chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness/ little fatigue/ very mild; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/ little fatigue/ very mild) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TACROLIMUS, ALLOPURINOL and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, 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 experienced FATIGUE (Tiredness/ little fatigue/ very mild). At the time of the report, FATIGUE (Tiredness/ little fatigue/ very mild) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 treatment information was provided.   This case was linked to MOD-2021-106460 (Patient Link).
Narrative: 86 y/o c/o loss of ability to control legs and arms since receiving 1st dose of COVID19 (Modera) vaccine on 01/29/21. Did receive 2nd dose of 02/26/21. Does have h/o b/l leg weakness in the past, however patient indicates this feels different. Labs ordered and were unremarkable. Neuro consult is pending for further evaluation.
Information has been received from a consumer concerning on her son 36 month old (also reported as 3 years old) with allergic reaction to antibiotics (unspecified) and "omnisaph" who on June 9th (year unspecified) was vaccinated with RECOMBIVAX HB (lot number, dose and site of administration not reported). On unspecified date after having the vaccination the consumer also started on amoxicillin. On 21-JUN-2011, the consumer broke out in hives very severely from the back of his head to his feet, his limbs swelled up, and he had bruising on his joints. The consumer was taking Amoxicillin at the the time of the adverse event. Also, it was reported that the consumer had been to see his pediatrician, who stated that the reaction seems to be "caused by the amoxicillin". The consumer also had appointments to see and allergist as well. When asked if the consumer's condition had improved his mother stated that" he was not fully recovered; he continued to get a little better, slowly". Unspecified treatment was given for the treatment of the adverse events. Blood test was performed (results not provided). At the time of the report, the patient was recovering. No further information is available.
Major change in bowel function; Stools became Messy, sticky and smelly, totally uncharacteristic of my prior functioning; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in right arm on 01Mar2021 (at the age of 75-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Prostate cancer 2006. No other medications/concomitant within two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Penicillin on an unspecified date and experienced allergy. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9808) via an unspecified route of administration in right arm on 08Feb2021 as single dose for COVID-19 immunization. On 04Mar2021, three days after receiving second dose of vaccination, patient experienced major change in bowel function, stools became messy, sticky, and smelly, totally uncharacteristic of his prior functioning. Condition was persisting for 3 months. AE resulted in visit to Doctor or other healthcare professional office/clinic visit. Patient tried various supplements with no change. Outcome of the events were not resolved.  Follow-Up (15Jul2021, 30Jul2021): Follow-up attempts are completed. No further information is expected.
covid 19; patient never went back to receive the second dose in her Primary Series; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid 19) and PRODUCT DOSE OMISSION ISSUE (patient never went back to receive the second dose in her Primary Series) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    In 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 COVID-19 (covid 19) and PRODUCT DOSE OMISSION ISSUE (patient never went back to receive the second dose in her Primary Series). At the time of the report, COVID-19 (covid 19) and PRODUCT DOSE OMISSION ISSUE (patient never went back to receive the second dose in her Primary Series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient never went back to receive the second dose in Primary Series of the Moderna Covid-19 vaccine. It would be more than 35 days between Moderna Covid-19 Primary Series doses. Treatment medications were not reported.
This case was reported by a consumer, via Merck Research Laboratories, and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with Havrix (GlaxoSmithKline).  The consumer is the mother of the subject.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Havrix (unknown).  On 25 August 2007, at an unspecified time after vaccination with Havrix, the subject experienced swelling in her right arm.  On 23 September 2007, the subject developed an injection site rash.  At the time of reporting the outcome of the events were was unspecified.  Follow-up was received from the initial reporting consumer, via Merck Research Laboratories.  The consumer contacted Merck and asked, "Is there a blood test that will show if my daughter has HPV vaccine in her blood?"  It was not reported if the HPV vaccine was administered to the subject.  No additional information was provided.
TRANSIENT GLOBAL AMNESIA; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm in Apr2021 at 00:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since the vaccination the patient has been tested for COVID. On 04May2021 at 00:00, the patient experienced transient global amnesia.  On 04May2021, the patient underwent a nasal swab test and the result was negative. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of transient global amnesia and included treatment with aspirin (MANUFACTURER UNKNOWN). The clinical outcome of the event transient global amnesia was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
1/ Patient presented to health unit with complaint of throat tightness, dysphagia, dizziness and tingling of mouth, lips, and neck. Received rabies vaccine 2 hours prior. States felt a little dizzy during training but only got worried when had difficulty swallowing with lunch. 2/ At presentation received: Epipen IM R thigh           Benadryl 50mg PO 3/ Five minutes after Epipen: Symptoms improved breathing and lips less tingling. Prepared for admission for 24 hour monitoring. 4/ One hour after Epi pen, symptoms resolved except mildly dizzy. Resting in sick bay and PCMOs preparing transport and starting IV line. Given Solumedrol 120mg IV . Patient was able to ambulate steadily to car. Feeling well reports legs feel weak but no other complaints-driven to hospital for admission.
