chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual blood had extremely potent odor after receiving vaccine. Odor was specifically coming from menstrual blood. The odor from a single drop of blood could fill the entire bathroom and adjoining bedroom. Smell was foreign and could be described as; toxic, rotten, decay, chemical. Patient had to remove used tampons from the house entirely after each use due to the potent smell as well as disinfect the trash bin and surrounding area near toilet (even if trash bin had plastic liner) to remove the smell.   Patient has never experienced menstrual or vaginal odor of any kind before. Patient has never taken any form of birth control. Patient takes no medications, supplements or vitamins. Patient has a perfectly regular menstrual cycle that occurs every 28 days with an almost identical flow/cycle each month.
Pt broke out in rash on 8/28/2004 with just a couple spots more on the 29th and a fever 100. Few more spots by Mon. On Thurs 9/9/04 spots are drying up.
On 03/30/99 pt received first vax. On 05/06/99 pt received second dose. Approximately 12 weeks post second vax, pt returned to the physician complaining of chronic malaise and fatigue. Blood work was performed which 'ruled out' Lyme disease, but 'Lupus' was 'questionable' and confirmed through additional blood work (nonspecific). The vaccinee was treated with anti-inflammatory medication (nonspecific). The pt was referred to a nephrologist. This case is considered to be medically serious. Additional information has been requested. On 11/5/99, pt received 2nd dose of Lymerix. The most recent information, received on 8/16/00, reports the outcome of the event as unknown.
This spontaneous report as received from a pharmacy technician refers to a multiple anonymous patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, intramuscularly. On an unknown date the patients have been administered GARDASIL post supported excursion. No adverse effects noted by any patients. This is one of several reports from the same source. Additional information has been requested.
Nausea, extreme fatigue, loss of appetite , headache  for about 60 hours.
patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 were reported.  No treatment information was provided by the reporter. It was reported that,  the vial did not undergo any temperature excursions.
extreme swelling at injection site; extreme tenderness at injection site; was real tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 12:00 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement (ongoing). The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 17Feb2021, outcome "recovered" (19Feb2021), described as "extreme swelling at injection site"; VACCINATION SITE PAIN (non-serious) with onset 17Feb2021, outcome "recovered" (19Feb2021), described as "extreme tenderness at injection site"; FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered" (19Mar2021), described as "was real tired".  Additional information: Patient reported that while reporting on son, Reporter adds that she had Covid in Nov 2020. The report not related to a study or programme History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Investigation assessment reported as no. Her arm was so tender she did not even want her clothes to touch it. She applied ice and that helped. She received the second dose 12Mar2021. Patient does not know if she kept the vaccine card or if she threw it away. Additional vaccines administered on same date of the pfizer suspect reported as none. Prior Vaccinations (within 4 weeks) reported as none. The patient was not visited to emergency room and physician office. Family Medical History Relevant to AE(s) reported as none. Relevant tests reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her 20 year old son with attention deficit/hyperactivity disorder (ADHD) and no drug reactions or allergies, who prior to receiving the GARDASIL he had swollen glands and did not feel well. On 13-SEP-2010, he was vaccinated with a dose of GARDASIL. Concomitant therapy included FOCALIN and ibuprofen. On 14-SEP-2010, the patient broke out in a rash which spread to his entire body. On 15-SEP-2010, patient went to the emergency room where he received cortisone. His rash resolved on 16-SEP-2010. No lab diagnostics studies were performed. No further information is available.
Chest/heart pain - stabbing lasting seconds multiple times per day Increased blood pressure  I've had low  blood pressure my entire life. After the vaccine my blood pressure moved from 93/49 and 86/62 in May 2021 to 136/82 in Jan 2022 following the Pfizer vaccine. Patient has lifetime of low blood pressure. Patient also reports chest pain. For 2.5 weeks following vaccine.
Information has been received from a physician concerning a 12 year old female with a history of convulsion who on an unspecified date was vaccinated with Gardasil (lot#unknown) 0.5mL IM. Concomitant therapy included diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis vaccine (unspecified) (+) tetanus toxoid administered the same day as the Gardasil. On an unspecified date, after the administration of Gardasil the patient experienced syncope and brief seizure-like activity. Subsequently, the patient recovered from syncope and brief seizure-like activity prior to leaving the clinic. No further information is available. Upon internal review, brief seizure-like activity is considered to be an other medical event (OME). Additional information has been requested.
