chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; Nausea; vomiting; fatigue; headache; lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the left arm on 07Jan2021 08:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included ankylosing spondylitis, migraine, anxiety, and insomnia. Concomitant medications included fluvoxamine (FLUVOXAMINE), and adalimumab (ADALIMUMAB). The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EJ1685) via unknown route of administration on the left arm on 17Dec2020 17:30 at a single dose for COVID-19 immunization. On 07Jan2021 18:00, the patient experienced Nausea, vomiting, fatigue, headache, lymphadenopathy, and body aches. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.  The patient recovered from the events in Jan2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 22 year old female who was vaccinated with her first dose of Gardasil. After the vaccination, the patient became nauseous, sweaty, threw up and had diarrhea. Follow up information reported that the physician thought the symptoms were not related to the Gardasil vaccine because the patient had developed them a week after having exposure with a friend with the same symptoms.  Additional information not expected.
After vaccination, could not sleep , hallucinations, didn't sleep until Friday night which he seemed to get a little better. Tuesday morning, he could not feed or dress himself. Went to see his PCP.  He went to hospital for CT Scan. If he worsens, take him to the ER. Has appointment to see his Neurologist on Feb. 4.
12 days after MMR-V - measles rash - confluent, red raised face, trunk, extremities including palms & soles. (not just scattered pink spots!). No occipital nodes. No splenomegaly. No mucous membrane involvement. No cough. Slight runny nose. T=101 degrees-102 degrees x 48 hrs. Patient is ex-premature infant 31 weeks gestation, otherwise well. Rash became petechial, but no ecchymosis. CBC was normal with nl. platelet ct. Rash faded after 1 week.
1) Kidney infection - horrible pain; 2) Lost all hearing in left ear.  First shot - February 11, 2021.  Second shot - March 12, 2021.  Two days after second shot - horrible pain in lower right side.  Kidney infection.  Lab tests confirmed.  Treated.  One month after Second shot, April 11 - lost all hearing in my left ear:  Sudden Sensorineural hearing loss, or SNHL.  Still no resolution.  Trying everything. I am deaf.
Symptoms: headache, fatigue, muscle ache, dizziness, slight nausea, diminished appetite, injection site redness, under arm pain Treatment: rest Time: 48+ hours Outcome: Symptoms declined
Subject began to experience severe pain & stiffness in the upper body starting May 2010. She was evaluated by her new M.D. In Nov. 2010 she was given the diagnosis of Psoriatic Arthritis. She is treated HUMIRA injections every other week.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. On unknown dates, the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M026317 with expiration date 11-JAN-2018 and lot # M037533 with expiration date 17-MAY-2018. Additional information has been requested.
11-30-06 PM patient developed diarrhea then later that evening nausea. No vomiting. Today 12/1/06 still has same symptoms but improving did not seek medical attention.
I had extreme pain in my left arm/ very hard time lifting her arm up; He said that I had inflammation from the vaccine; it caused the tissue to rub on bone spurs.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: Ew0164) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; DHA; LUTEIN. The following information was reported: INFLAMMATION (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "He said that I had inflammation from the vaccine"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "I had extreme pain in my left arm/ very hard time lifting her arm up"; TISSUE INJURY (non-serious) with onset 15Apr2021, outcome "recovered with sequelae", described as "it caused the tissue to rub on bone spurs.". The events "i had extreme pain in my left arm/ very hard time lifting her arm up", "he said that i had inflammation from the vaccine" and "it caused the tissue to rub on bone spurs." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, inflammation, tissue injury.  Additional information: Patient had extreme pain in her left arm from first shot. she had a very hard time lifting her arm up. After waiting for 4 months she went to go see an orthopedist who did X-rays and a MRI. He said that she had inflammation from the vaccine and it caused the tissue to rub on bone spurs. He did a cortisone injection. That helped her a lot. patient still have pain in her left arm though. No other vaccine in four weeks, Other medications in two weeks was Birth control, multi-vitamin, Calcium, DHA, luetin, no covid prior vaccination, post vaccination tested for covid (Nasal Swab). Patient administered dose 2 of Pfizer on 30Aug2021, Lot number Fc3182, dose 3 of Pfizer on 16Dec2021, Lot number Fe3594.  Follow-up attempts are completed. No further information is expected.
Shivers and nausea came first, proceeded by a fever and continued chills and tiredness throughout the day till about 8PM (temperature highest 101.4).
