chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; weakness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient not pregnant received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 26Feb2021 13:00 (Lot Number: EN6203) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. On 26Feb2021 15:00 patient experienced sore arm and weakness. No treatment was received. Patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
Fever 101.7 , nasal congestion/ rhinorrhea and fussiness. Treatment: Tylenol, symptomatic care.
pt recvd vax & 7 hrs post vax exp nausea, dizziness, vomiting & rash; 2 days later exp weakness, diarrhea & swelling of hands;
Malaise; Fever; Flat rash at injection site, in Crevices of arms, and near back and buttocks; injection site rash; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise, fever, rash and injection site rash. On an unknown date, the outcome of the malaise, fever, rash and injection site rash were unknown.   It was unknown if the reporter considered the malaise, fever, rash and injection site rash to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called and reported that she had given Shingrix concomitantly with Flu injection,  The patient was reporting malaise, fever, flat rash at injection site, crevices of arms, and near back and buttocks. The reporter did not have lot and expiration date for  Shignrix at time of call. The Vaers Details were updated. The reporter consented to follow-up.
Tingling in legs and hands. Balance and walking problems. Worsened from early '15 to later '15 when symptoms improved. Situation worsened dramatically from late '15 to mid '16. The second phase resulted in loss of motor controls, mostly in legs and inability to type, tie shoes, or button up shirt. Currently still balance problems, motor controls, and difficulty sleeping due to leg nerve noise and pain. Diagnosis: NMO
On Sunday, arm started itching, it was red and hot. On the 3/4 it was getting worse. Tried putting ice and heat but itching did not stop. Went to the doctor on 3/7, doctor recommended Benadryl (day and night) and use of cold towel. The symptoms have improved; not as itchy as it used to be. Ha a bit of a cough and nose running that disappeared. Patient took some Loratadine for allergies.
huge welt. hard , red and painful. 8 days after injection at injection site. keeps growing and traveling down arm.
Became pale after injection- initially cried, but then became pale and less responsive, but would open eyes with gentle stimulation- ?decreased respirations, but by the time I got my stethoscope on the chest- which seemed to stimulate him he recovered- pulse and respirations were strong and color pink throughout my observation. Mother states he had a similar response after Hepatitis vaccine at 1 month- both just after vaccine and on and off brief pale episodes during the next 24 hours. Sibling has a history of breath-holding.
Pain at injection site Same side muscle fatigue - specifically left calf, left vastus medialis, left hamstring, left gluteus complex, left rectus abdominus
pt recvd vax; bruising/petechiae started 3dec95 & worsened 4dec95;to hosp;platelet count 1,000;dx w/ ITP idiopathic thrombocytopenia purpura;father had ITP as a child;MD feels rxn to MMR;
Patient was vaccinated 9/29/17 at approximately 11:45am with AFLURIA. He called the pharmacy to report side effects/adverse reactions 10/4/17. Both he and his wife report having a different reaction after having their flu shots this year. He continues to have muscle soreness and is complaining of nosebleeds he attributes to the vaccine.
Patient developed diffuse redness of the skin and itchiness less than 15 minutes after receiving the vaccine. Vital signs initiall BP 178/92, HR 98, spo2 98%. Denied shortness of breath or other symptoms at that time. Patient took benadryl 25 mg PO, after about 10 minutes verbalized tingling of her tongue. No further progression of symptoms. 911 called & patient sent to ED for evaluation in stable condition. Medical staff
Patient did NOT have an allergic reaction to the COVID-19 vaccine.  Patient was given a second series Bivalent Moderna vaccine due to patient being adimate about getting a second booster dose along with partner and clinical nurse not realizing a booster dose had already been administered.  Patient did not tell the Nurese: RN that she had already received a bivalent vaccine.  Patient was administered first COVID booster dose on 09/20/2022 per record and then clinical nurse administered a bivalent Moderna dose on 12/15/2022 .  Patient is fine with no adverse reaction to the second Bivalent.  Process was talked about and new protocol put in place prior to giving the COVID-19 bivalent booster vaccine.
Mother noticed an apparent hive-like rash early morning on 9/10. Brought patient into clinic early evening. Patient with generalized hives on face, arms, torso, legs. Left deltoid with dollar size warm, red, raised area near DTaP site. Hives not near MMR, IPV injection sites. Patient was complaining of itching all over. No new foods, soaps, lotions, clothes, or environmental changes.
