chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19; just a headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (just a headache) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine (After receiving the second dose of the pneumonia vaccine.). Past adverse reactions to the above products included Hives with Pneumonia vaccine. Concurrent medical conditions included Rheumatoid arthritis, Egg allergy (Allergy to egg yolk), Fruit allergy (Papaya allergy), Fruit allergy (Banana allergy), Allergy to nuts and Fish allergy. Concomitant products included FLECAINIDE ACETATE for Cardiac disorder NOS.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19), HEADACHE (just a headache) and PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive for COVID-19), HEADACHE (just a headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on cardiac medication.  No treatment medications was reported.  Company comment: This spontaneous case concerns a 73-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 Vaccine. The clinical course and treatment details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-542346, MOD-2022-542350, MOD-2022-542351 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 Vaccine. The clinical course and treatment details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The next day about 20-22 hr p/vax pt stiffened, eyes rolled back momentarily-one time; no tx sought; will ask LMD for order to give on DT next time;
Information has been received from a physician concerning a 3-4 year old female patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (Lot # and route not reported). On approximately 18-AUG-2010, she was vaccinated with the 0.5ml second dose of VARIVAX (Merck) (Lot # 666923/0344Z), (route no reported). There was no concomitant therapy. The physician stated that two days after she received the second dose, on approximately 20-AUG-2010, the patient experienced redness at the injection side. Physician also reported that the patient was around a shingles patient at this time during this time. At the time of the report, the outcome of the patient was no reported. The patient sought unspecified medical attention. Follow-up information was received from a physician who stated that 36 months old female patient who on 09-AUG-2010, was vaccinated SQ into the left arm with the second dose of VARIVAX (Merck) (Lot # 666367/0248Z). At the time of vaccination the patient was suffering from otitis media. Otitis media was treated with amoxicillin. It was reported that on 10-AUG-2010, the patient experienced swollen upper left arm, warm to touch but had full range of movement (FROM). On 10-AUG-2010 had fever 101". At the time of the report, the patient had recovered. The patient did not seek medical attention. No further information is expected.
At 2:00 am following injection, could not move injected arm without intense pain. Hand was tingling and would go numb. Shoulder and armpit hurt. 10:00 am I started icing arm. Began feeling nauseas, weak and tired. My chest would hurt and my heart would pound on occasion. Joint pain started a few hours later, mostly in knees, hips, and lower back. By 4:00 pm, mild fever started (100.4°). I could barely get out of bed all day. My legs would shake when walking to the bathroom.  The area above my left breast under my collarbone became puffy and extremely sore. Left armpit also hurt. Fever broke late at night on 9/11. On 9/12, most symptoms improved except left breast/armpit pain, fatigue/weakness, and heart pounding. I got a stomach ache later on 9/12. I?d feel very weak if I tried to move around too much, so I stayed in bed. Through the night of 9/12, I woke up either freezing or sweating several times. The morning of 9/13 (today) I still felt weak. Left breast/armpit still hurt, and I could feel an almond sized swollen, tender lymph node  above my left collar bone.  I still feel weak and fatigued as I write this, and my heart continues to pound on and off.
From initial information received on 7/28/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of TD ADS ADULT, lot number U1185AA, administered in the left deltoid and a dose of TUBESOL 5 TU, lot number C1954AA, administered in the left forearm on 7/26/04. The patient had recently immigrated to the US and was administered the products because she had no documentation of her vaccination history and had to abide by the country's immigration laws. Five hours after vaccination, the patient developed fever, chills, general malaise, weakness, and paresthesia of her left arm and upper chest. She also experienced a local reaction (site not specified) of redness, swelling, and induration. Unknown length of time following administration of Tubersol, the patient's skin test was determined as positive with an area of induration, measuring 19 millimeters. As of 7/28/04, the events were resolving. From additional information received on 8/30/04 from the reporting physician, additional patient, vaccine, medication and lab information was provided. Per the patient, she has received unknown doses of BCG vaccine as childhood vaccinations. It was also reported that the TD ADS ADULT vaccination was administered IM, and the TUBERSOL skin test was administered ID. She had one positive TUBERSOL skin test with erythema, and induration 19 millimeters at the site of ID injection. The patient took over the counter ibuprofen (doses unknown) at the time of reaction with mild improvement. She was seen two days after the vaccination at which time she was approximately 60-80% better. From additional information received on 11/8/04 from a physician, it was reported that the patient was lost to follow up. No further information is anticipated. This case is considered closed.
