chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and CHILLS (chills) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.            No relevant concomitant medication was reported.  No treatment medication was reported.    Reporter did not allow further contact
Severe neck and upper back pain, headache, dizziness, and vision disturbances began 5/22/21. She was seen at urgent care about 5/27/21 and at her doctor the following week- misdiagnosed twice with myofascial pain. Symptoms mostly persisted. On 6/22/21 she saw an optometrist for the visual disturbances and was diagnosed with bilateral papilledma. Optometrist called us 6/23/21 and advised us to take her to the emergency room immediately. After many tests (below) she was diagnosed with Idiopathic Intracranial Hypertension.
Case number PHEH2016US022905, is an initial spontaneous report received from a pharmacist on 08 Sep 2016. This report refers to a 27 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168723) intramuscularly at a dose of 0.5 ml on 03 Sep 2016. On the same day after vaccination, the patient experienced Stevens Johnson syndrome. The outcome of the event was unknown. The seriousness and causality of the event was not reported. The seriousness assessment of the event Stevens Johnson syndrome was upgraded based on the Novartis Important Medical Events list.
BEGAN ITCHING AROUND NECK AND BACK.  THEN BEGAN ITCHING PALMS, BETWEEN FINGERS BACK OF ARMS, THEN HIVES ON BUTTOCKS, LOWER ABDOMEN, BACK OF ARMS, ITCHING AROUND NECK, ENTIRE HANDS ITCH.
Tdap in Right arm 4/18/2006 -reported redness around noon an 4/19/2006. 4/20/2006 1 1/2" diameter redness on right arm, tenderness to axillary area with lymph nodes swollen approximately 1/4" diameter per report. Denies fever.
On the morning of 8/9/2022, I woke up with sore throat, headache, general body aches and joint aches, a cough, and general malaise. The headache and the joint aches lasted for a couple of days. I coughed for probably two or two and a half weeks. I experienced loss of appetite. I had chills and a low-grade fever of 99 degrees. I took Tylenol, but it didn't help much with the headache, though it did help with the fever and chills. I experienced a slight pressure in the ears and brain fog, which both last concurrently with the cough. On 8/10/2022, I took a home antigen test and got a positive result. I called the doctor's office that day and got a prescription for Paxlovid, which I took for five days. The Paxlovid caused me to have intermittent diarrhea and nausea. On the rare occasions in which I had any appetite, I would eat something as simple as a piece of toast and immediately feel sick afterwards. The doctor also recommended that I take an OTC expectorant for the cough. I took Robitussin DM, which helped. The lack of appetite and upset stomach lasted for about six weeks. Also, some things tasted different than they did before I had COVID-19. Some of the taste changes have persisted to this day. Sweets especially don't taste the same. Sometimes they taste good, but not always. I have more of a normal appetite now, but it took maybe four or five months for it to return.
