chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was a 58 year old patient. He had ESRD on HD MWF.  He had previously been hospitalized 8/4/21 - 8/5/21 - diagnosed with Covid 19 during this stay - stabilized and was able to be discharged home. He deteriorated at home and was brought back to the ED via EMS 8/6/21 with ARDS secondary to Covid - 19. He was intubated and remained for the duration of his stay in the ICU. He had two code incidents 8/16/21 and 8/17/21. Upon the 3rd Code, they were unable to revive him and upon discussion with family - decision made to stop CPR and patient expired.
Pt received MMR, PCV-13 and Hep A vaccines 12/29. Pt had first lifetime simple febrile seizure (also had AOM and URI) on 1/10.
Patient had left sided Bell's palsy symptoms (slurred speech, droopy of face, saliva coming out of mouth) on 5/6/18. Patient went to Hospital and underwent evaluations by a neurologist who ruled out everything and speculated that it may have been caused by SHINGRIX vaccine.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, frequency, anatomical location or route were not specified) lot # K009107, expiration date; 21-JAN-2016. Concomitant medications were not provided. No adverse event was informed. Additional information has been requested.
Numbness in tongue, lips; Numbness in arms, legs and feet; heart palpitations; chest pressure; hard to swallow; double vision; This is a spontaneous report from a contactable other hcp (patient). This 29-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Sep2021 18:15 (Lot Number: FC3184) at age of 29-years-old as dose 2, single for COVID-19 immunization.  Medical history included COVID-19 (If COVID prior vaccination: Yes). There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217), on 28Aug2021 09:00 AM at age of 29-years-old in Left arm for COVID-19 immunization, sumatriptan and experienced known allergies: Sumatriptan, topiramate and experienced known allergies: Topiramate, norco and experienced known allergies: Norco, metoclopramide hydrochloride (REGLAN) and experienced known allergies: Reglan. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Numbness in tongue, lips, arms, legs and feet, Heart palpitations, Chest pressure, Hard to swallow, Double vision on 24Sep2021 18:45. The events resulted in Emergency room/department or urgent care. Treatment received for the events included IV fluids, Ativan, Steroid medication and Benadryl. The patient underwent lab tests and procedures which included Rapid Covid test Nasal Swab: negative on 30Sep2021. The outcome of the events was Recovered with Sequel in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Hypoaesthesia oral, Hypoaesthesia  Palpitation, Chest discomfort, Dysphagia, Diplopia and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
his spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:51, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505:
woke up at 3:30am shivering, left arm hurt, ache all over my body fever on an all all of May 1st of 99.8-100.1 tired not very hungrey. feeling better today may 2, 2021 no fever.
Mouth pain, can't eat, open, open, deep sore in gums, and on roof of mouth.  Went to dentist. Dentist said it was an immune system reaction to the vaccine.
2 weeks following second Pfizer shot, started experiencing fluttering sensation in my heart.  Happened to be in the hospital for something unrelated, so my sensation was detected by the hospital's heart monitor.  They followed up with an echocardiogram and confirmed that I have developed a Left Atrial Flutter.  Now I am wearing a heart rate monitor for 30 days and it is tracking data for my cardiologist.  Have been experiencing periodic pain in my heart.  Prior to the Pfizer shots, I never experienced any symptoms.  Also, I have 2+ hears of heart rate data available from my Smart Watch and can make that available.  Everything is different after that second Pfizer shot.
Fever and then rashes that started on the head/face /hairline and spreading downwards.
Localized swelling in right arm and redness approximately 8 inch diameter following flu shot. Now approximately 6 inches diameter.
I ADMINISTERED THE MODERNA COVID VACCINATION TO THE PATIENT. BEFORE THE 15 MIN WAS UP, THE PATIENT'S HUSBAND CALLED ME OVER TO TELL ME SHE WAS FEELING DROWSY (PATIENT IS SPANISH-SPEAKING ONLY). WHEN I ARRIVED TO THE PATIENT, SHE WAS SITTING IN THE CHAIR AND THEN LOST CONSCIOUSNESS, WE CONTACTED MANAGEMENT AND EMERGENCY SERVICES. AFTER LESS THAN 10 SECONDS, THE PATIENT REGAINED CONSCIOUSNESS. SHE THEN BEGAN SWEATING AND STATED TO HER HUSBAND THAT HER ARM FELT NUMB. THE FIRE DEPT ARRIVED AND BP WAS RECORD AT 100/76 MMHG, PULSE 76, BLOOD GLUCOSE 119. AFTER SOME TIME PATIENT FELT GOOD ENOUGH TO STAND AN WALK AROUND THE CLINIC AREA. ULTIMATELY, SHE FELT GOOD AFTER ANOTHER 15 MINS AND LEFT THE CLINIC AREA WITH HER HUSBAND.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient stated her throat was itchy and started coughing
Found unresponsive by family member after falling asleep. Started CPR .Rescue squad arrived. Transported to Hospital. Cease resuscitation order at 1:32 am.
awake this AM w/t101, lying lifeless eyes only 1/2opened; responds to verbal stimuli; sits up for seconds then falls over; walks funny; no rash;
Headache; BP 135/83 (pulse 72); repeat BP 126/80 (pulse 80).
