chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 08 November 2013 from a health care professional. A two month-old patient who had no illness at the time of vaccination had received on 04 November 2013 the following vaccines: an intramuscular dose 1 injection of DAPTACEL, lot number C4452AA (site of administration not reported), ACTHIB (lot number, route and site of administration not reported), IPOL (lot number, route and site of administration not reported), PREVNAR (other manufacturer, lot number, route and site of administration not reported) and Rotavirus (other manufacturer, lot number, route and site of administration not reported) and two days later on 06 November 2013, the baby had inconsolable crying for 12 hours and was taken to the ER and was then hospitalized for observation (dates not reported). No further information was available at the time of the event. The patient's outcome was not recovered/unknown. Follow up information received from a healthcare professional on 17 December 2013. The responsible physician contact number update. The patient had received dose 1 of ACTHIB vaccine (lot number: UH849AA), dose 1 of IPOL vaccine (lot number: H1605), dose 1 of PREVENAR vaccine (manufacturer: Pfizer, lot number: 652010) and an oral dose 1 of Rotavirus vaccine (manufacturer: Merck, lot number: H016259). Documents held by sender: none.
DEAD; DEVELOPED BLOOD CLOTS; COUPLE STROKES; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, she developed blood clots followed by a couple strokes, now she dead (cause unknown). It was not reported if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and strokes was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220136326-COVID-19 VACCINE AD26.COV2.S-Dead,Developed blood clots,couple strokes This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Small bowel obstruction. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pt c/o of left arm pain after injection and for several days after. Pt was in bed for 2 days after injection c/o generalized malaise and weakness. Pt c/o of feeling of funny heart rhythms and feeling of constant anxious feeling. Pt started having episodes of SOB and was very labored doing simple tasks such as using the toilet. Pt started using o2 for the first time and had to recover for any activity for several minutes. Different medications were tried to help control symptoms such as Morphine for SOB and ativan for anxious feelings. Symptoms were never well managed after vaccine. Pt eventually died from worsening symptoms on 3/20
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: After administering the immunization, the patient proceeded to the lobby where she sat down. She began to feel nauseous and rose from her seat. She then passed out. I ran out to the lobby and tried to get her to her seat, where she then fainted again. A this time we had a nurse come over and check her blood pressure that was approximately 90/50. After about 5 minutes her blood pressure normalized to approx. 120/80. After 15-30 minutes, her mother picked her up and took her home. No complications
Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient presented with break through chicken pox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Patient tested positive for COVID-19 after receiving both doses of the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after receiving both doses of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after receiving both doses of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after receiving both doses of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test positive: Positive.     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.   No Concomitant medications were provided by the reporter. No Treatment history was provided by the reporter   This case was linked to MOD-2021-114608 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: non significant follow up received on 10-MAY-2021 contains no new information
PT given MMR DTaP HDE Hep B. 1 -2 mins later PT had itchy teary eyes, cough, S.O.B. 4-5 mins given Nebuliza treatment oxapen 1.25 mg. Vomiting x 1 during treatment. Still SP?? Erinephroux 0.1 ml given. 6 mins later PT better. Sent home on prepared medication ITan (?) and Benadryl.
Patient inadvertently received vaccine after published expiration date. Moderna company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 at time of administration. Patient also did not call in to complain of adverse event.  This is administrative error without adverse event.
Developed rash over body that was itchy within 24 hours of getting flu and covid #2 vaccine Urticarial in appearance and some rash appearing like erythema multiforme. Per family no resp difficulty or vomiting
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that no temperature excursion had occurred. It was reported that the vaccine was placed in the refrigerator on 27-Nov-2021. No adverse events were experienced by the patient. No concomitant medications were reported. No treatment medications were reported.
