chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have experienced a side effect; Is it ok to take pain meds after the vaccine?; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 29-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have experienced a side effect) and MYALGIA (Is it ok to take pain meds after the vaccine?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (have experienced a side effect) and MYALGIA (Is it ok to take pain meds after the vaccine?). At the time of the report, VACCINATION COMPLICATION (have experienced a side effect) and MYALGIA (Is it ok to take pain meds after the vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED
This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot number: L027067, expiration date: 06-APR-2017; lot number: M019691, expiration date: 02-NOV-2017; dose was not reported) orally. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient should have received COVID19 PFIZER UPDATED BOOSTER 12+(BIVALENT) and received COVID19 (PRIZER AGE 12+) GRAY CAP.
Permanent damage to heart and kidneys; Permanent damage to heart and kidneys; This is a spontaneous report from a contactable consumer or other non hcp. A 90-years-old male patient (reporters uncle) received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 08Mar2021. This was on a Monday, and Caller reported that throughout the rest of the week until Friday (12Mar2021), the caller experienced muscle aches, fatigue (especially mental fatigue in a fog). The patients concomitant medications were not reported. On an unspecified date, the patient experienced permanent heart damage and damage to the kidneys. Caller mentioned he is 65-year-old and his 90-year-old uncle was hospitalized after the second shot. Caller is concerned regarding these possible side effects for the second dose and is seeking information. This report is cross referenced to reportum reference. Received call from consumer regarding the Pfizer COVID vaccine. While reporting for himself, he mentioned that his Uncle, who is 90, received first COVID injection and then went for his second injection. Right after that, he started getting negative symptoms. It did permanent damage to his heart and kidneys and ended up in the hospital for a couple of days. This report is to capture information for his uncle. He did not wish to create report. No further details provided. The outcome of the events were not reported.  Information on the lot/batch number has been requested.
Narrative:  Pt had recent cardioversion on 8-6-21 and was discharged. Was found to be COVID positive 8-10-21. Returned to ED 8-13-21 with dizziness, bradycardia, and fatigue. Pt received remdesivir for treatment, but did not have respiratory distress. Pt was admitted for cardiac issues (bradycardia) related to recent cardioversion and metoprolol therapy.
Initial report received on 08 May 2014 from a consumer who is the patient. A 62 year old female patient was vaccinated intramuscularly in March 2014 with ADACEL, batch and site of administration not reported. The patient denied any illness at the time of vaccination. On an unspecified date in March 2014, three days after the vaccine, she experienced stomach pain for 3 days and a dry cough for 3 weeks that went away. She then got a "zinging feeling in her jaw", date not reported. She went to the doctor who said her parotid glands were swollen and was told that it might be lupus. She was seen by her dentist who "cleared her". She also noted a sensitivity in her ears. Concomitant medications and medical history were not reported. Laboratory tests were not reported. The patient has not recovered. Documents held by sender: none.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 17-NOV-2009, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The zoster vaccine live (ZOSTAVAX) did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-DEC-2013, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir and acetaminophen (+) codeine phosphate (TYLENOL WITH CODEINE) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
acute tonsillitis; First symptoms were various lumps on my face and neck, which have not dissipated. The first were by my lips and on my chin, followed by my neck and jawline.; severe sore throat; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 53 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 (Batch/Lot Number: CW0167) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot Number: ER3737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included colitis ulcerative from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing Controlled , covid-19 from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported; mesalamine (MESALAMINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced first symptoms were various lumps on the face and neck, which have not dissipated. the first were by the lips and on the chin, followed by the neck and jawline. on 28Apr2021 08:00 with outcome of not recovered , severe sore throat causing oropharyngeal pain on 28Apr2021 08:00 with outcome of not recovered, acute tonsillitis on 07May2021 02:30 with outcome of not recovered. Therapeutic measures were taken as a result of severe sore throat and acute tonsillitis by taking Advil cold & sinus and gargling with hot salt water and antibiotics   Follow-up (11May2021): This is a follow-up spontaneous report from a non-contactable consumer. This consumer reported that:  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to a 6-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ, orally, lot # M042170, expiry date: 22-JUN-2018, and RECOMBIVAX HB lot# N006321, expiry: 08-NOV-2019. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional and additional information received on the same date. This case involves a 18 months old male patient (also reported as 14 months) who inadvertently received 0.5 ml dose instead of 0.25 ml dose of FLUZONE QUADRIVALENT from a multi-dose vial. The patient was not kept for observation. The patient's past medical history and concomitant medication were not provided. On 05-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UIB83AA, expiry date: 30-Jun-2019) via intramuscular route in the left thigh. It was a case of actual medication error due to accidental overdose. It was not reported, if the patient experienced any AE. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0162), on 04May2021 as dose 2, single (Lot number: EW0171) and on 13Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "carrier for hemophilia A" (unspecified if ongoing), notes: other medical history: carrier for hemophilia A; "high cholesterol" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: sulfa medications" (unspecified if ongoing); "Known allergies: medical tape/adhesive" (unspecified if ongoing); "known allergies: mushrooms" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; LISINOPRIL.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive; (30Jul2022) Negative, notes: On 30Jul I tested negative and was feeling mostly better; (05Aug2022) Positive, notes: Had a positive test on 05Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound case of covid. Tested positive on 21Jul2022. Started 5 day course of Paxlovid which was completed. On 30July, She was tested negative and was felt mostly better. She Started exhibiting new symptoms on 03Aug and Had a positive test on 05Aug. Other medications which were administered in 2 weeks were Pristiq, Lisinopril and Birth control. Patient received treatment for covid-19 include antiviral vaccine of Paxlovid on :21Jul2022 and was stopped on 25Jul2022.
