chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic reaction, incontrollable coughing and could not catch her breath; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction, incontrollable coughing and could not catch her breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction, incontrollable coughing and could not catch her breath) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction, incontrollable coughing and could not catch her breath) outcome was unknown.            No concomitant medications were reported. It was reported that patient experienced anaphylactic reaction within 20 minutes after the vaccination. The patient was sent to the hospital by ambulance from the clinic. On 07-Nov-2022, the patient started treatment, but no medications were reported.  Company comment: This spontaneous case concerns a unspecified age old female patient, with no medical history, who experienced expected serious (medical significant) event of anaphylactic shock, which occurred on same day within 20 minutes of booster dose of mRNA-1273 vaccine. After vaccination Patient experienced incontrollable coughing, could not catch her breath, Patient sent to the hospital by ambulance from clinic. No further information on risk factors, investigations, treatment given was available in the report. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female patient, with no medical history, who experienced expected serious (medical significant) event of anaphylactic shock, which occurred on same day within 20 minutes of booster dose of mRNA-1273 vaccine. After vaccination Patient experienced incontrollable coughing, could not catch her breath, Patient sent to the hospital by ambulance from clinic. No further information on risk factors, investigations, treatment given was available in the report. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a medical assistant concerning a 2 month old patient of unknown gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On 18-MAY-2017, the patient was inadvertently vaccinated with PNEUMOVAX23 lot # M027552 (strength, dose, route were unknown) instead PREVNAR 13 for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Chills, fever, shivering, nausea, headache, muscle aches. Started approximately 6 hours after vaccine. Lasted approximately 15 hours. Worst symptoms were nausea and shivering.
4"x 5" redness and swelling, decreased ROM, flu-like symptoms including nausea, headache, chills with shaking, muscle aches and pain.
Headache, tired and exhausted, feeling weak, muscles ache, left arm feels sore. Night time the chills.
pt recvd 3 Hep B vax on 0,1,6 months schedule.1st & 2nd vax were "Recombivax". 3rd in series was Energix-B.On 08NOV90 tested for HBsAB p/ needle stick from pt. w/ positive HBsAG & results were negative.
Crusted papular rash at left deltoid with mild swelling, began approx 5 days after immunization. (with Dtap and Poliovax 6/13/05) Similar rxn in twin sister.
I was diagnosed with glaucoma this summer; temperature went up to 98.8F/it's usually 97F; very, very, very mild headache; mild aching; This spontaneous case was reported by a patient and describes the occurrence of GLAUCOMA (I was diagnosed with glaucoma this summer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insect bite allergy (Reaction with Mosquito bite since she was 5 years old), Shellfish allergy, Herbal allergy (Sage allergy), Spice allergy (Sumac allergy) and Allergy to chemicals (Allergic to Preservatives).    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced PYREXIA (temperature went up to 98.8F/it's usually 97F), HEADACHE (very, very, very mild headache) and MYALGIA (mild aching). In 2022, the patient experienced GLAUCOMA (I was diagnosed with glaucoma this summer) (seriousness criterion medically significant). At the time of the report, GLAUCOMA (I was diagnosed with glaucoma this summer), PYREXIA (temperature went up to 98.8F/it's usually 97F), HEADACHE (very, very, very mild headache) and MYALGIA (mild aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 98.8 F.         Concomitant medication include eye drops for glaucoma. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID-19 positive test or diagnosis. No treatment medication details was reported.  Company comment- This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected serious (medically significant) event of glaucoma. Three doses of mRNA-1273 vaccine (given as first, second and booster dose) were administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-670153, MOD-2022-669963 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected serious (medically significant) event of glaucoma. Three doses of mRNA-1273 vaccine (given as first, second and booster dose) were administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination dates. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
fever up to 101, body aches, chills that lasted about 8 hours. swollen at the injection site and hot for 5 days
Very sore knot at injection site. Fever with severe chills starting about 10:00 PM. When I got out of bed during the night, I felt unusually groggy. For the next 4 days I felt like I had a milder case of the flu. On the 2nd day after the injection I developed a bright red sore area, on and above the elbow, and red streaks slightly higher up and on the opposite side of the arm.