After injection swelling started at injection site, possible hematoma formation under the skin, up to golf ball size at largest, ice applied and medical director also examined patient, swelling started to go down after 10-15 minutes, advised to continue with ice for 24 hours then can switch to heat and will also do 24 hour phone call check in, vital signs were normal
increased hair loss; swelling at the injection site; Fatigue; Flu-like symptoms; felt that she had a fever but did not take her temperature; patches of dry skin around her face /nose/ mouth; patches of dry skin around her hairline / skin flakes; skin flakes; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, immediately after receiving Shingrix, the patient experienced injection site swelling, fatigue, influenza-like symptoms, fever, dry skin face, dandruff and skin peeling. On an unknown date, the patient experienced accelerated hair loss. The patient was treated with medication unknown. On an unknown date, the outcome of the injection site swelling, fatigue, influenza-like symptoms, fever, dandruff and skin peeling were recovered/resolved and the outcome of the dry skin face was unknown and the outcome of the accelerated hair loss was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, fatigue, influenza-like symptoms, fever, dandruff, skin peeling and accelerated hair loss to be related to Shingrix. The reporter considered the dry skin face to be related to Shingrix.  Additional details were Provided as follows: The patient received dose of Shingrix in the left arm. Soon after receiving the vaccination, the patient had swelling at the injection site, the swelling was visible through shirts. The patient stated that,did not know how long it took for it to resolve, but did not think it lasted very long. Within approximately two days after receiving the vaccination, the patient had fatigue, and flu-like symptoms. The patient experienced fever but did not take temperature at tha time. These symptoms took a couple of weeks to resolve. Within two weeks to a month, the patient noticed patches of dry skin around her nose which spread to patches of dry skin on her face, and the corners of her mouth and into the front of her hairline (looked like dandruff). The dry skin produced a lot of skin flakes. The patient began to notice increased hair loss approximately one month after vaccination. The patient did not go to the dermatologist until a couple of months after receiving the vaccine. The dermatologist told the patient that he felt the patches of dry skin were due to the vaccine and gave her medication to put on it. The dry patches resolved with medication and took approximately four months from the time the dry skin started for it to resolve with medication.  The reporter did not consent to follow up. This case has been linked with case US2020AMR003766 and US2020003252 reported by same reporter.
After receiving flu shot, she awoke with less abilities to walk, dress herself, feed herself. On 12-5-11 with weakness, nausea, and chest pain. Went to hospital and was admitted. Stayed until 12-9 for observation. Was released but had to return next day and was diagnosed with Guillain-Barre syndrome by Dr. Was administered plasma exchange treatments. While taking treatments had chest pains & had two stents put in right coronary artery. Total time in hosp & rehab 44 days.
Received flu shot 1/6/09 left delt. 1/7/2009 - Left shoulder pain rated 7-8/10 started. 1/11/2009 - went to sleep 10 PM - increased somnolence through 1/13/09 AM. 12 & 13/2009 - whole body chills and shakes. 1/14/2009 PM  - pain moved to left side neck rated 5/10. 1/15/2009 - pain in shoulder mostly resolved, still sore and neck pain 2/10. 1/26/2009 - reports still has soreness in left shoulder, slight stiff neck - rating all pain as <1/10. Pain has been gradually decreasing. Pt stated felt like may have had a touch of the flu. Pt advised flu vaccine has been added to allergy list in case sn poss reaction.
After receiving both vaccines patient became pale, faint appearance.  Patient then progressed to a vasovagal reaction. Patient was unresponsive for approximately 45 seconds to a minute. Patient then became responsive with ammonia inhalant and pain stimulus to the Right ear. Patient monitored for 30 minutes post episode and released per medic.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-FEB-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA008566: US-009507513-1905USA014096: US-009507513-1905USA014100:
a weird rash 10 days after the first dose and it went away; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 21Jan2021 at 14:15 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation at drive through. Medical history included hashimoto's disease from an unknown date and unknown if ongoing (taking for four years). Concomitant medications included levothyroxine taken for hashimoto's disease from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Investigation assessment was not provided. Reports after the first dose, 10 days (31Jan2021) after, she had a weird rash for two days then it went away, and she was fine. The adverse event was not resulted in a visit to physician or emergency room. The outcome of the rash was reported as resolved on 02Feb2021.  Follow-up attempts are completed. No further information is expected.
I am breastfeeding. The first pump after my shot ( three and half hours after) 2oz of blood was pumped from the right breast
Patient reported feeling a little nauseous and was mid conversation after receiving the first vaccine and passed out for just a few seconds.
Vaccine appt was at 9am on 4.9.2021, vaccine administered at 9:15am, I took ibuprofen throughout the day (every 8 hrs) and went to bed feeling fine. I woke up at 1am the the next day (4.10.21) with a severe migraine and my heart racing. The migraine was so severe that just bending down made my head pound with extreme pain. I felt very hot and was sweating profusely and my clothes were soaked. I was also very thirsty and drank several glasses of water. I took 4 ibuprofen as it had been 8 hours since my last dose and laid back down in bed and tried to relax. I fell back asleep within 1-2 hours. I felt fine the next morning but did have a slight headache, but it was nothing compared to what I woke up to during the night.