Feeling sleepy yesterday; Itching around the neck and arm  but no rash; Chills; Headache; Nausea; Fever; Body ache; Felt tired; Vomiting; Tired muscle; Passed out in kitchen; Heavy chest which did not affect her breathing but it felt like adrenalin rush; A spontaneous report was received from a 51 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, headache, nausea (nausea), vomiting (vomiting), fever (pyrexia), itching around the neck and arm but no rash (pruritus), body ache (pain) with tired muscle (muscle fatigue), felt tired (fatigue), passed out in the kitchen (loss of consciousness), heavy chest which did not affect the breathing but it felt like adrenalin rush (chest discomfort) and felt sleepy (somnolence).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Mar 2021, 5 to 6 hours after the vaccination, the patient experienced chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache, felt tired and passed out in the kitchen. The patient also had heavy chest which did not affect the breathing, but it felt like adrenalin rush. On 07 Mar 2021, the patient felt sleepy and had muscle tiredness. Treatment included paracetamol and ibuprofen every 4 hours to treat the symptoms..  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache with tired muscle felt tired and passed out in the kitchen, heavy chest which did not affect the breathing but it felt like adrenalin rush and felt sleepy, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My right ear has been fluttering . About 10 hours last night, and continuing now. I had a concussion around 1990 from a bike accident with no helmet. I hit the ground on the right side of my head which effected my left ear and a lot of hearing loss. I?m theorizing that the moderna vaccine has triggered something and now my inner or middle right ear is pulsating. I?m thinking it?s blood flow I?m hearing. But whatever it is, it?s annoying
This non-serious spontaneous consumer report (initial receipt 08-DEC-2014) concerns a male patient. On an unspecified date, the under-five year old patient received seasonal influenza vaccine (manufacturer and batch number not provided). The patient tolerated the vaccination. Outcome was unknown. Linked to 2014047135.
leg pain for 2days.stomach pain for 10 days..sudden head pain followed by right side numbness. blurred vision dizzy unable to walk or talk for a hour or so first episode. 2ond felt like i was being flipped back wards..3rd. In bath tub. Head pain and fell to the left side.4th early in morning head pain and felt numbness on the left side again..
Child has varicella vaccine 9/18/03. She developed shingles when hospitalized 11/2-5/04.
Severe nausea and weakness started morning after second vaccine. Lasted most of day. Fever of 101.2 until ibuprofen taken to reduce temperature. Severe symptoms persisted for about 10 hours.
sore left arm; chilled; head was throbbing; temperature was 103 but went down a little bit; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore left arm, chilled, head was throbbing, temperature was 103 but went down a little bit, and lightheaded; all in Feb2021. Clinical course: The patient stated that she got the first shot of Pfizer vaccine yesterday afternoon. She stated she had a sore left arm, 2-3 hours ago she got chilled and her head was throbbing. Her temperature was 103 but went down a little bit. She felt lightheaded when she was doing lunches for daycare. She was not lightheaded anymore. She knew that it was normal. She went to check in online but cannot do it right. She took an Ibuprofen 40 minutes ago. The outcome of event temperature was 103 but went down a little bit was resolving, outcome of event lightheaded was resolved in Feb2021, outcome of other events was unknown.  Information on the lot/batch number has been requested.
