chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration; After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) and PRODUCT STORAGE ERROR (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) and PRODUCT STORAGE ERROR (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that, Date the vial was initially stored in the refrigerator was 12-Apr-2022. Date and time vial was first punctured was 13-Apr-2022 at 7:00 AM. Date and time of administration of vaccine was 14-Apr-2022 (this morning, probably prior to 9:00 AM). The vial was stored post puncture at Room temperature, drawn up into syringes.The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 16 hours. No concomitant medications were reported. No treatment medications were reported.
Patient received ROTATEQ on 8-25-08.  That evening had flecks (small spots) of blood in stool.  On 8-29-08 had another stool with small spots of blood in it.  Exam was benign.  Patient was followed clinically without reccurance.
Extreme vertigo with falls, ongoing vestibular imbalance with dizziness/nausea/vomiting/headache. Continuing as of this date (10/3/21)
Abdominal pain and chest pain. Seen in ED and found to have elevated LFT with AST 162, ALT 84, Alk Phos 114 which peaked at AST 695, ALT 809 and Alk Phos of 191 the following day and have started coming down since then.
Within 10 minutes of receiving vaccine, pt began to have mouth and tongue "tightness" and feeling that tongue was swelling. No obvious face or swelling noted to tongue, face, neck.  Pt denies shortness of breath but "tightness" continued so Benadryl 50mg administered orally.  Pt reported feeling much better and returned to baseline within approximately 15 min. Pt continued to be monitored for additional 30 minutes following Benadryl administration.
Fever & chills, muscle aches all over body, fatigue (slept a lot).
Patient presented with urticaria. Went to the ED and received a short course of oral steroids and Benadryl. Patient was stable to be discharged.
onset of shingles involving left forehead and scalp 16-18 days after shingles vaccine.
TIRED; This spontaneous report received from a patient concerned a 73 year old female.  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 not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination (dose series 1). No concomitant medications were reported.  On an unspecified date, the patient experienced tired (dose series 1). She reports she was fine after a day.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from tired.  This report was non-serious.  This case, involving the same patient is linked to 20211128823.
What risk if miss second dose of Bexsero?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was asking what was risk if missed second dose of Bexsero.
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus" (unspecified if ongoing); "hypertension" (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) all with onset 29Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (06May2022) Negative; (09May2022) Positive; (10May2022) Positive; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient became symptomatic on 29Apr2022. He had home antigen test Positive PCR test and started Paxlovid as anti-viral as treatment medication as lower renal dose due to diabetes from 29Apr2022 to 03May2022 . She retook home antigen test and was negative on 06May2022 and became symptomatic again on 09May2022, retook home antigen test and was positive 10May2022. Her symptoms include sore throat, runny nose which started on 09May2022 was recovering. She did not had know allergies and did not taken other medication in 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Heavy menstrual period ongoing from the start of my cycle; On and off cramps; breast tenderness; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:30 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 50-year-old) for covid-19 immunisation. Medical history included unusual periods, menopause from 2020 to an unknown, heavy menstrual bleeding from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Patient did not receive other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heavy menstrual period ongoing from the start of my cycle, on and off cramps, breast tenderness on 28Apr2021. It was reported that Heavy menstrual period ongoing from the start of my cycle on 28/29Apr. On and off cramps and breast tenderness. Although I have had unusual periods with clots being passed due to menopause for the last year. It had never ever lasted this long in my entire life. The outcome for all events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Information has been received from a registered nurse concerning a 60 year old female with history of a reaction to a flu shot (manufacturer unknown) in years past due to egg content of the vaccine, who on 20-OCT-2008 was vaccinated with a dose of ZOSTAVAX 0.5 ml, SC. After vaccination, the patient experienced nausea that had persisted. At the time of this report, the patient had not recovered. Follow up information was received from registered nurse which reported that no additional information is available.
no adverse event; Inbound call from HCP stating PNEUMOVAX 23 was inadvertently administered after it's expiration date.  No symptomatic side effects reported. No additional AE details or PQC.; This spontaneous report was received from a registered pharmacist and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 29-OCT-2022, the patient started was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T039322, expiration date: 09-SEP-2022 for prophylaxis (strength, dose and route of administration were not provided) after expiration date (expired product administered). No symptomatic side effects were reported (no adverse event).
Hypersensitivity rash 3 days after immunizations.  Hand swelling.
