chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT WAS SITTING IN WAITING AREA, WAITING THE REQUIRED 15 MIN POST-VAX, JUST A FEW MIN AFTER ADMIN, PT STARTED TO FEEL FAINT, LOOSE COLOR IN FACE AND BREAK OUT IN SWEAT. NO S/SX OF ANAPHYLAXIS. LOWERED PT TO THE FLOOR AND ELEVATED FEET. COLOR IMMEDIATELY RETURNED TO FACE AND PT REPORTED FEELING BETTER IMMEDIATELY. PT REMAINED CONSCIOUS THROUGHOUT. CHECKED BP 113/79 PULSE 69. HAD PT WAIT ANOTHER 15 MIN THEN LEFT WITH NO FURTHER COMPLAINTS.
Information was received from a PharmD student on 01-Sep-2010. On an unknown date, a patient (age/DOB/sex not provided) received influenza vaccine (manufacturer unspecified) and subsequently developed Guillain Barre. The patient sought medical attention. The patient's medical history and concomitant medications were unknown. The event outcome was unknown. No further information is expected. The case was originally reported to Merck & Co., Inc. (case # 1008USA04247). The case was reported as serious due to medical significance. The company considered events unassessable due to lack of information regarding time of onset. Information derived from this AE report does not change the current safety profile of the product.
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. Pertinent medical history was unspecified by reporter. Drug reactions/allergies were none. Concomitant therapies included COREG and lisinopril (manufacturer unknown). On 24-JUN-2015, the patient was vaccinated with ZOSTAVAX, lot # K015310, expiry date 17-DEC-2015, 1 shot (DF), subcutaneously, for prevention of shingles. On 26-JUN-2015, the patient experienced a painful knot at injection site and also redness around the area as well as feeling a little woozy after administration of ZOSTAVAX. The patient was seen by the pharmacist where meclinzine and ibuprofen were administered as well as ice put on the area for medical attention. Lab diagnostics studies performed were reported as none. The outcome of the events were recovering. Causality was not provided. Patient sought medical attention. No product quality complaint (PQC) was involved. No further adverse event information reported. Additional information has been requested.
The 6 Patients received full vial or 6 doses each of the Pfizer COVID Vaccine; Sore Arm; This spontaneous report from a contactable nurse reporting same events under the same suspect product for six patients. This is one of six reports. A 12-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0191 and expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 20May2021 at 09:16 (at the age of 12-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0183 and expiration date was not provided) for covid-19 immunization. The patient received full vial or full doses of the Pfizer COVID vaccine on 20May2021 and had sore arm. Caller was a Registered Nurse and a Clinic Manager at a Medical facility. They had a dosage error involving 6 patients. The 6 Patients received full vial or 6 doses each of the Pfizer COVID Vaccine. Patients were 12, 16, 17, 18 and 32 years old and still waiting for additional information of the last patient. She currently didn't had data on the genders of the patients. She agreed to be called back for additional AE reporting. Outcome of the event sore arm was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.  Follow-up (27May2021): This is a spontaneous report from a Non-clinical study report form via a contactable Nurse included that: Therapy dates of the suspect product updated, anatomical location where the vaccine was administered (right arm), Batch/Lot number updated, added new event (sore arm), onset date of the event, outcome of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.   Follow-up (16Jun2021): New information received from a Non-clinical study report form via a contactable nurse included that: No new adverse events were reported by the patient.   Follow-up attempts are completed. No further information is expected.  Follow-up (01Jul2021): This is a spontaneous report from a Non-clinical study report form via a contactable Nurse included that: No new adverse events were reported by the patient. New information included as patient received their 2nd dose today. Lot/ batch number: EW0183  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021616982 Same reporter/product/event, different patient;US-PFIZER INC-2021617272 Same reporter/product/event, different patient;US-PFIZER INC-2021617273 Same reporter/product/event, different patient;US-PFIZER INC-2021617274 Same reporter/product/event, different patient;US-PFIZER INC-2021617275 Same reporter/product/event, different patient
"It felt like flu-like symptoms". 103 temperature for two days, chills. Started approximately 24 hours after the injection.
Three hours after vaccination, states began to  feel cold inside, had leg muscle pain, joint and knee pain, and back was hurting. Also reported that she felt "like I was swallowing something". Drank orange juice and water without difficulty. Felt weak after sitting to rest for 40 minutes. Worked her entire night shift even after being advised to go to emergency room for reported "difficulty swallowing". She took Benadryl at 6am on 1/13/2021 and again at 9pm 1/13/2021. No problems with eating and drinking. States felt feverish for 15 minutes and it resolved without medication. On 1/15/2021 at 11:00am is feeling better other than injection site has mild tenderness.
Rash appeared around injection site within 48 hours of administration. Triamcinolone 0.1% cream prescribed. Rash cleared up within 30 days of initial vaccination.