12 year old patient received 5-11 pediatric vaccine as first dose instead of pfizer 12+. No adverse reactions noted.
She says her arm is numb down to the fingers and intense pain in her arm and into her back/neck and a small (maybe 1 cm) bruise at injection site. She sent to ER and they gave Rx for prednisone 40 mg daily x 5d.
Approx 2 hours after receiving the vaccine he felt lethargic with headache and malaise.  He fell asleep on his desk at school (this child has never done that before) and then came home feeling lethargic, went to bed and slept for a total of 19 hours straight.  He had no other neurologic symptoms, no respiratory symptoms, and felt well the following day.
Redness, edema induration is warmth X 3 days after vaccines - OTC SX relief.
can't sit still but I'm not sure if it is anxiety driven; muscle tension; skin feels like it's scratchy; This spontaneous case was reported by a pharmacist and describes the occurrence of RESTLESSNESS (can't sit still but I'm not sure if it is anxiety driven), MUSCLE TIGHTNESS (muscle tension) and PRURITUS (skin feels like it's scratchy) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced RESTLESSNESS (can't sit still but I'm not sure if it is anxiety driven), MUSCLE TIGHTNESS (muscle tension) and PRURITUS (skin feels like it's scratchy). At the time of the report, RESTLESSNESS (can't sit still but I'm not sure if it is anxiety driven) had not resolved and MUSCLE TIGHTNESS (muscle tension) and PRURITUS (skin feels like it's scratchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Expired Menveo Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 31st October 2022) for prophylaxis.   On 22nd November 2022, the patient received Menveo. On 22nd November 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 28-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
GBS; This case was reported by a other health professional via sales rep and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's comment: The reporter stated that the patient had an incident of GBS(Guillain Barre syndrome) in the past from potentially a Flu vaccine. No Flu vaccine brand name was specified in form. The reporter consented to follow-up.
Headache, Myalgia, Diarrhea, NauseaVomiting, chills, malaise, swollen glands Narrative:
Patient  developed a rash almost right away after administration. The Wednesday after the shot was given she developed throat tightness . The Saturday after the shot was administered she developed a fever blister on her mouth. Patient said she also experienced stomach upset and an altered sense of taste.
Erythematous Rash with areas of excoRiation in Center. B/L thighs and behind knees. (Not LPA patient - COVID 19 clinic) ONGOING RASH.  RASH is NOT Bothersome to patient, Not itching - No dRainage. SeveRal patches B/L anteRioR/posteRioR thighs/legs/behind Knees. No treatment foR RASH. Patient seen heR PCP. - Labs/Blood WHL checked and reported + WNL to me by daughteR. Pediatrics WAS COVID vaccine clinic. I gave to patients that met phace 1A CRiteRia.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-DEC-2015, the patient was vaccinated with improperly stored doses of GARDASIL (lot # K008931, expiration date: 04-MAR_2017; dose and route were not provided) and VAQTA (lot # L009445, expiration date: 01-JUN-2017; dose and route were not provided). The vaccines were exposed to -0.1 Celsius degrees for 1 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient had no known allergies.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) single dose pen. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   The reporters causality for event of pain with Adalimumab solution for injection was reasonable possibility (probable).   It was unknown if patient was enrolled in a clinical trial.
Rash on forearms; Hives; Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness), URTICARIA (Hives) and RASH (Rash on forearms) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Soreness). On 10-Feb-2021, the patient experienced URTICARIA (Hives). On 14-Feb-2021, the patient experienced RASH (Rash on forearms). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (Soreness) had resolved. On 13-Feb-2021, URTICARIA (Hives) had resolved. At the time of the report, RASH (Rash on forearms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received Added events, treatment medication. Updated reporter contact information ,patient demographics, outcome of event.
Pt received Tdap 6/1/18 Left deltoid at 243PM. During evening of 6/1/18 she experience pain 8/10, itching, sweating and swelling to left deltoid. Denies Fever and body rash. Prescribed AUGMENTIN 0 500mg-125mg 1 tablet 3x day. Pt saw PCP and was given 21 days of methylprednisolone and did not take AUGMENTIN. Follow care at PCP.
Admitted for Acute calculus cholecystitis, subsequently found to be COVID-19 positive with routine admission testing.
