chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; patient was administered PROQUAD after a temperature excursion; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 12-JAN-2022, the patient was vaccinated with a 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U019287 exp date 15-DEC-2022) (route not reported) after a temperature excursion. The temperature of excursion was 12.4°F for a time frame of 20 minutes. The previous temperature excursion was 6°F to 14°F (11.6F) for 25 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2203USA010843: US-009507513-2203USA010696: US-009507513-2203USA010795: US-009507513-2203USA010654: US-009507513-2203USA010652: US-009507513-2203USA010658: US-009507513-2203USA010686:
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Follow up information was received on 12-FEB-2016, from health professional regarding a 5 year old female patient. On 25-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
After the shot I did have a minor reaction and had a little soreness in shoulder. Approximately September 4 I started coming down with cough, cold, fever, ickiness, fatigue. September 8 I went and got tested and two days later I got the results and I was positive for Covid-19. I've been isolating since and feeling better now the last couple of days. It felt like a minor low grade flu. Monday, September 13 I started feeling better.
Patient ID:  72 y.o.    Admit Date:  8/12/2022   Discharge Date:   8/14/2022   Discharge Diagnosis:  Principal Problem:   Acute hypoxemic respiratory failure due to COVID-19 Active Problems:   DM (diabetes mellitus)   Long-term (current) use of anticoagulants   Essential hypertension   H/O mitral valve replacement with mechanical valve     Hospital Course:  72 year old vaccinated male was admitted for respiratory failure from Covid-19 pneumonia. He has been on Remdesivir with steroids and has improved. He will be discharged home today after receiving the 3rd dose of Remdesivir. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98.1 °F (36.7 °C) Heart Rate (Monitor): 60 Pulse: 63 BP: 119/61 Respirations: 18 SpO2: 99 % O2 Flow Rate (l/min): 3 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert   Consults:  None   Significant Diagnostic Studies:   CXR   Operations: nonr   Disposition:  Home    Discharge Condition:  Fair
Pt was given immunization about 30 minutes after 6 hour puncture window.  Contacted manufacturer. Representative stated that  their internal data shows that the immunization maintains potency for 24 hours at 2-30 degrees Celsius and and instructed to use our own judgement. Have not been able to contact the patient yet but will recommend not to repeat first dose and according to manufacturer data she should not experience any untoward effects and immunization should be effective.
aches in shoulder/back; Swelling size of an orange on arm; Aches in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (aches in shoulder/back), PERIPHERAL SWELLING (Swelling size of an orange on arm) and ARTHRALGIA (Aches in shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced BACK PAIN (aches in shoulder/back), PERIPHERAL SWELLING (Swelling size of an orange on arm) and ARTHRALGIA (Aches in shoulder). At the time of the report, BACK PAIN (aches in shoulder/back), PERIPHERAL SWELLING (Swelling size of an orange on arm) and ARTHRALGIA (Aches in shoulder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 99 (Inconclusive) elevated temperature of 99 degrees.         No concomitant medication was reported.  No treatment was reported.    This case was linked to MOD-2021-083604 (Patient Link).   Reporter did not allow further contact
After administering the shot, patient was very quiet. As I was filling out the rest of her paperwork, I asked her a question that she did not respond to, I noticed her sweating and start to fall forward. I was able to catch her, guard her head and lie her down, but she seemed to be seizing (clenching and unclenching her arms and feet, her eyes had rolled back, with teeth clenching ). She did not acknowledge when I called her name, but was making small noises. It lasted for a little over a minute before her vision was able to focus on me. I asked if she was alright, told her that she passed out and may have had a seizure; then I asked if she would like me to call an ambulance. She declined multiple time and stated that she fainted sometimes when she was scared (although never before with an immunization and no history of seizure, as was listed on the VAR). I offered her water (she declined) and to take her blood pressure (she declined) and told her to wait in the waiting room for at least 15 minutes while we monitored her. Patient was joined by her aunt (who was waiting for her outside) and I suggested that they make an appointment with patient's regular doctor, which patient again declined.  I settled them in, then checked on her at minute 5 and minute 10, she stated that she was "feeling fine" at both checks (no sweating or seizure signs either). When I went back to check at minute 15, they were already gone. Patient did not return my phone calls for follow-up later in the day.
I started feeling tired and memory was kind of foggy; stomachaches; zero energy; limited activity. For a few days to a week and then I took an at home COVID-19 test and it was positive. I reached out to my doctor, and he sent a prescription for molnupiravir until it was gone. Within a few days I started to recover and get better. Throat irritation has been something I have been trying to get over.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: 5 minutes after taking the vaccine pt stated that she felt dizzy and lighheaded. After about 10minutes later she started grabbing her throat indicating she cannot breath. we gave her 2 epipens 5 minutes after the 1st dose and called the ambulance
Chills, fever, diareaha, muscle aches, nausea, loss of appetite fatigue,
About 1 hour after injection I started feeling mild tingling in my face and throat. I then lost my voice for approximately 5 minutes. As the next few days started to progress I started noticing mild muscle spasms all over my body, mostly in my legs; waking up in the middle of the night, dry mouth, night sweat (1 occurrence), sudden onset of rapid and irregular heart beat (1 occurrence); kidney pain (right and left), upper abdominal pain (right and left). Prior to vaccine I did not experience any of these events.