This spontaneous report was received from a physician concerning to a 65 year old female patient with hyperthyroidism. The patient did not have any known drug reactions/allergies. There were no concomitant medications. On 11-MAY-2017, the patient was vaccinated with ZOSTAVAX lot # M035693 with expiration date on 07-NOV-2017 with its respective diluent for prophylaxis (the strength, dose, frequency, and route were not provided). On 16-MAY-2017, the patient experienced severe pain at injection site, raised red rash the size of a quarter, flu like symptoms, and low grade of fever. There was not treatment given for the adverse event, and no laboratory studies were performed. At the reporting time, the patient had not recovered from the events. The causality assessment was not provided. Additional information has been requested.
Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Tachycardia-Severe, Additional Details: Patient received vaccine on monday 12/13/21. Patient reports that 24 hours later, he was transported to Hospital with increased blood pressure, a heart rate of 200 BPM, and was gasping for air.  Paramedic on ambulance said this was the myocarditis associated with the vaccine, however I am unsure if this was actually diagnosed, or if it was just speculation on the paramedic's part.
neighbor had swelling in his knuckles, got tight; neighbor had swelling in his knuckles, got tight; This is a spontaneous report from a contactable consumer. This is report 2 of 2. This case is for the reporter's neighbour.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. No medical history reported. No concomitant medication reported. The reporter states his neighbour had swelling in his knuckles, got tight. Reporter says he has no numbers for the vaccine taken. He had his Pfizer vaccine over a month ago. His neighbour said,Its not bothering me now(3-4 days ago). The outcome of Events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I have tested positive for Covid using Antigen test on May 27, 2022.  This is less than one month since my 4th dose of the Pfizer vaccine. I do not understand why this has happened.  I have done nothing unusual. I am retired. I am now quarantined for 5 or more days. The symptoms of nasal congestion and sore throat are deminishing.
15 days after 2nd shot, my joints hurt, I developed a fever of 102.5 and terrible chills.
Pt. received flu shot and developed MS flare while pregnant.Pt. hemiparetic with residual after IV Solumedrol.60 day follow-up states it is unknown if the pt recovered.
I am being cold; I am in bed with the electric blanket, I was shaking with the side effects; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced being cold, she was in bed with the electric blanket, she was shaking that bad with the side effects on an unspecified date. She started getting shaking so bad when she was out of bed, she got colder. The outcome of events was unknown. A Product Complaint was filed.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. An elderly male patient of an unspecified ethnicity received PREVNAR 13 (batch/lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date at 0.5 ml, single for vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at injection site and swollen arms after receiving the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) vaccine. The events recovered on their own without treatment or medications. The information on the batch/lot number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018036735 same reporter/drug/event, different patient.
There was no adverse reaction , but patient received an expired lot on 04/03/2023 We received lot # FL2757 on 02/02/2023 , Kept in fridge up to 10 weeks following  CDC  temperature recommendation , BUD was 04/13/2023. The  expiration date is up to 18 month from the manufacturing date , which was 03/ 31/2023.  The expiration date is not on vaccine box , but the manufacturing date. Somehow it did not cross our mind the vaccine could be expired before the BUD , the vaccines expired before the BUD which was 04/13/2023. The expiration date is not listed on box , but we added the BUD on box  upon receiving the vaccines. From now on , I added both BUD and Expiration dates on box to prevent further incident.
48 hours after vaccine reports fever & chills with headache. Red, tender & swollen at injection site. Arthralgia developed 72 hours after vaccine. Treated with ice at site oral TYLENOL with some relief and BENADRYL with good relief no symptoms 7 days after vaccine.
Pt received his first Pfizer shot at 1305 about 5 min later while making 2nd dose appointment pt passed out hitting his head on the floor. Pt is assist onto stretcher after C- spine is secured and a collar is placed vitals are HR 77 spo2 96% BP 120/73 BG 109 12 lead. Sinus Rhythm. Pt is transported  to Hospital. To ED via EMS
Flu Vaccine was taken Friday September 17, 2021 around 8:45am at Hospital, after the vaccine on the left arm was a little sore, on Monday September 20, 2021 woke up with a small bump and redness. Tuesday morning bump got bigger and redness is tender and hot.
Pain and inflammation medial bicep Approximately 2x4 inches Resolving after 2 trails of Benadryl and heat compress
Vertigo, Vision changes, Retinal vein Occlusion of left eye, weakness, tachycardia, Hypertension
Pt received vaccine and was sitting in observation area. Observation nurse observed pt sliding onto floor. Pt was unconscious for 10-15 sec. On-site EMTs came to pt, placed him on his side. He resumed consciousness, was able to respond appropriately to questions. Pt did not hit head per both observation nurses. Pt denied hip pain, head pain. pt was hooked up to VS monitor. All VS were WNL  (BP 100/63, HR 64, PSO2 98% on room air, RR 16). Blood glucose was also checked = 86. When pt was assisted into seated position, BP dropped. After sitting up, pt then stated he felt nauseous and vomited. Pt was advised d/t nausea and BP instability he should be transported to ED for assessment. Pt stated understanding and agreed w/ plan of care.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 13:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Other medication in 2weeks is Yes. On 27Jun2022 patient started other medication in 2 weeks and brand is Revlimid. On Jul2022 patient stopped taking it. No any treatment an dno allergies were reported.  No follow-up attempts are possible. No further information is expected.
