chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia   As soon as she receiver her injection she felt "shaky". No sob, cp or dizziness. Initial vitals b/p 139/101, SaO2 99 pulse 122. Minimal food intake today. Provided water and cookie. F/U vitals 131/88, pulse 93 and Sao2 99%. Feels better after eating
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 26th March 2018, several hours after receiving SHINGRIX the patient experienced injection site lump, injection site rash and injection site pain. On 27th March 2018, 1 day after receiving SHINGRIX the patient experienced rash. In March 2018, the outcome of the injection site lump was recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site rash and injection site pain were recovering/resolving and the outcome of the injection site erythema and rash were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site lump, injection site rash and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injection site erythema and rash to be related to SHINGRIX. Additional information received were as follows: The registered pharmacist reported that patient received SHINGRIX on Monday. On the same night of administration before going to bed, the patient experienced a lump at the site injection and it was hurt with a rash. The patient woke up in the next morning and the rash covering the upper part of her arm and it was still sore. The rash continued to cover the arm all day yesterday as well as today. The rash reduced in size and it was measuring approximately 6 inches in diameter today. The rash not found to be uniform and it was red and swollen on Monday night and on Tuesday. The rash described as being irregular in shape and in a strange pattern.
My arm was sore within an hour of receiving the shot. I moved my arm around, trying to exercise it in some way to minimize the pain. The next day, I woke up and felt terrible. I was shivering, had a fever of 101.3, and had body aches all over my body. Flu-like symptoms.
Received 1 Pfizer COVID-19 dose and 3 Moderna COVID-19 doses; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 1 Pfizer COVID-19 dose and 3 Moderna COVID-19 doses) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M2A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Opioid abuse.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 1 Pfizer COVID-19 dose and 3 Moderna COVID-19 doses). At the time of the report, EXTRA DOSE ADMINISTERED (Received 1 Pfizer COVID-19 dose and 3 Moderna COVID-19 doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.No concomitant medications were reported. The reporter stated that the patient had no symptoms.      This case was linked to US-MODERNATX, INC.-MOD-2021-043143 (E2B Linked Report).; Sender's Comments: This report refers to a case of extra doses administered for mRNA-1273, lot #unknown with no associated AEs. US-MODERNATX, INC.-MOD-2021-043143:Crosslinked with patient 1 case (MOD21-052704)
Cellulitis at injection site 6cm x 7cm (left arm). Being treated with BACTRIM.
Patient had symptoms of bradycardia immediately with Heart rate going from 166 to 140 BPM. He also experienced desaturation on 09/28 at 2100.
Patient received first dose of H1N1 on 10/29/2009 and a second on 11/03/2009.
Pt noted rash on arms and back at 22:30 on 10/12/00, post vax. Took Benadryl. On 10/13/00, after eating seafood at 20:30, developed numbness in his tongue, tightness of his throat and hives on his neck. Treated at ER and given Benadryl, epinephrine and prednisone.
Received shot - mother states child c/o pain initially and conts to c/o pain on arm at the site. No redness or swelling - Mother is taking child to doctor for evaluation.
Tested positive for covid after 1st dose received on 03Jan2021; Tested positive for covid after 1st dose received on 03Jan2021; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 18th of 20 reports.  A patient of unspecified age and gender receive the first dose bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 03Jan2020 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient was tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for the virus (COVID-19) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
chills; very tired; fever; body aches; itchy at the injection site; Top of her lip is numb; light headed/ dizziness; feels like blisters in the bottom of her lip; feels itchy in the bottom of her lip; felt like she had flu; hot at the injection site; injection site was swollen; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site), CHILLS (chills), FATIGUE (very tired) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site). On 16-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (very tired), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), DIZZINESS (light headed/ dizziness), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 17-Apr-2021, VACCINATION SITE SWELLING (injection site was swollen), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE WARMTH (hot at the injection site) had resolved. On 18-Apr-2021, CHILLS (chills), PYREXIA (fever), MYALGIA (body aches), VACCINATION SITE PRURITUS (itchy at the injection site), HYPOAESTHESIA ORAL (Top of her lip is numb), ORAL MUCOSAL BLISTERING (feels like blisters in the bottom of her lip), PRURITUS (feels itchy in the bottom of her lip) and INFLUENZA LIKE ILLNESS (felt like she had flu) had resolved. At the time of the report, FATIGUE (very tired) and DIZZINESS (light headed/ dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided .   This case was linked to MOD-2021-080834 (Patient Link).
