chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. noticed redness and swelling in area of right arm where subq Pneumo was given at about 9pm. It spread from site of injection around back of the arm and it was sore. He c/o "chills" keeping him up all night, but he took his temp and it was about 98.4 - 98.7. He put a heating pad on it for comfort. He got up at 8am and had a terrible H/A, and he had "really achy joints, knees and hands. " And his hands hurt so bad "he could hardly open them." Due to a problem with our phones I did not speak to him until much later in the day though he had started calling us in the morning. By the time I spoke with him, 4:40pm, he was "much better," though the H/A "still comes" back when he stands."
Patient is a 79y.o. male with a PMHx significant for COPD, Bipolar, HLD, HTN, neuropathy, lumbar disc herniation, OA presented to the ED 12/23/21 with complaints of generalized weakness x1 week with exposure to son who tested positive for covid-19 one week ago. Patient reports that his symptoms began 7 days ago. He states that he was feeling generalized weakness initially which has progressed to shortness of breath, chest pain with coughing, fever, and generalized malaise. Pt reports that he had multiple falls while ambulating to the bathroom, he denies hitting his head. He reports that yesterday he did have an episode of diarrhea. He states that he has not had anything to eat x3 days due to poor appetite. Pt reports that his son tested positive for covid one week ago then, his other son picked up a covid-19 at home test the following day and the patient tested negative. Patient reports that he had his daughter bring him to the hospital because his shortness of breath had progressed and he felt that he was getting more and more sick. Patient reports that his breathing is improved since he has come to the ED and received supplemental oxygen and a nebulizer treatment. Pt denies HA, dizziness, palpitations, nausea, vomiting, constipation. Pt is a 1/2 ppd smoker x65 years, he states that he has been feeling so sick he has not smoked in a week. Pt denies alcohol and illicit drug use. Had One J/J vaccine.
Greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment medication were not reported.
LEFT ARM BEGAN TO TURN RED AND BECAME SWOLLEN A FEW HOURS AFTER THE INJECTIONS
got vaccinated, still got it/suspected vaccination failure; got it, around right eye; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The patient self reported the case via interactive digital media . The patient stated that It was the most horrible feeling in the world. The patient got vaccinated 3 years ago and still got shingles in and around right eye. The patient thought for sure he/she was gonna loose eye. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
This spontaneous report was received from a medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # M015931 with expiration date: 22-JAN-2018; lot # M007277 with expiration date: 09-FEB-2018; lot # L047134 with expiration date: 24-NOV-2017; lot # L039613 with expiration date: 08-OCT-2017; lot # L036853 with expiration date: 24-SEP-2017; (strength, therapy type, dosage and route unspecified). Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75  hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 8/5/1998; post vax pt exp Rt arm sore & inability to move; dx=tendonitis; tx=cortisone injections, Relafen, physical therapy
pt recvd vax; pt exp arm soreness & tiredness w/ 3rd dose;
Fever 102.2; chills; headache; joint pain; scalp pain; This is a spontaneous report from a contactable consumer. A 65-years-old female patient (Non-Pregnant) received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown) on 18Feb2021 17:30 via an unspecified route of administration, administered in left arm at a single dose for COVID-19 immunization. Medical history included lupus and allergies to medications included ceclor, dapzone, Vicodin, Atorvastatin. The patient's concomitant medications were not reported. patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Not tested covid post vaccination, Since the vaccination, patient has not tested for COVID-19. The patient experienced fever 102.2, chills, headache, joint pain, scalp pain. The patient's body temperature was 102.2 on 19Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
She got her vaccine, pain in the arm, fatigue but  nothing severe. She now is feeling unwell, cramping stomach and menstrual like symptoms, and it is now over a week late where she is typically normal. She was in pain all day yesterday and pain today, and she called her doctor and they have scheduled her an appointment for the middle of June, but will call her if they get a cancellation.
this is a positive but odd event: I had a heightened and dramatically improved sense of smell and taste after my shot. I could smell the new plastic smell of my laptop which I never smelt before. It was so odd. And I could really taste the cream in some pistachio ice cream. I can really say this was a dramatically heightened sense of smell and taste.
Swelling of lymph nodes under left arm pit. Started sometime during Wednesday night. Didn't know about it until Thursday morning when I felt slight pain and tenderness in my arm pit. Checked with my doctor and she confirmed it.