"5 inch diameter area of erythema and warmth on right thigh, some induration of lesion, palpable throughout and edges of lesion" per PA.
7 hours after the second shot.  Fever, chills, sore bones, headache.  Next day arm read and looks like fingerprints of where nurse squeezed arm to inject.  36 hours after I am feeling better.
tinnitus off and on in Sept 22  constant in Oct 22 some dizziness
Melanoma; I found that your vaccinations helped me with this cancer... my cancer lesions on my legs/an unexpected benefit from the Pfizer-Biontech Covid19 vaccine; I have total of 6 injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Karposi's Sarcoma", start date: 1998 (ongoing), notes: Agent states the Caller was diagnosed with Karposi's Sarcoma in 1998.; "Lesion on his legs" (unspecified if ongoing), notes: Caller reports vaccines helped Karposi's Sarcoma cancer, it helped with the lesions on legs. There were no concomitant medications. Vaccination history included: BNT162b2 (1st vaccine. Expiry Dt: EL3302/unknown. Route, Location: not provided. Previous Doses: No), administration date: 22Jan2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (2nd injection 1st Covid vaccine: Expiry Dt:EN6201/unknown. Route, Location not provided. Previous: 1), administration date: 12Feb2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (1st injection 2nd Covid vaccine. Expiry Dt: FC3180/unknown. Location: not provided. previous: 2), administration date: 07Aug2021, when the patient was 84-year-old, for Covid-19 immunization; BNT162b2 (2nd injection 2nd Covid vaccine. Expiry Dt: FC3182/unknown. Location: not provided. previous: 3), administration date: 11Sep2021, when the patient was 84-year-old, for Covid-19 immunization; BNT162b2 (1st Covid booster:18Feb2022 (5 vaccine). FJ6369. Expire Dt: unknown. Time, Location: not provided.), administration date: 18Feb2022, when the patient was 84-year-old, for Covid-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2022, outcome "unknown", described as "I found that your vaccinations helped me with this cancer... my cancer lesions on my legs/an unexpected benefit from the Pfizer-Biontech Covid19 vaccine"; EXTRA DOSE ADMINISTERED (non-serious) with onset 2022, outcome "unknown", described as "I have total of 6 injections"; MALIGNANT MELANOMA (medically significant) with onset 2022, outcome "not recovered", described as "Melanoma".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash (R) deltoid injection site area. Pain at injection site, chills, body aches.
heart palpitations; feel confusion/ Patient "doesn't know what to do"; sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to; have good days and bad days; still having side effects; fogginess; affecting his job performance; very fatigued/ tiredness/ chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days) and ADVERSE REACTION (still having side effects) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LISINOPRIL, VARENICLINE TARTRATE (CHAMPIX), CLONAZEPAM and CITALOPRAM for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days), ADVERSE REACTION (still having side effects), FEELING ABNORMAL (fogginess), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting his job performance) and FATIGUE (very fatigued/ tiredness/ chronic fatigue). At the time of the report, PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days), ADVERSE REACTION (still having side effects) and FATIGUE (very fatigued/ tiredness/ chronic fatigue) had not resolved and FEELING ABNORMAL (fogginess) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting his job performance) outcome was unknown.            Concomitant medication also included accumarol No treatment medications were reported. Patient visited his regular physician and was told patients who had COVID19 were experiencing those symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and added vaccination details,concomitant medications and events fogginess, affect job performance. Also updated reporter and patient details.
