chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; redness with third covid moderna vaccine; itchiness with third covid moderna vaccine; lymph node in neck; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COUGH (Cough), VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck). At the time of the report, COUGH (Cough) was resolving and VACCINATION SITE ERYTHEMA (redness with third covid moderna vaccine), VACCINATION SITE PRURITUS (itchiness with third covid moderna vaccine) and LYMPHADENOPATHY (lymph node in neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Ultrasound Doppler: Normal. On an unknown date, Bone scan: -7. On an unknown date, Investigation: Cough not related to covid or flu related.         Concomitant medication was not reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
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 33-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL, start date: 24May2022, stop date: 02Jun2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: The product Paxlovid for  COVID 19 treatment its treatment start date was 02Jun2022 and treatment stop date was 03Jun2022 . other medication in 2weeks product: DayQuil/NyQuil throat losenges start date from 24May2022 and stop date was 02Jun2022
Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.    Medical History information was reported. On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 04-Oct-2021.  No treatment medications were reported.
Began hives 12/27 eve escalated thought night, by 10:00am headed to ER (epi injection, Benadryl, Pepcid, steroids) next morning woke up hives again mild, following day flare like first day back to ER added steroids. Managing daily morning flare ups at home w steroids, Benadryl, Allegra, Pepcid?watchful eye for anaphylaxis.
Hypertrophic Cardiomyopathy; Chest Pain; Chest Pressure; Numbness in Left Arm; Back Pain; A spontaneous report was received from a nurse concerning herself, a 41-years-old, female patient who experienced hypertrophic cardiomyopathy, chest pain, chest pressure, numbness in left arm, and back pain.   The patient's medical history was not provided.  concomitant medications included metoprolol, omeprazole and acetylsalicylic acid.   On 21 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 [Lot number 0412L0A] intramuscularly in the for prophylaxis of COVID-19 infection.   On 25 Jan 2021, four days after the vaccine administration, the patient started experiencing chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy and was hospitalized in emergency room for 48 hours from 25 Jan 2021 to 26 Jan 2021. The event hypertrophic cardiomyopathy was also considered to be medically significant. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events chest pain, chest pressure, numbness in left arm, back pain and hypertrophic cardiomyopathy were considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
When he received his chicken pox vaccination he developed a fever overnight and stayed fussy throughout the night and the next day.
Fever of 102, nausea,  severe chills, body aches, injection sight pain for 24 hours starting at 5;30 a.m. on the 11th.  Tired and weakness after that.   Treated with ibuprofen for fever and body aches and pepto bismol for nausea.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 18-JUL-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010478, expiration date: 01-SEP-2017, route of administration was not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No reactions Vial had been opened/punctured on Friday Nov 18th-which was past the 12 hour exp time.
Ag test positive; Ag test positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 32-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: FA7485) and on 05Aug2021 as dose 2, single (Lot number: EW0198) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26May2022, outcome "unknown", COVID-19 (medically significant) with onset 26May2022, outcome "unknown" and all described as "Ag test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (26May2022) Positive, notes: Nasal Swab; Body temperature: (26May2022) T 103.  Conclusion: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer biontech covid-19 vaccine injectable lot EW0198 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0198, fill lot ET8441, and the formulated drug product lot EP8623. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to 6149611 6148854 the release of the reported batch was within specifications.202200766131 7217670 compound bnt 162 covid-19 vaccine suspension for intramuscul ar 2ml multiple dose VIAL X 1 FM9992 'For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Approx 5 in area of erythema developed next to site of DTaP/IPV injection. No itching/pain. No sign of systemic reaction.
