chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented for an initial dose of her COVID-19 vaccine. I administered the 0.5 mL dose in her left arm at 1551. I recommended that the pt stay in our seating area for observation after administration. She said she was going to walk around the store with her son.  She returned at about 1611 stating that she was having difficulty breathing and just felt like she was having a reaction. She also mentioned that she had a metal taste in her mouth. I immediately had her sit in a chair located in front of the pharmacy and informed my pharmacy manager. I went out to her with my immunization cart in hand. She was seeming flustered or overwhelmed, face was flushed, eyes were glossy. I got the BP cuff and checked her blood pressure which was elevated at 155/108 with a heart rate of 95. I gave her a water and asked her to stay and sit for bit, at least 5 mins to recheck her BP. She kept saying she was feeling better, however I insisted she continue to sit. Moments later, she told me her tongue was swelling and had the metal taste in her mouth again. D/t the tongue swelling, I administered 50 mg of Benadryl at 1623 and relocated her to the observation area for additional privacy. She said she was feeling nauseous, so I gave her the garbage bin, just in case. I grabbed her another water to sip from. After about 10 mins or so, I checked her BP again, which still remained elevated at 155/108 with a HR of 90. I checked her tongue and it appeared normal, no visible swelling. Her son who was with her said it looked normal too. After a few mins, she said she was feeling much better and was ready to go home. At this point, it was almost 1 hour, post vaccine administration. Pt left with her son who is an EMT and said he would keep a close eye on her. They have benadryl at home. Pt also stated she would not be getting the booster dose of the vaccine after I recommended speaking with her PCP about getting it in a facility better equipped to handle anaphylaxis.
On 03/25/15 client called the health department to report having swollen lymph nodes, sore muscles, fatigue. Denied having a fever, airway compromise, or hives/rash. Stated he had a runny nose on Monday. Client went backcountry skiing all day 03/24/15. Client asked PHN about going to a concert tonight and drinking. Client encouraged to rest, take Motrin and rehydrate. Instructed client to call Dr if symptoms worsen. On 03/26/15 client went to urgent care. Per medical records he had negative mono and strep tests and 3+ tonsils with white exudates. Urgent care diagnosis: tonsillitis and possible vaccine reaction. Client was given prednisone taper and ibuprofen. On 03/29/15 client to ER. Per records from this visit, client had a fever of 38.1, airway patent and open, breathing spontaneous and non labored, no evidence or symptoms to suggest allergic reaction. Diagnosis from ER: Tonsillitis. Client given Augumentin. On 04/03/15 client's mom called health department to report continued symptoms and ER/urgent care visits, stating that she had read that tonsillitis was a rare adverse event from typhoid vaccine. Per client's mom, steroids and antibiotics "have not helped." Mom states that client can swallow better, but tonsils and throat "visible looks the same." Client's mom denied client having trouble breathing. Mom also stated that client had had a severe headache after vaccinations and still had occasional headaches. Client took Tylenol for severe headache and mom reported that it helped. Mom also reported that client's tongue was swollen. Client was called this same day by PHN to check in. Client was encouraged to finish antibiotics to fight off tonsil infection. Client denied having trouble breathing and stated his throat and tonsils felt the same. Client encouraged to call primary care physician/urgent care or seek medical help if infection worsens or if it does not improve after finishing antibiotics.
I had large red, swollen, itchy spot at the injection site. The tingling when down my arm. These symptoms are still ongoing. I email my doctor about this. They gave me a prescription for it.
This spontaneous report was received from a pharmacist via a company representative and refers to a 72 year old female patient. The patient had a history of seizures. On 21-APR-2015, the patient was vaccinated with ZOSTAVAX (dose, frequency not provided). No concomitant therapy was reported. On 23-APR-2015, the patient developed a headache. On 26-APR-2015, the patient went to the emergency room because she was having a seizure (medically significant). Patient sought medical attention-she called the pharmacist. She was not admitted to the hospital. The outcome of the events was reported as recovered, as of 27-APR-2015. Causality assessment was not provided. No product quality issue was involved. Upon internal review, event seizure was considered to be medically significant. Additional information has been requested.
