chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Restless sleep; achy muscles; Felt very tired after the 2nd; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 12:00 (Lot number: EP6955) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "some medicines give me a rash" (unspecified if ongoing), notes: known allergies: yes - some medicines give me a rash. Concomitant medication(s) included: AMLODIPINE; MULTIVITAMIN & MINERAL; ELDERBERRY [RUBUS IDAEUS LEAF;SAMBUCUS NIGRA FLOWER;SAMBUCUS NIGRA FRUIT]. Vaccination history included: Bnt162b2 (Dose No. 1), for Covid-19 Immunization. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 18Mar2021 21:00, outcome "recovering", described as "Restless sleep"; MYALGIA (non-serious) with onset 18Mar2021 21:00, outcome "recovering", described as "achy muscles"; FATIGUE (non-serious) with onset 18Mar2021 12:30, outcome "recovered" (Mar2021), described as "Felt very tired after the 2nd". Therapeutic measures were not taken as a result of poor quality sleep, myalgia. It was unknown if therapeutic measures were taken as a result of fatigue.  Additional information- It was unknown if COVID tested post or prior to vaccination. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had been tested for COVID-19 was unknown. Patient became aware of the events reported on the same day March 18 as her vaccine shot.  No follow-up attempts are possible. No further information is expected.
THE  NEXT DAY I FEEL TOOO BAD I HAVE HIGH FIVER, BODI PAIN, HEADACHE, NECK PAIN , AND TOO COOL I  TAKE TYLENOL AND AVIL EVERY 4 HOURS I DONT GO TO THE HOSPITAL BECAUSE I SCARE
Hives Chills Body Aches  Nausea  Starting around 11am
erythema nodosum; prolonged high fever; serious adverse reaction to the vaccine;   This spontaneous report has been received from a consumer, concerning a currently 45-year old female patient reporting on herself. The patient's concurrent conditions included Behcet's syndrome, Ehlers-danlos syndrome, migraine, coeliac disease and asthma. The patient's concomitant medications were not provided.  On unspecified date, the patient revived a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX), (dosage information not provided) for prophylaxis.  After the vaccination, it was reported that the patient experienced a serious adverse reaction to the vaccine including prolonged high fever and erythema nodosum. At the time of the report, the patient's outcome was unknown. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX).  The events of pyrexia, erythema nodosum and vaccination complication were considered medically significant by the reporter.
Booster shot; her blood sugar level were high; my blood sugar was up like I never seen it like 240; it stayed up there and then today, two hours after eating was at 150; that's not normal for me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "Booster shot"; BLOOD GLUCOSE INCREASED (non-serious) with onset 21Dec2021, outcome "unknown", described as "her blood sugar level were high; my blood sugar was up like I never seen it like 240; it stayed up there and then today, two hours after eating was at 150; that's not normal for me". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received her booster shot yesterday it's that her blood sugar level was high. She wanted to know if this is a common side effect and inquired that is this something you will be able to help with. Consumer stated that got the shot yesterday and then sometime yesterday her blood sugar was up like she never seen it like 240 (further not clarified), that's got to be wrong but it stayed up there and then today, two hours after eating was at 150 which she guess is not enough to kill her but that's not normal for me.  The lot number for bnt162b2 was not provided and will be requested during follow up.
She called about 2 hours after she got the shot said her arm was "very sore, and throbbing a little".
Redness; A huge welt around the injection site; Feverish; Lump at the injection site which started itching; Lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection site), VACCINATION SITE URTICARIA (A huge welt around the injection site), VACCINATION SITE PRURITUS (Lump at the injection site which started itching) and PYREXIA (Feverish) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B02A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and METOPROLOL 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 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump at the injection site). On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Lump at the injection site which started itching). On 20-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (A huge welt around the injection site) and PYREXIA (Feverish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; Manual therapy (Ice) for Erythema and Manual therapy (Ice) for Vaccination site mass. At the time of the report, VACCINATION SITE MASS (Lump at the injection site), VACCINATION SITE PRURITUS (Lump at the injection site which started itching) and PYREXIA (Feverish) outcome was unknown and VACCINATION SITE URTICARIA (A huge welt around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient received vaccine after vaccine given felt pressure in the leg and 2 minutes later patient passed out for 10 seconds came too . given Gatorade and nutrigrain  bar . patient felt fine after coming too waited in office for 45 minutes and then was to leave with mom.
Headaches, bodyaches, chest congestion and flu like symptoms. Insomnia, paranoia, uncontrolable shaking of hands, wheezing out of breath, Loss of vision, anxiety attacks, fatigue, not able to concentrate or read, depression and an odor that came from his skin. Information from medical records state costocondritis, body ache, chills, fever, headache, neck pain, myopericarditis. Autopsy report received & states COD as 80% total body burn, septicemia and multiorgan failure.
I had a fever of 99.7 and body aches and coughing and sore throat swollen glands. Running nose. COVID-19 was positive. Doctor gave me PAXLOVID.
EXTREME MUSCLE ACHES IN THE BACK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extreme muscle aches in the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme muscle aches in the back. This report was non-serious.
