chrisvoncsefalvay/vaers-outcomes huggingface dataset:
massive headache; muscle pain; felt super-hot at first, then felt like she was freezing; muscle pain; feels really cold; skin is hot to the touch; felt like she had to throw up or vomit; body aches; chills described as having goosebumps and feeling like her hair was standing; stomach upset; dry heaves; fever; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (body aches), CHILLS (chills described as having goosebumps and feeling like her hair was standing), ABDOMINAL DISCOMFORT (stomach upset), RETCHING (dry heaves) and PYREXIA (fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills described as having goosebumps and feeling like her hair was standing), ABDOMINAL DISCOMFORT (stomach upset), RETCHING (dry heaves), PYREXIA (fever), TREMOR (shaking) and NAUSEA (felt like she had to throw up or vomit). On 16-Mar-2021, the patient experienced HEADACHE (massive headache), the first episode of MYALGIA (muscle pain), FEELING OF BODY TEMPERATURE CHANGE (felt super-hot at first, then felt like she was freezing), the second episode of MYALGIA (muscle pain), FEELING COLD (feels really cold) and SKIN WARM (skin is hot to the touch). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 500 mg. At the time of the report, MYALGIA (body aches), CHILLS (chills described as having goosebumps and feeling like her hair was standing), ABDOMINAL DISCOMFORT (stomach upset), PYREXIA (fever), TREMOR (shaking), HEADACHE (massive headache), FEELING OF BODY TEMPERATURE CHANGE (felt super-hot at first, then felt like she was freezing), NAUSEA (felt like she had to throw up or vomit), the last episode of MYALGIA (muscle pain), FEELING COLD (feels really cold) and SKIN WARM (skin is hot to the touch) outcome was unknown and RETCHING (dry heaves) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 101 degree Celsius High. On 16-Mar-2021, Body temperature: 97.5 degree Celsius normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 15-Mar-2021, about six or seven in the evening the patient had stomach upset and she felt like she had to throw up or vomit. On the same day around 9 pm or 10 pm, the patient had a fever of 101 degrees. On 16-Mar-2021, the patient had goosebumps again in the morning. On 16-Mar-2021, the patient missed work due to symptoms.  Treatment medication included unspecified inhaler.
This spontaneous report was received from a consumer reporting about his approximately 24 years old daughter. On an unknown date in 1994, the patient was vaccinated with dose 1 of VARIVAX (lot# and route not reported) and on an unknown date in 2012, the patient was vaccinated with dose 2 of VARIVAX (lot# and route not reported). Product circular # reported as 9904705. No concomitant medications were reported. Patient sought medical attention (office visit). Antibody titers were checked recently and the results revealed "low antibody levels". Additional information has been requested.
pharmacy was off site for a clinic/  vaccinator by accident picked up a box of moderna that was not fully thawed. There were other doses of Moderna that were thawed and ready for use, but she picked up the wrong box of Moderna.  The dose was half frozen.    The patient was administered only 1/2 of a dose as the vaccine had only 1/2 of the liquid in the syringe.  The patient was made aware of the 1/2 dose and was monitored.  There were no side effects or ill results from the 1/2 dose.  Awaiting guidance from Moderna as to whether or not to revaccinate.
Information has been received from a physician, via a company representative, concerning a 16 year old female patient who in January 2007 ("last month"), was vaccinated with the first dose, 0.5ml, of Gardasil. The physician reported that in January 2007 ("last month"), the patient experienced a grand mal seizure after receiving her first dose. In addition, the physician reported that the "patient has no history of seizures and was taken to the ER. The physician did not know if the patient was admitted. It was unknown if the patient recovered. Upon internal review, grand mal seizure was determined to be an other medical event. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (31Jul2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive; (31Jul2023) Negative; (Aug2023) positive, notes: positive Covid test again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 treatment included Paxlovid from 24Jul2023 to 29Jul2023. Other medication included Tylenol from 24Jul2023 to 27Jul2023. The patient had rebound of Covid symptoms on 03Aug2023 at 05:00 AM and positive Covid test again after negative test on 31Jul2023. This further event was recovering with no treatment.  No follow-up attempts are possible. No further information is expected.
