chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not normal; food tasted like metal; Terrible headache; fever of 104°F; absolutely freezing with chills; weak; very tired/crazy tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not normal), DYSGEUSIA (food tasted like metal), ASTHENIA (weak), FATIGUE (very tired/crazy tired) and PYREXIA (fever of 104°F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Sleep disturbance and Osteoporosis since 01-Jan-2021. Concomitant products included TRAZODONE from 15-Jan-2019 to an unknown date and MARIJUANA for Insomnia, DENOSUMAB (PROLIA), VITAMIN D [VITAMIN D NOS] and CALCIUM for Osteoporosis, MAGNESIUM for Restless leg syndrome, PROBIOTICS NOS, VITAMINS NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (very tired/crazy tired). On 22-Apr-2021, the patient experienced ASTHENIA (weak), PYREXIA (fever of 104°F) and CHILLS (absolutely freezing with chills). On 26-Apr-2021, the patient experienced DYSGEUSIA (food tasted like metal) and HEADACHE (Terrible headache). On 27-Apr-2021, the patient experienced FEELING ABNORMAL (not normal). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 24-Apr-2021, PYREXIA (fever of 104°F) and CHILLS (absolutely freezing with chills) had resolved. On 26-Apr-2021, DYSGEUSIA (food tasted like metal) and HEADACHE (Terrible headache) had resolved. On 01-May-2021, FEELING ABNORMAL (not normal), ASTHENIA (weak) and FATIGUE (very tired/crazy tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Body temperature: 104 (Inconclusive) 104°F. On 30-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included migraine medication.    This case was linked to MOD-2021-133524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: New Follow Up Document received on 06-Jul-2021,concomitant medication details updated.
pt was given the monovalent vaccine instead of the bivalent. Pt aware she can get the bivalent vaccine 2 months after receiving the monovalent
Pt passed out in waiting room post HPV vaccination. She was conscious, VS were 100/70, HR 78, O2 98%. Received juice and sat for >20 mins. Was ok to leave with mom.
This solicited report was received from a consumer and refers to her friend's daughter - a female patient of unknown age enrolled in a market research. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced "a horrible reaction". The reporter stated that because of this event she did not vaccinate her son with any HPV vaccine. The outcome of the event was not reported. The reporter considered the event to be related to GARDASIL. Additional information is not expected as there was no consent for follow up.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. Admitted to rule out TIA/stroke. Likely symptoms from prior stroke in setting of active infection per neurology. Patient intermittently febrile in ED. Nonproductive cough x3 days. Sore throat. Daughter was sick. Diagnosed with COVID pneumonia, remained stable on RA through entire hospitalization, acute kidney injury on CKD stage 3/4 prior to admission.
No Adverse Event; Received Moderna Covid 19 Bivalent booster as a primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster as a primary series).    No concomitant medication were reported. Pharmacist stated that on they accidentally provided Moderna Covid19 Bivalent vaccine as a primary series instead of a booster. No treatment information was provided by the reporter.
Heart beats really rapidly for about a minute a couple times a day. Also, feel small heart palpitations that I've never experienced throughout the day.
It started the following day around 12pm on Wednesday. I started to feel nauseous and unwell. I wasn?t able to eat much because the nausea was so bad. Around 9pm, I started to violently vomit as the nausea got worse . I continued to vomit and have several diarrhea through the night until about 5am.   I had a fever of 101 , body aches, chills, vomiting and diarrhea . I have been sick many times in my life, but nausea like this has never been so unbearable , along with the violent vomiting .   Thursday I was still not well, as my body was completely depleted of all fluids and I was severely dehydrated .
Large raised red area at injection site started the day after injection and it has now been 8 days and it is still there and itching and warm to touch
patient reports that she woke up next day 1/28/21 with arm pain/dizziness--developed itching/rash on back/stomach/chest/abdomen, treated with claritin with minimal effect. Reports flushing on face. At time of this writing, pt reports continued rash, improvement on abdomen with worsening on back.
Local reactions: 9cm erythema/induration, left arm (TD); 10cm erythema/induration, right arm (Menactra).
Death N17.9 - Acute kidney injury (CMS/HCC) J18.9 - Bilateral pneumonia
On 02/25/21, patient started seeing double vision. It continued to worsen and vision became extremely impaired. Patient went to the eye clinic on 02/27/21 and staff examined her and had patient go immediately to the ED to rule out stroke, tumors, etc. MRI and all other tests were negative. Patient went back to staff and was diagnosed with Sixth Nerve Palsy in the left eye. Patient had to get prisms added to her glasses. Patient did get a second opinion from an Ophthalmologist, and they validated the sixth nerve palsy. Patient was notified vision could be impacted for 6-12 months, but sometimes it is not fully reversible. Patient also has to wear a eye patch when driving as deficits are still present.
Rapid onset aching, pain in all 4 extremities and hips. Intermitent extreme pain, fatigue. Unable to work. All testing negative. Diagnosed with Fibromyalgia on 11/30/2011.