This spontaneous report was received on 29-JUN-2017 from a registered nurse concerning a female patient of unknown age. No information regarding the patient's concurrent conditions, concomitant therapies, allergies or medical history was provided. On 26-JUN-2017, the patient was vaccinated with an improperly stored dosage of GARDASIL 9, (route and dosage not reported) lot # M034780, expiration 15-APR-2019 for prophylaxis. No adverse event was reported. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004116.
BOOSTER DOSE OF MODERNA COVID VACCINE GIVEN TO PT. NO ADVERSE EFFECTS.
Received call from Immunization Staff and spoke with patient and nurse. Patient advised she received TDaP booster on 7/11/2017 (last TDaP was 3/7/2007). She reported vaccine site was sore, but nothing unusual until this am. She awoke fine, but over the last few hours she felt dizzy and funny. Her eyes felt blurry, she cannot lay down or close eyes due to increased sensation of dizziness (head spinning), she advised most of sensation was to temple region of head. She feels like she has to move slowly but denies any fever, N/V, speech impairment, no paresthesia or muscle weakness/numbness, no neck pain or sinus/ear pain, no rash or lymphadenopathy. Nurse advised HR in 80's and normal with BP 118/80 and afebrile. Patient admits to not eating today so just ate before seeing immunization staff and drank some water. She reports a history of migraine headaches 2-3 times per week on TOPAMAX daily. This dizziness/head and visual sensation was not typical of her headaches but had location of symptoms was similar (has ocular migraines). Brief review of electronic medial record identified prior C/O dizziness since 2014. She has been evaluated by neurology several times since 2014. A note 10/5/2016 documented: "Patient states they (HA) occur on average two times a month. She has aura symptoms of visual floaters and tunnel vision and then within 30 minutes she feels bilateral frontal and occipital pressure and pressure behind her eyes which last for several hours to all day long even with abortive medications. Headaches are always associated with photophobia/phonophobia and sometimes nausea and vertigo. "She was diagnosed with migraine w/aura. 7/13 pt states is better but is seeing HCP for continued dizziness and funny feeling in her eyes. She did leave work yesterday and out of work today due to this reaction. HCP note: Dizziness and giddiness: Dizziness and light-headedness, was thought to have had an allergic reaction to TDaP vaccine. Unremarkable exam today, negative Dix Hall pike maneuver. After reviewing daily food intake and hydration status, likely patient was  dehydrated and has not been taking in enough calories on a daily basis. Additionally, has not been consistent with Vitamin D supplement that was prescribed to her for a vitamin D level of 20. Will repeat labs to R/O other cause: thyroid/hypoglycemia/vitamin D. Recommend pt have six small healthy meals vs 3 big meal to maintain daily nutrients level and prevent dehydration. Declined nutrition consult at this time. May F/U with PCM to review lab results. Pt ambulated without difficulty out of exam room, no dizziness or fainting observed.
Sore left arm including deltoid and elbow. Some elbow swelling. Since 9/14/11.
Patient developed high fever (103 degrees 24 degrees) after receiving injections.  Clinical exam suspect oral herpangina.
No adverse event reported; A patient was givien a VARIVAX shot deltoid instead of subcutaneous; This spontaneous report, was receivend from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent drug reactions, allergies and concomitant medications were not reported.   On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) in the deltoid instead of subcutaneous, (incorrect route of product administration) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No adverse event was reported.
Since 2013 I have had my thyroid checked every year during my annual physical and my TSH level has been between a 1.8-2.4. (I have records to prove that) We started seeing a reproduction specialist and as a part of the first appointment, I had a blood panel done on Sept 6th prior to getting my 1st of 2 doses of the vaccine. My TSH came back as a 3.25 which is normal but for fertility they like to get it below 2.5 so they put me on Levothyroxine for 6 weeks and then checked my TSH again.  I received the 2nd vaccine dose on 9/28/21 and on 10/18/21 when my TSH level was retested it was a 17 which is dangerously high. I had to stop trying to get pregnant and was sent to an endocrinologist.  The doctors were shocked as they never see it shoot up like this, it is usually a gradual increase if you have an autoimmune issue. He then ran a full blood panel and diagnosed me as subclinical hypothyroidism, secondary to Hashimotos thyroiditis.  There is no explanation for this other than the link between when I was dosed the vaccine and had my blood tested.
Pain at the site of injection. For two weeks since the vaccination I have experienced severe aches and pains all around my rib cage, shoulders, neck and upper back. Temporarily relieved by over the counter pain killers. Still have pain at the left shoulder where injection was administered. Muscular pain feels like traveling in to the bones. Body very stiff getting up in the morning. Had no such problem before vaccination.