I had my last booster and flu shot on same date. Since then I have had to call the emergency number 3 times due to my heart beating super fast. It was worse than heart palpitations. The last time I called was last week. I think that it was a change in my blood pressure. I was light headed and felt I would pass out and my vision was blurry. I also had pressure in the top of my head. The medics came over and checked my blood pressure. They determined it was high but it was ok. I still asked to be taken to the ER. They kept me there for 4 or 5 hours and gave me a prescription for migraine. The symptoms returned shortly after they gave me the medicine. I was sent to have a CT scan performed. The results were normal. I scheduled an appointment with my doctor after that. He referred me to an ophthalmologist. The ER prescribed 2 medications for migraines but I have not taken them. In November I had a heart ultrasound done and was placed on a heart monitor for 1 week. I went to see a cardiologist. He advised the heart ultrasound was normal. I called the ER because my heart was beating like crazy for more than a minute. I had no stress factors that contributed. I have also been experiencing extreme fatigue so I had a full panel blood test and determined that my Vitamin D was low and that cholesterol was slightly high. I do still the pressure in my head and my eyes. It feels like my eyes have changed and it comes and goes. I have also experienced brain fog and extreme fatigue. I had a change in my periods. They are extremely painful and they are showing up a week earlier.  When I drink wine, it seems that I am having an allergic reaction. After having half a glass of wine, I started having the palpitations and feeling like I am having a hangover.
A few days after the shot, my lower back really started to hurt. So much, that I ended up in the ER thinking it could be kidney stones. ER staff were unable to determine the cause of the pain. Exactly one week after the shot (Tuesday), I start sweating profusely and nearly passing out at work. A day later (Wednesday), my heart rate went through the roof and I was dizzy, out of breath. By Friday night I was in an urgent care clinic with a resting heart rate of 145BPM. (My normal is in the 50s). I was diagnosed with Arterial Fibrillation. I have no history, or family history of heart issues. I run 3-5 days a week....3-10 miles at a time. In the military...very healthy.
Severe upper arm pain to the point that I could  not lift or move my arm. Initial severity resolved after about 24 hours, but still sore with limitations 48 hours later.
Patient fainted in waiting room after vaccination with no head injury. Patient remained in chair seated during incident. She became quickly responsive and drank water. She experienced warmth and tingling in hands that resolved by end of 30 minute , Observation window she denied paramedics being called
felt "like pulled the muscle" on right arm; "bruise but no color change" in injection site; tenderness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (felt "like pulled the muscle" on right arm), VACCINATION SITE BRUISING ("bruise but no color change" in injection site) and VACCINATION SITE PAIN (tenderness in injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 211B21A and 036A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Apr-2021, the patient experienced MUSCLE STRAIN (felt "like pulled the muscle" on right arm), VACCINATION SITE BRUISING ("bruise but no color change" in injection site) and VACCINATION SITE PAIN (tenderness in injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE STRAIN (felt "like pulled the muscle" on right arm), VACCINATION SITE BRUISING ("bruise but no color change" in injection site) and VACCINATION SITE PAIN (tenderness in injection site) outcome was unknown.            This case was linked to MOD-2021-079274 (E2B Linked Report).; Sender's Comments:  MOD-2021-079274:Husband's case
Patient with Bells Palsy & Pfizer booster within a month of symptoms. 49YF with history of diabetes, sleep apnea, dyslipidemia, and obesity.  She presents to the hospital on 1/27/22 with a 2-day history of facial paresthesias.  About 2 days ago, she dozed off and when she woke up, she had an abnormal feeling on the left side of her tongue.  She has also noticed an achy sensation on the left side of her head on the top.  She tells me that it felt as though she was having pressure there from a hair clip which she took out. This morning, she was brushing her teeth and she noticed that her mouth felt abnormal on the left side and water was dribbling out of the left side of her mouth.  Her smile also looked asymmetric.  She has noticed some tearing of her left eye and tells me that it feels very dry.  She has not had any vesicles in her ear or any ear pain, no upper respiratory infections recently.  She received the Pfizer booster sometime after Christmas within the last few weeks.  She has not had any fevers or chills.  No nausea or vomiting.  No chest pain or trouble breathing, no unilateral weakness of her extremities.  No difficulty with balance or coordination.  She has never had a history of stroke, TIA, or MI.  She went see her primary care provider and was instructed to come to the emergency department for further evaluation.  A neurological consultation was requested.   Discussed with neurology in the absence of other strokelike findings, the progression to the upper facial weakness this should be treated with 7-day course of steroids, eyedrops and eye patch.  Reviewed the patient's labs without any significant anemia, metabolic abnormality, COVID-19 testing.  At this time I have discussed Bell's palsy with the patient, outpatient treatment, the importance of primary care follow-up and I will give her a referral for neurology.  She is comfortable discharge at this time on 1/27/22.  We did advise her that given her diabetes history she should check her glucose carefully and be in close contact with her primary care physician.