I work up the day after vaccine #3 with acute muscle spasms all over chest and upper back, unable to fully inhale without acute stabbing pain in chest.  Had GI surgery on 8/11 (16 days prior, advised to get vaccine 2 weeks post-op so that I could restart Humira), so there was concern that my presentation could indicate a pulmonary embolism. Before going to the ER that evening, I tried both narcotic pain meds and muscle relaxants... with only intermittent ~2 hour relief... then I would resume hyperventilating.
experiencing a rash on my shins; This spontaneous case was reported by a consumer and describes the occurrence of RASH (experiencing a rash on my shins) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced RASH (experiencing a rash on my shins). At the time of the report, RASH (experiencing a rash on my shins) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Fallow up received and contains no new information.
My heart is pounding out of my chest; I gained 20 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "My heart is pounding out of my chest"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "I gained 20 pounds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Customer reported that his/her heart was pounding out of chest and he/she gained 20 pounds since vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On Saturday, 7/23/16, patient experienced dizziness and light headedness. No pain around injection site. Reports full-body pain particularly in the face. Patient believes it may be an infection from her know. Doctor was contacted and patient was told to call back in a few days if still experiencing symptoms.
The patient did not develop any adverse reactions. However, the same flu vaccine was given twice in 2 weeks and 4 days on 9/12/22 and 9/30/22.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an adult subject of unspecified gender who was vaccinated with Engerix B for prophylaxis.  The subject's medical history included hemodialysis.  On an unspecified date the subject received unspecified dose of Engerix-B. On an unspecified date between 01 October 2006 and 16 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
Fever, chills, nausea, difficulty concentrating, difficulty breathing, muscle weakness with debilitating and extreme pain requiring trip to emergency room.
1:am Rigors and body aches, pounding headache, next day all over body rash, headache, local site and left arm redness, pain and firmness down to elbow, fever 102.9,  2/7/21 evening around 6 pm vomiting (for hours) ER visit 8-11.
On day 2 I had a low grade fever On day 10:       High blood pressure 205/77 for over an hour.       Difficulty breathing; A fast heartbeat(90); Dizziness; Chills; Uncontrollable shaking for over an hour.       Rash on face for less than an hour Starting on day 11:       Blood pressure gradually reduced to my normal level over days       Headache continued for several days
pain at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR150538   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient who reported that, she received her Shingrix vaccine in the left arm. The reporter reported that, she had some redness and pain at the injection site that resolved in a few days.  The reporter did not consent to follow-up. Additional Supportive Information: The case had been linked to US2022AMR150538,reported by the same reporter, for a different dose.; Sender's Comments:  US-GSK-US2022AMR150538:Same reporter
A consumer report has been received. The report concerns a 7 year old, patient of unknown gender, who had been receiving unknown FLUMIST QUADRILAVENT, 0.2 Millilitres, Unknown. The patient experienced high fever, fatigue and runny nose. The patient recovered from the event of high fever, fatigue and runny nose on an unspecified date. The reporter's descriptions of the event was as follows: Unknown. The report was considered to be non-serious.
Information has been received from a medical assistant concerning a 12 month old male who on 4/17/06 was vaccinated in the left thigh with a first dose of MMR II/Varicella vaccine. (lot 652234/0951R). There was no illness at the time of vaccination. On 4/24/06, seven days after vaccination, the pt developed a rash on the trunk, extremities, welts on and off for thirteen days all over his body and fever. Subsequently, the pt recovered. There was no quality complaint involved. Additional information is not expected.
A HCP called and reported an AE. The HCP stated that a husband and wife received their first doses of VAQTA on 24 FEB 2020, but then never received their booster dose 6 to 18 months later.; No additional adverse event reported; This spontaneous report was received from the pharmacist and refers to currently 72-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-FEB-2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but then, never received booster dose (6 to 18 months later) (booster dose missed). No other adverse event was reported   This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008877:
Developed upper respiratory infection, bronchitis and inflammation of the heart wall.  Some coughing and having to catch my breath still continues to today 07/19/21.  I have never had issues with allergies, asthma, respiratory infections, etc.
cough; vomiting; fatigue; nausea; Chills; muscle aches; chills; sore left arm; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), VOMITING (vomiting) and MYALGIA (muscle aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included CLOPIDOGREL for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills). On 16-Mar-2021, the patient experienced COUGH (cough), VOMITING (vomiting), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency; PARACETAMOL at an unspecified dose and frequency; RIVAROXABAN at an unspecified dose and frequency; RUPATADINE at a dose of 10 mg and FLUTICASONE at a dose of 200 pg/ml twice a day. On 13-Mar-2021, PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills) had resolved. At the time of the report, COUGH (cough), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Oxygen saturation: 90 or less (Low) oxygen levels went down up to 90 or less when he was standing up and 95/97 (Inconclusive) if he sits down levels go back to 95/97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Blood Pressure Medication Doctor advised him on not taking the 2nd dose
Within 10 minutes of my dad receiving his COVID-19 vaccine he suffered a major stroke.