Patient noticed a large lump form on his arm about 2-3 days after the vaccine.  Lump has not gone down in size, is not painful, no redness, no restriction in movement, and does not seem to be causing the patient any problems. Patient has not tried to do anything to get the lump to go away.
35 year old woman, history of shingles 8 years ago. Developed shingles rash in same distribution as she had 8 years.ago 9 days after receiving second dose of pfizer-biontech covid 19 vaccine.
Information has been received from a physician concerning a 36-year-old white female with allergies to penicillin, "sulfa" clarithromycin (BIAXIN), erythromycin (E-Mycin), levofloxacin (Levaquin), and ciprofloxacin hydrochloride (CIPRO) who on 23-Sep-2003 was vaccinated with a dose of varicella virus vaccine live (lot information not available). It was unknown if there was an illness at the time of vaccination. Subsequently the patient developed a localized rash and a fever. The reporter indicated that she "believes patient has recovered". Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 03-Oct-2003, 10 days after vaccination, the patient was seen for achiness, nasal congestion, and redness and slight tenderness at the vaccine area. The outcome was reported as recovered on 10-Oct-2003. No relevant diagnostic tests or laboratory data were reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 7 year old patient of unknown gender. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 31-JAN-2017 the patient was vaccinated with GARDASIL 9 (strength, dose, lot# and expiration date were unknown) intramuscularly for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects reported. Additional information has been requested.
A consumer report has been received. The report concerns a 5 year old. Female consumer, who had been receiving nasal FLUMIST (intranasal) started on an unknown date. The patient experienced fever, sneezing, abdominal pain, and rash started on 16-MAR-2014. The patient recovered from the event of fever, sneezing, abdominal pain and rash on unspecified date. The report was considered to be non-serious.
4 days soaking sweats; 4 days chills; 6 days of Insomnia; 1 week Ill; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old patient of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Medical history included multiple sclerosis, heart attack and mechanical mitral valve. The patient had known allergies (unspecified). Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced one week of illness. On 05May2021, the patient experienced six days of insomnia. On 07May2021, the patient experienced four days of chills and soaking sweats. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent lab tests which included nasal swab and the result was found to be negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events 6 days of Insomnia, 4 days of chills and soaking sweats and 1 week of Illness were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Blurred vision and itching to L eye began at 5:00 pm; L eye swollen in A.M. of 10/15/09 Ms. Converse took Benadryl PO on evening of 10/14/09
Pt became unresposive, eyes glossy and rolling backward, not able to talk, somewhat slumped over in chair. Called 911 and give 1 dose epinephrine (Epi-Pen).
Case number PHEH2014US016823 is an initial spontaneous report received from a nurse on 20 Aug 2014 with a follow up information received from a nurse on 23 Sep 2014. This report refers to a 14-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with initial dose of 0.5 ml MENVEO (batch number: M14031) intramuscularly in the right arm on 08 Aug 2014. On the same day, she was also concomitantly vaccinated with 0.5 ml of GARDASIL (other manufacturer and batch number: K001500) intramuscularly in the left arm. On 09 Aug 2014, a day after vaccinations, she experienced arm swelling at injection site of right arm larger than a baseball and pain in arm. She started KEFLEX as treatment for 10 days. The outcome was reported as complete recovery. Seriousness and causality of the event were not reported. Follow up information received from a nurse on 23 Sep 2014: Patient demographics (height and weight), site of vaccination of MENVEO and GARDASIL, event (pain in arm), treatment and outcome updated. GARDASIL was changed as concomitant vaccination.