Officer reported feeling dizzy, blurred vision, lips were numb and tingling to the left side of his face. Vitals signs were taken and his condition and complaints were  reported to NP. An evaluation was done and a granola bar was given since the officer reported he did not eat this morning. Another set of vital signs were taken and then NP consulted with Dr. who recommended that the officer be seen in the ER for further evaluation.  Officer was then transported to local ER by wife.
An initial report was received from a nurse on 25.Jan.2012 and concerns a male patient of unspecified age who, on an unspecified date, received the fourth oral administration of VIVOTIF (batch no: not reported). The patient's medical history and concomitant medications were not reported. On an unspecified date, 1 day following the fourth VIVOTIF administration, the patient began to experience waves of nausea and had vomited once. No further information was provided. At the time of reporting, the patient had not yet recovered. The events were considered non-serious.
About 6 hours after I received the vaccine, I got a massive headache.  I went to the emergency room several times and they treated me for a migraine.  The headache lasted a couple months.  I also started having Grand Mal seizures, one of which left me unresponsive in the ICU for a few days.  I also dislocated, and eventually fractured my left shoulder after a seizure.  I have continued to have seizures, even on medication, since I received the vaccine.  My seizures are being treated with Keppra and Lamictal.  I have now been diagnosed with Epilepsy.  I have never had a seizure before having this vaccine.
Slight pins and needles feeling on left side of body from neck to top of left knee a few hours after 2nd dose of vaccination.  Over the course of days, the discomfort only occurs in left hand thumb, index and middle finger.  3 weeks later, the numbness is only on index finger tip of left hand.  About 4.5 weeks later(June 14th), the burning sensation still persist only on left hand index finger tip.  Have no history of carpal tunnel.
I believe this SAE is unrelated to the vaccine, but this happened within 30 days of a study vaccine, so I am reporting it per protocol. I am preparing my FDA annual report and noticed this - I had not known previously. Patient was hospitalized for severe gastroenteritis with dehydration on day 27 after vaccination.
Dull pain, 4/10, X1-2 days, located in chest radiating to neck and back, arms (biceps/shoulder) b/l, lateral knees (b/l).  Treated with Tylenol and Ibuprofen (alternating) and medication use instructions, increase hydration, and RTC precautions.
Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concomitant products included CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]), CALCIUM, MAGNESIUM, VITAMIN D NOS, METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (Broke out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Broke out in hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 09-Aug-21, the age was corrected to 84 years.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 contains non-significant information.
~24 hours after (12/15), chills started, no fever, general malaise, lasted about 36 hours ~48 hours after (12/16), lymph nodes in left armpit swollen, painful to touch. Pain subsided after about 36 hours, swelling has still not abated.
This is a non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 25-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
w/projectile vomiting, lasting 4 hrs; taken to ER; blood test done all neg; adm for observation & to check for shunt failure; d/c next day; sz started the next day w/no fever; taken to neurologist; 3 wks recovery; MD felt poss vax related;
some vaccine leaked out of the muscle right after injected; some vaccine leaked out of the muscle right after the patient was injected; some vaccine leaked out of the muscle right after the patient was injected; Inadvertent exposure to vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2021) for prophylaxis.   On 12th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th February 2020, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The batch number for Shingrix was reported as TJ35C. Based on a batch number review the batch number was updated to TJ35Z. Some vaccine of Shingrix leaked out of the muscle right after the patient was injected, which led to accidental underdose, Inadvertent exposure to vaccine and exposure via skin contact The reporter consented to follow up.   Follow up information received from pharmacist on 23rd March 2020: On 12th February 2020, immediately after receiving Shingrix, the patient experienced injection site leaking. the outcome of the injection site leaking was unknown. It was unknown if the reporter considered the injection site leaking to be related to Shingrix. An additional full dose was given as recommended by pharmacist call center representative.
Pink macular papular rash confined mainly to trunk and nape of neck. No fever, no URI. Sx, no vomiting, no vomiting. Is improving.
