chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    Concomitant medications were not reported.  None of the patients have reported any adverse reactions at this time.  Treatment medications were not reported.  This case contains information for patient 03 out of 06.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Patient 3 out of 6
Mother noticed a red, swollen whelp on both of the inside of thighs within 2-3 hours after receiving vaccines. They were 3x4 in. mother gave her a cool bath and ran to the store for BENADRYL. By the time she was home and received BENADRYL redness, swelling were gone.
Severe site erythema, warmth, induration, pain and edema to about 8cm surrounding injection site.
HEAD COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced head cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head cold was not reported. This report was non-serious.
pt stated neck became stiff 2NOV93 so stiff was in bed for 2 days; 2NOV93 went to MD dx w/strep infection & took PCN as ordered; 5NOV93 became more ill, went to ER seen by MD: states neck spasms, problems w/numbness in face & eyesight;
Auto-inoculation left deltoid arm parallel to injection site. Redness with small pustule.
Episode of like a sleep paralysis; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the first dose of 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 experienced episode of like a sleep paralysis on an unspecified date. Nurse stated, "I am a Nurse, I am going today to get my second, my booster for the Pfizer vaccine. And last time I went to get my booster, they turned me away because I had side effects and I'd told them that. I otherwise felt fine besides having like episode of like a sleep paralysis. And they freaked out and they wanted me to contact you guys to make sure that it is okay. So, they rescheduled me for today. And I send my, I did that online, like my COVID checking thing and I told them about my symptoms but I haven't been contacted by anybody. So, I just wanted to call to be sure before I go for the second COVID Vaccine." The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
256pm c/o lightheaded, BP150/84 p 84 P 78, gave water to drink.  301pm BP 154/67 P 82,  313pm BP 156/68 P 76,  315pm pt arrived to Covid clinic, pushed to exit by staff(RN stated pt was fine.
Patient has red, warm, swollen area to right upper arm that is palm sized. Sx started on 6/11/19, Mom drew a border with a pen. This border washed off while patient was in kiddie pool. New border was drawn 6/12/19 and today there is slight redness outside the borders. Today in office, 25mg of benadryl was given PO in tablet form. Instructions were given to patient to start using motrin routinely at home to help decrease inflammation/clotting. Antibiotic Augmentin 875/125mg prescribled today for a course of BIDx10 days.
After my first dose, I became very dizzy that night and called my doctor. She gave me advice. The next morning after the first dose, I was very, very tired and stayed in bed the entire day. The second dose I was not as tired, but still experienced some fatigue
This spontaneous report as received from a medical assistance refers to a 80 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L012521, expiration date: 01-FEB-2017 (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (Lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 23-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This report is one of the several reports received from the same source. Additional information has been requested.
-  got my phizer vaccine in my left arm  - walks to 10-15 min waiting room  - sits down and is looking at my phone for 3-5 mins  - slight nausea hits and I start feeling dizzy - my eyes start going black snd I feel really hot - I tell the lady watching everyone that I don't feel good. A nurse and another woman come and put me in a wheelchair so I don't fall out of a chair if I faint  - my eyes are going more black and I'm profusely sweating all over my body - I faint and convulse for 5 seconds - I wake up from passing out and my hands and feet are extremely tingly and feel like they have a million pins in them -  my hands started cramping really bad and I can almost not open them for 5 minutes - over the next 15 mins the tingleynes and hand cramps completely fade away and I feel normal
Patient presented to ER via ambulance with an anaphylactic reaction to a flu shot. Shortly after receiving a flu shot at work, patient experienced itching, numbness to extremities, weakness, shortness of breath, and eventually became cyanotic. Epipen was administered and life squad called. IV was started and aerosols were given en route. Upon arrival to ER patient was blue and hypotensive. Treatment included hydration, Solumedrol, Pepcid, Benadryl, and aerosol treatments. Patient was still short of breath and was admitted to ICU for observation. History and physical revealed that patient had a similar reaction to iodine IVP dye two years ago. Reaction resolved and patient was discharged the next day. A follow up report received 11/21/2003 adds: (in hospital) Pt improved and was discharged 2 days later.
Pt. felt flu like symptoms, (R) arm red and swollen at site of inj.
This child broke out with just a few rashes on arms and back. She had a small amount that were disappearing fast.
Presented to Emergency Dept with acute chest pain, somewhat positional, on 03 July -- two days after reported receipt of 2nd dose Pfizer vaccine.
Severe pain in upper left arm & shoulder (SIRVA.) Treatment has included resting, stretching, icing, heating, and taking NSAIDs for inflammation and pain. Symptoms have improve since day 3 after vaccine, but pain in the left shoulder still exists - especially when pressure is put on the arm.
"not feeling well"; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("not feeling well") in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE ("not feeling well"). On 13-Mar-2021, MALAISE ("not feeling well") had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-061036 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-SEP-2011, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the female patient was treated by a physician at a clinic for a blistering vesicular outbreak, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of the 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 outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Arm warm to the touch and presented with reddened skin below injection site. Slightly swollen. Patient had some difficulty moving the arm due to pain.