Narrative: COVID infection following COVID vaccine series 06/16, MODERNA, dose #1 07/14, MODERNA, dose# 2 09/13 COVID swab, result: detected 09/13 SARS-COV-2 Variant Sequencing result: pending 09/22 COVID swab, result: detected 09/12 pt cc: cough, fever, loss of taste or smell, myalgias, diarrhea exposure; unknown 09/21 clinically resolved
Friday night I woke up he was foaming in the mouth, I sat him up and elevated him and cleaned him up I called 24 hour doctor line. The doctor recommended going to er. We stayed home, He was coughing and seemed irritated. Breakfast he seemed fine very lathargic, no fever, lost conciousness and I called paramedics . The paramedics could not get his body tempature 80. I waited when I got to the hospital 4 hours later and went to his room thay had a heat machine and thermal blanket on him, he was concious but looked like he was going to sleep, his blood pressure started going up and down and up and down. He was very cold to touch. He had a cough and they were given him 2 types of antibiotics to help clear up pnemonunia which then damaged his kidney and he got septisis . They had to use an ultrasound to get ivy and foley in because of fluid. Physical therapy had to  get him in and out of bed. Doctors said they had done everything they could do and sent him rehab before sending him  to hospice. He was Hypothermic, kidney failure and sepsis.
Headache CHILLS AND FATIGUE Narrative: CHILLS BEFAN 28 JAN AND CONTINUE INTERMITTENTLY. HAD HEADACHE FOR ONE DAY AND IS CURREN TLY EXPERIENCING FATIGUE
Her period was not regular when she received the booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer: Pfizer BioNTech Covid-19 vaccine), for COVID-19 Immunization, reaction(s): "Menstruation irregular". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Her period was not regular when she received the booster".  Additional information: Daughter received the primary series last year. She received the booster in November. Since then, she has not had her period. Her period was not regular when she received the booster, however, it is non existent at this time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vital signs 108/61 pulse 71 pulse ox 100%,; ED Note: 43 y.o. male otherwise healthy presents to the ED with syncope s/p second Moderna Vaccine, onset 1530 this afternoon. Patient reports after receiving the shot, he felt a burning sensation to the injection site on his left arm. He then explains that he began losing his peripheral and ended up losing his vision. Patient then initially felt better but notes he got bad real fast. He mentions he ended up losing consciousness but is unsure for how long. He reports a history of syncope following blood draws but never before with vaccinations.  Patient states when he woke up, he felt sweaty, clammy, and nauseous. He notes he currently feels fine otherwise and denies any chest pain, shortness of breath, or palpitations. He denies having any symptoms following administration of the first dose of the Moderna Vaccine.  evaluated the patient at bedside and the patient has verbalized agreement and understanding to the plan at this time of discharge without further questions.  The patient is comfortable with further observation of his symptoms at home.  I discussed our workup, answered all questions and made sure there were no other concerns.  I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.
Came to clinic with concern of vaccine reaction. Received Rabies vaccine #2 on 4/16/18 at approximately 1400. Noticed at 1800 hives on lower arms. Hives spread to axillary regions, buttocks, lower back, and neck by this am. Per patient no known exposrure to anything else yesterday. Per patient she took PO BENADRYL. No facial or neck swelling. No difficulty breathing. RN spoke with Dr. upon patient arrival and he indicated to put a referral in to see him if she needed anohter dose in series. Patient does and therefore referral placed. Per patient her only allergy is tomatoes and has had hives with exposure to them. Did not eat tomato products yesterday.
This case was reported by a pharmacist via call center representative and described the occurrence of numb lips in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced numb lips. On an unknown date, the outcome of the numb lips was recovered/resolved. The reporter considered the numb lips to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced numbness on the inside of the bottom lip. The health care professional had no patient or product information. The numbness resolved 3 to 4 days after receiving the vaccine. The health care professional called to ask if we have any other incidents of patients experiencing numbness on the inside of the bottom lip.
Shortness of breath, fast heart rate, dizziness, headache, tiredness. This lasted for 24 hours. Five days later, tingling and pain to hands and fingers, extremities.
patient had pain on left breast and painful blister rash mid line of breast/ over next day rash spread to under breast
2 days S/P vaccine developed approx. 3 inches in diameter swollen firm mass. Warm and painful to touch. Oral temp of 99.5 and stiff neck.
chills, fever , 100.8  for 4 days.  Pain in left breast and left arm pit. dilated pupils, high blood pressure, heavy breathing. started Nov. 16 3:00pm.