Death; This case was received via VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 10-Feb-2021 The patient died on 10-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  It was reported that Patient had no scanned records on file and no further noted regarding events from this time to date of death. No autopsy results were available. 27 days from date of vaccine to date of death.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information cannot be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death
patient was administered Tenivac Subcutaneously instead of intramuscular; redness at the injection site; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 years (also reported as 37 years) old female patient who experienced redness at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 29-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6187AA via subcutaneous route in left back upper arm.  On 29-Apr-2019, on same day after the vaccination, the patient experienced injection site redness (vaccination site erythema).   It was also a case of actual medication error due to inappropriate route of vaccination as Tenivac administered Subcutaneously instead of intramuscular.  (Other relevant tests included no lab data.)  Final diagnosis was injection site redness.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
pt recvd Tetanus vax & pt devel rt brachial plexities also referred to as neuralgic anyothropy, autoimmune deficiency & permanent nerve damage to rt upper extremity;
both doses of Pfizer BioNTech COVID 19 Vaccine the Bivalent Gray Cap; Arm swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, 30 ug single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (COMIRNATY). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2;bnt162b2 omi ba.4-5 (Dose: 01, Lot/exp/NDC Unknown), when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "both doses of Pfizer BioNTech COVID 19 Vaccine the Bivalent Gray Cap"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "Arm swelled up". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient received the Pfizer BioNTech COVID 19 Vaccine the Bivalent Gray Cap. Her arm swelled up and was swollen for 4 weeks or more. She had complications in that regard. She was okay then. This was just mentioned in passing. She appeared to have recovered completely and has normal function now. The event occurred after the second dose.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml single-dose vial (SDV) (lot # L019297, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that a patient received a dose of ZOSTAVAX, subcutaneously (dose 1), from an unspecified pharmacy on 17-MAR-2014. The pharmacist reported that this patient was inadvertently administered a second dose of ZOSTAVAX on 18-MAR-2014. No adverse effects reported. The outcome of inadvertently second dose administered, one day after first dose and no adverse event is unknown. The reporter considered inadvertently second dose administered, one day after first dose and no adverse event to be not related to ZOSTAVAX. No further information provided. Additional information will be requested.
Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side.; Swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 05Feb2021 at 08:45 at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 15Jan2021 at 08:45 AM at single dose for COVID-19 immunisation. Medical history included allergies to cephalexin and codine. Concomitant medications included ibuprofen (ADVIL). On 06Feb2021 at 08:00 AM, the patient experienced swollen painful lymph nodes in under arm, along collarbone, and neck up to base of the skull on the left side. The patient was not pregnant at the time of vaccination. No treatment was received. The patient was not tested covid-post-vaccination. The outcome of the events was recovering.   Follow up (17Feb2021): This follow up report contains no new medically significant safety information.  Follow up (18Feb2021): This follow up report contains no new medically significant safety information.
Developed flushing, swelling of both legs and feet. Later had some urticarial rash on legs and abdomen.
Myalgia, Arthralgia, NauseaVomiting, chills,headache Narrative:  Good afternoon, I wanted to reach out to you because I received my second COVID vaccination yesterday, January 12th at 9:30am. I have been experiencing some side effects as a result of the vaccination and felt as though I should let your department know for data tracking purposes. My side effects are as follows: - Chills - Nausea - Joint pain - Muscle aches - Headache I started feeling off last night around 9pm and I woke up at 3am this morning with severe joint pain and a headache with the other symptoms escalating as the day went on. I have been taking Tylenol every 4-6 hours which has helped. Please let me know if you have any questions or if you need any more details.
Chills, fever 103 degrees, nausea, vomiting, severe dizziness, confusion
Pt states that he came in on 4/9 and got a shingles shot. Pt states that he had some soreness on arm and slight aches the next day. Pt states he was working today and some coworkers noticed he was breaking out in a rash on his forehead. Pt states he also has rash around injection site of his arm. States he is feeling a little more achey again but no trouble breathing.