Underdose; Boostrix administered to 15 months old; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 14-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 237ZH, expiry date unknown) for prophylaxis.   On 11th October 2022, the patient received Boostrix. On 11th October 2022, unknown after receiving Boostrix, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 10-Nov-2022 Reporter's comment:  The call was from licensed practical nurse. The nurse reported that the 15-month old patient was administered with Boostrix.  The reporter consented to follow up. Additional Supportive Information: The 15 month old patient was administered with Boostrix which led to underdose and inappropriate age at vaccine administration.
had a headache all night long. It was a numbing chilling kind of headache, almost like brain freeze.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 16Mar2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 20:30, the night of the vaccine, the patient had a headache all night long. It was a numbing chilling kind of headache, almost like brain freeze. It was pretty constant through the night. Now it was two weeks later and she was still getting moments of these headaches coming and going. They did not feel like ordinary headaches. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the headache occurring. The clinical outcome of the event headache occurring was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Approximately 24 hours following SHINGRIX administration at a pharmacy, the patient had confusion, global weakness for several hours. Went to sleep as usual without seeking care that night, followed up in clinic the following day and felt normal. Normal neurologic exam and vitals the day of clinic visit (10/29). Mild erythema and tenderness in right arm injection site.
fussy x 5 days crying a lot; appetite loss; doesn't want to nurse but hungry; cried & jerks arms which hasn't done a/; wakes up cries-didn't do prev; t102 x 2 days;
At 2:30AM after immunization patient experienced stiff neck, chills, site of ZOSTAVAX injection was raw and oozing clear fluid. Patient developed a 100 temp fever. Took MOTRIN resolved the temp.
RN  vaccinated client approximately 1505 and immediately noticed client turn pale and client stated "I feel dizzy". RN signaled RN  to bring anti-gravity chair. PHN  joined at 1506. Client was able to transfer herself into anti-gravity chair. PHN  took vitals at 1506: blood pressure 122/82, pulse 94, oxygen sat 99%. RN  brought client water. Client stated dizziness was improving at 1508. Client's Mother present and stated client had not ate or drank water all day. Client reported being nervous, but did not share information with RN. Client reported no relevant medical history, no medications and no allergies. RN gave client snack and water. Vitals at 1511: blood pressure 120/86, pulse 95, oxygen sat 99%. Vitals at 1516: blood pressure 110/80, pulse 93, oxygen sat 100%. Vitals at 1521: blood pressure 114/84, pulse 89, oxygen sat 99%. Last vitals at 1533: blood pressure 120/80, pulse 88, oxygen sat 100%. Per client dizziness has resolved. PHN advised client to follow up with provider and gave ER precautions. PHN asked client to stand from chair and take a few steps to assess for gait and dizziness. Client stated "feeling fine". Mother would drive client home. Client left facility with steady gait at 1535.
Feels nauseous; Site is swollen; Site is hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Site is hard), NAUSEA (Feels nauseous) and VACCINATION SITE SWELLING (Site is swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, EZETIMIBE and LOSARTAN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Site is hard) and VACCINATION SITE SWELLING (Site is swollen). On 17-Mar-2021, the patient experienced NAUSEA (Feels nauseous). At the time of the report, VACCINATION SITE INDURATION (Site is hard), NAUSEA (Feels nauseous) and VACCINATION SITE SWELLING (Site is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner and blood pressure medicine.  No treatment information was provided.
Patient developed macular, erythematous, burning rash of the neck, trunk, and extremities about 10 hours after the vaccine.  No urticaria.  No wheezing.  No oral or ocular lesions.  No GI or GU symptoms.  No fever.  No myalgia.  No fatigue.
vomiting; Headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 12:30 (Lot number: 33130BA) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Dysphonia" (unspecified if ongoing); "Vertigo (vestibular disorder)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: dilantin, reaction(s): "Known allergies: Dilantin"; Known allergies: venlafaxine, reaction(s): "Known allergies: Venlafaxine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 17Dec2021 02:30, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset 17Dec2021 02:30, outcome "unknown", described as "Headache"; DIZZINESS (non-serious) with onset 17Dec2021 02:30, outcome "unknown", described as "dizziness". Therapeutic measures were not taken as a result of vomiting, headache, dizziness.  Additional information: Patient was not received other vaccine in four-weeks. The patient did not receive any other medications in two-weeks. Patient was not diagnosed with covid-19 prior to vaccination. The patient not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Chest pain; Pins and needles in the arm of the vaccination; Quivers in the heart and rapid beating sounded like a-fib; Soreness in arm of vaccination; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), PARAESTHESIA (Pins and needles in the arm of the vaccination), HEART RATE IRREGULAR (Quivers in the heart and rapid beating sounded like a-fib) and VACCINATION SITE PAIN (Soreness in arm of vaccination) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), PARAESTHESIA (Pins and needles in the arm of the vaccination), HEART RATE IRREGULAR (Quivers in the heart and rapid beating sounded like a-fib) and VACCINATION SITE PAIN (Soreness in arm of vaccination). On 05-Feb-2021, PARAESTHESIA (Pins and needles in the arm of the vaccination) had resolved. At the time of the report, CHEST PAIN (Chest pain), HEART RATE IRREGULAR (Quivers in the heart and rapid beating sounded like a-fib) and VACCINATION SITE PAIN (Soreness in arm of vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 02-Feb-2021, patient had electrocardiogram lab test with normal range. Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.
