chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This is a spontaneous report from a contactable other health care Professional (HCP). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient diagnosed with COVID-19 was unknown. Since the vaccination the patient tested for COVID-19 was unknown. The patient received any vaccines within four weeks prior to the vaccination was unknown. On an unspecified date the developed shingles. The outcome of the event was unknown.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
Initial unsolicited report received from a Pharmacist on 03-Oct-2018. This case involves a patient (reported as senior, age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date, instead of FLUZONE HIGH DOSE. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered (reported as FLUZONE QUADRIVALENT was administered to a senior inadvertently. Was intended for senior to receive FLUZONE HIGH DOSE). 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 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.
muscle pain; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced muscle pain on an unspecified date. He was asking how long the muscle pain lasted. The outcome of the event was not recovered.  Information on the batch number and lot number has been requested.
Patient told physician she had headache, shortness of breath and diarrhea after flu shot.
12/28/2021 in the afternoon I had a swollen lymph node and post nasal drip after 4 days I had sneezing, runny nose. and coughing. I didn't take any medications at all. I just stayed home for 8 days. On 08/15/2022 I was positive for COVID-19 again but I still didn't take any medication. I stayed in training for 5 days in quarantine.  After I got COVID-19 for 2 times I was diagnosed with bilateral knee arthritis which I never had it before. I was diagnosed on 05/20/2022 from my doctor.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid from 26Sep2023 as treatment for the events.   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.
Severe pain and some swelling in Right ankle joint. Started night of injection and progressively improved for three days. Pain was 8 or 9 on scale of 10.
pass out; felt she had breathing problems; her heart was racing; clamminess; dizziness; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (pass out), DYSPNOEA (felt she had breathing problems), PALPITATIONS (her heart was racing), COLD SWEAT (clamminess) and DIZZINESS (dizziness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Benadryl and Visine (she had complete redness around her eyelids and big red patches on her cheeks). Past adverse reactions to the above products included No adverse event with Benadryl; and Redness with Visine.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced PRESYNCOPE (pass out), DYSPNOEA (felt she had breathing problems), PALPITATIONS (her heart was racing), COLD SWEAT (clamminess) and DIZZINESS (dizziness). At the time of the report, PRESYNCOPE (pass out), DYSPNOEA (felt she had breathing problems), PALPITATIONS (her heart was racing), COLD SWEAT (clamminess), DIZZINESS (dizziness) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        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.   It was unknown that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. It was reported that patient has had similar reactions since after using Visine and Benadryl.  It was reported that patient believes her symptoms may be an allergic reaction to PEG or propylene glycol included in these medications. Treatment medications included PEG or propylene glycol.
Father says that his son has developed a lump on the arm he received his flu shot in.  It is slightly red and the arm is mildly sore. Instructed him to apply ice to the area, give Tylenol for pain/fever, and Benadryl for reaction.  If condition worsens go to the ER. They have no primary care physician to contact.
POTS; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 13-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2013 following vaccination, the pt experienced Postural orthostatic tachycardia syndrome (POTS), dizziness and headache. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Patient c/o dizziness and bilateral arm tingling within 10 mins after vaccination. Symptoms subsided within 30 min following her vaccination. Patient  left with no complaints.
Patient reports that she began to experience ringing in the ears after the first dose of the vaccine and the ringing in the ears has continued.
Headache, Myalgia, Arthralgia, 3pm left shoulder felt like typical vaccination 4pm shoulder more painful and body aches starting back, neck, shoulder 5pm diffuse joint pain and muscle aches 6pm difficulty swallowing dinner (I have Parkinson's disease, so this can happen) Narrative:
Patient stated he could feel his lip was swollen. The RN was unable to see swelling. He was observed eating and drinking after his vaccine. She asked him to stay past is 15 minutes and he chose not to. Back in his unit he stated his tongue was swelling. His co-workers gave him Benadryl and Claritin. He saw the physician who was unable to determine any issues. Patient was very sleepy due to the Benadryl and Claritin.
1245 on 8NOV91 pt c/o pain in rt arm @ inject site & radiating down to fingers; area red swollen & raw to touch; c/o pain w/movement;
61 year old female patient administered an expired 0.5ml dose of Act Hib, no AE; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 61 years old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ135ABA and expiry date: 26-Nov-2020) via an unknown route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  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.
of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FX5095) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
HEADACHE, VOMITING, FEVER, SMALL PETECHIA CHEEKS AND UNDER EYES APPROXIMATELY 12-14 HRS FOLLOWING MENINGOCOCCAL, T-DAP, AND HPV VACCINES RESULTING IN ED VISIT, TREATED AND RELEASED, INSTRUCTED TO FOLLOW UP WITH PCM IN 2 WEEKS FOR CBC REPEAT.