chills; fever; nausea; dry heaves; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020 10:00, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd March 2020 21:30, 11 hrs 30 min after receiving Shingrix, the patient experienced chills and fever. In March 2020, the patient experienced nausea, dry heaves and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, fever, nausea, dry heaves and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, nausea, dry heaves and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient received 2nd dose of Shingrix around 10 am on day before reporting. Around 9:30 PM she started having chills and a fever. Around 1 AM, 15 hrs. after vaccination the patient started having nausea with dry heaves, and ton day of reporting, she has a headache. She took her temperature about 2 hours after having Tylenol and she had a fever of 100.1 degree Fahrenheit. The reporter consented to follow up. The outcome of the events were reported as not recovered/not resolved in the database however in source document, it was mentioned as recovering/resolving, so kept as reported in database.
Moderna Covid vaccine was wrongly given to person under 18 years old (patient was 17 years old at the time)
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot number M023718, expiration date 09-AUG-2018, lot number M031574, expiration date 11-NOV-2018, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008038: US-009507513-1702USA005634: US-009507513-1702USA008035: US-009507513-1702USA008036:
Around July 21st I had pain on my upper right back/shoulder. It was localized to one general area. I thought I had maybe pulled a muscle while sleeping somehow. The pain was bad enough that I had trouble sleeping for 2 nights. Then a few days later around July 25th I realized my back was itching, and I discovered two red/itchy/hot spots on my back halfway down on my right side. I though they were maybe bug bites and hoped they would resolve on their own. On July 26th in the  evening they hadn't improved  and I also realized that my lymph node on that right side at the base of my armpit was swollen enough I could feel it. The next morning I went to urgent care. They diagnosed it as shingles  due to the appearance of the spots - the larger one had small blisters, and  they were all on one side of my body and they were also painful. And I had chickenpox as a small child.
Unsure if related to vaccine lowering immunity but came down with  shingles on the left side of my face three weeks after my second vaccine.  Thought I should report just in case.
Left arm had a small 1/2 dime size area that was hard. No redness, no swelling and no pain. Have mother continue to monitor.
Abnormal thought process; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW 0172), via an unspecified route, administered in left arm on 20May2021 at 08:15 (at the age of 26-year-old) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), depression and anxiety. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8736), via an unspecified route, administered in left arm on 28Apr2021 at 10:00 (at the age of 26-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other medications the patient within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 12:00, the patient had abnormal thought process. The events were reported as non serious. The outcome was not recovered for the reported event.  No follow-up attempts are possible. No further information is expected.
patient received second dose 3 days after first; patient received second dose 3 days after first; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 3 days after first) and INTENTIONAL PRODUCT USE ISSUE (patient received second dose 3 days after first) in a male 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 (No relevant medical history provided).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 3 days after first) and INTENTIONAL PRODUCT USE ISSUE (patient received second dose 3 days after first). On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 3 days after first) and INTENTIONAL PRODUCT USE ISSUE (patient received second dose 3 days after first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
Information has been received from a registered nurse concerning an 85 year old male with no allergies or drug reactions, with anemia and chronic kidney disease who on 24-FEB-2011, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular in the left deltoid (lot number 667915/1111Z, exp. 02-MAR-2012). Concomitant therapy included ascorbic acid/vitamin B complex, amiodarone, darbepoetin alfa, LASIX, ferrous SO4, SYNTHROID, lidocaine, nystatin, omeprazole (MSD) and simvastatin (MSD). Two weeks after the PNEUMOVAX 23 injection (on approximately 10-MAR-2011), the patient developed "a knot" in this left biceps muscle. Also was reported than on 24-MAR-2011, the nurse saw the patient and the "knot" was smaller than a ping-pong ball, and the knot was without redness or drainage. It was noted no laboratories were performed. It was reported that the patient did not receive treatment for the event. At the time of the report the patient was recovering. Follow up information has been received from the registered nurse who reported that the retired patient on the afternoon at 14:01 of 24-FEB-2011, was vaccinated with a second dose of PNEUMOVAX 23, intramuscular in the left deltoid (lot number 667915/1111Z, exp. 02-MAR-2012). On 24-MAR-2011, the patient complained of knot on left bicep decreasing in size. The patient questioned if knot was due to PNEUMOVAX 23 administered on 24-FEB-2011. The patient did not seek medical attention. Additional information is not expected.