Pediarix was given instead of Hepatitis A. Pt did not return to clinic due to any adverse affect from wrong vaccine given. I called and spoke with Father about the incident and recommended he bring patient back in to complete the Hepatitis A series.
tested positive to covid.; tested positive to covid.; lot of inflammation in his lungs; This is a spontaneous report from contactable consumer. This consumer reported similar events for 2 patients. This report is the first of 2 patients. A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Feb2021 at single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was at a gathering where 9 out of 10 people (himself included) tested positive to covid. The patient experienced 102 fever, trouble breathing which required treatment by nebulizer, lot of inflammation in his lungs. The patient experienced a similar reaction 3 days after the 2nd dose of the vaccine in Feb2021 however he had tested negative in Feb2021, but at the time of report, 3 weeks after the second dose, the patient was positive (Mar2021). The patient had a positive Covid-19 test one day after first vaccine dose administration. The patient resulted negative to Covid-19 test in Feb2021 (3 days after the 2nd dose) and three weeks after receiving second dose of suspect vaccine the patient resulted positive to Covid-19 test in Mar2021. The outcome of the events was unknow. Information on the Lot/Batch number has been requested.
2019 Novel Coronavirus RNA detected 12/2/2021 Admitted to hospital 12/2/2021-diagnosed with pneumonia  and discharged 12/3/2021
Patient purchased PO Typhoid pills 6/8/06. Consumed #1 pill 6/14, #2 pill 6/16, #3 pill 6/18, #4 pill 6/20/06. Developed itchy rash on arms 6/18/06. Today rash has generalized to a fine, angry, clustered rash with welts on her legs. She showed rash to a pharmacist who recommended Benadryl. Intervention/intervened patient to check with PCP, no other new meds, soaps, detergents, foods introduced recently. Go to ER if respiratory problems develop. Plan: call Friday to check on progress. 6/23 -  message left. 6/27 - message left TAM, no response.
pt recv vax 4AUG97 & 9AUG97 pt exp low grade fever, joint pain, neck pain & exhaustion;lab eval revealed negative tests for lyme disease & lupus;
January 19, 2022 I came home from a trip and took at COVID test on the 22nd thru a drive thru and was positive for Covid.  No symptoms present and just did it as a precaution measure due to traveling.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-JUL-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as shingles. The outcome of the events is unknown. 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. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 16-SEP-2011 the patient was vaccinated with dose 1 of VAQTA (lot # not reported). No concomitant medications were reported. The health care worker stated that patient received two doses of VAQTA one each on 16-SEP-2011 and dose 2 VAQTA (lot # not reported) on 15-DEC-2011. No adverse effects reported. No further information available. Additional information has been requested.
9 days after getting the vaccine, my arm is red, swollen, warm and the skin is hard in a circle around the injection site approximately 3-4 inches.
Information has been received from a pharmacist concerning a "post menopausal" female volunteer at her facility who was vaccinated as a child with her first dose of MMR II (lot# not reported) and currently has negative titers. Also the patient had an allergic reaction to the first dose of MMR II. She may have received a partial dose of the vaccine sometime after the initial dose, but she does not remember the details. Her outcome was not reported. Additional information has been received from a pharmacist stating that she is not even sure that the patient had a reaction to MMR II. She states the patient "had a reaction to a childhood vaccine, but is not certain that is was MMR II. Furthermore it is also not certain that the patient was ever given MMR II". Additional information received from a pharmacist indicating that the patient had no previous records of having a vaccine, only remembers "a shot and my parents saying I was allergic". It was reported that she had no titers. Additional information is not expected.
rash around the injection site; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (rash around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE PRURITUS (rash around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not taking any concomitant medications. The treatment reported was topical cream for the rash.
she tested positive for Covid on the same day; she tested positive for Covid on the same day; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in Mar2021(3 weeks prior 12Apr2021) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive her second dose of Pfizer BioNtech Covid-19 vaccine last 12Apr2021, however she did not receive her 2nd dose because she tested positive for Covid on the same day. The patient stated that she didn't have the exact date but she received it 3 weeks prior 12Apr2021. Her healthcare provider recommended that she wait 30 days after testing positive to get the second dose but her vaccination provider told her wait longer than 6 weeks and start the series again. She was asking if she could receive the 2nd dose of the Pfizer BioNtech Covid-19 or restart the vaccination series again after what her vaccination provider and healthcare provider recommended. The outcome of the events was unknown.  Information about lot/batch has been requested.
Tetanus shot administered and pain in shot location has lasted three weeks and has not subsided.  Tetanus was administered with Flu shot in the same arm.