Suspected vaccination failure/Is the 3rd time (shingles) since I got the shingles vaccine; Is the 3rd time (shingles) since got the shingles vaccine; Worst pain ever; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient never had shingles until he/she got the shingles vaccine worst pain ever this was the third time since he/she got the shingles vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Redness, swelling and pain at injection site. Tenderness and slight rash also noted.
Diverticulitis I went to ER. For granuloma Anulare, I had surgery on right wrist.
10APR dad reported rash starting on face & spreading to body t102; pt taken to MD; reported poss rxn to MMR; 13APR92 dad reported rash was worse but fever gone; 14APR92 rash improved according to MD;
Information has been received from an LPN concerning an 88 year old male patient with hypertension and hardening of arteries who on 18-OCT-2006 was vaccinated IM with a 2nd dose of Pneumovax 23 (lot #651437/0899F).  Concomitant therapy included influenza virus vaccine (unspecified), given at the same visit.  On 19-OCT-2006 the patient experienced local pain, tenderness, redness and warmth at the injection site after vaccination with Pneumovax 23.  Medial treatment was sought, and the patient was treated with cool compresses and TYLENOL.  Subsequently, the patient recovered.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  There was no product quality complaint involved.  Additional information has been requested.
nausea, vomiting, abdo pain p/vax; problems began in 1985 p/receiving series of inject; chronic abdo pain, n,v, abdo distension, early satiety; elevated lipase suggesting acute pancreatitis; tranit time was prolonged @ 120min;
Post vax, the pt developed varicella along with 3 of her classmates. The pt had between 50-75 lesions and sought unspecified medical attention. Follow up data states the patient was febrile. On an unspecified date in March, 2000 the patient recovered. No further information is available.
Breath holding spell post immunizations for about 15 seconds- no change in color noted. MA ran to get RN and mom was following with child in arms and blowing in his face - Mom handed baby to RN at which time baby had good color, had chest rises while taking breaths and was tracking with eyes. Monitored in clinic by MD - O2 sats were 97% on RA following this event. Follow up call was made to mom on 11/2 at which time mom stated there were no more episodes of the breathholding overnight and patient is doing well today.
On internal audit, we discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 36  days.  Appropriate steps were taken to notify the authorities and are coordinating efforts to notify patients to repeat vaccination.
Swollen glands; Fever; Muscle aches; Tiredness; Injection site pain; Injection site rash; injection site swelling; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), LYMPHADENOPATHY (Swollen glands), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Tiredness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID (ESTER C [ASCORBIC ACID]) and MAGNESIUM GLYCINATE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (injection site swelling). On 28-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection site pain). On 30-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen glands). On 08-Apr-2021, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (injection site swelling) had resolved. On 30-Apr-2021, PYREXIA (Fever), MYALGIA (Muscle aches), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Injection site pain) had resolved. On 04-May-2021, LYMPHADENOPATHY (Swollen glands) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) 100.1.         Patient had developed round rash at injection site, mild swelling, mild itching after receiving of first dose of moderna vaccine. After receiving second dose patient developed swollen glands in lower right side of neck which is at the same side as the injection.  Patient other concomitant medications include vitamins and omega fish oil 640mg oral. No treatment information was provided.   This case was linked to MOD-2021-069698 (Patient Link).   Reporter did not allow further contact
On the evening after the second Rabavert was received, pt. complained of chills, whole body ache, hot flashes, Temp 99. He called the oncall doctor who did not return his call. Episode lasted 24 - 36 hours. Pt. started feeling better after that and is back to work.