One week after DT and Hepatitis vaccine, this patient developed a bilateral symmetrical joint pain. Eventually involving all joints except ankles and feet. No swelling, warmth, redness, or tenderness.
On 5/17/02, parent returned to the clinic with the pt to report hot, red, swollen and indurated injection site on right arm (deltoid). The swelling involved most of the upper arm from the elbow to the shoulder with limited activity and some secondary pain.
Left and right thigh child received immunizations on 10/19/05. Dtap and Comvax. Mom calling 10/20/05 stating child's face broke out in welts. No resp distress, no facial swelling or eye swelling. Questionable rash at injection sites and slight red at sites. Child also had fruit chunks slightly different than what had in past, today. RN to call 10/21/05 to get update on child's condition.
Fever; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously 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 16Apr2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 12:00, the patient experienced fever, headache and chills. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache and chills was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain; Dizziness; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Chest pain"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills".  Additional information: NDC and UPC number of COVID Vaccine: Unknown. Reason for no lot number: of COVID Vaccine: Other. LOT#: Consumer stated, You said LOT#, where can I find that? Mam, I am having chills right now and I want to know what should I do? I am having chest pain and dizziness? Should I go to emergency room? Consumer stated, I just got the Pfizer two days ago and I am having chest pain and dizziness. Like I wanted to know what should I do? Consumer confirmed the name of the product as Pfizer COVID Vaccine. Consumer was informed about the Medical Information Department for the concern and was provided with the contact# as, option 3 from 8am to 8pm, Monday to Friday as per. Consumer stated, So, I cannot call them now? and hung up the call abruptly. Thus, further probing could not be done. Hence, limited information available over the call. This consumer reported in response to Non-HCP letter sent to consumer via telephonic follow-up activity which included that: Phone-Out 14:17 PM, 1st attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Phone answered by consumer who refused to provide information, consumer wishes to not be contacted again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Abdominal Rash; This case was reported by a physician via call center representative and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. The patient experienced abdominal rash.
Woke up the next morning and couldn?t move my arm. It was very swollen and red at injection site, tender to touch. Had a 101.3 fever with chills, sweats and severe body ache on day 2.  Symptoms feel worse than when I had covid 19
cavity; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (cavity) and INJECTION SITE PAIN (pain at injection site) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 09-Mar-2021, the patient experienced DENTAL CARIES (cavity). On 06-Mar-2021, INJECTION SITE PAIN (pain at injection site) outcome was unknown. At the time of the report, DENTAL CARIES (cavity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported. However, the patient was scheduling appointment to see dentist.
FLUMIST administered 11-12-14 at 4 pm. Mom reports child woke on 11-13-14 with congestion, headache and achiness. Mom reports child started with hives on 11-17-14 and continued with stuffy nose. 11-20-14 mom called office to report this. Advice given to observe. Mom sched appt 11-24-14 due to hives not completely resolved.
Patient developed rash to face and generalized redness to torso a day after Pfizer booster bivalent was administered
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 5/22/21 and 6/19/21.Covid + 3/06/22. Admitted after recent hospitalization for ARDS w/chronic resp failure, presented from LTACH after cardiac arrest w/ROSC achieved after 7 minutes of CPR. In ED, found to have significant GI bleed w/acute blood loss anemia, hypovolemic/hemorrhagic shock w/multiorgan failure (speculated cardiac arrest was also due to this) requiring pressors. Also was found to have resp failure, 2/2 multifocal PNA. Dx'd with ESBL K.pneumoniae on 3/17/22 and acute on chronic HFmrEF. Transfused and admitted to ICU for ventilatory and pressor support. EGD by GI team showed copious amounts of hematin/blood clot in stomach but no identifiable bleeding source; H/H was trended every 6 hours, administered blood products prn. Found to have acute renal failure requiring dialysis and electrolyte management by nephrology. Cardiology team suspected his cardiac arrest, type 2 MI, acute on chronic heart failure as sequelae from hypovolemic shock 2/2 GI bleed. Although patient medically stabilized over the next few days, his lack of mentation  was demonstrative of anoxic brain injury. EEG findings were consistent with generalized moderate-severe cerebral dysfunction. Transitioned to DNAR/COT. Expired on 3/29/22. Treated with meropenem and vancomycin.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 13-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot # L011529, expiration date: 03-JUL-2016), which were improperly stored for 10 days. The outcome was unknown. This is one of several reports from the same reporter. Additional information has been requested.