Information has been received from a registered nurse (R.N.) concerning a 58 year old male patient with no drug reactions/allergies, who on 31-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23 (lot number 672041/1477AA, expiration date 14-MAY-2013) (dose and route not reported). On 20-JAN-2012, the patient also received a second dose of PNEUMOVAX 23 (lot number 672041/1477AA, expiration date 14-MAY-2013) (dose and route not reported). There was no concomitant medication. It was reported that on 20-JAN-2012, the patient developed injection site reaction following vaccination with PNEUMOVAX 23. The injection site reaction was described as swollen and painful with the patient complaining of "not feeling well". The patient caught a "cold" following the second vaccination with PNEUMOVAX 23 and experienced mild nasal congestion on 23-JAN-2012. Treatment given for adverse experience included TYLENOL and ADVIL. The nurse asked for a lot check for PNEUMOVAX 23 (lot number 672041/1477AA, expiration date 14-MAY-2013). The patient sought unspecified medical attention, he contacted office. No lab diagnostics studies were performed. On an unknown date, the patient recovered from the adverse experience. Injection site reactions swollen and painful, not feeling well, a cold and mild nasal congestion were consider to be disabling, the patient could not work 4 days. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
Initially, localized, small red area where needle went in but two days later, area started getting more red, hot, itchy swollen and has been progressively worsening for 6 days currently 4" x 2 1/2" rash. Doesn't hurt, just itchy, elevated hot.
tiredness; chills; muscle ache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (when patient was young).   On 26th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tiredness, chills and muscle pain. On an unknown date, the outcome of the tiredness, chills and muscle pain were recovered/resolved.   It was unknown if the reporter considered the tiredness, chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she received the first dose of the Shingrix vaccine in her left arm and she did have some chills, tiredness and muscle aches. For the tolerability of 2nd dose, refer case US2020AMR057149 reported for same patient.
soreness in arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (soreness in arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness in arm). At the time of the report, MYALGIA (soreness in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, SARS-CoV-2 antibody test negative: noraml Negative.     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.   no concomitant medications reported. no treatment details reported.
I started getting symptoms of general illness. I took an at home COVID test that was negative so the next day, I had a positive COVID test. I had head cold symptoms like a stuffy nose, loss of appetite, and cough. I was prescribed Paxlovid. I took that for 5 days. I also take Nyquil at nights. I tested positive for 10 days then got a negative COVID test. Then I started getting nasal congestion again. I tested positive again. On 5/15/2022, I started feeling an ache in my right jaw and I couldn't close my mouth properly. I did research and it looks like I have COVID jaw. I have a night guard that I wear at night and this morning it felt some better.
Information has been received from a physician concerning her daughter a 2 yr old female with no known medical history or allergies who on 08Feb05 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 23Jan06 the pt developed what was diagnosed as herpes zoster on left side of face, V1 distribution. She was sent immediately from the pediatrician's office to an opthamologist to rule out eye involvement, which was negative. She was taking acyclovir suspension and had a slight fever to 100 degrees for one day but was afebrile at the time of the report. The lesions on her face were cultured by the dermatologist. The child was presently recovering and had only a few crusted lesions on her face, most of the lesions were gone. It was noted that she does not want isolates collected. There was no product quality complaint involved. The pt's herpes zoster was considered to be an other important medical event (OMIC). Additional information has been requested.
BLOODY NOSE; ACHES; CHILL; FEVER; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. 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, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced flu-like symptoms. On 14-MAR-2021, the subject experienced bloody nose. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced chill. On 13-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chill, fever, aches, bloody nose, and flu-like symptoms. This report was non-serious.
Headache, Arthralgia,  Fatigue, injection site pain and swelling  Narrative:  Other Relevant History:
Mom called 11DEC91 & stated pt had fever 104 all night & was crying out & jerking in sleep; told to take to ER; Dad stated pt had been given an overdose of immun & had been taken to ER for treatment; ER felt pt had virus when immun given;
redness below the injection site; Swelling below the injection site (an inch and a half below the injection site); Yesterday it developed itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Yesterday it developed itching), VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (Swelling below the injection site (an inch and a half below the injection site)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], ESTRADIOL, NORGESTIMATE (PREFEST), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), ACETYLSALICYLIC ACID (BABY ASPIRIN), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and IPRATROPIUM BROMIDE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Yesterday it developed itching). On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (Swelling below the injection site (an inch and a half below the injection site)). At the time of the report, VACCINATION SITE PRURITUS (Yesterday it developed itching) had resolved and VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (Swelling below the injection site (an inch and a half below the injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment taken or applied she just put ice on it.