Headache, Myalgia, Arthralgia & NauseaVomiting Nausea, headache, body aches, joint pain
Swelling at site, hot and red skin at site, muscle pain, headache, trouble sleeping, burning skin at side, bumpy skin at site, itchiness at site
Sore arm started at midnight after shot - still have that; had low-grade fever, chills, and headache for 24 hours afterwards.
RECEIVED VACCINE AT 1615. BECAME SYMPTOMATIC AT 1624. "DIZZY". TREATED BY FIRE DEPARTMENT RESPONDING TO C/O DIZZINESS.   INITIAL VITALS SITTING: 104/72, 86, O2 SAT 97%, ECG-SINUS RHYTHM.  BLOOD GLUCOSE 108.  CONTINUED TO MONITOR.  PATIENT DENIES CURRENT MEDICATIONS AND ALLERGIES AND CLAIMS NO PAST MEDICAL HISTORY.  1635: STANDING BP 72/45, 79, O2 SAT 97%. 1636: SITTING BP 105/72, 80, 96%. 1642: SITTING BP 118/80, 83, 98%.               STANDING 119/84, 103, 98%, RR 20.
Five minutes after the patient's vaccination, he was standing behind his girlfriend, who was also receiving the vaccine.  After her vaccine, they both got up to leave the vaccination room, when he started to "stare off" and was lowered to the ground.  Patient likely had a vasovagal response; he never lost consciousness and was able to respond to questions immediately after.  Blood pressure and heart rate checked immediately after the event and 15 minutes post-event.  Vital signs stable.  Patient monitored for 15 minutes total, and patient then left the pharmacy to go to the food court to eat lunch.  (Patient reported some incidents of hypoglycemia, but reported eating breakfast ~1.5 hours prior to vaccination).
Woke up 3:00am on 11/01/2008 with fever.
This spontaneous report was received from a registered nurse referring to a 17 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
Patient reports that the next morning he woke up with  fever, body aches, headache, fatigue, shortness of breath, fatigue, congestion, dry throat and he feels his HR is elevated(never measured above 100BPM).
right eye--eye floaters, blurred vision, dark vision, decreased eyesight, flickering movement in eye, unable to read up close.  These symptoms developed one week after receiving 2nd Pfizer shot.  No previous eye problem. Saw ophthalmologist on 3-9-2021.  OCT Macula OU (retina) and OCT RNFL OU (optic nerve) pictures. Dr. said it was Macula ERM (epi retinal membrane).  Was told to come back in a year. Problem still exists to this date, 8-10-2021.  At time of doctor visit I inquired as to relation to Covid shot, with no response.  After researching previously reported retinal issued related to Covid vaccine, I am submitting this report and will be visiting my doctor again to visit other possible diagnosis related to Covid vaccine.
extremity tendonitis andperipheral arthralgia perhaps reactive arthritis no pre-existing contributing condition  tightened tendons both hands with left hand especially could not make complete fist nor stretch fingers straight out yet muscles remained relaxed, pain on pain scale was 3-5 on scale of 10, feet hurt when standing or walking with some arthralgia symptoms persist as of this date with minimal relief
Approx. 8 hours, post vax, pt had a seizure at home and was immediately seen at ER and transferred to a medical center. Seizure lasting about 5-10 minutes. Temperature 97.6F (AX), BP 94/70, P 155, R 48. Infant was alert and moving extremities but lethargic at hospital prior to transfer. Dilantin level very low.
pt c/o blurred vision on 2 occasions; once in 1990 & once in 1991 p/receiving flu-immune; seen by ophthalmologists-dx: early cataracts; pt is type II diabetic;
Information has been received from a pharmacist referring to 3 newborns (numbered 165, 166 and 167). Background: Since June 2015, there had been 1645 times (30 minutes each time+ 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 Minutes each time= 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 04-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Gave Zostavax instead of Varciella vaccine to a 12 year old. Patient also received Influenza, HPV, TDAP, MCV4 that day. Mother only signed one of the consent forms of the three she filled out. 0.5mL IM Zostavax in the right deltoid.
On 07-Jan-1999 the pt experienced breakthrough chickenpox. Subsequently, the pt recovered.
Lower leg pain, swelling.  Admitted to the emergency room on 03/29/2021. Ultrasound was done. Diagnosis was left leg DVT.   Treatment prescribed is 15 mg of Xaralto twice a day. Had a follow up visit with a physicians assistant on 04/09/2021. She prescribed 20mg of  Xarelto  once a day for the upcoming 2-3 months. Also prescribed Bisoprolol Fumarate 2.5 mg once per day.