chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Consumer also repots having a cold; Consumer reports significant swelling at injection site/muscle; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Consumer also repots having a cold) and VACCINATION SITE SWELLING (Consumer reports significant swelling at injection site/muscle) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in February 2021 and COVID-19 (thinks may have been covid).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Consumer reports significant swelling at injection site/muscle). On 18-Aug-2021, the patient experienced NASOPHARYNGITIS (Consumer also repots having a cold). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In April 2021, VACCINATION SITE SWELLING (Consumer reports significant swelling at injection site/muscle) had resolved. At the time of the report, NASOPHARYNGITIS (Consumer also repots having a cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         No Concomitant medications were provided.
HEARD NOISES, HAD HALLUCINATIONS, AND HAD HEADACHES  PATIENT CURRENTLY HAD A UTI AND WAS EXPERIENCING SYMPTOMS FROM IT.
Breakthrough case admission after 2 vaccines  Pfizer 2/8/21 Lot# EL9261 ; Pfizer 3/1/21 lot# EM9810
Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
swelling at the injection site; Rash; burning at injection site; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FX6073) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at the injection site"; RASH (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning at injection site". Additional information included: there are three patients were given Prevnar 20 from the same lot number FX6073 and all three patients had the same adverse events. Rash, burning at injection site, and swelling at the injection site. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170676 same drug and AE, different patient;US-PFIZER INC-202201170677 same drug and AE, different patient;
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included Birth control patch. The patient never had COVID-19 positive test. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was reported that no symptoms were reported after any of the vaccines. The patient did not seek medical care and no treatment received.
Pt vac w/ Engerix-B dev sore arm at inject site; dull ache lt shoulder & under breast.
Received my second Covid shot in February, got pregnant shortly after and miscarried at 5 weeks. Can be totally unrelated, miscarriages happen for so many reasons. But just in case there is correlation, I was instructed to file the report
Initially was light nausea and head spinning, then that amplified to worse nausea with tingling appendages. Then over the course of a couple hours, had migraine symptoms felt like I was going to vomit then my legs started going numb. Afterwards was slurred speech, all appendages including lips were tingling and numb. Horrible stomach ache, unable to focus on people talking and unable to respond clearly with a fever over 102 Fahrenheit with chills. After fever broke perfuse sweating eventually able to make more sense while speaking and head started to clear so I could understand more.
Blacked out; Severe vomiting; Diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of blackout in a female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, 2 hrs after receiving Hepatitis B vaccine, the patient experienced blackout (serious criteria GSK medically significant), vomiting and diarrhea. On an unknown date, the outcome of the blackout, vomiting and diarrhea were unknown.   The reporter considered the blackout, vomiting and diarrhea to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Hepatitis B vaccine and experienced blackout, severe vomiting, diarrhea. The patient visited to emergency room. The reporter asked was there any safe vaccine. The information regarding consent to follow up was not reported. No further information was available.
PROQUAD was administered to a patient on 10/7/2020 when the excursion had occurred on 10/3/2020; This spontaneous report has been received from a nurse referring to a 4 years old male patient. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 03-OCT-2020, the vaccine of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) underwent temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (7 Fahrenheit) for 15 minutes. Involved lot numbers of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) included lot # S021623, expiration date: 09-JAN-2021; lot # T015598, expiration date: 02-NOV-2021; lot # S022912, expiration date: 19-JAN-2021 and lot # S023014 is an invalid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), expiration date reported as 25-MAR-2021. There was previous temperature excursions of 9 Fahrenheit for 15 minutes. The digital data logger was involved in recording excursion details. On 07-OCT-2020, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # S021623, expiration date: 09-JAN-2021). No other lot numbers of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) were administrated.
Morning of 13th statrted to C/o pain behind L ear. Woke up on the 14th with redness and swelling along L jaw and neck. Went to express care, told pulled muscle.  On 15th, to private MD, said it was mumps.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (patient took Alcohol from 2010 to 01-JAN-2021, 3 to 5 beers a week.) from 2010 to 01-Jan-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 24-Mar-2021 at 11:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Nov-2020 and the estimated date of delivery was 17-Sep-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Pregnancy test: positive (Positive) positive. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The estimated date of conception was 17-Dec-2020. Genetic testing and Ultrasounds were Normal on an unknown date. Previous pregnancy reported on 09-May-2020 without any complications.
Female employee developed dyspnea and hives post first vax. Due to the episodes, the pt was instructed not to complete the vax series. As stated by the reporter, this case involved 'an historical documentation of an employee who had not completed the hepatitis b vaccine series and said it was because of a reaction of dyspnea and hives. She did not receive the vax from this institution.' Recently, the pt accidentally stuck herself with hepatitis b recombinant vax needle. It was uncertain if the needle was infected. The reporter indicated that it was decided not to give the pt (employee), hepatitis b immune globulin for this exposure due to the low risk nature, but save the hepatitis b immune globulin for a high risk exposure.' No further information is available.