Her vision went disassociated; Double vision; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Her vision went disassociated) and DIPLOPIA (Double vision) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Her vision went disassociated) and DIPLOPIA (Double vision). At the time of the report, VISUAL IMPAIRMENT (Her vision went disassociated) and DIPLOPIA (Double vision) outcome was unknown.            Reportedly, the patient was taking unspecified medications for unknown indication concomitantly. She reported that she could not determine which vision was the right vision and she had difficulties putting her glasses back in the case. This lasted about a minute to two minutes
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Patient was given COVID shot in the shot administration room and then walked back to the pharmacy. He then fell/began having a seizure which was around a minute after administration. The pharmacist turned him on his side and held his head. The seizure lasted around 5 -10 seconds. 911 was called and first responders assessed patient. Patient reported that this has happened multiple times before after recieving vaccinations. After their assessment, he was able to walk out of the pharmacy.
abscess on her pharynx; sore throat; This is a spontaneous report received from a contactable consumer (patient herself).  A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: solution for injection; Lot number and Expiration date: UNKNOWN),  via an unspecified route of administration on 18Apr2021, as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported.   Patient reported that a week later on 27Apr2021, she got a sore throat. Caller reported that she went to the doctor on 30Apr2021 and was tested negative for covid but was diagnosed with an abscess on her pharynx. Patient described it as a pouch full of puss. Patient reported that she was prescribed an antibiotic and steroids as treatment for events. Patient stated that her throat does not hurt anymore. Patient reported that she will go to an ENT on Friday to make sure it was completely gone. Patient asked if was is safe to take the second dose even if she was taking antibiotics and steroids. Patient stated her last dose of the steroid was today and she would only be on the antibiotic on Sunday. Patient inquired would there be a problem, and response was given. Drug Interactions. Patient also inquired if she can wait more than three weeks apart. The outcome of the events was resolved for sore throat and unknown for abscess on pharynx.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
CLASSIC SYMPTOMS OF GUILLAIN-BARRÉ SYNDROME; This spontaneous report received from a consumer via a company representative concerned a 66 year old female of unspecified race and ethnicity. 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 administration not reported, batch number: Unknown) dose was not reported, one total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient started experiencing classic symptoms of guillain-barré syndrome which began from lower extremity paralysis and went up to bladder dystonia and bowel dysfunction. It was reported that patient would literally poop on the bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the classic symptoms of guillain-barré syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210918928-covid-19 vaccine ad26.cov2.s -classic symptoms of Guillain-Barré Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Injection hit blood vessel, bleeding,  dark blue bruise.  Intense Swelling down arm to elbow,  deep redness  and itching Friday 3-12-21  to today?s date 3-15-21 continues.    3-13-21 fainted after shower, 3-14-21 some dizziness during day.   No dizziness as of 3-15-21.   Swelling down some,  Itching continues.
I started to have a hard time catching my breath, then my heart was racing, I was light-headed and sick to my stomach.  I started a hacking cough to the point of dry heaving and then my eyes became blood shot and pus collected in the corner of both eyes.  Then I started to sweat profusely and shiver.  All of these symptoms began about 5 hours after receiving the flu shot.  I was still having a hard time breathing when I awoke the following day.  My heart was still racing, my eyes and cheeks were swollen and I was light-headed.  I felt like something was in my lungs and I couldn't take a deep breath.  I called my doctor's office and was told to go to the ER.
they can only feel where the injection was by slightly pressing on it; redness and itching at the site of the injection; redness and itching at the site of the injection; hat localize area is warm to the touch; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it), VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch). On an unknown date, the patient experienced VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it). At the time of the report, VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it), VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Patient showed symptoms of allergic reaction shortly receiving Pfizer Covid vaccine at 3:42 pm. She began with dizziness and nausea. At this point blood pressure and pulse was checked (BP 146/89 and Pulse 126) Pt started complaining of numbing of arm and legs then difficulty breathing and turning blue follow right after. A dose of Epinephine 0.3mg was given at this time. Patient is agitated, hyperventilating and pale but was talking. A few minutes after the injection , patient and family ask to call for EMT. 911 was called. EMT came to assess and check vitals. Vitals seems to be normal. Patient is still agitated. Patient was given oxygen canula. EMT stated that she may not need to be taken to hospital but would continue to monitor her and get her to calm down a little more. Patient was wheeled out to the EMT van for more privacy.