Full body aches, fatigue, mild euphoria/delerium. Periods of chills and hot feeling though no fever. Symptoms started 24 hours after injection, 90% resolved at 42 hours post. Took low dose of Ibuprofen and drank liquids.
eye lids where swollen; around eyes was burning; skin waspeeling all over face; cheek swelling; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus. Concomitant medications included multi vitamin gummies (MANUFACTURER UNKNOWN), B12 gummies (MANUFACTURER UNKNOWN), vitamin D3 gummies (MANUFACTURER UNKNOWN) and vitamin C gummies (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient was allergic to nickel. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, at 11:00, after 2 hours of receiving the vaccination, the patients lower half of right cheek started to swell. On 24Mar2021, on the next day, both eye lids were swollen and the area under eyes were also swollen, skin around eyes was burning and skin was peeling all over face. Therapeutic measures were taken as the result of adverse events, which include treatment with antihistamines (FENISTIL). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of burning sensation, cheek swelling, eye lid swelling and skin peel was recovered on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a RN concerning an adult female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently, the pt developed an injection site reaction that included pain, swelling, redness and warmth. Unspecified medical attention was sought. The pt was treated with OTC ibuprofen (Advil) and cold compresses applied to the site. The pt has reported improvements in her symptoms. A product quality complaint was not involved. The reporter also mentioned another female pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N)(WAES#0404USA01121).  Additional information has been requested.
Returned to student health on 10/22/09 with c/o itchiness and redness at site of injection as well as multiple raised,red papular lesions on extremities and torso. Student was treated with keflex 500mg po twice daily for 7 days. Student returned 11/29/09 abd lesions were gone.
The day after vaccination, I had chills, my entire body ached, and I was very tired. I was 100% fine the next day. So, day one of shot: no side effects. Day two: side effects all day long. Day three: no side effects.
GBS/Arachnoiditis,  flaccid weakness lower ext, pain and neurogenic bowel bladder.
Rash and swelling; Rash and swelling; This spontaneous report was received from a 77-year-old male patient regarding himself. The patient's pertinent medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant therapies included tiotropium bromide (SPIRIVA RESPIMAT) and several others.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) one time dose (lot # and expiration date not reported) intramuscularly as prophylaxis (reported as "vaccine"). On an unknown date, the patient had an allergic reaction of rash and swelling to with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. The patient did not sought medical attention. No lab diagnostics or studies were performed. Unspecified product quality compliant was reported. The outcome of the events rash and swelling was reported as recovered. The reporter considered the events rash and swelling to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA000084: US-009507513-2009USA010369:
Initial misuse report received on 14 October 2013 from a health care professional. A 42 year old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient who was 42 years old received the FLUZONE HD. List of documents held by sender: none
Development of acute mononucleosis that resulted in a trip to the emergency room, and subsequently 6 doctor?s appointments for treatment and follow up. Recovery is not fully complete and is still ongoing at this time (09/19/2021)
Patient got 2nd dose of Shingrix, and he got a mini stroke same day in the evening. Wife said he has immobility in left side, he can only lift his left arm half way. He has slurry speech some time of the day. His doctor did his MRI, and his heart was good.
Starting last night some nausea, then a lot of sweating in the night as well as ongoing mild nausea. Low fever. Now I have general fatigue and muscle aches.
2 days after shot I broke out again with shingles and the doctor stated he never seen a case of shingles hang like this. It lasted about 2 weeks but I do still have it. I was going to urgent care and my doctor and they were shooting me up with prednisone and I was pretty involved in seeing my PCP during that time.
Left supraclavicular lymphadenopathy in the ipsilateral arm as the vaccine. The patient reports a similar reaction to previous influenza vaccination, which spontaneously resolved.
Leukoplakia on her gums; sore after receiving vaccination; left arm  got red; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOPLAKIA ORAL (Leukoplakia on her gums), VACCINATION SITE PAIN (sore after receiving vaccination) and VACCINATION SITE ERYTHEMA (left arm  got red) 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 Biopsy (Gum biopsy).    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LEUKOPLAKIA ORAL (Leukoplakia on her gums), VACCINATION SITE PAIN (sore after receiving vaccination) and VACCINATION SITE ERYTHEMA (left arm  got red). At the time of the report, LEUKOPLAKIA ORAL (Leukoplakia on her gums), VACCINATION SITE PAIN (sore after receiving vaccination) and VACCINATION SITE ERYTHEMA (left arm  got red) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event updated, Reporter contact information updated
Initial case was received from a nurse on 02 December 2009. A 16-month-old male patient received an intramuscular left thigh injection of ACTHIB (lot number UF727AA) and a subcutaneous right thigh injection of MMR (Merck, lot number 0609Y) on 25 November 2009. Medical history included allergic rhinitis and eczema; the patient was not ill at the time of vaccination. At approximately 4:00am the morning after vaccination, he woke with a fever of 102 degrees F. He began having convulsions, and became unresponsive. He was taken by ambulance to the emergency room where he was diagnosed with dehydration. He was treated and discharged from the hospital, and the event was considered to be recovered. On 07 December 2009: A corrective version has been created, using the receipt date from the previous version, in order to add the Sanofi Pasteur SA ACTHIB lot number of D0586-1. No additional information has been added. Documents held by sender: None.
Patient administered with expired vaccine after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial did not undergo any temperature excursions. Date vial was initially stored in the refrigerator was unknown. Total of 102 doses were given from LOT 026C21A with expiration date 24-Oct-2021. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received included non significant information.