chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache; Extreme body aches; Joint pain.; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient 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 12Feb2021  at 12:00(at the age of 71-years-old)  and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on unknown in 2021 at 18:00(at the age of 71-years-old); as a single dose for COVID-19 immunisation. The patient also received booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Aug2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), high blood pressure and chronic back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN) and fentanyl citrate (NARCO) for unknown indication from unknown date and unknown if ongoing. The patient previously took levaquin (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On an unknown date in 2021, the patient experienced severe headache, extreme body aches, joint pain and difficulty breathing. It was reported that this was patient's 3rd dose, and each time the side effects got worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, extreme body aches, joint pain and difficulty breathing were not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
That night I began coughing. I have asthma and had trouble breathing. Four days later I was diagnose with bronchitis.
injection site / redness; pain in the injection site; injection site, swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 23rd October 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site swelling. On 26th October 2020, the outcome of the injection site erythema, injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in left arm and the day after she had pain in the injection site, swelling and redness that lasted for 3 days. The vaccines lot number and expiration date was not provided. The reporter consented to follow-up.
Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Allergy to vaccine.   On 01-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Feb-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE REACTION (Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira). At the time of the report, INJECTION SITE REACTION (Injection site reaction/ A squished circle the size of the band aid at site of injection in leg with Humira) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  The reporter's causality for the event(s) of a squished circle the size of the band aid at site of injection  in leg with Humira (adalimumab) was a reasonable possibility.  No concomitant medication reported. No treatment medication reported.  Primary reporter did not had the lot number information, because the packaging was discarded.  It was unknown if patient was enrolled in a COVID-19 vaccine trail.
Patient reported to our clinic after receiving the SHINGRIX vaccine at an alternate site. On 2nd day after SHINGRIX vaccine, patient reported rash/swelling, fever and body aches. Rash/swelling continued for two weeks with rash growing to entire vaccinated arm between the elbow and axilla.  Entire axillary are was swollen. Initial symptoms passed after about 2+ weeks, but still has swelling to the posterior axillary which is troublesome.
Jaw is all swelled; Infection; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), SWELLING FACE (Jaw is all swelled) and INFECTION (Infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Sore). On 18-Mar-2021, the patient experienced SWELLING FACE (Jaw is all swelled) and INFECTION (Infection). At the time of the report, PAIN (Sore), SWELLING FACE (Jaw is all swelled) and INFECTION (Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included antibiotic which dentist wanted to prescribe the patient.
Right arm slightly red and slightly swollen the day following immunization. 2 days later right arm more swollen, more red with red streak going down arm, and 'itchy". Advised Mom to take child back to doctor or walk-in-clinic.
Brain fog; Could not remember simple things such as house address; Felt like had a marijuana high and looked very high; Hard time forming words and sentences and answering questions; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FC3180) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included bell's palsy, allergy to bee stings and latex. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified birth control pills (MANUFACTURER UNKNOWN) within two weeks of vaccination. On an unknown date in Aug2021 at 17:30, the patient had brain fog, could not remember simple things such as her house address and felt like had a marijuana high. The patient had a hard time forming words and sentences. When her husband asked her questions she had a hard time answering him. Her husband also commented that she looked very high. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events.. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, could not remember simple things such as house address, felt like had a marijuana high, had a hard time forming words and sentences and answering questions were recovered on an unknown date in Aug2021.
I have severely  limited mobility in my right shoulder, and sharp pain when I lift objects. Initially I thought it was the standard side effect of the shot, but this condition has remained since March 15. I reported it to a doctor at a urgent care clinic and they recommend I see an orthopedic doctor. I am not able to get an appointment until September.
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 2013-05188, 2013-05251-05257, 2013-05259-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 37-year-old female patient who had received Trivalent inactivated influenza vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and 21 days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
pt recv vax 4FEB94 & 2 days later 6FEB94 pt devel fever 100 & a red, raised rash on body;pt was not hosp;
For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 (Lot number: EP2533) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alpha Gal IgE" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EN6202,, lot unknown=False,, administration date=05Mar2021,, dose number=1,, vaccine_location=Left arm), administration date: 05Mar2021, when the patient was 45 years old, for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious), MOOD ALTERED (non-serious), PREMENSTRUAL SYNDROME (non-serious) all with onset 03Apr2021, outcome "recovered" and all described as "For 3 consecutive months after my 2nd shot, I experienced immediate & unusually heavy periods, with painful cramping/excessive bleeding/mood changes/PMS". Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, mood altered, premenstrual syndrome.  Additional Information:  Facility type: Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected.
SWELLING AT RIGHT ARM FOLLOWED BY INCREASING SEVERE PAIN OF RIGHT SHOULDER. UNABLE TO LIFT ARM ABOVE SHOULDER FOR 2 WEEKS +.
stayed tired all day and lounged around the house.; left arm was a little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was a little sore at the injection site) and FATIGUE (stayed tired all day and lounged around the house.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (First Dose) on 05-Jan-2021, Pfizer Vaccine (Second Dose) on 26-Jan-2021 and Pfizer Vaccine (1st Booster Dose) on 03-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.    On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Apr-2022, the patient experienced VACCINATION SITE PAIN (left arm was a little sore at the injection site). On 24-Apr-2022, the patient experienced FATIGUE (stayed tired all day and lounged around the house.). At the time of the report, VACCINATION SITE PAIN (left arm was a little sore at the injection site) and FATIGUE (stayed tired all day and lounged around the house.) had resolved.            No concomitant medication was provided.  No allergies were reported. It was reported that the patient was never tested or diagnosed with COVID. The AE did not cause patient to seek medical care.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow-up received includes vaccine administration dates of historical vaccine updated.