I think it was injected into a Brachial Nerve in  my bicep instead of my deltoid   It sill tingles and throbs and is achy 4.5 weeks later
Patient had immunization on 4/9 first dose of the Pfizer vaccine and began with a headache shortly after and Sunday morning while in the shower had a syncopal episode.
Headache, joint pain, and 15 hours after injection hot flashes sweating and nausea. Fainted 2 times within a few minutes. 10 minutes later it all passed and felt okay.
Purplish- Red Bruising, not blotchy, Slight Swelling, annoying pain with movement but able to complete activities of daily living first noticed May 5th continually spreading now approximately 7 inches in length.
Received Covid vaccine at school setting. 10 min after vaccine- client stated felt tightness in back and chest and it felt hot there -kind of like hot flash but different. Also got upset stomach and little light headed.  A co-worker (teacher ) took her pulse and it was 66.  Lasted for about an hour and then felt better. She notified public health by phone after 30 min and was recommended she call her healthcare provider. Called her back 30 min after that (about hour and 10 min after vaccine) and she had not called provider and was feeling much better. Denies having problems with any shots in the past
Sluggishness; Feel bad, off and crappy; Fatigue/Tiredness; Chills; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness), FEELING ABNORMAL (Feel bad, off and crappy), FATIGUE (Fatigue/Tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness), FEELING ABNORMAL (Feel bad, off and crappy), FATIGUE (Fatigue/Tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, SLUGGISHNESS (Sluggishness), FEELING ABNORMAL (Feel bad, off and crappy), FATIGUE (Fatigue/Tiredness), CHILLS (Chills) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
arm ache started sunday am, hard to lift arm, by afternoon area red, swollen.. continues to be red , swollen, difficult to move arm..
Pt had 50 cents piece size raised area on left deltoid that was red and warm to touch.
L arm swelling redness pain with open sores left shoulder. Diffuse muscle aching. Extremity stiffness pain. Better but not completely gone 07/03/02.
Received covid booster shot 12/4/2021 and developed a sore arm, sore back and neck muscles, sore throat, ear pair in left ear, congestion, (developed ringing in left ear that lasted 4 weeks).  Had an appointment with urgent care nurse practitioner and she prescribed antibiotics for an ear infection.. The next day I noticed a loss of taste and smell and decided to get a rapid covid test which came back positive.  My husband and son also became ill and tested positive for covid.   I took a pregnancy test January 2022 and tested positive for pregnancy, which means I because pregnant around the same time I received the booster.  Currently, I am still pregnant.
chills; sick in the stomach; itching; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ABDOMINAL PAIN UPPER (sick in the stomach) and PRURITUS (itching) 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 No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), ABDOMINAL PAIN UPPER (sick in the stomach) and PRURITUS (itching). At the time of the report, CHILLS (chills), ABDOMINAL PAIN UPPER (sick in the stomach) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had a long sleeved shirt on. The practitioner had me push my sleeve up high on my shoulder then injected it very high (closer to the shoulder joint than I?ve ever had with previous injections). The next day I got a sharp shooting pain into my shoulder blade. Since then I?ve had worsening pain and tingling around my shoulder and scapula.  It?s keeping me up at night and each day I am Losing range of motion and increased pain.
After an hour started getting headache. Progressed to pain at injection site. Stiff neck. Severe joint pain, muscle pain, horrendous headache , sweats, shaking & teeth chattering. Dizzy if tried to stand up. Needed assistance to get to bathroom.  No sleep until after 10 am on 3/31/21. Napped until 3 pm.  Starting to feel better now 6:22 pm.
extreme pain; soreness in left arm; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female patient who was having extreme pain and soreness in left arm while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm as Immunization  On 07-SEP-2022 the patient had extreme pain (pain in extremity) soreness in left arm (myalgia) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that pain and soreness was there in left arm and inside of arm coming down to elbow and into left shoulder.  Action taken was not applicable.  The patient was treated with PARACETAMOL (TYLENOL)  and IBUPROFEN (IBUPROFEN) for Myalgia and Pain in extremity.  At time of reporting, the outcome was Not Recovered / Not Resolved for all.