Headache (intermittent, 01/16/10) Swelling and redness at injection site (1/17/10) Tingling in entire left arm coincident with swelling (intermittent) Recent onset (1/31/10) intermittent shortness of breath and pain in left shoulder and arm. Area of mildly hyperpigmented patch around injection site. (Note:  all above related historically)
Arm Reaction/face reaction; This case was reported by a consumer via call center representative and described the occurrence of skin reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rhus radicans (Poison Ivy) for an unknown indication.   In June 2019, the patient received Shingrix. On an unknown date, the patient started Poison Ivy at an unknown dose and frequency. In June 2019, less than a month after receiving Shingrix, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was not recovered/not resolved.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that received Shingrix vaccine and was unsure if reaction was due to vaccine or poison ivy.  The patient reported that her arm had indication of something occurring on her skin and on the side of her face because she sleeps on that same arm.  It was unknown if the reporter considered the skin reaction to be related to Poison ivy as well. The patient declined to provide demographic information including phone number and address.  The patient would not accept case number as a reference.  The patient abruptly disconnected prior to asking for consent. The patient mentioned she would call back call center, but first wanted to visit the vaccination facility for medical advice since GlaxoSmithKline could not provide medical advice.
1/22  8:000 PM  had 3 jerks quick jerks of left arm,  1/23 around 11:30 when laid down on and off little jerks from head to toe on and off.  When I woke up  around 8:30 could feel some.   During day some little ones mostly arms or hands, once in a while legs,  Monday 1/23 around 9:00 PM a hard jerk on left shoulder and at night kind of a hard one on left arm.   Seemed to have seattled down to mostly subtle ones in hands or arms on and off.  Legs feel kind of stiff or tight.    Once in awhile felt pulsating through out, but that seems to have gone away.  Mild pain feeling around shoulder blades on and mostly off.  Never had before.
extreme chills that prevented sleep, shaking, 100 degree fever, body pain, headache, nausea, fatigue lasted about 36 hours.  Fatigue for 4 days after.
Experienced much worse arm pain/hurts to put pants on because arm; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced much worse arm pain/hurts to put pants on because arm) and HEADACHE (a slight headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Experienced much worse arm pain/hurts to put pants on because arm) and HEADACHE (a slight headache). At the time of the report, PAIN IN EXTREMITY (Experienced much worse arm pain/hurts to put pants on because arm) and HEADACHE (a slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported, No treatment information was provided by the reporter.   This case was linked to MOD-2021-320520 (Patient Link).
Blister at injection site. Skin peeled.  Approximate size green pea. Red line less than an inch.
Patient is  a 70y/o female with dementia. She was escorted by her sister-in-law to a vaccination at Pharmacy on 3/17/2021. She then participated in a vaccine event at her residence on 3/25/2021. She did not experience any extreme side effects, but did complain of fatigue and myalgias to her case worker for about 2 weeks. We have instructed the patient to not get any more COVID vaccines at this time.
This is a spontaneous report from a contactable nurse manager (other HCP) and from a contactable medical assistant (other HCPs), who reported similar events for 3 patients. This is the second of three reports. A 72 year-old female patient received on 05Aug2015 PREVNAR 13 (lot number L77777, expiry date Jan2017, NDC number: 0005-1971-02) intramuscular on the left deltoid at 0.5 ml single. No vaccines were given four weeks prior or on the same date along with the suspect vaccine. Relevant medical history included rheumatoid arthritis, insomnia, chronic obstructive pulmonary disease, osteopenia, High blood pressure, chronic allergies (unspecified), gastrooesophageal reflux disease (GERD) or reflux all ongoing and hysterectomy in 1992. Concomitant medications included losartan (manufacturer unknown, tablet) oral at 100 mg, 1x/day, for blood pressure, methotrexate (manufacturer unknown, injection) subcutaneous at 1 mL/25mg once weekly for rheumatoid arthritis, Calcium + D (tablet) oral (Calcium 600mg]/[Vitamin D 200 units), at 1 dosage form daily as supplement, sulfasalazine (manufacturer unknown, tablet) oral at 1000 mg, 2x/day, for rheumatoid arthritis, temazepam (manufacturer unknown, capsule) oral, 15 mg one at night as needed for insomnia, DUONEB (nebulizer solution) at 0.5-2.5mg per 3mL solution, 3mLs or one vial every 6hrs as needed for shortness of breath and chronic obstructive pulmonary disease, folic acid (manufacturer unknown, tablet) oral at 1 mg, daily as supplement. The patient experienced localized cellulitis on unknown date and redness, itching and warm to touch on 13Aug2015 in the morning all events occurred at the site of injection. It was quite a large area of redness and it was warm to touch. The patient saw a nurse practitioner in their office on 13Aug2015 and cephalexin-at 500mg capsule, one capsule by mouth 4 times daily, treatment for 7 days was administered for cellulitis. It was unknown if the cellulitis was related to vaccine injection. Patient had not had cellulitis before. The outcome of cellulitis was unknown, the patient did not recover from the other reported events. Redness, itching and warm to touch was considered related to the vaccine. Medical assistant believed the events were related to the vaccine.