Information has been received from a health care professional concerning four children who were vaccinated with one dose of varicella virus vaccine. Two of the pts subsequently developed severe cases of varicella and two pts developed mild cases of varicella. The pts sought unspecified medical attention. No further information is available.
608hr p/vax devel soreness & swelling on upper part off arm;had fever took 2 ASA;BP inc so pt took xanax to get it down;temp was down to 100 @ bedtime;next morning fever was down;
Patient became very pale and clammy. He stated that he felt tingly all over. He was assessed by Dr. and RN. They laid him flat on the table, and lifted his legs. An ice pack was placed on his neck. They reassessed vital signs. He was given water, crackers and juice. He then was feeling much better.
One time:  woke up day after vaccine very lethargic. Many time:  Parts of my body turn red and feels like 'on fire' - even today having an episode.
Initial and follow up information has been received from a physician concerning an 80 year old female who in approximately JUNE 2007 was vaccinated subcutaneously with a single dose of Zostavax (Oka/Merck).  On 18-JUN-2007 the patient developed shingles on her left chest wall, left breast, and abdomen (previously reported as side).  Unspecified medical attention was sought.  Subsequently the patient recovered.  No further information was provided.  There was no product quality complaint involved.  No further information is expected.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient (encounter key# 424169) of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 32F (0 Celsius) for 104 hours; also there were reported temperatures of 48F (8.8 degrees C). The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Lump like ball in the arm for almost two weeks; For the first 4 or 5 days, after receiving the first dose Pfizer Covid Vaccine, had chest pains; her heart literally had chest pains for 4 or 5 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm right on 08Apr2021 13:30 as 1st dose, single for COVID-19 immunization. Medical history included Chronic pain from 2004 and ongoing, high blood pressure from 2010 and ongoing, asthma from 2004 and ongoing. The concomitant medications were not reported. The patient did not receive prior vaccination within four weeks and other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events reported prior vaccinations. The patient has not received the second dose Pfizer Covid Vaccine yet because the she was scared.On 08Apr2021, at night the patient experienced chest pain. It was reported that for the first 4 or 5 days, after receiving the first dose Pfizer Covid Vaccine, had chest pains. The patient had high blood pressure because of chronic pain issues. The patient stated that her heart literally had chest pains for 4 or 5 days. The patient was reading about inflammation of the heart. The patient knows that inflammation of the heart happens in young people, the patient was wondering if this happened to her. The patient stated that few hours after first dose there was a lump like ball started forming and it went away but took almost two weeks to go away. When the patient pressed on it, the lump like ball felt like a bruise more like. She stated that she also had chest pains which began at the night when she received the first dose Pfizer Covid Vaccine on 08Apr2021, and this went away about 5 days later. The outcome for the events lump like ball started forming was reported as recovered on an unspecified date in 2021 while for had chest pains and her heart literally had chest pains for 4 or 5 days was reported as recovered on 13Apr2021.  Information on the lot/ batch number has been requested.
Site where DTAP was given is re, hard, and swollen.  Meds given for treatment are benadryl and motrin.
10/20/2009 4pm called Dr. as arm became very sore. No redness or swelling. 6pm had chills and felt very hot. Temp 102.7 (oral, digital). Took IBUPROFEN before Temp. 7pm took XANAX; "Settled me down". At bedtime felt very cold. 10/21/09 felt "washed out", "Felt wiped out for 5 days". 10/29/2009 fully recovered.
Received DTaP, HIB, PCV13, IPV at appointment. Had 2 minute tonic clonic seizure on 8/13. Not febrile at time of seizure as far as we know, but mild fever earlier in the day. Admitted to the hospital for workup.  No clear etiology was found.
Joints very achy and painful, especially knees.  Swelling hand, arms, feet and legs up to knees.  Difficulty in walking or closing hands, manual dexterity.
Client presents to clinic requesting yellow fever for cruise - says vaccine mandatory for cruise and her personal physician "refuses" to give her waiver letter - 5 days after vaccination, client calls and says she "has body aches and is feverish". Client  later called back and her physician "for evaluation - client calls us 3/29/07  and says she is experiencing muscle weakness and tingling. Client again returned back to her personal physician for evaluation.
