chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started to have extreme cramping and vaginal dryness. August and September menstrual cycle were extremely heavy, bleeding through tampons and  pads. I have not had my menstrual cycle since September.  October, November and December I have not had a period.  I have all the symptoms of heavy cramping and tender breasts but NO period.  Prior to the vaccine I was regular every month. I write down my cycles in my calendar- and I never had cramping, not even when I was young.  These cramps are so bad I have had to take pain killers to alleviate the pain.  I went to the OGBYN and she felt it could be related, but she is a new doctor for me because my old OBGYN passed away.
I had a stroke on April 30, 2021, 10 days after the second dose of Pfizer on April 20, 2021.  The stroke was the result of a blood clot.  I've never had blood clots until I subjected my perfectly healthy body to the Covid vaccination.  On the morning of April 30, 2021, I was suddenly overcome with a sense of disorientation and dizziness.  Spouse drove me to the ER. They discovered I had experienced a stroke. Let me be absolutely clear.  The Pfizer vaccine is the sole reason I developed blood clots and had a stroke.  I was perfectly healthy until I got vaccinated.  I now have brain fog, dizziness, and every day is a challenge. I feel so dumb for falling for the get vaccinated garbage.
Hives; Headaches; Shortness of breath; Eye pain; Itchy skin; Sinus problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 10:00 (Lot number: FC3181) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE; FINASTERIDE. The following information was reported: URTICARIA (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Hives"; HEADACHE (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Headaches"; DYSPNOEA (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Shortness of breath"; EYE PAIN (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Eye pain"; PRURITUS (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Itchy skin"; SINUS DISORDER (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Sinus problems". The events "hives", "headaches", "shortness of breath", "eye pain", "itchy skin" and "sinus problems" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, headache, dyspnoea, eye pain, pruritus, sinus disorder.  Additional information: The patient administered dose 2, single on 24Sept2021 11:00 AM, administered in arm left, (Lot number: FE3592). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid 19. Since the vaccination the patient had not tested for covid 19.  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Dec2021): Follow-up attempts are completed. No further information is expected.
12 year old received a dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received a dose of Moderna) had resolved.        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.   No concomitant medication reported. No treatment information was provided.
approx 12-15 mins post vax devel red rash/hives over face, extremities & parts of torso;no breathing problems, acts well & playing;saw MD immed following onset of sxs-administered adrenalin;observed for 20mins;hives & rash ceased;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-290627, MOD-2021-291235 (Patient Link).
pt recvd vax;hands mildly shaky 3 days p/vax;mild incoordination,somewhat lightheaded;difficulty ambulating,poor balance;vision began to change;opsoclonus w/ irregular mvmt of arms & legs;small high brain stem lesion associated w/ myoclonus
Vomiting, diarrhea, chills, dizziness, headache - ache in my arm was so bad I took an old (very expired) hydrocodone. I had chills and headache starting around 4pm, by 11 pm I was vomiting, and had diarrhea. I was in the bathroom until approximately 6 am,  the chills/dizziness and headache continued until after noon the next day.
28AUG95 pt became nauseated, vomited x3; same noc t103 ended 30AUG;29AUG pt broke out in fine rash on face, neck & shoulder;spread to rest of body by 30AUG;parent took pt to MD was told by one that pt could have measles-poss MMR rxn
feeling numbing in left arm; feeling numbing in face; achy joints; nausea; intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (feeling numbing in left arm), HYPOAESTHESIA (feeling numbing in face), ARTHRALGIA (achy joints), NAUSEA (nausea) and HEADACHE (intense headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (feeling numbing in left arm), HYPOAESTHESIA (feeling numbing in face), ARTHRALGIA (achy joints), NAUSEA (nausea) and HEADACHE (intense headaches). At the time of the report, HYPOAESTHESIA (feeling numbing in left arm), HYPOAESTHESIA (feeling numbing in face), ARTHRALGIA (achy joints), NAUSEA (nausea) and HEADACHE (intense headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
L shoulder with vaccination pustule with surrounding blistering, minimal erythema, (+) axillary tenderness. Tx: Keflex 250mg po qid x 14 days.
This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient received PREVNAR 13 (NDC number: 00005197102; Lot T08483; Expiry Date: Sep2019) on 19Dec2017 at 0.5ml single intramuscular, for immunization (over 65 doctor recommended). The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling at injection site on 19Dec2017. Outcome of the events was not recovered, patient still had redness and swelling at the injection site. Pharmacist considered the event redness and swelling at injection site related to pneumococcal 13-val conj vaccine.