Child was given DAPTACEL on 3-5-09, on 3-6-09 her leg was red about 1-2", on 3-7-09 swelling and redness was about 5-6 inches around, no fever, itching at the injection site. She was admitted to hospital 3-7-09. Disc. 3-8-09 - treated with IV vancomycin and IV SOLUMEDROL and IV BENADRYL.   3/16/09 MR received for DOS 3/7-8/209 with D/C DX:  Cellulitis R thigh.  Skin infection. ? Staph.  Pt presented with redness, swelling and tenderness of R thigh injection site which was rapidly expanding. Tx: abx, benadryl and steroids and d/c
pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Reporter did not allow further contact
Initial and follow up information has been received from the Merck pregnancy registry for GARDASIL via a medical assistant (also reported as a nurse) concerning a 24 year old female who on 03-APR-2007 was vaccinated with the first dose of GARDASIL.  On 05-Jun-2007 the patient was vaccinated with the second dose of GARDASIL.  Concomitant therapy included prenatal vitamins (unspecified).  The patient was 9 weeks and one day pregnant.  Unknown medical attention was sought.  The patient delivered by primary cesarean section secondary to arrest of active labor at 8cm.  She delivered a healthy and normal infant at 40 weeks estimated gestational age, weighing 9 lbs. 7 oz.  Upon internal review primary cesarean secondary to arrest of active labor at 8 cm was considered to be an other important medical event.  Additional information has been requested.
For 5 days, severe headache and very dry eyes.  Starting on day 6 post injection, headache was reduced, but still dull and lasted another week.  The dry eyes stemmed from the back of the eyes.  2 weeks later, I'm still feeling the effects of this.  2 weeks later - I still have a dull headache and slightly dry eyes from the back of the eye.
I contracted COVID-19 with symptoms of fever of 101.6 at highest point, myalgia, joint aches, diarrhea, dizziness, vision problems, cough, congestion, chest pain, shortness of breath, minor difficulty breathing, metallic taste in my mouth, and fatigue. I went to the Emergency Room on 05/26/2022 where I was examined, and released with Paxlovid 5 day supply.  I was ill for 7 days before my symptoms began to resolve. I am still having lingering symptoms of loose stools, fatigue, and vision problems. I am having issues with my vision focusing on my puzzle I'm working, but it is improving today.
December 1, 2021 Moderna vaccine Vial transferred from Freezer to Fridge. January 3, 2022 Moderna vaccine administered.
Information has been received from a registered nurse concerning a 16 months old male patient. On 11-OCT-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route were not reported) (Lot #: H009639; Expiration date not reported). Concomitant medications included PEDIARIX, Hib conj vaccine (unspecified carrier) MMR II, hepatitis A virus vaccine (unspecified) and PREVNAR. On 22-OCT-2012 the patient developed a chickenpox rash, on the thigh where the shot was given after receiving VARIVAX (Merck). The patient sought unspecified medical attention. No treatment was given for the event. At the time of the report, the patient's outcome for chickenpox rash was reported as recovered/resolved. The relatedness for chickenpox rash was unknown for VARIVAX (Merck). Additional information has been requested.
Woke up with whole-body muscle aches, chills, and a slight cough. Feeling tired, weak, and fatigued. Headache.
Approximately 10-15 sec after the immunization given the patient's eyes rolled back and patient's upper body (chest, shoulders & bilateral upper extremities) began to twitch. RN states that episode lasted less than 1 minute.  Further reports that pt was unresponsive less than 1 minute and was pale in the face.  Pt came to and complained of dizziness.
the chapped/dryness is moving outside the lips and into nose area; it's getting worse; chapped/swollen lips; chapped/swollen lips; the gums on left side of mouth were tender/The tenderness in the gums; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734, 8733), via an unspecified route of administration on 19Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Two days after second dose on 21Apr2021 the patient experienced chapped/ swollen lips/ blown up lips, the gums on left side of mouth were tender. The tenderness in the gums had resolved but her lips were swollen, and the chapped/dryness was moving outside the lips and into nose area. She states it was getting worse and wanted to know if this had been reported before. The outcome of event tenderness in the gums was resolved on an unspecified date in 2021. For the rest of the events the outcome was not resolved.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for vaccination. Lot# was unspecified. On an unknown date the patient developed shingles after receiving a dose of ZOSTAVAX. The outcome of shingles was unknown. Causality was not reported. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
This spontaneous report was received from an office manager regarding a 13 year old male patient. Patient's medical history and current condition was not reported. On 25-JUN-2015, in the physician's office, the patient experienced seizures immediately following the administration of the first dose in the series of three of GARDASIL (lot # K008931 and expiry date 04-MAR-2017), 0.5 milliliter (ml) intramuscularly. Concomitant medication were not reported. The outcome of the event seizures was reported as recovered on 25-JUN-2015. Causality assessment was not provided by the reporter. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
positive erythematous "streaking" in axillary area of arm in which vaccine injection given. Plus pain (external) at site injection & more erythema. Treatment: Nsains, ice.