VACCINE NOT SWIRLED BEFORE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced vaccine not swirled before administration. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine not swirled before administration was not reported. This report was non-serious.
JOINT PAIN; FEVER; WALKING DIFFICULTY; DIFFICULTY IN STANDING; SEVERE LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced walking difficulty. On MAR-2021, the subject experienced difficulty in standing. On MAR-2021, the subject experienced severe leg pain. On 20-MAR-2021, the subject experienced joint pain. On 20-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from walking difficulty, difficulty in standing, and fever, and was recovering from joint pain, and severe leg pain. This report was non-serious.
Swelling, redness, warmth at injx site (started 6:00am 10/3) Fatigue, body aches, chills, nausea (started 12:00pm 10/3)
This spontaneous report as received from a registered pharmacist refers to a 27 year old male patient. On 18-JUN-2013 the patient was vaccinated subcutaneously with 0.5 ml dose of properly reconstituted ZOSTAVAX (lot # J001010, expired date: 24-APR-2014) instead of (Merck) VARIVAX due to staff error, not product confusion. No adverse effect reported. The patient didn't seek any medical attention. Additional information has been requested.
Hives immediately became visible around injection site and them proceeded to move down the rest of the arm. 50mg of Benadryl given PO. Ice pack to area. Patient was observed for 30 minutes. No other issues or complaints. The L. arm was less reddened and less raised areas. Patient did have a caregiver with him. She was given the information of events and to seek medical treatment in the event that hives worsen or there are any swallowing or breathing difficulties. They both verbalized understanding.
Patient reported to clinic the day after her vaccine. Stating that she has pain in her left shoulder and feels that she was stung by a bee. She complained of myalgias and fatigue. Patient reports that when she woke up the day after her vaccine and her feet were hurting her tremendously and she could not walk.
The breast on the side that I got my vaccine in was particularly more visually swollen and tender/sore than the other breast for a full week prior to the period that happened after. This is unusual for me.  That breast is ever so slightly naturally bigger than my right, but they always are affected equally/in tandem in regards to my cycle.
Pain, swelling, and redness at injection site and radiating (beginning about 16 hours after injection) Fever reaching 103.2 degrees Fahrenheit (beginning about 25.5 hours after injection and initially unresponsive to acetaminophen). Chills and shivering related to fever noted above. Headache.
Information has been received from a registered nurse concerning a 12 month old female who on 08-APR-2008 was vaccinated subcutaneously in the right thigh with a dose of VARIVAX (Merck) ( Lot # 659357/1567U).  On the same day the patient was also vaccinated with suspect therapy a dose of MMR II (Wistar RA 27/3) (Lot # 657637/1485U).  On 17-APR-2008 the patient felt warm and developed rash, multiple erythema and papules on trunk and back of head.  Subsequently, the patient recovered from feels warm, rash, multiple erythema and papules.  The patient was seen in office.  Additional information is not expected.
Got Moderna vaccine on Tuesday (02/01/21) morning at about 10 45 am or so. Today (02/03/21) noticed the area was a little swollen, very red and hot to the touch and a softball sized area around where the shot was given is sore to the touch. Took ibuprofen yesterday since she was achy and felt fine today when she woke up. However, she noticed the area when taking a shower about 10   minutes ago. Advised to go to urgent care to get it checked out to make sure not infected.
This spontaneous report as received from a other health professional refers to a 12 month old female patient. The patient had no medical history, concurrent conditions or concomitant medications. On 10-MAR-2017, the patient was vaccinated with a dose of VARIVAX subcutaneously, (lot # M023383, with an expiration date in 11-MAY-2018), for immunization (dose, dose number, frequency and strength were not provided). On 22-MAR-2017, 13 days after onset of therapy the patient experienced "rash, redness, edema at injection site", the patient was diagnosed with vaccination site cellulitis and treated with sulfamethoxazole trimethoprim (BACTRIM). The nurse requested VZV packet to be sent, no product quality complaint (PQC) was involved. Additionally, it was reported that there was no intervention to prevent serious criteria and the patient was not hospitalized or experienced a significant incapacity nor disability. At the time of reporting, the outcome of vaccination site cellulitis was unknown. The causal relationship between vaccination site cellulitis and VARIVAX was not provided. Additional information has been requested.