Had rash on body. On neck, arm pits, side of back and groin area as a result of second dose.; This is a spontaneous report from a contactable consumer. This 43-year-old male consumer reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; brand=er8737, lot number=ER8737) via an unspecified route of administration on 07Apr2021 at 04:15 PM on left arm (at 43-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, known allergies and other medications in two weeks were reported as none. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; brand=EP6955, lot number=er8737) via an unspecified route of administration on 17Mar2021 at 04:30 PM (at 43-year-old) on left arm, as dose 1, single for COVID-19 immunization and experienced odd cold sore like break out on checks next to his lip. This was about 5cm break out and lasted a few days. On 10Apr2021 on 06:00 PM he had rash on body. On neck, arm pits, side of back and groin area as a result of second dose. No treatment was received for event. On 11Apr2021 the patient recovered.  No follow-up attempts were possible. No further information was expected.
Tubersol .5 as an IM and they were supposed to receive the Tetanus TD vaccine/no ae; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient who received 0.5 mL TUBERSOL (TUBERCULIN TEST) (with an unknown batch number) for Tuberculin test via intramuscular route at an  unknown administration site instead of TETANUS TOXOID (Wrong vaccine administered)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error case due to Wrong vaccine administered.  It was unknown whether adverse event was experienced or not.  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 and Module VI of the 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.  Information on the batch number was requested.
Tested positive for COVID; Cough; Nasal congestion; Loss of taste; Loss of smell; Chills; Muscle ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 26-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with IBUPROFEN ongoing from 07-Sep-2021 for SARS-CoV-2 infection, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headache) had not resolved and AGEUSIA (Loss of taste) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported  Treatment medications for SARS-CoV-2 infection included:Musinex All in One Cold/Flu-20 ML: Mornings from 08-SEP-2021 to till date. Musinex Nightshift Cold/Flu-20 ML: Evenings from 08-SEP-2021 to till date. Goodie Powder from 07-SEP-2021 to till date. Nose spray 2 times a day from 08-SEP-2021 to till date   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up received and it contains no new information On 12-Sep-2021: Follow up received: Patient initials, gender, age, events event outcome  and treatment medications added.
mom phoned 2DEC93 to state pt had ?sz in parking lot in clinic 15NOV93; pt spitting mucous-unresponsive; pt agitated; pt was not seen by MD;
only the liquid component of the vaccine was administered to a patient with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who was administered only the liquid component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Jul-2023, the patient was administered a dose of 0.5 ml once of the liquid component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ843AB; expiry date: 24-Feb-2024; strength: standard) (single component of a two-component product administered) (latency: same day) via unknown route in the left thigh for Immunization. There are no adverse event(s) in this case.  It was reported, "Nurse called saying that the lyophilized component of PENTACEL wasn't reconstituted using the liquid component, so only the liquid component of the vaccine was administered to a patient. Nurse asked how many Hib's are necessary for the whole series and what should they do next? Nurse also asked if they can use a standalone Hib component to make up for the dose?"   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.
Paxlovid indication : COVID 19 Treatment; Paxlovid indication : COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 at 15:00 as dose 2, single (Lot number: ER8733), in left arm and on 27Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Keflax allergy" (unspecified if ongoing), notes: Known allergies: Keflax. Concomitant medication(s) included: METOPROLOL, start date: 20Dec2019; ELDERBERRY [SAMBUCUS NIGRA FRUIT]; CALCIUM; MAGNESIUM; ZINC; COQ10 [TOCOPHERYL ACETATE;UBIDECARENONE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Paxlovid indication : COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Test positive again approximately 4 days after last negative test; Positive, notes: With round one of covid I tested positive until day 8; Negative, notes: Tested negative day 9 & 10; Negative, notes: Tested negative day 9 & 10. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken Paxlovid from 24Aug2022 to 29Aug2022 for the treatment of Covid-19.
severe reaction/ she said she was very very sick; oxygen level was down for 3-4 hours; everything hurt and was aching; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and remdesivir (REMDESIVIR), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose ("4 doses") for COVID-19. Medical history included COVID-19 from Jan2021 to Jan2021. The patient's concomitant medications were not reported. Patient had COVID-19 on January. While she has the COVID-19 infection, she took 4 doses of remdesivir. When she got out of the hospital, after 4 weeks, she had the first dose of the Pfizer COVID-19 vaccine. She thinks that she had taken the vaccine too close to her medication (remdesivir) and because of that, she developed a "severe reaction" with the first dose of the vaccine. She said she was "very very sick: her oxygen level was down for 3-4 hours, everything hurt and was aching". She said it's like having COVID-19 all over again. Her symptoms lasted for a day but 3-4 days later she still didn't feel good. She wanted to know if she should take the second dose after her reaction with the first dose. She said she wanted to speak with a doctor about her concern. The patient underwent lab tests and procedures which included oxygen saturation: down on her oxygen level was down for 3-4 hours. The action taken in response to the event for remdesivir was post-therapy. The outcome of the events was unknown. The event severe reaction/ she said she was very very sick was assessed as serious.  Information on the lot/batch number has been requested.
Menstrual bleeding started just next day after vaccination, which is 15th day of my cycle