chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; neck and back ache; neck and back ache; injection arm very tender; Nausea; fatigue; This is a spontaneous report from a contactable consumer. A 49-year-old female patient started to receive BNT162B2 (Solution for injection, lot number and expiry date was unknown), via an unspecified route of administration on 18Dec2020 10:00 at single dose in the left arm for immunization. Medical history included migraines and COVID-19 from an unknown date. Concomitant medication included acetylsalicylic acid (ASPRIN), potassium, curcuma longa (TURMERIC [CURCUMA LONGA]), ospemifene (OSPHENA) and black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]). The patient previously took penicillin and experienced allergies. On 18Dec2020 19:00, the patient experienced headache, neck and back ache, injection arm very tender, nausea and fatigue. No treatment received all the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  The following information on the batch number has been requested.
Lack of energy; Irritable; Moody; loose stools; Tired, Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lack of energy), IRRITABILITY (Irritable), MOOD SWINGS (Moody), DIARRHOEA (loose stools) and FATIGUE (Tired, Exhaustion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced DIARRHOEA (loose stools) and FATIGUE (Tired, Exhaustion). On an unknown date, the patient experienced ASTHENIA (Lack of energy), IRRITABILITY (Irritable) and MOOD SWINGS (Moody). At the time of the report, ASTHENIA (Lack of energy), IRRITABILITY (Irritable) and MOOD SWINGS (Moody) outcome was unknown, DIARRHOEA (loose stools) had resolved and FATIGUE (Tired, Exhaustion) had not resolved.            No concomitant information was reported. No treatment information was reported.
Patient is reported to have died at home, the day after his COVID test.  Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day.  The patient "was having palpitations".  The family tried to convince him to go to the Emergency Room, but he refused.  Patient died at home.
Mom states pt cried x 3 days on & off p/shots & had fever, but did not take temp;
seven minutes after vaccine was received patient started to feel dizzy and like he was going to pass out, his arms started to tingle, and his head then started to fall and he wasted his water, a nurse saw his head drop, he saw the nurse run to the car and then the feeling went away.
daily severe headaches, debilitating at times; This is a spontaneous report from a non-contactable nurse (patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There is no other vaccine in four weeks, no other medications in two weeks. The patient experienced daily severe headaches, debilitating at times on an unspecified date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information in the case, a contributory role of BNT162B2 to the reported event Headache cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 20 year old female with allergy to pencillin, amoxicillin and sulfa, who on 08-MAY-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included unspecified "birth control" therapy. On 06-JUL-2007 the patient was vaccinated intramuscularly with a second dose of GARDASIL. "Almost immediately post vaccination the patient experienced extreme nausea, dizziness, and vomiting. Physician reported that the patient almost fainted twice. The patient was retained in the physician's office for about three hours until the symptoms subsided. There was no product quality complaint. Additional information has been requested.
Pt recvd vax & exp h/a, nausea, & malaise the next day;
swollen lymph node (and slight pain) on the left collarbone (same side of the injection)
Bruise on site of injection very bad pain on the underside of left arm. Not at all like my past Flu shots! pain lasted two days.
Sudden onsite 6pm the next day of fever, chills, sweats, headache, body aches
large welt in area of vax & very warm for a day, & came down w/flu p/recvd vax;
got them despite having the vaccine/suspected vaccination failure; Shingles were in my eye; bad eye pain; blurred vision; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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), ophthalmic herpes zoster (serious criteria GSK medically significant), eye pain and blurred vision. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, eye pain and blurred vision were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, eye pain and blurred vision to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient, shingles were awful. The patient got shingles despite Shingles vaccination. Shingles were in the patient's eye and almost lost his/her eyesight. The patient credit the vaccine for keeping shingles from being worse than shingles were. The patient said that yes, shingles were bad, but they stopped just before blinded the patient. The patient stated if the patient had not been vaccinated, so instead just suffered several days of bad eye pain and blurred vision but his/her physician were able to treat the patient. The patient was literally moments from rupturing his/her retina and when they caught it. The physician hit him/her with the massive rescue therapy and because he/she had been vaccinated, his/her antibodies saw this as an appropriate treatment and allowed body to respond and took only 2 days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
05/11/2022 - I had a sore throat and I was tired. I did an at home test COVID-19 test on 5/11 and it was positive. And I went to the urgent care on 5/12 to confirm and it was positive. I was prescribed methyl prednisone. I had sneezing the 2nd day. No other symptoms. No fever. No cough. Note: I got the flu shot in October or November 2021, but I don't remember the exact date.
