chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hypertensive Crisis - BP @ 11:45 184/154. @ 11:50 it was 220/150  @ 12:00 pm it was 184/118 HR between 64-74  Chest pain - level 5 (felt like somebody was sitting on her chest). Numbness and tingling circumoral and down into airway (first complaint....then moved into other).
At 12:00am on 10/24 patient started vomiting throughout the night, temp 101 at 0900, chills, restless, no rash, no breathing difficulties.
Redness and swelling of the shot site and radiating out 6+".  Hot to the touch, painful and itchy.
By night time I was shivering and had a fever of 101. I had muscle aches and my skin was sore. This lasted approximately 24 hrs. When I woke up on the morning of 9/13/21 I felt fine. I get the flu shot every year and never feel any side effects, so I'm pretty certain this was from the shingles vaccine. I'm not complaining, I'm glad it's available, but thought it should be reported that there were noticeable side effects from that vaccine. Oh, and a sore arm, but that's to be expected.
Lab work revealed a negative titer, subsequent to a first and second dose of varicella virus vaccine live. It was noted that the pt is currently pregnant, however, she was not pregnant at the time of vaccine. Additional information has been requested.
Narrative:  74yo male patient with myositis, Morbid obesity, paraplegia, neurogenic bladder was found down at home and received CPR from EMS as he was pulseless on 11/24/2021. Pt was taken to hospital and placed on ventilator. Pt then died at hospital on 11/29/2021. Pt had received covid vaccines on 2/6/21, 2/27/21, 3/27/21 from facility - not recorded where or why 3 doses since date was before booster injections were approved. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (warm and achy like I'm getting the flu), PAIN (body aches), PYREXIA (fever/ high temperatures/ warm) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (warm and achy like I'm getting the flu), PAIN (body aches), PYREXIA (fever/ high temperatures/ warm) and HEADACHE (headaches). At the time of the report, INFLUENZA LIKE ILLNESS (warm and achy like I'm getting the flu), PAIN (body aches), PYREXIA (fever/ high temperatures/ warm) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details was not reported by the reporter. Concomitant medications details was not reported by the reporter.
congestive heart failure; vision problems; balance issues; shingles, herpes zoster; Information was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding the pt's current condition, historical condition, concomitant medication was not provided. On or about 05-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles, herpes zoster, congestive heart failure, vision problems, and balance issues. The outcome of the events was unknown. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX). The pt claimed damages as results of injury to themselves, loss of consortium, loss of service and economic losses.  Upon inernal review, congestive heart failure was considered as medically significant.
pt recvd vax;inject site became red,hot,swollen & painful on 3feb95;pt returned to clinic on 6feb95 @ which time rt deltoid area still hot & red; pain has subsided;
NAUSEA AND VOMMITING AND FEVER AND HEADACHE AND CHILLS  STARTED  3/19/21,  DIAHHREA CALMED DOWN YESTERDAY 3/21/2021
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 4:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.89.  Concomitant products were not provided. On 24-May-2021, Excursion time was 8 AM, 9 AM, temperature was 35, 35 total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 03 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 19-MAR-2018, the patient was vaccinated with a dose of expired VARIVAX lot # L044524, expiry date: 09-NOV-2017, 0.5 ml, subcutaneously. Concomitant therapy included sterile diluent. No adverse effects were reported.