Severe tinnitus.  It as not stopped since March 22, 2021 when it started.  Very high pitched ringing inside my head.  It never stops.
felt sick for 4 days/pretty sick; sore red arm; This is a spontaneous report from a contactable consumer (patient, self-reported).   A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 09Feb2021, as a single dose for COVID-19 immunization. The patient medical history included COVID-19 in an unspecified date in Nov2020 for 2 weeks but did not have to go to the hospital and recovered. Concomitant medications were not reported. Patient and her husband also received the Pfizer-BioNTech COVID-19 Vaccine first dose 2 weeks ago, on 09Feb2021. On an unspecified date, the patient felt sick for 4 days and had a sore red arm for a week and asked if this is normal. The patient asked is it true that if you had COVID-19, you would get more severe side effects on the vaccine and is it normal to get a pretty good reaction after this first vaccine. Patient and her husband both got pretty sick after getting the vaccine not the day of but the next day. She mentioned her arm was red and sore for about a week. Overall, it took her 4 days before she felt okay. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
chills; fever; aching arms; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK 4176) via an unspecified route of administration on the left arm on 22Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included allergies, high blood and cholesterol; and diagnosed with COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. On 23Jan2021, the patient experienced chills, fever and aching arms. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, fatigue, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 17 December 2008 via an interview between the subject and attorney (s). The subject was vaccinated with LYMERIX at his place of employment on 11 February 2000, 17 March 2000, and 22 February 2001. After the first vaccine, he developed joint pain. He was reportedly advised that he had rheumatoid arthritis. After the third LYMERIX vaccine and prior to April 2002, he developed fatigue and insomnia. On unspecified dates after the third LYMERIX vaccine he developed depression and brain fog (including confusion). In 2002 he developed hair loss and nausea. In 2006 he developed burning, tingling, and shooting pains. In 2007 he developed high blood pressure. Treatment included VIOXX, prednisone, and methotrexate, which he eventually discontinued due to side effects. With the exception of brain fog, the events were unresolved at the time of reporting. This case was assessed by GSK to be medically significant based upon follow up information.
she was prescribed with some antibiotics due to a sinus infection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: SINUSITIS (medically significant) with onset Dec2022, outcome "unknown", described as "she was prescribed with some antibiotics due to a sinus infection.". Therapeutic measures were taken as a result of sinusitis.  Clinical course: Reporter mentioned that his wife received the Pfizer-BioNTech Covid 19 Vaccine (gray cap bivalent) 2 days ago (on the 7th). And then she was prescribed with some antibiotics due to a sinus infection. He wanted to know if there would be a contraindication between the vaccine and the antibiotics she was prescribed. It was not clear if the infection was due to the Pfizer-BioNTech Covid 19 Vaccine.  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.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, lot number L001325 and expiry date: 13-JAN-2017, (dose, route of administration and injection site were not provided). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information has been received on 03-AUG-2015 informing that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received on 05-AUG-2015 from the reporting certified medical assistant via telephone call. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old patient of unknown gender. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot number was confirmed as L001325 with an expiry date of 13-JAN-2017. This is one of the several reports received from the same reporter. Additional information has been requested. Patient's details, suspect details, event information and narrative were updated.
17JAN95 pt exp sz (infantile spasm) w/in 4hrs p/vax-lasted about 15mins;called MD/nurse was told pt probably angry;low fever 100.5;told to give motrin;18JAN95 2nd sz (infantile spasm) same time of day;taken to ER dx infantile spasms;jerks
Dizzy; Tired; Headache; Nauseaus; Constipation; Swollen face; This is a spontaneous report received from a Pfizer sponsored program COVAX US support. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy, tired, headache, nauseaus, constipation, swollen face. The outcomes of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Approximately five hours after receiving TDAP vaccine, patient had seizure - went to ER - then to Dr. Treatment DILANTIN 100mg qd.
This spontaneous case, initially received from other health professional (pharmacist) on 25-Sep-2018, concerning a 65-year-old, elderly, female patient. On 24-Sep-2018, suspect vaccine, FLUCELVAX QIVc was left in the cooler and the temperature reached 34.4-degree F. The average of the incident was about 35.4-degree F for a period for 45 minutes. This was the first-time excursion. On 25-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) which underwent temperature excursion. The patients had not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case was linked to case number: 201804054 due to same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed that the vaccine was administered on 25-Sep-2018 and temperature excursion also occurred on 24-Sep-2018. The narrative was amended accordingly.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: W/in 15min the pt had pain on left side up her neck and down her arm. Said neck "aching as if she was getting a sore throat". Had concerns of an allergic rxn so admin 1 dose of benadryl. No reports of difficulty breathing, swelling, or itching. W/in next 10 minutes her voice started cracking severely. Called emergency services number because she started to experience chills and some shaking in addition to voice loss and pains on L side. Declined hospitalization. F/u 3hrs later and pt ok but still no voice.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
3 inch wide red area approx 2/3 of the way around his arm. Patient reported redness, swelling, warmth in that area. Also reported dizziness and upset stomach. Patient came back to the pharmacy 5 days after injection and said symptoms were resolving.
Initial information received from other company (Merck) on 21 December 2012. This information was initially reported by a healthcare professional. A female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Batch number, dose number, route and anatomical site of vaccination were not reported) on 01 December 2012. It was reported that on an unspecified date, after vaccination, the patient had experienced an unspecified "reaction". Laboratory investigations and corrective treatment were not reported. At the time of report, the outcome of the event was not reported. Follow-up information received from the healthcare professional on 23 April 2013. The patient's age was updated as 75 years. The patient had received 0.5 ml dose of FLUZONE (batch number U45224AA, expiry date: 4/21/13) intramuscularly on the left arm. List of documents held by the reporter: None.
Pt began exp flu-like sx approx 1 mo p/flu vax; sx progressed, & pt sought med tx on 14MAR91; pt dx GBS secondary to flu vax; pt unable to return to work due to residual weakness & fatigue;