MISSED TO TAKE HIS THIRD DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1784) was received from a nurse on 11-Jul-2019. It describes an 18-year-old male consumer who "missed to take his third dose of Vivotif according to schedule", while being on oral Vivotif (lot number: 3003253) for typhoid fever prophylaxis.  Case report: The consumer was supposed to take his third dose of Vivotif 10-Jul-2019 but forgot to take it. He missed the dose as he left on a local road trip.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take his third dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take his third dose of Vivotif according to schedule" was considered as not applicable.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective."  According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 3 months after vaccination developed meningococcal sepsis, year reported as 2008 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
This spontaneous report as received from registered nurse refers to a 47 year old male patient. Concurrent conditions and relevant medical history was not reported. On 10-JUN-2014 the patient was vaccinated with first dose of M-M-R II, (0.5 ml, subcutaneously) (Lot number: H018950 with expiry date 18-OCt-2014) in the left deltoid. Concomitant medications were not reported. On 17-JUN-2014 (reported as approximately one week after), the patient experienced prolonged injection site pain in his left deltoid. The patient did not specify at what time and on what date he began to have this pain, but he reported that approximately one week after he received the dose of M-M-R II, his left arm was very sore for up to three weeks. The patient rates his pain on a scale of 1-to-10 as a "3 or 4." He stated that the last night his arm hurt, he rates the pain an "8" on a scale of 1-to-10. The following day, the pain completely gone. The patient did not specify the specific dates that he experienced this pain, but he told the nurse that he thought he may have injured his left arm while lifting weights. On 23-JUL-2014, the patient was vaccinated with second dose of M-M-R II,(0.5 ml, subcutaneously)(Lot number: J014876 with expiry date 21-NOV-2015) in the left deltoid. The patient informed the nurse that he experienced pain with this injection, much like he did after he received his first M-M-R II dose. The nurse provided the patient with ibuprofen after he received his second M-M-R II yesterday, 23-JUL-2014. The patient did not sought any medical attention. The outcome of vaccination site pain and pain in left arm experienced on 17-JUN-2014 was reported as recovered/resolved. The outcome of the vaccination site pain experienced on 23-JUL-2014 was not recovered/not resolved. The causality of the events with M-M-R II was not reported. Action taken with suspect therapy was not applicable. Product quality issue was not involved. Additional information has been requested.
Initial pregnancy report received from a non-healthcare professional on 06 November 2014. It's a linked to mother case 2014SA154538. A child patient (age and gender not reported), whose medical history and concomitant medication was not reported, had received intramuscularly a dose of FLUZONE, (batch number, expiry date of vaccine, dose, cycle in series and site of vaccination not reported, on 12-Oct-2009 (One pregnancy, not her first), 26-Oct-2010 (while nursing), 13-Dec-2012 (the next pregnancy) and on 12-Sep-2013 (another while nursing). On an unspecified date, patient experienced severe allergy to eggs and peanuts, get very sick and the same time child's mother received the vaccine and was also nursing. No illness at the time of vaccination reported. Corrective treatment and lab investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Secondary, medium-sized rash at injection site. Very itchy until  rubbing alcohol applied, which immediately resolved the itch. Rash lasted approximately 24 hours.
On the day following the vaccination, I had fever 100.3 and when I took a nap in the afternoon I had nightmares and had difficulty waking up.  It felt as though I had been drugged.
Tinnitus- loud ringing in ears, especially left ear. Began within 24 hours of 2nd Moderna vaccine and has increased in noise level. Sounds like cicadas.  Immediately after vaccine I had pressure/pain in both jaws, and my ears felt clogged. The jaw pain was replaced by the ears ringing.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient age was reported as 41 years and 9 months.  It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations.  No treatment drug information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Initial case received from a consumer, who is also the patient, on 13 August 2010.  A female patient received an injection of MENACTRA (lot number U2990AA) and ADACEL (lot number C3382AA) on 09 August 2010.  The evening of vaccination she woke up cold and shaking violently, and began having diarrhea attacks.  The following day she reported being completely disabled, was unable to get out of bed, unable to eat, and unable to care for her children.  She reported being dizzy, weak, and nauseous, and had a headache.  She later developed a red ring on her arm at the injection site, which was 4.5 inches in diameter, and she observed spasms at the injection site.  Outcome and treatment were not reported.
Moderna booster vaccine administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry submitted to Moderna requesting validation of vaccine potency. A response from Moderna is expected between 8-10 business days. Expiration date currently not printed on the vaccine vial or carton. Vaccine expiration date listed in database lookup tool is 12/31/2069. Patient contacted on 12/4/2021 and  12/6/2021, unsuccessful attempts to speak with patient.
While waiting to leave, patient began "feeling head tightness, dizziness and tasting vaccine." She also stated that she had just received Botox to forehead and lips. Patient suddenly  was unable to speak to due to expressive aphasia. Vital signs obtained and were 130/102, HR105 and SpO2 99% on room air. Patient is alert and oriented x3. Patient given gatorade and cool fan to face.  When able to speak, patient started to complain of "tingling" to bilateral hands and arms. EMS notified and patient was escorted to front entrance via wheelchair.   EMS arrived on scene at 0914 and care was transferred to EMS. Vital sign BP 176/104 P88 O2 100% on room air.