Fever; Shortness of breath; Just didn't feel right.; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got his second shot of Pfizer COVID-19 vaccine on Saturday, 27Mar2021. On 30Mar2021, (in afternoon) the patient experienced fever, shortness of breath and just didn't feel right. The reporter was curious could this be a side effects of the vaccine. Reporter was informed about Pfizer Medical Information Department and was also informed about safety report. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
After getting his 2nd Moderna COVID 19 injection, in his right arm, the patient began experiencing numbness and tingling in his right hand and the bottom of his right foot.  It was very strong numbness such as when the hand is asleep and he could not use the hand.  He had 3 fingers that stayed awake.  This stayed this way for a day or two then his face went numb on the right side and  his right arm developed numbness as well, though there was no drooping or disruption of his speech.  He was concerned enough he went to the emergency department and they diagnosed him with Paresthesia.  The numbness left his face and arm after a few days but has remained in his hand and foot.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787 US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
Mild malaise; Injection site very itchy; Arm inflammation; Arm swelling; Sore arm; Muscle ache/  Back muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Mild malaise), VACCINATION SITE INFLAMMATION (Arm inflammation), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Arm swelling) and INJECTION SITE PRURITUS (Injection site very itchy) in a  patient of an unknown age and gender 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.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE SWELLING (Arm swelling). On an unknown date, the patient experienced MALAISE (Mild malaise), PAIN IN EXTREMITY (Sore arm), INJECTION SITE PRURITUS (Injection site very itchy) and MYALGIA (Muscle ache/  Back muscle aches). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at a dose of 10% cream. At the time of the report, MALAISE (Mild malaise), VACCINATION SITE INFLAMMATION (Arm inflammation), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Arm swelling), INJECTION SITE PRURITUS (Injection site very itchy) and MYALGIA (Muscle ache/  Back muscle aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication not provided.  The patient reported the injection site swelling and inflammation resolved about 2 and a half weeks after the first shot.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Follow-up information received updated event outcome. On 28-Jun-2021: Follow-up received updated event and suspect dosage details.
First dose: sore left arm/Second dose: sore left arm; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support by a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EN6206) as dose 1, single (at the age of 60 year) for covid-19 immunisation, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single (at the age of 60 year) for covid-19 immunisation. The consumer reported no medical history that was relevant, but she does take thyroid medication and has taken that for years. The patient did not have vaccine in four weeks. With the Covid 19 vaccine she had a sore left arm with the first Covid 19 vaccine. It was an extremely painful left arm. She put ice on her arm after her injection. It was extremely painful. When she went to get her second Covid 19 vaccine she brought ice with her. The second Covid 19 vaccine was not as bad as the first Covid 19 vaccine but was still sore in her left arm. She received both Covid 19 vaccines in her left arm. With the first Covid 19 vaccine her sore arm lasted about 2 days and on the third day the pain started subsiding. She did not have to go to the doctor or hospital for treatment for her sore arm after receiving the Covid 19 vaccine. She states she and her husband have the same primary care doctor. When probing adverse events with other vaccines she reports she gets her other vaccines like she's supposed to and has never had any problems. Therapeutic measures were taken as a result of first dose: sore left arm/second dose: sore left arm. The outcome of the event was not recovered.
a week later, very tired and rash (skin raised, hot, not itchy, red) on upper left leg appeared.  Shot put in back of left arm.
Patient presented to the pharmacy on 01/05/2016, with a report of soreness at the site of injection after he got a flu shot at this location on 11/27/2015, two days later he felt the soreness on his right shoulder. He did not report this to a doctor or treat it. He decided to report after he noticed blue discoloration under his arm.
Inadvertently administered Varicella vaccine that was due on 09/12/2023. Noticed vial was expired (08/13/2023). Pt tolerated injection and there were no s/sx of adverse reaction status post administration of vaccine.
48 hours, post vax, pt awoke crying, inconsolable crying which lasted 2 months. No kidding. Then off and on for months at a time, around the clock. for another year. Now, episodic, lasting weeks. Irritable, depressed. Complete personality change overnight and was a good sleeper, never cried, but now is a depressed child with developed gross motor delays and complaint of fingers hurting her. The annual folow-up states pt "still has bouts of depression and inconsolable crying. Has bouts of easily triggered tantrums. Still has severe gross motor delays. Bouts of insomnia. Gastrointestinal problems i.e. severe bloating. I want to emphasize that none of the above symptoms existed prior to that DTaP vaccine. Approx. 36 hrs after the vaccine, pt awoke crying inconsolably and has never been the same since. This last "bout" of depression and crying lasted 2 months. The G.I. problems and gross motor delays are a constant. The mood issues are episodic."