Patient  came to the center for a Moderna vaccine at 5pm. The patient expressed that she felt dizzy shortly after immunization (before leaving the immunization chair). Her head began to fall backwards so I quickly supported the patient's head and neck area and was able to keep her from falling out of her chair. The patient fainted but regained consciousness approximately 3 seconds later. The patient came back alert but nauseous. The patient vomited in a trashcan and then felt fine. The patient blamed the reaction on her severe anxiety and said the exact same thing happened after a nose piercing. I observed the patient for 30 minutes and sent her on her way. The patient left healthy and happy. I told the patient to warn the pharmacist prior to receiving her second dose. No drugs were administered. Written up in SCRT and VAERS. I followed up with the patient at 7 pm and she was home safe.
Began with lump under left armpit 5 days after first vaccine. Followed by tightness in upper left arm following week, continued into lower arm the week after. The following week the whole left arm felt tight.  5 days after 2nd vaccine small lump appeared on lower  left bicep, hardness ran from lump down through crook of elbow.  2nd lump appeared a few days later below hardness trail in the forearm below crook of elbow.
11/1/18 LD (quadracep) area erythema warm to touch very tender from deltoid (L) arm to elbow with swelling - cellulitis. Rx with cephalexin, BENADRYL. Area 3 cm x 3 cm. 11/2/18 return visit improving.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.     On 12-Feb-2022 at 2:01 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 2:01 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose of COVID-19 vaccine No concomitant drug information was provided.  The 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022  No treatment drug information was received.   This case was linked to MOD-2022-542869.
Information has been received on 26-MAY-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 25-FEB-2009 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
S/P IPV,MMR, AND DTAP 48 HOURS AGO, PRESENTED WITH REDNESS AND SWELLING IN RIGHT DELTOID, ON EXAM RIGHT ARM SWELLING, WARMTH AND ERTHEMA OF DELTOID, APPROX. 10X5 CM IN DIAMETER.  CHILD DX WITH CELLULITIS AND GIVEN KEFLEX 250/5 SIG. 7CC PO QID X 10 DAY, AND SENT HOME WITH INSTRUCTIONS TO GO TO NEAREST ED IF SIGNS OR SYMPTOMS GET WORSE.
5days p/vax pt exp rt jaw tightness, pain in spinal column, fever. sx persisted but to a lesser degree 1 full month p/vax
Patient was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient was pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 25-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 25-Mar-2021, EXPOSURE DURING PREGNANCY (Patient was pregnant) had resolved.            On 12-Aug-2020, the patient tested positive for pregnancy. Concomitant medications were not provided. Treatment information was not reported.
Post vax 1st Anthrax, four hours later, had macular/papular rash to body. Worse in the left arm where pt received vax.
A report was received a health professional on 10/15/02, concerning a 45year old female patient who experienced no cartoid pulse, stopped breathing and collapsed, immediately after receiving Fluvirin on 10/15/2002. The patient had no relevant medical history and was not taking any other medications. She had receive the influenza vaccine in the past  ( Fall 2001) but could not confirm whether or not it had been Fluvirin. On 10/15/02, the patient received Fluvirin. Immediately after, the patient complained that she felt very warm. The patient's face then turned ashen and she slumped over. The nurse administering the Fluvirin could not detect a cartoid pulse and noted that the patient had stopped breathing for approximately one minute. At that time, emergency paramedics were called. the nurse was initiating CPR when the patient roused and asked what was going on. She was then taken by the paramedics to hospital for observation. The patient recovered without sequalae on the same day. The patient was described as being healthy and an endurance runner, and had a baseline blood pressure of 127/80 with a pulse of 48. The reporter has assessed the relationship of Fluvirine to the event as probable. The follow up states apical rate dropped to 42, and the vaccinee was transported to hospital by ambulance. The vaccinee was admitted to a coronary care unti under the care of a cardiologist for 1.5 days. An EKG, MRI, and EEG were performed. The diagnosis was of severe vasodilation leading to shock resulting in lack of oxygen to the brain, which resulted in the vaccinee's heart stopping. At the time of the report the vaccinee had recovered. There was insufficient info to determine the reporter's causality assessment.
Pt recvd vax noon; & had sz, t101 AX, given APAP;
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-DEC-2015, the patient received an expired VARIVAX (Merck) (lot # J013905, expiration date: 30-OCT-2015), dose and route were not reported. No adverse effect reported. Additional information has been requested.
10JUN97 pt became irritable for 2 days;mom treated pt w/APAP;pt was also teething @ the same time;13JUN97 through 15JUN97 pt devel a fine red raised rash from face to trunk & down legs lasting 3 days;sl irritability w/scratching;
Severe pain in whole right arm where shot was administered.  Could not move arm all day!  Severe pain!