"Black and blue" coloration on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING ("Black and blue" coloration on the injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 028A21) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (takes diabetic medication). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE BRUISING ("Black and blue" coloration on the injection site). At the time of the report, VACCINATION SITE BRUISING ("Black and blue" coloration on the injection site) had resolved.            Concomitant medication included "Diabetes medications" (unspecified). and Aspirin  The event onset 7-10 days after first dose and which resolved spontaneously within approximately one week.  No medications were taken for the treatment of the event.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information received on 06-Aug-2021 included no new information.
Hives over 90% of her body, pain and swelling in joints, toughness swallowing and pain in throat.
Fever that went to 101F; Became tired; Shortness of breath; Pain from her head to her toes; Swelling below the injection site; A spontaneous report was received from a Healthcare Professional concerning a female  patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 25 Jan 2021, post vaccination over few days, she was tired, had fever that went up to 101 F and pain from her head to her toes, self treated with Tylenol and Motrin. She had an episode of shortness of breath and used two puffs of albuterol. She noticed swelling below the injection site around 10 cm x 5 cm. She reported no problems to her first shot.   Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of events were not reported.; Reporter'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.
Tdap given approx. 4:30pm on 8-8-11. Pt came in office on 8-9-11 with c/o red dt, edema, warm to touch, & pain. Saw PA. Line drawn around red area. Pt. returned to office AM 8-10-11, red area enlarged, edema but less tenderness & warmth. Tx with KEFLEX 250mg 1 Tid x 7d, & Prednisone. 8-15-11 pt states she is doing fine.
Mother states patient went to school after receiving vaccine and displayed seizure behavior 2 hours after vaccination, i.e., "stood up, fainted to the floor and twitched".
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-DEC-2014 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (HSA, lot # J006136, expiration date 22-OCT-2016, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 324 hours with the highest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Site of injection was red and warm to touch. There were raised bumps near injection site. It resolved on its own in three to four days
Vasovagal syncope post vaccine; nausea, sweating, disorientation, rapid heart rate, faint.
SEIZURE at exactly 28 minutes post-injection.  Unconscious for 34 minutes.  Observed at clinic until ambulance transportation to Medical Center
5-10 minutes after patient received vaccination he complained of feeling disoriented.  Patient was seated  approximately 6 feet in front of pharmacy counter and I went out to check on him.  Patient was sweating profusely and again complained of feeling disoriented.  I asked if he was feeling nauseous and he said no.  I placed a cold compress on the back of his neck and had him try to relax and breath evenly.   I then  got a ice pack for him and wrapped it in towels to protect the patient from the cold.  Offered patient some water which he denied.  Offered to call an ambulance and patient denied.  I took the patients blood pressure and it was 140/84. Patient states this is slightly higher than normal for him.  After 5 more minutes patient began to recover quickly.  Sweating stopped and his color returned to normal.  Patient stated he felt much better.  I took patients blood pressure again and it was 133/94.  Patient stayed under observation for another 15 minutes and said he felt fine and left the pharmacy.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. On an unspecified date in 2009, the patient was vaccinated with dose 1, GARDASIL 0.5 ml, intramuscularly (IM). Lot number was not specified. But again on an unspecified date in 2012, the patient was given her second injection of GARDASIL. Dosage and the lot number were unspecified. No adverse effect was reported. Additional information has been requested.
diagnosed with COVID after receiving first dose of vaccine; diagnosed with COVID after receiving first dose of vaccine; This is a spontaneous report received from a contactable consumer. A 58 year-old male patient received first dose of BNT162B2 (COMIRNATY Vaccine , solution for injection, Lot No unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunization. Patient Medical history and concomitant medication were not reported. Patient was diagnosed with COVID-19 after receiving first dose of vaccine. he patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Apr2021. Outcome of event was unknown.  Information on the lot/batch number has been requested
Headache,aches, stiff neck & along spine, heart racing, bouts of high anxiety lasting 6 plus hours.  Duration- 2weeks.