Headache, fatigue, trigger of autoimmune inflammatory symptoms including fibromyalgia and neuropathic pain
Sore on the roof of mouth after 1st dose; No energy after 1st dose; Rash on the top of mouth after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (Sore on the roof of mouth after 1st dose), ASTHENIA (No energy after 1st dose) and RASH (Rash on the top of mouth after 1st dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 26-Mar-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 STOMATITIS (Sore on the roof of mouth after 1st dose), ASTHENIA (No energy after 1st dose) and RASH (Rash on the top of mouth after 1st dose). At the time of the report, STOMATITIS (Sore on the roof of mouth after 1st dose), ASTHENIA (No energy after 1st dose) and RASH (Rash on the top of mouth after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.   Patient noticed a sore on the roof of her mouth. She said she could feel it with her tongue. She says that now she can see it and it looks like a rash on the top of her mouth. She says it is a darker red color. She says it is sore and feels like when you burn the roof of your mouth. She also says that she still doesn't have any energy.
Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain
Information has been received from a physician concerning a female who was vaccinated with VAQTA vaccine. Subsequently the patient experienced allergic reaction to VAQTA vaccine. The outcome of the event was not reported. Additional information has been requested.
Expired vaccine used; Patient received 0.3 ml of booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (Patient received 0.3 ml of booster dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03AC21A, 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (Patient received 0.3 ml of booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (Patient received 0.3 ml of booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessment was provided for OVERDOSE (Patient received 0.3 ml of booster dose).    No concomitant medication information was provided. The reporter called to verify if moderna covid 19 lot was given extension on expiry date similar to Pfizer vaccine. The reporter stated that patient received expired vaccine and wanted to know whether or not if Lot expiry date was extended. If date is not extended then nurse assumed that patient needed to be revaccinated. No adverse reaction were reported after administration of expired vaccine. No treatment medications were provided.
Severe numbness and tingling in both hands for a couple of hours along with shortness  of breath beginning the day after I received the vaccine.
response to the vaccine only lasted few hours overnight; incorrectly administered/some may have been inserted into the subcutaneous space; some of the vaccine had dripped onto my skin when the needle was removed.so all of the vaccine did not enter the muscle; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (response to the vaccine only lasted few hours overnight), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered/some may have been inserted into the subcutaneous space) and ACCIDENTAL UNDERDOSE (some of the vaccine had dripped onto my skin when the needle was removed. So all of the vaccine did not enter the muscle) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION COMPLICATION (response to the vaccine only lasted few hours overnight), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered/some may have been inserted into the subcutaneous space) and ACCIDENTAL UNDERDOSE (some of the vaccine had dripped onto my skin when the needle was removed. So all of the vaccine did not enter the muscle). In 2022, VACCINATION COMPLICATION (response to the vaccine only lasted few hours overnight) had resolved. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered/some may have been inserted into the subcutaneous space) and ACCIDENTAL UNDERDOSE (some of the vaccine had dripped onto my skin when the needle was removed. So all of the vaccine did not enter the muscle) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had bivalent booster this weekend. It was reported that patient had bivalent booster this weekend. It was incorrectly administered as some of the vaccine had dripped onto patient skin when the needle was removed. So, all of the vaccine did not enter the muscle, and some may have been inserted into the subcutaneous space. Patient usually had a strong 24 hr response to getting the vaccine and this time it only lasted few hours overnight.  No treatment information provided.
Fever up to 101.1* F: Tylenol 320mg q 4 hrs x 3 doses, resolved after 12 hours Headache, onset at 5:00 a.m. morning after injection, resolved 18 hours later Muscle aches, onset 12 hours post injection, resolved after 24 hours Diarrhea, onset 40 hours post injection
Pt was given a booster dose of .25ml of Moderna.  Pt was not eligible for the Moderna vaccine due to age.   No adverse event. Pt tolerated the vaccine well.  Notified patients mother.
onset of erythema, inc warmth, swelling rt arm around vax site next day extension of erythema down rt arm over next several days;examined by MD 25NOV97 cellulitis;
Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. There was no information about concurrent condition, concomitant medication and medical history. On 15-DEC-2016, the patient was vaccinated with a dose of M-M-R II (lot # K020188, expiration date 22-OCT-2016) (therapy type, dose and route unknown) for prophylaxis (expired vaccine used). No adverse effect was reported. Additional information has been requested.