This was a booster dose of Moderna after receiving the J&J vaccine in March 2021.  2 days after receiving the J&J vaccine in March I'd had a sudden onset of tinnitus that remained at a constant 4/10 volume afterward.  I filed a separate VAERS report about that first incident.  2 days after receiving the Moderna booster in late November I had a sudden increase in the tinnitus effect (ringing with some whooshing, no pulsing, no negative effect on the sound of music or speech), nearly doubling it to about a 7/10 volume.  Over the next few weeks the strength of the effect varied from day to day, at some points going as high as 8/10 volume and at others going down to as low as 2/10 or 3/10 volume, but this eventually stabilized to a constant 6/10 volume and has remained there ever since.
Can I break out in shingles from the vaccine/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix shot and still got shingles from the vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
really really sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION COMPLICATION (really really sick). At the time of the report, VACCINATION COMPLICATION (really really sick) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non Significant Follow-up appended no new information
Initial case was received from a health care professional on 07 October 2013. A 50-year-old male patient had a history of Insulin Dependent Diabetes Mellitus, received a dose FLUZONE MDV vaccine on 25 September 2013 (route, site not reported and batch number UH906AB). Patient had not reported concomitant medication. It was reported that on 03 October 2013 patient feels feverish (temperature noted as 99.6F), exhausted and aching all over. No corrective treatment was reported. At the time of report the outcome of event was unknown.
mouth cold sores; This is a spontaneous report received from a contactable Pharmacist reporting different events under the same suspect product for 10 patients via medical information team. This is one of 2nd report. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date unknown) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had an outbreak of mouth cold sores. Outcome of the event was reported as unknown.  Information about lot/batch number has been requested
I had laparoscopic cholecystectomy 6/28/2021 and presented to my PCP with shortness of breath and dyspnea.  On July 6, 2021, I was diagnosed with findings on CT scan revealing extensive embolic material in the subseqmental and segmental branches of all 5 lobes as well at the bifurcation of the right main pulmonary artery.  There was a small infiltrate in the left lower lobe which may likely be developing pulmonary infarct.  There was also embolus present in the left lower lobe pulmonary artery with extension into multiple seqmental and subsegmental branches.  Since starting blood thinner I have not had any breathing issues.  Will need to take blood thinner for remainder of my lifetime.
Mild headache started 1:30 pm, then mild backache & uneasy stomach itching to R eye Thurs evening - Friday 11/6/09, R eye sore & still itching. Saturday 11/7 R eye swollen shut, sore, & itching. Sunday 11/8, states more swollen shut. Applied cold compress Fri evening, Saturday, & Sunday. Monday 11/9, R eyelid pink/red in color & swollen. Eye visible.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 15-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804109 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
patient was fine until a week later when started getting dizzy and throwing up. taken to ER, but didn't tell them had been vaccinated. Couldn't find anything wrong and was sent home after a few days.  Went to ER again and this time wife told them he had been vaccinated week before symptoms started. Did brain MRI and found a blood clot. Pt currently in rehab.
The second dose of Rabavert planned to be received on day 22; Case reference number US-BN-2022-001627 is a spontaneous case report initially received on 22-Jul-2022 from a health care professional via Communication (reference number USBAV22-0630) and concerns a 21-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 30-Jun-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) at a dose reported as standard dose, intramuscularly, at an unknown site of administration, for pre-exposure immunization against rabies.  On an unspecified date, 22 days after the first dose (as reported), the patient showed up for the second dose of RabAvert (batch number: unknown) for pre-exposure immunization against rabies (explicitly coded as 'Missed dose').  At the time of this report, it was unknown whether the patient experienced any adverse events due to RabAvert vaccination, nor if the patient received the second dose.  Additional information received from on 22-Jul-2022 included local case ID.; Reporter's Comments: A 21-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure immunization against rabies and on an unspecified date, 22 days after the first dose the patient showed up for the second dose of RabAvert and it is unknown if the patient received the second dose, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 21-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure immunization against rabies and on an unspecified date, 22 days after the first dose the patient showed up for the second dose of RabAvert and it is unknown if the patient received the second dose, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.
Patient reported to the clinic at approximately 0900 on 06 Sep 17 with hives all up her left arm extending onto the left side of her chest and the left side of her neck. Pt states that they are very itchy and put Benedryl on them the night before. Pt denies any difficulty breathing.
Employee experienced pretty bad achiness, within 48 hours developed rash, still has at time message left (12/28/2020), injection site pain.
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21.  Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery.  Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.