This case was reported by a physician via sales rep and described the occurrence of rotator cuff tear in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date without side effects). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rotator cuff tear, injection site erythema and injection site pain. On an unknown date, the outcome of the rotator cuff tear, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the rotator cuff tear, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced redness and pain at injection site and tore rotator cuff. The reporter did agree to be followed up from GlaxoSmithKline.
Sharp heart stabbing pains were felt for 1 hour on Friday the  12th of November from 3-4PM PST.  The pain lessened over the night but felt like burning/pins feeling every few minutes around the heart area. Saturday: Woke up fine but after 12:00PM, the pain came back and intensified where I couldn't handle it anymore so I went to an urgent clinic on Saturday the 13th. Ran EKG, Troponin test, and Chest X ray. EKG was fine, troponin was fine. Chest x ray was fine. I felt the pain every few minutes. Went to my primary doctor on Monday the 15th of November. After his examination, he recommended  that I take Buspirone. I do take it and it has helped but I still feel the hear area pain a few times a day.
This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date the patient was vaccinated with RECOMBIVAX HB (lot# reported as 1000AA, expiry date reported as 26-APR-2014, dose, route unknown). The patient called to inquire if she needed to restart the RECOMBIVAX HB series as she received a telephone call from her physician's office today that she had been administered an expired RECOMBIVAX HB. No adverse effects were reported. Additional information is not expected as contact details of reporter or the physician were not provided.
Patient became extremely weak...could not stand...dizzy...pt fell...ambulance took him to the ED where he was admitted for severe dehydration. He was given IV saline and then admitted to the hospital  for 3 days and is now in a rehab nursing home unable to walk or stand with weakness and now confusion
This spontaneous report was received from a 22-year-old female patient reporting on herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In approximately 2006 (at the age of 11), the patient was vaccinated with three subsequent doses in month 0, 2 and 6 of GARDASIL intramuscular injection (dose, lot number and expiration date were not reported) as a protection from human papilloma virus (HPV). On an unknown date, the patient was tested positive for HPV type 16. The patient did not report if she had any symptoms or diagnosis nor if she sought for medical attention after having the test results. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as no contact details were provided.
Post vax the patient had a severe local reaction, with swelling, erythematous, tender upper arm approximately 10x20cm. The patient was treated with diphenhydramine and NSAIDS.
Pt presented with shortness of breath and cough and was tested positive for covid.The pt was given NC and supplementa O2. They were restared dexamethasone and remdesivir and antibiotics.
Patient received FLUVIRIN, then approximately, one minute later complained of lightheadedness, she sat down then lost consciousness for approximately 15 seconds, then had seizure like movement, for approximately 5 seconds.  She then slowly woke up.  Paramedics arrived and her vitals were normal.
small area that is more firm than the rest of the arm; injection site is red and warm; injection site is red and warm; The site is tender and soreness that weekend following injection; the site became itchy; headache; she felt feverish and reported a fever of 102.2; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm), VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE PRURITUS (the site became itchy), VACCINATION SITE ERYTHEMA (injection site is red and warm) and HEADACHE (headache) in a female patient of an unknown age 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.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm). On 08-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (she felt feverish and reported a fever of 102.2). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (the site became itchy). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE ERYTHEMA (injection site is red and warm) and VACCINATION SITE PAIN (The site is tender and soreness that weekend following injection). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. On 08-Jan-2021, PYREXIA (she felt feverish and reported a fever of 102.2) had resolved. At the time of the report, VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm), VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE PRURITUS (the site became itchy) and VACCINATION SITE ERYTHEMA (injection site is red and warm) had not resolved and HEADACHE (headache) and VACCINATION SITE PAIN (The site is tender and soreness that weekend following injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient received the vaccine on 5/16/07. On 5/29/07 she developed enlarged cervical lymph nodes a hard palate apthrus ulcer, a morbilliform rash and low grade fevers. This lasted several days.
Moderna COVID?19 Vaccine EUA. Swollen milk ducts in the breast in the same side as the vaccine including lactation. The patient is not, and has never been pregnant.