Pt recv vax on 11/6/98; on same day pt exp hives, swollen lips, pruritus; tx=Benadryl
Patient usually receives the flu shot every year with no problems - Pharmacist decides to administer the shingles vaccine first (shingrix) within a minute patient starts to have itchy throat, by the time the flu shot is administered it's become apparent to the patient that she is experiencing symptoms- she reports chest tightness, difficulty breathing and reaches for her inhaler, pharmacist reaches for the epipen as symptoms progress and shows obvious distress... pt adamantly refuses the injection, pharmacist insists she says NO, pharmacist then offers to administer diphenhydramine 50mg as an alternative and pt accepts... symptoms seem to stop getting worse after treatment with diphenhydramine... pharmacist recommends that patient goes to the hospital, pt refuses, she starts feeling better and wants to go home. pharmacist again recommends the hospital for follow up as symptoms may return patient says No, pharmacist then trains husband on how to use the Epipen and recommends a second dose of diphenhydramine in about 6 hours ...
RABIES VACC.GIVEN AT ER 3-31-08, WE GAVE RABIES BOOSTER # 2 ON 4-3-08. CLIENT REPORTS ON 4-4-08 STARTED HAVING SEVERE HEADACHE LT. SIDE OF HEADAND NECK THAT LASTED FOR 2 WEEKS. SINCE RECIEVING RABIES BOOSTER ON 4-3-08 HAS HAD PAIN IN DELTOID AREA OF LT.ALSO "ELECTRICAL JOLT LIKE FEELINGS LT. ARM,"ALSO NUMBNESS LT. HAND.
Information has been received from a registered pharmacist, "who administers vaccines", concerning a 67 year old female with no pertinent medical history, drug reactions or allergies noted on her pharmacy forms, who on 28-JAN-2008 was vaccinated  subcutaneously into the left upper arm with "one single dose" of zoster vaccine live (Oka/Merck) (lot# 658324/1821U) at the pharmacy. Concomitant therapy included celecoxib (CELEBREX), citalopram hydrobromide (CELEXA), vitamin D (unspecified), calcium (unspecified), magnesium (unspecified), amlodipine besylate (NORVASC), hydrochlorothiazide, aspirin and unspecified natural remedies. On 10-FEB-2008 (previously reported as approximately 11-FEB-2008), 14 days after the vaccination, the patient reported an injection site reaction. The patient called the pharmacy to report that she developed a "white or light colored circle area about 1/2 inch in diameter at the injection site." The patient stated that "it is not as pink as normal skin." The pharmacist noted that the area was not warm, raised, or red. The area was painful to touch and the pharmacist mentioned that the patient was having "spasms at the injection site and around the arm in that area." At the time of reporting the events had not resolved and the patient was trying to get an appointment with her physician. There was no product quality complaint. The patient was reported to be recovering at the time of reporting. Additional information has been requested.
Patient was re-vaccinated on 02/27/2003.  Uneventful course.  Scab off 03/15/2003, appeared healed-dry.  On 04/03/2003, patient noticed vaccination scar was fluid filled with white cloudy fluid.  No erythema, no itching etc.  04/04/2003: Was collected fluid: did testing (see results to follow) once fluid appeared.  Uneventful healing within 2-3 days.  No fever.
Initial soreness at injection site at upper right arm + and right shoulder.  3 hours later I had weakness in right arm. Next morning (13 hrs later)  Aches and pains thru entire body.  All joints and muscle fatigue.  Difficulty in moving joints.  Difficulty walking and used a walker.  Bedridden for 3 days. Slept most of the days and nights.  Could walk around on day 4 still having substantial  pain.   Very tired.  Today is day 22 since my Covid 2 inoculation and I still have latent tiredness and legs aches and pains which prevent me from walking more than  100 feet without using assistance from a walker.
Large area erythema, increase warmth, induration area approx 10 cm pale erythema with dark erythema with induration approx 4x7 cm. (+) urticaria.
1st vaccine 1/30/21; 2nd vaccine 2/20/21; developed SOA 2/21/21; seen in ED for ongoing SOA 2/23/21
16-old-year patient administered a Moderna COVID-19 vaccine as a booster shot on 1/14/2022. Patient previously vaccinated with Pfizer COVID-19 vaccine on 5/3/2021 and 5/24/2021. This is a medication error as booster shots with Moderna (rather than Pfizer) are not currently approved for this age group. No adverse events occurred.