Approximately 36 hours after initial vaccine administration I experienced a sudden drop in breastmilk supply, with no other changes that could explain this change other than receiving the vaccine.
pt recvd vax temp elevated to 103 p/vax; took pt to ER was released the same day;
Fever, mild generalized diffuse macular rash, herpetiform vesicles on neck
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 29-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J014400, expiration date 13-NOV-2015) that was stored improperly. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
patient started to get dizzy immediately after receiving the vaccination, made him stay seated and talk to me- he stated his throat was starting to close and I immediately administered one epi pen into his thigh. He started coughing and breathing a little better. Few minutes later he was having difficulting breathing and indicated he needed another epipen. I administered the epipen. He could breathe but was experiencing severe side effects from 2 epipens. We called EMS and sat with him til they arrived. All occurred with in 10 minutes after administration. EMS walked him to their ambulance.
pt recv vax 29OCT97 & rash began 10NOV;became itchy new lesions w/vesicles, pustules daily until reported 13NOV97;lesions covering face, arms, legs, trunk;fever x 2 days w/runny nose a/lesions started;
Narrative:  Admit to Hospital 9/11/21. Covid vaccine in March outside agency Patient states that 5 days ago he developed the onset of a productive cough, dyspnea, fatigue, headache, generalized weakness, and has had one episode of vomiting. Last night the shortness of breath got worse. The patient has COPD. He does not use home oxygen, He received his Covid vaccinations around March of this year. He was exposed to someone with Covid recently, No abdominal pain or diarrhea. Medical Decision Making Patient has covid-19 associated with pneumonia and hypoxia. He will require hospitalization. Home on oxygen
Arm pain; fatigue; slept nearly nonstop starting the night of injection; odd cheek canker; GI issues; increased temp; headache; body ache; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported, "Arm pain was worse than any previous immunizations I have had. Massive fatigue (slept nearly nonstop starting the night of injection), odd cheek canker, GI issues, increased temp, headache, body ache. Day 3 now, seem to be better!" on an unspecified date. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications. On unspecified date, the patient received the first dose of the Pfizer COVID-19 vaccine. She was heaving heavy cramps because of her menstrual cycle and her husband wanted to know whether she can get the second dose and her husband was got response as, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if patient had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer patient to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient healthcare provider knows patient health situation and has access to information that can better help inform this decision. Outcome of event was unknown.  Information on Lot/Batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Recently from the reporting date, the patient had SHINGRIX and experienced pretty severe side effects, but these side effects were past in a few days. The patient was asking if it was likely that he/she would experience the same side effects with the second shot of SHINGRIX or would the side effects be less.
dehydration; This is a spontaneous report from a contactable Nurse.   A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. After vaccination on an unknown date, the patient went to ER and was diagnosed with dehydration. Patient was hydrated and recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Undiluted Pediatric vaccine 0.2ml, no reaction after 21/2 hurs per family.
Severe chills and fever starting about 11 hours post dose and continuing through the night. Somewhat relieved by tylenol
This spontaneous report was received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date an unspecified number of patients were vaccinated with GARDASIL (dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. On an unknown date the GARDASIL reached  a temperature as low as 30F for an unspecified amount of hours and most likely had been administered. The reporter thought that the proper storage range for GARDASIL ws 35F to 46F because they had always bene considered in range at 35F at her office. No adverse effect reported. Additional information was received from a nurse practitioner concerning a 12 year old female patient On 03-JUN-2014, the patient was vaccinated with 3 dose of GARDASIL, injection (lot number reported as J008188). No adverse reaction reported. Additional information is not expected.
10/26/2021 I began to take Ozempic injections once a weak and began taking it on this day. I had severe chest pain and then it went away. That afternoon I had visual disturbance, diaphoresis and it went away. The following week I took a second dose of Ozempic on Nov. 2nd, at night I had severe chest pain tachycardia, chest pain and pain down my left arm. After sitting down it went away. On Nov. 3rd I went to work and as I was sitting down I started feeling like I was going to pass out and went to the ER. EKG at ER showed I was having a heart attack and from further work up found a blood clot that was a 95% blockage. The next evening I was able to get discharged.  Nov. 19th I was having shortness of breath and went back for 5 days and cardioverted me on Nov. 22nd. Symptoms are no longer there and have cleared up since then. I am currently in cardiac rehab as well.
Developed vertigo 11/08/2021, attributed to labyrinthine disorder after neurology evaluation and testing. Probably unrelated to Moderna booster. Now improved but continued mild symptoms.