Patient developed full body tingling on the evening of 12/17, 12/18 developed full body itching and hives, scratching so hard she is making herself bleed. No facial edema or swelling no sob
Joint pain in left knee; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non- pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route of administration in the right arm on 22Mar2021 at 09:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 23Mar2021 at 12:00, the patient experienced joint pain in the left knee. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event joint pain in the left knee was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
a large red hot spot appeared next day about 3 inches away from injection site and 3 small red spots on arm and face appeared
No adverse effect reported. 14 year old received 3rd dose of Pfizer. At this time booster dose only approved for 16 and up.
Patient is a 75 y.o. year old male with complex medical history including bladder cancer receiving palliative chemo, and percutaneous nephrostomy tubes and urostomy, CKD, CAD with hx of CABG, GERD, admitted after cardiac arrest in the field, coded and ROSC, now in CCU, also found to be covid + on admission.
patient was complaining of reaction s/p 1st dose covid vaccine approximately 15-20minutes after vaccine administration. Patient was alert and oriented and states that she is "itchy all over" including her throat. Her SBP at the time is 180s and elevated HR in the low 100s. O2 sat remained >98%. She denies any reactions to previous vaccinations but had an anaphylactic reaction to walnuts before. Patient examined with no visible rashes, patent airway, no enlargement or swelling of tongue or lips.  Verbal order from Dr to start IV access and was given Benadryl 25 mg and Dexamethasone 4mg IV. Patient tolerated well.  Vital signs rechecked every 2 mins with SBP trending down and HR stabilizing in the 90s. Patient denies any chest pain, SOB, cough, but complains of mild nausea.  Patient was kept in clinic for observation for 2 hours and was discharged in stable condition. Spouse came to drive patient home as she was somnolent from benadryl 25mg IV administration.  Spoke with patient again today 3/27 to check on her. She states there is still some pruritis at R deltoid injection site with some swelling. She notes it is about 50% improved in itchiness and swelling since the evening of vaccination. Patient reports that she did not have any swelling of tongue, lips, or throat during observation post vaccination and since being released from clinic observation.
1-2 days after Flu Mist administered by her school (#2) child had rash-pain behind left ear followed by drooping left site lip-eye partial closure. 02/28/07-records received from PCP for DOS 2/15 and 2/19/07. DX Bell's Palsy. C/O onset 5 days ago, rash on body,pain behind left ear, PE:face droops left of of left eye, left eyelid unable to close completely unable to wrinkle forehead. Return visit on 2/19/07 eye partial closure of left eyelid. mouth droops.
SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-OCT-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: PCR (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20211151782.
Recipient received Janssen COVID vaccine on 3/22/2021 via a closed POD clinic. He came to the pop-up vaccine clinic held on 7/24/2021. He discussed with onsite vaccinator and physician that he had already received a Janssen COVID vaccine and is scheduled to travel to the mainland. He stated that he was counseled by the physician volunteer which had him decided to receive a Moderna vaccine. The POD team leads were not consulted prior to the vaccine being administered. There was no adverse reactions after the 15 minutes observation period.  Follow up phone call on 7/27/2021. There was no adverse reactions since receiving the dose on 7/24/2021.
Shortness of breathe WHENEVER I do ANYTHING.  Whether it be getting dressed, doing dishes,  any walking. I have seen a pulmonologist,  had a cat  scan, used two types of inhalers and had blood work done. As of YET, there has been no reason for this sudden situation.
pt recv vax; fever 104; v; saw MD & was given APAP;to hosp & IV fluids given;
I received the second vaccine on 2/24/2021, on 2/25/2021 I had body aches and pain, my back was really bad, I had received an injection in my lumbar region on 2/15/2021 and was feeling great until the second injection. I saw my APRN and was prescribed a steroid which helped, but as soon as I finished the pain came right back. I saw my eye doctor in May, and he wants me to get lab work and testing for and myasthenia graves. I have never had any eye problems in the past. One of my first symptoms was a terrible headache and eye pain. It was very scary. I was diagnosed with Covid-19 on 8/25/2021. My lungs were affected with getting Covid-19, I am shortness of breath, I am on an antibiotic beginning on 08/27/2021 and I was given antibiotics and an inhaler and told to take baby aspirin.  I am still struggling at this point.
24 hours after injection, Headache, stomach pain, chills , fatigue, nausea  lasted 18-20 hours total
She has been very lethargic, pale, weak, and dizzy. Seems extremely out of it in certain periods of time. Her dizziness is so bad that it causes her to vomit from too much motion if she's just eaten. She's not responding like normal. She's always been happy and healthy.