Information has been received from the author of a literature, title as stated below. This literature marketed report as received from the authors refers to a 54 male patients of unknown age with HIV infection which diagnosed in 12 patients before vaccination and in 42 after vaccination. On an unknown date, the patients were vaccinated with a dose of hepatitis b vaccine (manufacturer unknown) (Lot numbers, expiration dates, dose and route were not provided). Concomitant medication included combination antiretroviral therapy (cART). On an unspecified date, the patients experienced vaccination failure reported as vaccine non-respondent. The reporter stated that to assess and quantify the effect of hepatitis b vaccine (manufacturer unknown) response on CD4 lymphocytes reconstitution after cART initiation, all available CD4 counts for participants from cART initiation to one year post-cART were analyzed. The outcome of vaccination failure was unknown at the time of the report. The reporter considered vaccination failure to be related to Hepatitis B Vaccine (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same literature. Additional information has been requested.
Info has been received from an RN concerning a 6 year old male with no medical history or allergies who on 5/10/00 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 6/9/05, the pt developed chickenpox characterized by a widespread rash all over his body. Unspecified medical attention was sought and the pt was treated with acyclovir. At the time of this report, the pt was recovering from the chickenpox. Additional info has been requested.
Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
Pt reports headache, pain at site of vaccine, chills, muscle/body aches. Started a few hours after the vaccine, reports she was finally able to fall asleep, she called us to report shortly after waking up, cannot tell yet if it is any less severe than yesterday.
5 days after vaccine, had fever of 103-104. Pediatrician called. Mom instructed to alternate Infant Tylenol and Motrin and Increased fluid intake. Next day taken to ER. Fever continued to be high. Diagnosed with dehydration and mom reported child had rash on neck and chest.
Fever; body-ache; joint pain; head-ache; fatigue; light-headedness; This is a spontaneous report from a contactable consumer (the patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK9231), via an unspecified route of administration on 22Dec2020 at 22:30 (at the age of 25-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date and Post COVID Inflammatory Response which resulted in exercise induced asthma afterwards (dates not specified). The patient is allergic to mangoes. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 09:00, the patient experienced fever, body ache, joint pain, headache, fatigue and light-headedness. The patient did not receive any treatment for the events. The clinical outcomes of fever, body-ache, joint pain, headache, fatigue and light-headedness were reported as recovered on an unspecified date in Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Quality 7/10 pain in every joint of body, specifically joints and bones on top of foot, toes, wrists, which resolved in 3 days.  Left should joint pain still lingering 8 days later.  Back of head down patient's neck has pressure and soreness.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M039202 with expiry date 11-MAR-2018 and lot # N005796 with expiry date 26-MAY-2018 (dose, route of administration and vaccination site were not reported) for prophylaxis. Administered doses of VAQTA underwent a temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 10 days. There was no previous temperature excursion. Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA013078: US-009507513-1709USA013077: US-009507513-1709USA013075: US-009507513-1709USA013076:
Erythema, edema and tenderness right shoulder starting few days after injection. Cellulitis treated with Zithromax suspension 500mg QD 3 times.
Hospitalized: 3/13-3/22/21. Pericardial effusion, pleural effusion. Have had 3 thoracentesis as outpatient since release from hospital: 4/8/21 (removed 800ccs fluid), 4/19/21 (removed 1400ccs fluid), 4/26/21 (removed 1500ccs fluid). Scheduled 4th thoracentesis for 5/3/21 - have appt with thoracic surgeon on 5/13/21.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 5 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K009894, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
PATIENT WAS WRONGLY ADMINISTERED MODERNA INSTEAD OF AGE APPROPRIATE VACCINE PFIZER
This was the second dose rec'd after initial shot on June 6th when I also had adverse effects the following morning. Felt nauseous throughout the early part of day and threw up once. The second shot gave me a severe headache when I awoke, also felt a little nauseous, and inflamed left arm for two days.
Weakness and numbness in right side extremities around 8pm on 10/2, lasting approximately 2 hours Emergency  room visit.  Admitted to hospital around 9:30pm.