Broken blood vessels in left eye; Slight face numbness; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (Ringing in ears). On 20-Apr-2021, the patient experienced HYPOAESTHESIA (Slight face numbness). On 21-Apr-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) and HYPOAESTHESIA (Slight face numbness) outcome was unknown and TINNITUS (Ringing in ears) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  Company comment:This case concerns a 41-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious unexpected hypoaesthesia and ongoing tinnitus. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Tinnitus ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-083153 (E2B Linked Report).; Sender's Comments: This case concerns a 41-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious unexpected hypoaesthesia and ongoing tinnitus. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Tinnitus ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-083153:CROSS LINKED WITH DOSE 1
Mom reports fever 105 within 24hrs after receiving DTap, IPV, Hep B-Pediarix, Prevnar & Hib vaccines.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with M-M-R II or HSA (human serum albumin), dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of measles, mumps, and rubella were exposed to 53F for 3.5 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012857, 1403USA012858, 1403USA012859, 1403USA014860, (same reporter link) Additional information has been requested.
Besides mild redness and pain at the site of injection, tiredness, muscle aches, shivering, and joint pain, especially knees. Much better today, day 4, but still have joint pain and redness and warmth at injection site.
to ED c/o cough, SOB, weakness, decreased appetite, +pneumonia; TX: zinc, singulair, decadron, remdesivir, rocephine, zithromax, lovenox. D/C'd to home
PATIENT INTO CLINIC WITH MOTHER FOR VACCINES, PATIENT WAS ON A CATCH UP SCHEDULE.  PATIENT DUE FOR TD#3, POLIO#3 AND MOTHER CONSENTED TO INFLUENZA VACCINE.  VACCINES ADMINISTERED WITHOUT DIFFICULTY. IT WAS DISCOVERED AFTER PATIENT LEFT CLINIC THAT PATIENT RECEIVED HIGHER THAN RECOMMENDED DOSE OF POLIO VACCINE, PATIENT RECEIVED 1.5CC OF POLIO VACCINE INSTEAD OF 0.5CC  PHONE CALL TO SANOFI PASTEUR, OUR MEDICAL DIRECTOR AND PATIENT. PATIENT WAS SEEN BY OUR MEDICAL DIRECTOR, NO ADVERSE REACTIONS UPON PHYSICAL EXAM.
I had the typical body aches; fever of 99.9; headache. I also developed stomach/chest type pain (heartburn symptoms 4-23-22 into 4-24-22.  I reached out to the nurse line on Sunday morning to see if bad heartburn was a side effect of the Covid-19 booster shot (this was my second booster). She recommended that I go to the ER. While in the ER the doctor did an EKG, chest X-ray, 2 troponin blood samples. He thought it might be heart related and put me on a nitroglycerin drip for awhile and wanted to admit me. The hospitalist looked at blood work & past EKGs and determined it was most likely my acid reflux intensified & took me off the nitroglycerin drip. He gave me Lidocaine-Diphenhyd-Al-Mag-Sim Mouthwash solution to swallow. This helped immensely. The next day I saw a PA at my clinic. She confirmed that it's was my acid reflux in overdrive. I am still having stomach issues since the vaccine on April 22nd.
Raised, tender area with approximately a 4 inch oblong red, inflamed area. Tender and warm to touch.
Pain in left arm and back, numbness in hand after about 2 weeks-- at emergency department discovered low potassium levels, ruled out heart problems, indicated was pinched nerve.
left sudden sensorineural hearing loss , ear numbness. symptoms began 48 hours after vaccination.  Treatment began 3 days after onset of symptoms and included high dose prednisone and trans-tympanic dexamethasone shots. The patient partially recovered after 3 weeks of treatment.
On Day 7, I noticed a large swollen lump where the vaccine was injected. It was red, itchy, and hot. Most of the swelling went down after 24 hours, but 4 days later I still have a very large rash that extends from my shoulder to my elbow. It is red and has clear borders. It is still itchy and slightly warm.
No reaction first day. Then 2nd day, I had nausea, body aches, lump at shot site and itchy, no fever, BAD headache for 24 hours. Then full recovery.