Pt states the night after receiving the covid vax she had redness, pain and swelling at the injection site.  Pt stated that about 8 days later that she developed a rash surrounding the injection site and still has it.  Pt contacted her PCP and they told her she may have an allergic reaction to the covid vax but did not suggest taking any medication.
Left arm vaccine site increased on 4/12/19 to 4cm redness at site from 2cm redness on 4/11/19.  Pt. complains of itching and some pain. Right arm vaccine site increased to double the size of redness from 3 inches on 4/11/19 to 6 inches of redness on 4/12/19 also pt. complains of itching and pain at that site also. Dr. ordered benadryl and motrin and ice to site on 4/11/19 and to continue treating with Motrin, Benadryl and Ice along with Keflex 250 mg capsules, 2 capsules three times a day for 10 days. Will follow up on 4/16/19 unless s/s worsen prior.  May consider allergy referral before 2nd dose of Menveo.
Baby had been asleep since leaving doctors office.  Baby awoke screaming crying with a remarkably hoarse voice and wheezing (possibly stridor).  No wheezing when baby was calm.  Symptoms lasted until about midnight.  Sometime between 10pm-12am rectal temp taken for 1st time, 100.8 degrees Fahrenheit. Tylenol given.    Next morning Temp of 100 at 6AM. Tylenol given. 10AM there was some hoarseness with crying lasting a half hour. No other episode. Went to doctor at 1pm.  O2SAT was 100%, no wheezing or hoarseness.
This was an administration event that has the capacity to cause error. The medication itself is supposed to be administered orally. However, for many NICU patients, they are NPO and have an NG tube. GSK does not make a comment on whether or not that the vaccine can be administered via a tube, however, they direct you to website and the CDC makes the recommendation that it can be administered via the NG tube. THe problem with this recommendation is that (1) there is no data to support this and (2) the vaccine packaging is NOT compatible with NG tube. Due to this, the RN administered the rotarix vaccine thru an empty oral syringe that was set up to vent the OG tube and clamp the tubing for a few minutes to prevent backflow.  This type of administration is unsafe and, if the vaccine can be administered via the NG tube, then the vaccine should be compatible with tube as that is the type of syringe the majority of hospitals use.
Tingling, pins and needles, burning sensation of muscles, R/O Guillain Barre, also considered CIPD, chronic vaginitis.  Treated with Neurontin, prescribed by neurologist.
w/in 24 hrs of vax devel t103 suddenly, became mottled w/marked peripheral vasoconstriction-none centrally; Had 97% O2 sat; dec activity, poor feeding, & irritable; adm to hosp for septic workup which was neg & sx disappeared completely;
~ 10 hrs post injection began feeling tired and chilled ~ 20 hrs post injection fever (38 degrees) and nausea ~ 48hrs post injection temp reduced to 37.4 degrees (still high for me) and noticed sore armpit on left side. Still light headed. ~56hrs post injection began feeling normal. Armpit still a little tender
Myalgia, Arthralgia, Fever, PAIN AT INJECTION SITE Narrative:  EMPLOYEE REPORTS HAVING FLU LIKE SYMPTOMS. REPORTS 100.3 FEVER NEXT DAY AND PAIN 6  HOURS POST VACCINATION.
swollen lymph nodes in neck.; Painful Lump; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis. The patient was allergic to green onions. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications within the two weeks of vaccination included FLONASE SENSIMIST, BENADRYL and TYLENOL for unknown indications received from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, the patient experienced painful lump/ swollen lymph nodes in neck. It was reported that, looking straight forward/ holding head straight, particularly when driving, for longer than a few minutes causes the swollen area to throb and this was not normal to her. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for adverse events. The clinical outcome of the events swollen lymph node and lymph node pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Low grade fever, headache, joint pain began about 28-24 hours after injection and lasted for about 18 hours and resolved.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. No medical histories, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L001334, expiration date: 13-JAN-2017 and lot # L034367, expiration date: 08-SEP-2017; doses and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Broke out in rash on face and arms next day went back to MD 4 days later gave me cortisone went back 1 week later gave pills for itching 1 week later referred to dermatologist-creams now given still have to date
She got very dizzy immediately after vacinne.  Nurse had to catch her and help me put her in chair.  She sat there for awhile.  Then I took her into the waiting room (had to support her a lot).  I again had to put all of her weight on me to take her to my car and get her home.  I'm VERY disturbed that this could have been serious.  They didn't even have her stay at medical center until she felt better.  She said that she couldn't see while feeling this way.
This case was reported by a consumer and described the occurrence of fever in patient who was vaccinated with Pediarix for prophylaxis.  The reporter is the mother.  The report was initially received from a consumer and subsequently confirmed by a nurse.  On 30 September 2005 the subject received 2nd dose of Pediarix in the right arm.  On 30 September 2005, less than one day after vaccination with Pediarix, the subject experienced fever and injection site pain.  On 01 October 2005, the events were resolved.