Approximately 2-3 minutes after vaccine administration patient began having a seizure (convulsing/uncontrolled movements, random eye movements, unresponsive but conscious) in observation area chair. The paramedics were called immediately. The seizure lasted about a minute.  The father was insistent that he get up and walk around. After 2-3 minutes he returned to his seat. Pharmacist attempted to take blood pressure reading. During blood pressure check the patient complained of fatigue and nausea and then began having another seizure. This also lasted about 1 minute.  About 2 minutes later the paramedics arrived and took patient to ER.
she had a burning sensation up her arm and down her neck /she had burning sensation in her arm where she received her injection on the left side; It went up to her ear on left side/she had burning sensation in her arm where she received her injection on the left side and went up to her ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EN9809) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "she had a burning sensation up her arm and down her neck /she had burning sensation in her arm where she received her injection on the left side"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "It went up to her ear on left side/she had burning sensation in her arm where she received her injection on the left side and went up to her ear".  Additional Information: After her first dose, she had burning sensation in her arm where she received her injection on the left side and went up to her ear, lasted a few minutes.   No follow-up attempts are possible. No further information is expected.
Info has been received from an RN concerning a 4 year old male with autism who on 8/6/01 was vaccinated with a dose of varicella virus vaccine live. On approximately 3/22/05, the pt presented with "4 chickenpox/rash". It was reported that on 3/28/05, the rash was "still itchy" and the pt would not be attending school. The pt had a follow-up visit with the doctor, and the diagnosis was "undetermined if chickenpox". Unspecified medical attention was sought. At the time of the report, the pt was recovering. There was no product quality complaint involved. Additional info has been requested.
Came in on 11-5 after 6 days said swollen/red/fever about 2 x 4 size. Advised pt. to see MD and came back to say it was technique of administration and did not give pt. any meds since it subsided.
Severely swollen lymph nodes under left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19May2021 at 12:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 08:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. On 20May2021 at 15:00, the patient experienced severely swollen lymph nodes under left arm. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severely swollen lymph nodes under left arm was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Uper respiratory problems; hospitalized x 2 day; discharged 12FEB92; 14FEB92 called parents; stated pt is doing fine now; Seen by MD for check up this morning;
10cm erythema, warmth, slight induration. Left upper arm from shoulder to elbow swollen. Treatment: cool compresses, elevation, Clarinex, Prednisone
The evening of 19AMR92 pt recvd 1 dose of Engerix-B & later that evening devel night sweats, vomiting, fever, pain in arm where given shot; pt seen in ER or MD office for tx;
Patient received vaccine on 5-8-2007 in L Deltoid. The site hurt initially but the discomfort was gone the next day. The site began hurting again 1 week later and called office and was instructed to use warm compresses and Tylenol or Advil and to call back if no better.The patient denied any redness at the site and denied fever. She states her arm did feel better but became very sore on May 27th. Hurts more at night than during the day. States she can not lift her arm above her head and getting dressed is difficult. States she feels fine otherwise, denies redness, swelling at site or fever.
Now, they found one in the adrenal gland and it is not a good one so they have to remove it; This spontaneous case was reported by a consumer and describes the occurrence of ADRENAL NEOPLASM (Now, they found one in the adrenal gland and it is not a good one so they have to remove it) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Kidney tumor (Doctors found a tumor on the kidney last year in September) in September 2020.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADRENAL NEOPLASM (Now, they found one in the adrenal gland and it is not a good one so they have to remove it). At the time of the report, ADRENAL NEOPLASM (Now, they found one in the adrenal gland and it is not a good one so they have to remove it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment history was reported.  Patient wanted to get the booster shot.
Red raised rash starting around vaccination site and spreading over several day. Covered about half of upper arm starting just below vaccination site and going down from there.  Rash warm to touch.
Severe vomiting. 30 times in 6 hours. Diarrhea 30 times in 6 hours. Body aches, dizzy, nausea, chills, mild fever.
Immediate rxn, moderate erythema & local swelling size of small orange, ice applied given Tylenol.  Rxn at DPT site, HIB site & Hepatitis B site - same rxn for all, same tmt.
pt recvd vax 26MAY94 PM red warm to touch-t102 R; warm compresses TO site & APAP given; taken to ER; t103.9 & still cranky; blood & urine taken;
Large amount redness and itching in left upper arm, also headache that started 09/11/21. 09/13/21 redness improving, continues to have headache and itching. Has not taken any meds for side effects.
Rash and bumps started on legs at injection site and spread all over body. She was fussy and restless.
Side effects began with vomiting and fever on day after vaccination.  Vomiting continued for 4 days.  In addition to symptoms above patient developed blisters inside her nose and around her mouth.
I woke up with a sore throat at 1:00AM on April 23, 2023. Throughout the day I began to sneeze. I then had nasal congestion that turned into severe sinus pressure that also affected my ears. The following Thursday I did a telehealth appointment because the pressure in my ears was very painful. I received a 4-day treatment of prednisone and amoxicillin if that did not help. The prednisone relieved the pressure but hearing in my left ear became distorted. The pressure and my hearing seemed to return to normal on or about May 9, 2023.