Pfizer Monovalent COVID-19 vaccine administered to patient as second dose after first dose of Moderna Monovalent vaccine making it a mixed COVID-19 vaccine primary series.
Treatment of COVID-19; Treatment of 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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EW0150), in left arm, on 30Apr2021 as dose 2, single (Lot number: EW0167), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "lichen sclerosis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Known allergies: Buckwheat" (unspecified if ongoing); "Known allergies: rhubarb cause anaphalaxis" (unspecified if ongoing), notes: cause anaphalaxis; "anaphalaxis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) Positive, notes: home rapid test. Therapeutic measures were taken as a result of covid-19.  On 16Aug2023, investigation results for lot number EW0150 were reported as follows: The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine Injectable lot EW0150 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0150, fill lot EP8690, and the formulated drug product lot EP8587. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.  Follow-up (16Aug2023): This is a follow-up report from Product Quality Complaint Group providing investigation results for lot number EW0150.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300277247 same patient/reporter; different vaccine dose/event;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fell over after a few minutes after vaccine. Pt was standing by pharmacy, declined sitting. Patient reports feeling a little dizzy, heard thud and fell over. Awake right after falling over, didn't black out. Pt hit back of head, reports no HA so far, hurts a little, but not dizzy. Pt called advice nurse, waiting to hear back. Pt reports don't need to go to urgent care or emergency. Will follow-up with primary provider. Spoke to pt about importance of seeing dr, make sure no bleeding/SE.
Hx of ADD and past vaccine injection, vasovagal events. Pt was administered vaccine and was observed by sister to be faint, slow to respond  to questions. pt was diaphoretic, dazed, slow to respond, faint, Unable to obtain BP. EMS notified, EMS on scene at 9:53.  A&O x4, After EMS evaluation pt declined transport to hospital  for further evaluation. Pt given snack and water and pt walked without assistance with sister out of the building.
One half hour after the vaccines were administered the infant vomited liquid brown vomitus. The next day after vaccinations (Thursday), infant had a temperature of 103 degrees and again vomited X1-brown vomitus. The following day (Friday), infant had 2 black liquid stools. He was taken to the ER and was admitted.  They did stool testing which was positive for blood in the stool. Infant was discharged home in 1 day.
RIGHT LEG PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: feels sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced right leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of right leg pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20220200404.
16JUL92 630PM crying, fussy; 17JUL92 230AM lethargic, confused; 330PM t104.7;
TOOK A DOSE WITH FOOD; TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-208) on 22-Jan-2019 and a follow-up information was received on 23-Jan-2019. The report describes a female consumer who "took unrefrigerated doses" and "took a dose with food" The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer picked up Vivotif and left it unrefrigerated for 24 hours at room temperature before taking the first dose. Afterwards, the consumer refrigerated the Vivotif. When the consumer took the second dose of Vivotif, she took it with food.   The action taken with Vivotif with respect to the events "took unrefrigerated doses" and "took a dose with food" was not applicable.  The clinical outcome of the events "took unrefrigerated doses" and "took a dose with food" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" and "took a dose with food" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" and "took a dose with food" was considered as not applicable.
breathing needs oxygen now; rash on legs; fever; This is a spontaneous report from a contactable consumer (patient). A 93-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269, expiration date not provided), via an unspecified route of administration in arm left on 08Feb2021 at 04:00 (age at vaccination 93-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient received facility type vaccine in the Hospital. The patient was not pregnant at the time of vaccination. The medical history included high blood pressure and she had an open-heart surgery. The patient had COVID prior to vaccination. The concomitant medication included amlodipine, pantoprazole, clopidogrel and atorvastatin. Patient did not receive other vaccine in four weeks of vaccination. The patient stated the other medications received in two weeks included amlodipine, pantoprazole, clopidogrel and atorvastatin. The COVID was not tested post vaccination. On 12Feb2021, patient's breathing needs oxygen now, rash on legs and fever. It was unknown if the patient received any treatment. The outcome of events was not recovered. The explicit consent was obtained as yes.  Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL and a dose of either VAQTA (MSD) or HAVRIX at the same time as GARDASIL.  The physician reported that this was not the only office to have this happen.  The outcome was unknown.  No additional Adverse Event (AE) information was reported.  Upon internal review seizure was determined to be an other important medical event.  This is one of several reports from the same source.  Additional information has been requested.
4 days after vaccination with DTaP, IPV, and MMR child developed rash consistent with Henloch-Schonlein purpura.