Cough, fever, throwing up, wheezing, chest tightness, runny nose.
Unable to breathe deeply - albuterol inhaler was not helpful. Started aching in joints and unable to move. I took 800mg MOTRIN and symptoms got better. This lasted 24-36 hrs.
mom reports onset of fever 102-103 on tuesday 20MAY eveniing 7:00 pt exp lethargy on 21MAY & rash, swelling, inflammation, approx 3" x 5" @ site of inj;mom called MD;
Arm ache; body aches; fever; This is a spontaneous report received from a contactable consumer or other non-healthcare professional. A 22-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), via an unspecified route of administration on 07May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on unknown date as dose 1, single for COVID-19 immunisation. The patient experienced arm ache, body aches, fever on an unspecified date. The outcome of the events was reported as recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant refers 7 unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-DEC-2016, the patients were vaccinated with improperly stored VARIVAX (lot # L046888, expiry date: 23-NOV-2017) for prophylaxis. Medical assistant reported that the product underwent temperature excursion at 34.0F for 3 hours. No data logger was involved. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
magnet sticking to injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (magnet sticking to injection site) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (magnet sticking to injection site). At the time of the report, VACCINATION SITE REACTION (magnet sticking to injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (The patient have allergy towards Clindamycin.).    On 25-Jan-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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18 Jun 2021 contains Non significant information.
Screaming since 11 PM on 9/27/05. no fever, no reaction at site.
Patient was given 3rd dose of primary series of Covid Moderna (6months- 5 years) instead of dose of Moderna Covid Bivalent. No adverse symptoms noted after administration.
I developed a surface blood clot in my right leg after receiving the second Covid shot.  I am a healthy non-smoker.  I noticed the clot the morning after I received the second Covid shot.
Canker Sores; Intermittent Headache; Intermittent fatigue; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL3248; expiration date not reported), via an unspecified route (administered on left arm) at the age of 61-years-old on 27Jan2021 02:00 PM as single dose for COVID-19 immunization. Medical history included hypertension and sulfonamide allergy (Allergies: Sulfur-based) both from an unknown date and unknown if ongoing. The patient reported unspecified concomitant medications. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient experienced canker sores, intermittent headache and intermittent fatigue on 27Jan2021 16:00. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Excessive Urination, Felt like the start of a UTI.  Pain lasted 1 day however severe urination continues
Reporting as patient has completed Moderna vaccine series and was admitted to the hospital with diagnosis of "pneumonia due to COVID-19 virus"
Spoke with patient's mom on 1/22, she said last time when the patient had the vaccine (1st dose), pt has mild temperature and sore arm only. But this time, she said the night of 1/21, pt had fever 103 and was very tired. He also had diarrhea.
p/taking 2nd capsule devel stomache cramps & nausea; This occurred 5 hrs p/taking the Typhoid vax; no fever; this persisted for 48 hrs;
Acute respiratory failure with hypoxia  Pneumonia due to COVID-19 virus Patient was treated with Covid medications including convalescent plasma, remdesivir and dexamethasone. Patient is able to wean off oxygen, currently requiring a minimal amount of oxygen support with exertion. Patient will complete antibiotic course
Patient felt dizzy and nauseous and feverish she was sweating. Patient described that she felt she was having "hot flashes".
Tongue thickening  after 10 minutes and resolved after 2 rounds of epinephrine 5 minutes apart. Refused transport to ER. Husband took home. Had a epi- pen. Last reaction as teenager to mold.
At 07:38, BP-60/40 with profuse diaphoresis. Had syncope X 2 and left arm was swollen and red. Pulse 80 and weak (had collapsed 2 time during the night). At 07:40, BP-76/39, lethargic, pale and diaphoretic. IV fluids and O2 on transport to the hospital. BP was 112/70. Pt was given IV Rocephin in the hospital. He had arm cellulitis and axilla was hard. On 6/15/01, BP was normal. Warm compresses applied to left arm. Continues to be tired.
12 hours post-dose woke up with chills, fever, headache, full body aches, injection arm swollen, red, and painful