sore right arm; headache; a little bit of nausea; loose bowel movement, very sudden; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose bowel movement, very sudden), PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, High cholesterol and Blood pressure high.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (loose bowel movement, very sudden). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea). At the time of the report, DIARRHOEA (loose bowel movement, very sudden), PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea) outcome was unknown.            Concomitant medication of the patient included medication for osteoporosis, medication for high cholesterol and medication for high blood pressure.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-328939 (Patient Link).   Reporter did not allow further contact
following injection-fatigue, nausea, shivering/rigors(12hrs post injection), swelling/redness quarter size to site/tenderness (1-2hrs post injection), 48hrs later post injection- still fatigue, nausea, swelling. redness and tenderness to site- 3" diameter now
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX by a certified physician assistant (PA-C) at a healthcare facility/clinic as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-FEB-2014 the patient was treated by the certified physician assistant (PA-C) at the healthcare facility/clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Bullous 1x2cm x1/2 cm high L lateral . Left deltoid, ____12cm and round puffy, ______ with good _________
Sick; Lethargic; I ran a fever of 101; I have not felt well; I feel like i have covid19 all over again.; Cough is horrific, it kept me up all night long; tired; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old patient of unknown gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6204), via an unspecified route of administration in left arm on 12Mar2021 at 12 am (at the age of 51-year-old) as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination included Effexor. The patient's medical history includes that the patient tested for COVID-19 prior vaccination. The concomitant medications were not reported.  The consumer stated, "So I have the vaccine done on 12March, and  I feel like i have covid19 all over again. Very tired with a horrible cough (on 12March, 01:00 AM). The next day (on 13Mar2021) I was very sick I was like just lethargic and tired. Then I ran a fever of 101, I have not felt well since I had it, and yesterday I developed like horrible cough and I just feel like I have Covid all over again. I just don't know what else I am supposed to do because this cough is horrific, it kept me up all night long so I am just looking for some direction."  The patient had not tested covid post vaccination. The patient visited physician office due to the events  and also not receive treatment for events "I feel like i have covid19 all over again. Very tired with a horrible cough, and I have not felt well". The outcome of the events was not resolved for event "I feel like i have covid19 all over again, I have not felt well, Cough is horrific, it kept me up all night long, and tired". The outcome of rest event was unknown.  No follow-up attempts are possible. No further information is expected.
Myalgia, Fever, Should/neck pain Narrative:  Other Relevant History:
Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Covid Arm. Red raised hard knot, Swelling, reddness, heat, itching at injection site and approx 1 inch circular  surrounding injection site.
I am not sure if this correlates to obtaining the vaccine,  but approximately three months after I received the second Pfizer injection, I developed tinnitus.
COVID-19; Still feeling winded weeks later, labored breathing when exercising; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DYSPNOEA (Still feeling winded weeks later, labored breathing when exercising) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Asthma and Allergy NOS. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) from 20-Mar-2022 to 26-May-2022, MIRABEGRON (MYRBETRIQ) from 03-Jan-2022 to 26-May-2022 and SOLIFENACIN SUCCINATE from 01-Mar-2022 to 27-Apr-2022 for an unknown indication.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced DYSPNOEA (Still feeling winded weeks later, labored breathing when exercising). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 27-Apr-2022 to 30-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown and DYSPNOEA (Still feeling winded weeks later, labored breathing when exercising) had not resolved.            The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Patient previously received a COVID-19 Vaccine.  Company Comment:  This spontaneous case concerns a 56-year-old female patient with concurrent Asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth in the COVID-19 vaccination series. Patient had completed COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and presented with labored breathing during exercises approximately 2 weeks later. No information was provided on the previous 3 doses of COVID-19 vaccination prior to current mRNA-1273 vaccine.  The concurrent asthma could be considered as a contributory factor to COVID-19 including the other non-serious event of dyspnea The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 56-year-old female patient with concurrent Asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth in the COVID-19 vaccination series. Patient had completed COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and presented with labored breathing during exercises approximately 2 weeks later. No information was provided on the previous 3 doses of COVID-19 vaccination prior to current mRNA-1273 vaccine.  The concurrent asthma could be considered as a contributory factor to COVID-19 including the other non-serious event of dyspnea The benefit-risk relationship of mRNA-1273 is not affected by this report.
Two days after receiving the vaccine I started having abdominal discomfort and diarrhea and extreme fatigue, which lasted about 18 hours. I began observing  bloody mucus toward the end of the episode, but the symptoms subsided the next day, leaving me very tired. After one more day of rest the symptoms disappeared.
Complaint of immediate pain at injection site that has persisted for 3 weeks. Difficulty raising left arm more than 45 degrees. Seen by Primary Care Physician, on 10/10/2016 and prescribed ADVIL and shoulder exercises.
I felt like I had the flu after getting the vaccine; I spiked a fever, body aches all over my body. After 3 days or so, I was able to go back to work. A week later, I had heart palpitations that came on its own while sitting idle. I wrote them off thinking it was my anxiety causing it, but it happened several times in the day. Shortly after, I had shortness of breath randomly in the day while doing random things like brushing my teeth or washing TV. Weeks or so after, my doctor prescribed me an inhaler to help with my shortness of breath. She ordered a CT scan of my chest and found three spots on my lungs; it shouldn't affect my breathing, so we still haven't determined the cause of my shortness of breath. I just use the inhaler whenever I may struggle catching my breath during cardio workouts or anything. It hasn't gotten any worse, but hasn't gotten better either.
Fever & chills. Aches & pains. Weakness. Patient told to take TYLENOL PM for fever. LORCET PLUS for pain. Continue routine meds.
No adverse reactions.  patient was monitor for 15 minute,  patient oxygen level and heart rate was taking before vaccine was administered per clinic protocol, and it was all within normal range. Patient shows no signs or symptoms of any adverse reactions . Patient and aunty left the clinic medically okay..
Case previously recorded as MA2009-6260. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Patient presented to the vaccination site on 11/07/21. The client notified RN that she received a single dose of COVID vaccine in another country April 2021. RN submitted a medical consult via text message, requesting to proceed with the COVID vaccine Pfizer first dose. Per CDC guidance, approval to proceed with COVID vaccine Pfizer was obtained from medical consult team via text message from RN. Client received COVID vaccine Pfizer first dose Lot# FF8839 on 11/07/21. The client did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1520 unassisted and with a steady gait. Appropriate databases notified.