , in initial version Treatment was not captured .which is captured now .
This spontaneous report as received from a licensed practical nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, an unspecified number of patients received an improperly stored dose of GARDASIL lot # K007264 exp. 02-MAR-2017 (dose, route of administration were not reported). There was no adverse effect reported. PQC was not involved. This is one from several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a 78 years old female patient. In September 2009, the patient was vaccinated with ZOSTAVAX, one dose, for shingles prevention. On 24-JUL-2017, the patient experienced herpes zoster. The outcome of herpes zoster was reported as resolving. The causality assessment was not provided.
Breakthrough case admission after 2 vaccines Moderna 3/23/21 Lot# 002B21A;  Moderna 4/23/21 Lot# 018B21A
Fever, NauseaVomiting, fatigue, losing voice,chills,tremors hot and cold sweats, Narrative:
Headache (did not take medication prior to vaccine). V/S   B/P 135/88, HR 100.
Patient experienced a syncopal episode immediately following vaccination. Pt also become hypotensive, lightheaded, and pale.
A report was received from a health care professional on 12/12/03 concerning a 3 year old vaccine of unspecified sex who inadvertently received Fluvirin on an unknown date. On an unknown date, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
No adverse effect reported.; The second dose of GARDASIL 9 on 4/19/2019, and the third dose of GARDASIL 9, on 7/11/2019; Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  On 10-FEB-2019, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. On 19-APR-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. On 11-JUL-2019, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R009615, expiration date was 07-DEC-2020; strength, dose and route were not reported) for prophylaxis (Inappropriate schedule of product administration). No adverse effect was reported.
I been suffering for diarrehea for 2 days. Cough and chest congestion for 7 days, and a runny nose for around 6 or 7 days. I tested for COVID but all tests came back negative. My doctor told me I seemed to have all the symptoms but all the tests were negative.
administration of expired Tenivac to a patient with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml total (1 X) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA, Expiry date: 24-Sep-2023) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult to a patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, Pharmacist requests to confirm the expiration date for TENIVAC. Is it the day, month, year! HCP reports that the tenivac was administered past expiration. The caller declined to provide additional information about the administration of expired Tenivac to a patient.   Action taken: not applicable.  Outcome: Unknown   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 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.
She got her vaccine, she came home, little soreness in the arm, was otherwise OK.  She cooks all the time, and at about 6:30 she felt really sleepy, weak.  She sat on the couch and told him that she felt weird, and started having chills.  It was 90 that day and she was freezing, put an electric blanket on her and was feeling worse and worse.  She called her husband at 9:30 as she was weak, dehydrated, severe banging headache not able to lift her head, weakness and she took 2 Tylenol.  She kept freezing throughout the night and then going into sweats.  She was out of it.  She was hallucinating and seeing people that had already died in her life, her mother, father, sister and woke up not knowing where she was.  She felt like she had to go to the bathroom, but her bottom was sore too.  About 24 hours later when she tried to  move from the couch to go to the bathroom which is 8 steps, she had shooting sharp pains in her lower back.  She felt it was inflammation and she slowly got to the bathroom, and she is now in agony as she cannot sit to use the restroom.  She is now having problems with her stomach and is constipated, and it got worse and worse.  Her husband has a cane and he went to get it, and she is having a hard time to sit up to even move as the pain is unbearable.  The pain got worse and worse, and she laid down all Saturday and they brought her food and drink as she cannot make any food, cannot bed, stretch or get into the shower as it is upstairs and she is not able to go up stairs.  She feels terrible due to the pain that is in the lower back and shoots down to her legs, and having problems stretching her arm to reach, lift or bend.  She feels crippled at this point.  She went to her rheumatologist on Monday and got her Orencia shot for her RA.  She is a walker, walks everywhere and is used to moving around, cooking and very mobile and now she cannot do anything of that.  She is scared, wanting to know if she is going to get better or is she going to get worse.  She lives on $1000.00 a month and cannot afford the copays to get her medicines and visits to her doctor and does not have the money to be able to take care of herself.  Her regular PCP died in a car accident 3 weeks ago and is not able to see a doctor as she owes everybody due to the copays.  She is now wondering where to go from there.    She went to the ER yesterday and they were honest with her and told her that they did not know what to call it.  They took x-rays of her spine and they saw inflammation and they told her that if she continues to have the symptoms that she needed to return to the ER.  She said she would not go back as she has such severe pain and it is a struggle to get in and out of the car and the potholes cause severe pain.  They gave her steroids and to get Lidocaine patches.  She did not have this problem before the vaccine.  She was very active and could dance, paint, etc., and has been doing the same thing for years ago and had to use a cane 8 years ago when she had minor knee surgery and now cannot walk without one.
Felt tired after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired after first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, Flonase and CETIRIZINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (Felt tired after first dose). At the time of the report, FATIGUE (Felt tired after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO treatment information was provided by the reporter.   This case was linked to MOD-2021-261749 (Patient Link).
Vaccine was administered to someone under the age of 18. No known adverse outcomes at this time.
Patient experienced hives all over body in the evening following vaccine administration. She visited her doctor and was prescribed a course of steroids to treat symptoms.
Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next day, except minor pain on lower stomach.
"Covid Arm:" itchy rash appeared around injection site about one week after the injection. At its worse, rash extended from shoulder almost to elbow on outside (not underside) of arm. Started subsiding after 24 hours and was gone after a few days.  Breast Pain: Sharp pain in left breast (same side as injection arm). Pain was not constant, but seemed to be triggered by pressure on side of breast or certain strenuous movements by left arm. Pain would typically build for about a second, then subside after a few seconds. Almost felt like a painful muscle cramp but without any visible muscles cramping. Occasionally, a dull pain would remain for a while. No other lymph node sensitivity noticed. No lumps or swelling noticed. Breast pain started about a day after the arm rash. and was most intense for a few days before gradually subsiding over the next few days. All sensitivity was gone in a little more than a week.
No adverse events other than the patient received these two same vaccines on 8/10/18 AND 8/29/18 at the same clinic.
Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and  loss of appetite, chills, on  02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.
Received varivax on 04/25/2000 and diagnosed with chicken pox on 03/11/2002.
This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not tested positive for covid-19. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included covid test which resulted positive. It was reported that on an unspecified date in Aug2021 the patient was symptomatic and tested positive for covid-19. It was further reported that the patient was not hospitalized. The patient received the treatment for the events was unknown. The patient was resolving from the event covid-19.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
could not lift the arm for months; still have some pain in the shoulder of the left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in 2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 2, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), Lot number: unknown), for COVID-19 immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not lift the arm for months"; ARTHRALGIA (non-serious), outcome "not recovered", described as "still have some pain in the shoulder of the left arm". The events "could not lift the arm for months" and "still have some pain in the shoulder of the left arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint range of motion decreased, arthralgia. Additional information: In Fall 2022, patient received the fourth Pfizer shot and a flu shot. They said taking both simultaneously and in the same arm was fine. That was exactly what the patient did. As a result, the patient could not lift the arm for months. The patient ended up getting an X-ray as well as an MRI. The best the doctor could recommend was physical therapy, which ultimately helped, but occasionally, patient still had some pain in the shoulder of the left arm. Patient was convinced, as was patient's physician, that the patient should not have gotten both the same day and in the same arm. They did not feel there was any problem with the particular batch of Pfizer booster that patient received that day.  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.
Deep sleep, below normal temp; lethargic, blank stare, mottled to blue in color; hypoventilating, shock-collapse, hypotonic, respiratory arrest, unresponsive.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.