chills; muscle aches, like someone plugging him into an electric outlet; strong pain in his neck and back bone; strong pain in his neck and back bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: ER8736) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing), notes: sometimes, but he believed this was normal of all people. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; IBUPROFEN taken for headache, neck pain, back pain. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number:ER8737), administration date: 31Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 22Apr2021 03:00, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 22Apr2021 03:00, outcome "not recovered", described as "muscle aches, like someone plugging him into an electric outlet"; BONE PAIN (non-serious), NECK PAIN (non-serious) all with onset 22Apr2021 03:00, outcome "not recovered" and all described as "strong pain in his neck and back bone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, myalgia, bone pain, neck pain.  Additional information: The concomitant medication included multivitamins. The patient stated that he got his second shot a week ago, on 22 APR 2021, and almost every night since then, around 3 am, he got chills, but he had no fever. His temperature has stayed below 37 degrees Celsius. But even with no fever, patient had had chills, and muscle aches, like someone plugging him into an electric outlet. Patient had a strong pain in his neck and back bone. Patient reported this was all just happened at night, and he would take Ibuprofen and the symptoms go away within an hour. Patient stated that when he got the vaccine, he was told symptoms could last for 2 to 3 days, but it had been almost 7 days now that the patient had been having these side effects and he was wondered if that was normal. The patient stated that he took no prescription medications and was otherwise healthy.  No follow-up attempts are possible. No further information is expected.
Pt stopped by and showed me her arm, which was hot, tender and red at the injection site. It progressed and got worse 2 days after the injection. I recommended BENADRYL and to involve and follow up w/ her dr.
Medical assistant had a covid vaccine ready for a different patient and she was working on writing down the covid immunization record. When a student grabbed the vaccine thinking it was the injection that the patient needed, and without any directions or any supervision she proceeded and administered the vaccine on the right gluten.
Had some redness and swelling later that night, possibly from barrier that was used for shot. 2 days post shot, it was red, swollen, and warm. It started to fade and shrink, but never fully went away. Redness and swelling started to come back and the spot has grown over the past week. Site is slightly uncomfortable, not really a pain.
Redness on left thigh, vaccines given Wed, onset insidious, severity: moderate. Cephalexin 250mg/5mL, 4.5 mL, po, QID, 10 days for cellulitis.
130mm Induration, wheal on right arm-appeared several hours after injection- as of 6/4/04 it is still there, warm, red, itchy, painful.
feet neuropathy; more hand stiffness; trigger finger on the right hand; swelling in the armpit with the last two doses of booster vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431030-00 (agency).  A 50-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 03Dec2021 (Batch/Lot number: unknown) to 2022 at 40 mg (40 mg,1 in 2 week), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, unknown manufacturer), for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2022, outcome "unknown", described as "feet neuropathy"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Jun2022, outcome "unknown", described as "more hand stiffness"; SWELLING (non-serious) with onset Jun2022, outcome "unknown", described as "swelling in the armpit with the last two doses of booster vaccine"; TRIGGER FINGER (non-serious) with onset Jun2022, outcome "unknown", described as "trigger finger on the right hand". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "feet neuropathy", "more hand stiffness" and "trigger finger on the right hand" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "swelling in the armpit with the last two doses of booster vaccine" not related to BNT162b2. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events neuropathy peripheral, musculoskeletal stiffness, swelling, trigger finger and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a nurse prescriber refers to a 72 year old female patient. Information on patient's concurrent conditions, medical history and concomitant medications were unknown. On 03-APR-2019, the patient was vaccinated with PNEUMOVAX 23 1 dosage form (lot/batch, expiry date were unknown) in the upper left arm for prophylaxis. On 23-APR-2019, the patient was vaccinated with SHINGRIX (dosage schedule, lot/batch, expiry date were unknown) in the right arm for prophylaxis. On an unknown date (reported as after receiving SHINGRIX), the patient experienced reaction on the left arm which was further specified as redness, swelling at site and fever. On an unknown date, the patient had liver and kidney function test which revealed elevated kidney function levels and elevated liver function test. The patient also had sedimentation rate test which showed a value of 150 with unspecified units. The patient did not received treatment for the events. The outcome of the events was reported as recovered. The causality assessment was not reported. No product quality complaint (PQC) was involved. Upon internal review, the event renal impairment was determined to be medically significant.
PT exp myalgia & low-grade fever for 24hrs p/1st Engerix-B vax; rxd w/APAP; PT recd 2nd dose of Engerix-B (1cc/IM del) 28JUN91 which was uneventful;
Diagnosed Urticaria.  Uncontrollable itching, started on the feet at night time.  Was unable to get any sleep.  After a month I saw my PCP who referred me to the allergist who ran a series of tests, all of which came back unremarkable/normal.  The itching continued but had spread to my full body.
Two days post-injection patient developed a red rash across the neck that has not subsided. Patient States that rash is flush red and itchy since time of the injection.
Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media  on 05-DEC-2020.  This case involves a patient of unknown age and gender who got sick (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported that the last flu shot the patient have had (approximately 25 yrs ago ) made him/her so sick, the patient thought would die and the patient have never had the shot or the flu since then & didnt  plan on ever having one again.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.