On 8-30-13 (12 days after my shingles shot) I developed red splotchy spots on my face and it was itchy. It was much worse the following day so I went to see Dr. He put me on Rx of Acyclovir and Metronidazole lotion Rx. He felt it was a reaction to the vaccine.
On 1-27-21 in the afternoon her mouth felt "tingly" and at around 5p.m. patient felt pain in arm. and the arm swelled. it also hurt for her to mover her arm. She also felt fatigued and she rested the rest of the evening. The next day she also felt fatigued. Her arm felt warm to the touch. She also had a headache and felt "spacey." She took a Benadryl to see if it would make her feel better.  Today (Feb 5, 2021) she noticed redness at 2 p.m. around the site of injection and it looked a little "rashy." Patient applied Vaseline intensive care to rash. She says it still feels warm to the touch.
Mom reports pt devel unusual screaming p/vax from about 3PM until 730PM w/moderate fever; APAP was given x 3; pt had about 1/2 hr period of vomiting on the way home from clinic;
Nasal congestion, headache, fatigue, joint aches, fever, mild dizziness.  Treated with Tylenol, advil.  Symptoms still ongoing
felt nausea, lightheaded and dizzy.  developed itching and redness on chest.  25mg benedryl IM administered.  Called emergency response.  Patient taken to ED.  Reports in ED not remembering the events.
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: 1808980, and expiry: UNKNOWN) dose was not reported, administered at the right arm, on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced head hurts. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced temperature keeps changing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head hurts, body aches, and temperature keeps changing. This report was non-serious.
Pfizer children's shot (5-11 year old) was given to this child who is 13 years old. Error was found later in the day. We contacted Pfizer and they said that it should be ok, and that pt should get adult dose in 21 days. Patient's mother was contacted about error.
This case was reported by a health care professional and described the occurrence of swelling of knees in a 26-year-old male subject who was vaccinated with ENERGIX B. On 25 June 2008 the subject received 1st dose of ENGERIX B at 1.0ml. On 26 June 2008, 1 day after vaccination with ENEGERIX B, the subject experienced swelling of knees and pain. On 28 June 2008, two days later, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B. Follow- up information was received on 12 September 2008 via physician assistant, who reported that the subject was diagnosed with monoarticular, arthritis, with a date of onset listed as 26 June 2008. All events were reported to be resolved as of 28 June 2008. The healthcare professional did not consider the events to be serious, and to be possibly related to vaccination with ENGERIX B. The healthcare professional also indicated that the events could have been associated with obesity and possible arthritis / tendonitis.
This spontaneous report was received from a healthcare worker and refers to a 3 year old patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-NOV-2015, the patient was inadvertently administered a dose of GARDASIL 9 (dose and route were not reported, lot # L013429 with expiration date: 21-JUL-2017). No adverse effect was reported. Additional information has been requested.
Patient received Pfizer COVID vaccine on 6/19/21 (lot # EW0180), 7/29/21 (lot # EW0181), and Moderna COVID vaccine on 1/24/22 (lot # 084J21A). On 11/21/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID pneumonia, acute sepsis, acute UTI, and acute kidney injury. As of today (11/28/22), patient is still admitted in the med/surg unit.
grandson recv vax & grandfather was dx w/herpes zoster;It was reported that the vaccinee did not devel a rash;
Arm hurts, I feel drained and tired, a little cold.  Same things happened when I got the first dose 3 months ago.
Menveo reconstituted with normal saline; Menveo reconstituted with normal saline; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA756A, expiry date 31st October 2023) for prophylaxis.   On 30th September 2022, the patient received Menveo. On 30th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: The health care professional (HCP) reported that patient received Menveo vaccine reconstituted with normal saline solution. The reporter consent to follow up. Additional Supportive Information: The patient received Menveo vaccine reconstituted with normal saline solution which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from an investigator concerning a 24 year old female with gastrooesophageal reflux, anxiety depression and who used contraception and was previously enrolled in a study; It was reported that the patient received 3 injections of placebo on 18-MAr-2003, 28-APR-2003 and in 03-SEP-2003. She completed the base study on 06-FEB-2006. She subsequently entered the study extension and was eligible to receive active vaccine via the market "Ex-Protocol Approach". On 23-OCT-2007 the patient was vaccinated with a first dose of GARDASIL stated. Concomitant therapy included PRILOSEC, WELLBUTRIN and "CYCLEN". She subsequently had a menstrual period in November and her first day of last menstrual period (LMP) was on 17-NOV-2007. The site contacted her on 26-DEC-2007, to come for the second vaccination and then the patient told them that she was pregnant. She had a positive home pregnancy test on 23-DEC-2007, and was estimated to be 6 weeks pregnant on 26-DEC-2007. Her estimated date of delivery is 23-AUG-2008. In follow up information it was reported that the patient had an elective termination of pregnancy on 16-JAN-2008. No complication reported. Upon internal review elective termination of pregnancy was determined to be an other important medical event. The reporting investigator had not indicated if the event was related to GARDASIL. No further information is available at this time.