Information has been received from a hospital buyer concerning an adult female with no allergies who on 06/10/03 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot # 644219/1079K), in the left arm. This was reported to be the only vaccination that the pt received this day. Subsequently, the pt developed a sore left arm with a 6 inch radius around the arm that was red, puffy and swollen arm. The pt sought medical attention and was treated with cephalexin (Keflex) and diphenhydramine HC1 (Benadryl). There were no lab diagnostic test performed. It was noted that the pt "gets a pneumococcal vaccine 23 polyvalent every year." The reporter stated that "she is holding the rest of this multi-dose vaccine and would like lot 1079M check[ed]."  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Rotating cold and hot flashes; Inability to sleep for 2 nights; Body aches; Heart palpitations; Extreme pain in eye sockets; Constipation; Night sweats; Headache all day and night; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA173696) via an unspecified route of administration in the left arm on 06Nov2021 at 12:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (FLU) on 16Oct2021, within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3U1558A) via an unspecified route of administration in the left arm on 16Oct2021 at 08:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. On 06Nov2021 at 15:00, the patient experienced rotating cold and hot flashes, inability to sleep for 2 nights, body aches, heart palpitations, extreme pain in eye sockets, constipation, night sweats and headache all day and night, since the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rotating cold and hot flashes, inability to sleep for 2 nights, body aches, heart palpitations, extreme pain in eye sockets, constipation, night sweats and headache all day and night was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
approx 3-4min p/vax pt fainted this was p/pt had been about walking & talking;
Pfizer-BioNTech COVID-19 Vaccine EUA: a few minutes after vaccination patient reported feeling funny with arm shaking then briefly experienced loss of consciousness: patient reported to return immediately back to baseline. No status epilepticus or tonic-clonic seizures witnessed. Patient immediately transported to emergency department (ED) and arrived awake with vital signs within normal ranges but refusing to answer questions. On physical exam noted to rhythmic movement of right arm but no convulsions. Administered intravenous fluids and left medically stable. Diagnosed with psychogenic non-epileptic seizure.
I had burning all over especially in my hair. It felt as if my hair was on fire states patient.
just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component), with no reported adverse event; just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component), with no reported adverse event;Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a nurse and consumer/ non-healthcare professional via Media Information (under reference 00794305).  This case involves a 2 months old female patient who just received the liquid vial (dtap-ipv component) and it was not mixed with the powder (hib component) of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] [product preparation issue][vaccine underdose].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On 30-Sep-2021, the patient received a first dose of suspect PENTACEL (VERO) [Total, lot number for Powder vial (Hib component): UJ425AA, lot number for Liquid vial (DTaP-IPV component): U6899AA and expiration date: 21-May-2022] via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to Inappropriate reconstitution technique and vaccine underdose(same day latency).  It was reported "Nurse states that she has questions about PENTACEL if only half was given. Nurse states that just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component). Nurse asking if she should give the shot again after mixing it or if she should just give a Hib."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt awoke @ noon on 1SEp93 w/temp around 104; given APAP, temp cont to stay between 102-104 for 15 straight hr; used APAP & cold compresses, liquids; recommended mom call MD & notify;
The registered nurse reported that on unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L051124, expiration date 14-OCT-2018, dose and route unknown), GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017, dose and route unknown, captured in 1609USA010854) and M-M-R II (lot # L036851, expiration date 23-SEP-2017, dose and route unknown, captured in 1607USA008489). The temperature excursion information included the highest temperature of 53.2 degrees Fahrenheit for 30 minutes. No adverse effects were reported. Follow up information has been received from the registered nurse on 20-SEP-2016. She said that no patients who received the improperly stored vaccines experienced any adverse symptoms. She said she had no additional information. This is one of the several report received from the same reporter. This report refers to the improperly stored PEDVAXHIB. Additional information has been requested. Reporter and narrative were updated.
Patient recieved Pfizer vaccine lot FA6780 diluted 7/15/21 at 16:03  on 7/16/21 at 12:58, vaccine was in frige at 69.0 degrees F. No adverse effects per patient. Error in vaccine adminsitration realized at 16:00 on 7/16/21.
ADACEL administered 11/7/08, Pt arm redness, swelling, fever to 102 deg. 8x9 cm red, raised area of administration site on 11/10.
Post vax, the pt developed total body erythema, faint fine papular rash over entire body, fever of 101-103, headache, itchy hands, feet swollen, and it hurts to walk.
missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Reporter did not allow further contact