On 09/29/21 at 1330 contacted and arrived to assist patient who complained of chest pain. No signs of severe distress. A&Ox4 and verbal. Patient was transferred to urgent care via wheelchair with 2 members of urgent care staff.
Apparently, my minor son (age 15 at the time of vaccination) was inadvertently given Moderna Vaccine.  He is now unable to receive a second dosage b/c apparently Moderna was not/is not (yet?) cleared for use for patients younger than 18.  He is now 16.
Patient called in the morning and stated his arm was swelling. He said it was from the pneumonia vaccine at the time. However, his girlfriend called back in the afternoon and stated it was his right arm which is where he received a flu shot. She said he had a rash spread down to his elbow. I advised them to go to the ER or urgent care.
Full scalp psoriasis; This is spontaneous report from a contactable consumer. A 60-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: ER8733), intramuscular, administered in arm left on 29Mar2021 09:54 AM (age at the time of vaccination was 60-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included psoriatic arthritis from 2010.The patient's concomitant medication included adalimumab (HUMIRA) via subcutaneously from 2010 indicated for psoriatic arthritis. The patient had not administered any vaccine prior vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202), intramuscular, administered in arm left on 02Mar2021 03:07 PM (age at the time of vaccination was 59-year-old) as dose 1, single for covid-19 immunisation. The patient had minor psoriasis, about 5 days after the first Pfizer vaccine, had a full scalp psoriasis issue. Had to shampoo with coal tar shampoo to get it to go away and covid test post vaccination/covid test result: positive. Humira taken approximately 5 days after both vaccines and approximately 5 hours after Humira injection full scalp psoriasis annoying but not life threatening on 02Apr2021. The patient assumed the immune response meant that the vaccine was working. Mostly resolved but still have some residual psoriasis in ear canal. Used honey and coconut oil masks on head for 1 hour prior to shower for days to relieve and soothe. not used anything in ear canals yet. Might try warmed olive oil and honey. The outcome of event was not recovered.  Follow-up attempts were completed. No further information was expected.
Information has been received from a physician concerning a female who on 05-MAR-2008 was vaccinated with her first dose of Gardasil (Lot # not reported).  On 07-MAR-2008 the patient broke out with an itchy rash all over her body, "from head to toes".  The physician reported that the patient had taken BACTRIM for a period of time prior to receiving Gardasil.  The patient sought unspecified medical attention.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a physician concerning a female who on 05-MAR-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (lot # 660387/1967U). On 06-Mar-2008, previously reported as 07-MAR-2008, the patient broke out with an itchy rash all over her body, "fromhead to toes". The physician reported that the patient had taken BACTRIM for a period of time prior to receiving GARDASIL. The patient sought unspecified medical attention. Follow-up information received 11-APR-2008 from a medical assistant, reported that the patient had an itchy red rash all over her body and was treated with BENADRYL for relief. The patient recovered from the itchy red rash on an unspecified date. On 27-FEB-2008, also reported as one prior to vaccination, the patient had a urinary tract infection and was treated with BACTRIM. No additional information is expected.
I got the full dose of the Moderna Covid-19 vaccine Fever Chills Dizziness-took my blood pressure and it was really low I was staying hydrated through the process My heart rate was normal My blood pressure went really high the next day-09/8/2021 And my blood pressure drop low and my heart rate was high at 90 The fever broke after a few hours
CDC reports: 7 mo infant developed fever to 104.4, local rxn @ inject site & screaming episode day following immunization.