like a metallic taste; feels like he had a bad cold; coughs; still has no taste and it has been 2 weeks; got a real nasty taste down deep/fells like it is coming out of throat/ lungs; does not feel that great; a sore arm; headache; felt like he had the flu but was not throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), DYSGEUSIA (like a metallic taste), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs) and AGEUSIA (still has no taste and it has been 2 weeks) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZHA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache). On 01-Apr-2021, the patient experienced DYSGEUSIA (like a metallic taste), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs), AGEUSIA (still has no taste and it has been 2 weeks), TASTE DISORDER (got a real nasty taste down deep/fells like it is coming out of throat/ lungs) and MALAISE (does not feel that great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu but was not throwing up), NASOPHARYNGITIS (feels like he had a bad cold), COUGH (coughs) and PAIN IN EXTREMITY (a sore arm) outcome was unknown, DYSGEUSIA (like a metallic taste), AGEUSIA (still has no taste and it has been 2 weeks) and MALAISE (does not feel that great) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not take any concomitant medications. Treatment also included unspecified mucus release pills.
Sore throat for two days. My on-line doctor visit recommended that I complete this form. Will treat with ibuprofen for 3 days and follow up with doctor.
Went black, did not loose consciousnes, but hit the head on the tiles; Hit head on the tiles; Woke up and could not even walk; Heart was in a fast heartbeat; Weakness; Slept whole day; Dizziness; Tired; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immune disorder (NOS) and Knee surgery NOS in 2019. Concurrent medical conditions included Macular degeneration. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3, MAGNESIUM and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced FEELING COLD (Freezing) and FATIGUE (Tired). On 22-Mar-2021, the patient experienced SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) (seriousness criterion medically significant), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day) and DIZZINESS (Dizziness). At the time of the report, SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), FEELING COLD (Freezing), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day), DIZZINESS (Dizziness) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-056437 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-056437:Crosslinked case
chills; temperature (38.6C (101.5F); headaches; This is a spontaneous report from contactable consumer. This 54-year-old female consumer (patient) reported that: A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 2 via an unspecified route of administration in arm left on 09Feb2021 09:30 AM (age at vaccination was 54-year-old), as dose 2, single dose for covid-19 immunisation. The patient had no known allergies. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications in two weeks were vitamins and food supplements. The patient had no other medical history. The patient concomitant medications were not reported. The patient historical vaccine includes received the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3247 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 19Jan2021 11:15 AM, as dose 1, single dose for covid-19 immunisation. 12h after the second shot, on 09Feb2021 09:30 AM, patient experienced chills, temperature (38.6c (101.5f) and headaches. The patient underwent lab tests and procedures which included body temperature: 101.5 Fahrenheit on 09Feb2021 temperature (38.6C (101.5F). No treatment received for the events. Outcome of the events was not recovered.  Information on the lot batch number has been requested.  Follow-up attempts completed. No further information expected.
DIZZINESS, WEAK, FINGERS/LIPS TINGLING. PARAMETIC CAME, SYMPTOMS IMPROVED, REFUSED TRANSPORT, DRIVEN HOME BY DAUTHER.
Expired Vaccine used; inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-400101, MOD-2021-400101 (Patient Link).
Soreness, Redness, inflammation at injection site and body aches (so severe that patient cannot get out of bed).
Had 2nd COVID vaccine at a retail pharmacy on 3/3/21.  On 3/12/21, present to our hospital ER after an unresponsive episode at home.  Patient has a recent diagnosis metastatic adenocarcinoma.  She had a pancreatic stent placed 3/10/21, minimal intake since that time.  Hypotensive on admission, hemoccult positive, received IV fluids and blood.  Decision to be comfort care, hospice consult.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU, intradermally (dose, anatomical location, lot# and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MRK) intradermally (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date (reported as afterwards the vaccination), the patient did have a bit of redness at the injection site, but it looked to be getting better (at the time of the report). The relatedness between the event and therapy with ZOSTAVAX and sterile diluent (MRK) was not reported.