soreness at the injection site,; Headache that was off and on; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site,), HEADACHE (Headache that was off and on) and MYALGIA (muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site,), HEADACHE (Headache that was off and on) and MYALGIA (muscle aches). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site,), HEADACHE (Headache that was off and on) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The morning after patient received his vaccinations his right arm, the arm he received his SHINGRIX was swollen, red, itchy, and warm to touch from about mid upper arm above his elbow up to his shoulder. It was a localized reaction. It is not getting any worse and patient is taking BENADRYL and contacting his doctor if symptoms get worse.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 5/1/2023 SYNCOPE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 5/1/2023 HYPERTENSIVE URGENCY
arm sore; she could hardly use it (her arm)/not being able to rise her arm up to put food in her mouth or to take her coat off; This spontaneous report was received from a 72 year old female patient with high blood pressure. The patient's medical history was not reported. She had no drug allergies or reactions. Concomitant therapies included "blood pressure medicine".  On 03-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the right arm for prophylaxis (dose, frequency and route, as lot # and expiration date were not reported). On the same date, her arm was "messed up", right after receiving the vaccine she was driving and her arm got sore and she could hardly use it (her right arm). She reported not being able to rise her arm up to "put food in her mouth" or to "take her coat off". The consumer mentioned sought medical attention and being prescribed 2 different creams, but could not remember the names of them. The creams did not work. On an unknown date, a routine blood work was performed but the results were not provided. The outcome of the events was not recovered at the report time. No additional adverse event, no product quality complaint and no more information were provided.  The causal assessment between all the events and the suspect therapy was not provided.
Patient reported today 7-7-14, 2 days after injection, got an itchy rash under breasts and down Rt arm below injection site. Lasted 10 days.
Full Tonic Clonic Seizure, epilepsy, global developmental and physical delays, Autistic symptoms/tendencies.
15 min p/vax, pt developed red facial rash, wheezing, trouble breathing, drowsy, c/o stomach pain.Tx with epinephrine and benadryl.Stomach pain abated.Tx with Claritin, wheezing and breathing trouble abated. Itching,  began tx w/prednisone. Slightly groggy. Dx Allergic reaction probably due to MMR.
Redness, swelling of left thigh. DX cellulitis. Resolving since starting Clindamycin.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, l arm swollen at site, no redness/warm to touch, extreme fatigue (malaise)
I had a nasal infection for several years. The doctors tried everything. About two weeks after I had my first Covid-19 Vac. my infection went away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had a nasal infection" (unspecified if ongoing), notes: I had a nasal infection for several years. The patient's concomitant medications were not reported.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I had a nasal infection for several years. The doctors tried everything. About two weeks after I had my first Covid-19 Vac. my infection went away.".  Additional information: Patient had a nasal infection for several years. The doctors tried everything. About two weeks after patient had first Covid-19 Vac. infection went away. patient had two more boosters. The infection is still gone.  Follow-up attempts are completed. No further information is expected.