Patient taken to hospital after feeling very dizzy immediately following shot. Patient was profusely sweating and felt like he couldn't breathe.
Congestion, sore throat, headache, fatigue coughing was related to sinus draining. That started on 11/4/2021 which was when I started taking Dayquil. Those symptoms lasted about 8 days before I reached out to my doctor. Once I reached out to her, that's when we added the steroid nasal spray Fluticasone for the next 4 days. Along with the Dayquil. None of the symptoms were going away, so I went to go see her after two weeks with the symptoms on 11/18/2021. She prescribed an azithromycin pack along with everything else I was doing. I was well about 5-6 days later, so last Tuesday 11/23/2021 when I finally recovered.
After 3 days of sore injection site the pain subsided. Then 10 days after the injection a sore, hot, itchy, rash on the arm where the injection occurred. The rash was initially about the size of the palm of my hand. It spread to roughly the size of my entire hand over the next few days. It is still present, but not as bright red.
After taking the vaccine it aggravated my RA and Fibermyogyia and took me completely out of remission. I had this flare up for two months now.
Per the patient, patient received COVID-19 vaccination and was observed for 15 to 20 minutes after injection. About 20-25 minutes after vaccination, however, patient became short of breath, felt throat closing, and had tongue swelling, facial flushing, itching around her neck, and nausea. Patient used a rescue inhaler, took Benadryl, and called EMS. Other meds included Zyrtec which was taken the evening prior to the vaccination, and Allegra and Tylenol which was taken the morning of and prior to vaccination.   Per patient, EMS was called but patient did not wish to go to their affiliated hospital. Once it was safe to be released from EMS, patient drove to an urgent care center. Per patient, urgent care provider observed eye redness and puffiness. Patient states vital signs were normal upon arrival at urgent care except for BP which was higher than normal. Patient received famotidine and prednisone at urgent care, and is taking these medications at home.   The day after the injection, patient noted a significant swelling of the injection arm from the elbow upwards; swelling is still present but subsiding. Body aches and injection site pain are also present.
Arm pain, headache, low grade temp, congestion, excessive mucus, cough, coughing up mucus.  When I had my first Covid shot in January, I had these reactions for close to 3 weeks.  Every since then, I have excessive mucus and the doctor diagnosed post nasal drip.  Now, after years of flu shots, I have had a very similar reaction after the flu shot.
PATIENT STATED SHE HAS THE FLU AFTER RECEIVING THE FLUZONE HD. SHE SAID SHE HAD SLEPT ALL DAY AND HAD RUNNY NOSE. THEN SHE SAID HER LEG WAS NUMB AND MIGHT BE GUILLAIN-BARRE SYNDROME.
Muscle and joint pain, when arm is moved, particularly when arm is raised. Sleeps on right side, pain wakes patient during the night.
Was fussy all night, slept fitfully but began vomiting at 11:30 am. By time of consult at 3:40pm he had vomited 5 times already; afebrile; irritable but consoled by mom and fell asleep within 10 mins in clinic; exam: normal exam, pupils normal; fontanelles normal.
Nausea, vomiting, felt as if she passed out, light headed, dizzy.
Information has been received from a physician concerning a male in his late 50's who on an unspecified date was vaccinated with PNEUMOVAX 23 single dose (lot# unknown). On an unspecified date the patient experienced fever, myalgia and redness at injection site. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. This is one of two reports from the same source.
This spontaneous report was received from a Nurse Practitioner (N.P) concerning a 50 year old non pregnant female patient. The patient's pertinent medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (Lot # and dose were not provided), subcutaneously. Concomitant therapies were not reported. On 03-JUN-2016, 3 days after onset of therapy, the patient experienced severe swelling from her shoulders down past her elbows, redness, severe heat, itching and fluid filled blisters across the swollen region. It was reported that on the same day, the patient received treatment for the events; she was taken to the emergency room of an unspecified hospital for an unspecified length of time. At the time of the report, some of the symptoms had improved, but not all of them, however, the patient present status was reported as recovering. The events did not involve cancer, overdose or a product quality complain. Additional information is not expected as there is no permission to contact the physician.