Began a new menstrual cycle on 3/17/2021 which had the same flow and lasted the usual length of around 5 days despite the previous cycle beginning on 3/10/2021 while on oral contraceptives (never have been pregnant). My menstrual cycle was supposed to begin this week around 4/4/2021 and I am feeling symptoms of it such as bloating however I'm nearly half a week late despite having a very regular cycle before the vaccine.
the patient received an improperly stored dose of VARIVAX on 2/4/2020; This spontaneous report has been received from a pharmacy technician referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 04-FEB-2020, the patient was received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S019461, expiration date: 24-JUN-2021; frequency, route and dose details were unknown) for prophylaxis (product storage error). The sterile diluent used for reconstitution was properly stored.      The vaccine was stored between -14 degrees Celsius to -10 degrees Celsius for 2 hours 30 minutes and between -9 degrees Celsius to 8 degrees Celsius for 5 hours 40 minutes. There were no previous temperature excursions. The digital data logger was involved.
Left upper arm with redness and swelling for three days at injection site. Felt "sick" for 3 days.
Lightheadedness; headache for more than two days; Nausea; fever for two days; Chills; Exhaustion; Muscle pain; Upset stomach; Injection site throbbing; All over body pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 08:30 (at the age of 67-years-old) as a dose 2, single for COVID-19 immunisation. Medical history included diabetic, chronic obstructive pulmonary disease, obesity, depression, and hypertension pulmonary (pulmonary hypertension). Concomitant medications taken within two weeks prior to vaccination included sertraline hydrochloride (ZOLOFT), gabapentin, diltiazem, bupropion and unspecified medication all from unknown date for unknown indication. The patient previously took DEMEROL and experienced drug allergy in the form of itching, also received statin drugs and experienced allergy as severe muscle pain. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot Number: EN6202) via an unspecified route of administration in the right arm on 13Mar2021 at 13:30 (at the age of 67-years-old) as a dose 1, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 09:30, the patient experienced light headedness, headache for more than two days, nausea, fever for two days, chills, exhaustion, muscle pain, upset stomach, injection site throbbing and all over body pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache was recovered after for more than two days on an unknown date in Apr2021, of fever was recovered after two days on 08Apr2021 and of light headedness, nausea, chills, exhaustion, muscle pain, upset stomach, injection site throbbing, all over body pain were resolving at the time of this report.  No follow-up attempts were needed. No further information was expected.
pt recv vax 11FEB97 & 25FEB97 pt devel a gen red, raised, itchy rash, a temp & malaise;pt recovered;
8/17/21 patient had a headache and was tired. Came to work on 8/18/21 but started feeling worse throughout the day so she went home. Fever >100, headache, body aches, cough, difficulty breathing, fatigue. PCR test done on 8/20/21 with positive results coming on 8/23/21. Patient has had little symptom improvement to date.
c/o Headaches, Right arm numbness, R arm severe pain, nausea, agitated, hurts to swallow, emotional after HPV vaccine.
Pt. states after receiving the 1st dose of Moderna 03/17/2021, started experiencing symptoms 03/17/2021 5:00pm ER visit due to face numbness and exterior of the body. Treated with Benadryl and steroids. Allergist communications recommends not receiving the 2nd of the series 07/23/2021. No noted Primary visit. No other symptoms noted.
After first vaccination mom was tired in bed flu symptoms for a few days. Had MG symptoms come back and talked to her Dr. Went for 2nd vaccination and very tired &had Severe MG symptoms dr said to take then stop taking Mestinin as she continued getting sicker he called and said not to get any therapeutic drugs called Solaris not to see a dr and she died few days after.
Information has been received from a physician concerning a 23 month old male with no past medical history who on 4/9/03 was vaccinated with varicella virus vaccine (lot # 641156/0794M). There was no illness at the time of vaccination. Subsequently, on 3/22/04, the patient developed a severe case of shingles on his face, was hospitalized and diagnosed with Ramsy Hunt syndrome. Medical attention was sought. He was given IV Acyclovir. There was no product quality complaint involved. The patient recovered. There were also three other cases reported (WAES0404USA01827, 0404USA01828, and 0404USA01829). Additional information has been requested.
This case was obtained from a non-scientific publication on 10 February 2014. A 25 year old female patient, with an medical history and concomitant medications was vaccinated with flu vaccine last November, year not specified, (manufacturer, batch, site and route of administration were not reported). The patient's mother vaccinated her family every year. The patient's previous medications were not reported. On an unspecified date the patient developed back pain, chills and a fever of 101 degrees. The patient was advised by her mother to visit a doctor right away where an "on-the-spot test" confirmed she had influenza. The patient was treated with TAMIFLU, dose, route and duration were not reported. The patient's mother stated that "the doctors seem to think that her flu strain probably wasn't covered in the flu shot". The patient outcome was not reported. Further details were not available at the time of this report. Documents held by sender: None.