Patient was given the Shingrix diluent and not the reconstituted vaccine together. No symptoms.
pt recvd MMR vax on 1APR91 & 10 to 15 minutes post vax pt exp thickness of tongue, sore throat, difficulty breathing; PE was nl w/no resp distress; tx w/DPH & pt recovered;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PAIN (non-serious), outcome "unknown", described as "asking what type of pain relief medication she can take".Additional information: Reason for no lot number of Pfizer Covid Vaccine: The reporter was unwilling to complete the report. The patient states that yesterday when she got the vaccine they said not allowed to take any types pain relief medication. The reporter states that she already gave all this information to the other place that transferred her to this number and been waiting over an hour and they said that this department could answer her question and states can call handler just get her to Medical Information? She refuses a report and to answer further questions.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & drove approx 1.5blocks, became weak, tachycardic, felt faint;spouse headed for ER however w/in approx 5min began feeling better & did not go in ER;inj site began itching & burning immed preceding dyspnea rxn tachycardia;
Dizzy, seizure, vomiting. Weak. (My wife had vaccine at same time and had similar occurrence).
A RASH AFTER MY SECOND SHOT - MOSTLY IN LEG ARE - SPREA D TO OTHERS IF TOUCHED - I HAVE NEVER HAD ANY SKIN ISSUES IN MY LIFE UNTIL I TOOK THIS SHOT - THEY ARE SMALL , VERY ITCHY , BUMPS.  IF SCRATED LEAD TO ALMOST A WELT . THIS HAS BEEN ONGOING 3 WEEKS NOW , IT IS MISERABLE AND i CANNOT WEAR SHORTS - IT IS ALMOST LIKE CHICKEN POX AND IT IS ALSO VERY UNCOMFORTABLE
Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
day 2 after immunization, pt reports pain to lower back/upper buttocks. Red raised bumps noted with intense itch  1/2 inch x 1 inch area. No neuralgia pain noted.
Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient receive vaccine around 315p, pt called at 457p saying shes having she was having rash/hives all over her body and wheezing
I started having pain in my hips, shoulders, hands and feet within a week to 10 days, maybe sooner. I thought it was due to a particular task I was doing at work, but after leaving the job, the pain continued, eventually leading to ER visits & admission.
10:48 C/O Feeling faint and nauseated, ice pack behind neck 10:54 BP-107/71 P-76 transported via wheelchair to exam room and transferred to the exam table and elevated legs; c/o tongue feeing funny/big lightheaded, nausea and shortness of breath 10:55 c/o hands feeling tingly. Rescue squad dispatched. 10:56-BP -104/64, P-61 EPIPEN given I left thigh 10;58- BP- 109/68, P- 69 10:59- BP- 107/75, P-74; states her tongue feels better 11:02 BP- 118/76, P84 11:05 Rescue squad arrives 11:20 Transported via Rescue Squad to the hospital
Pain in the arm when given in the same arm as the flu shot; This is a spontaneous report from a contactable pharmacist. An elderly male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medications included flu shot. On an unspecified date, the patient experienced pain in the arm when given in the same arm as the flu shot. So recommended to pharmacists to give future flu/pneumonia vaccines in two separate arms. The outcome of the event was unknown.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Medium
Approximately 15 minutes after patient received a Pfizer Covid-19 and Shingrix vaccine, he lost consciousness, but was visibly breathing. I called 911, then patient stopped breathing . He regained consciousness before I could begin CPR. While waiting for EMS, we took 2 BP readings (142/128 & 96/68) and I questioned patient's wife about medical history... she said that he had passed out 3-4 times in the past year. (Pt had not disclosed this on his vaccination Questionnaire)
Delayed reaction hives 3 days after first dose of vaccine. Took allergy medicine to relieve symptoms.
Information has been received from a health professional, for the Pregnancy Registry for Gardasil, concerning a female patient who was vaccinated with a dose of Gardasil. Concomitant suspect therapy included a dose of M-M-R II. Other concomitant therapy included "other unspecified vaccines". The reporter mentioned that the patient was pregnant but miscarried after receiving Gardasil. Unspecified medical attention was sought. No additional information was available. Upon internal review, miscarriage was determined to be an other Important Medical Event. Additional information has been requested.
Had appendicitis 3 days after my 2nd dose. Had to have my appendix removed