chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine  was not applicable. The outcome of sore arm at injection site was not reported. This report was non-serious.
Local arm pain close to injection site, dizziness, back pain close to elbow to the head, dirrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting, tiredness. Still experiencing adverse effects.
Right after giving injections, but before pulling out needle, I noticed area right around injection site swelling. Pt said it did not hurt. I also had other pharmacist on duty look at it. We called the local urgent care they recommended ice and BENADRYL. Pt stayed in pharmacy waiting room about 20 minutes - swelling reduced considerably.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: she is scared of needles and has history of dizziness after a blood withdrawl or after administration of a shot and didnt inform about it before administration of covid vaccine.she was little dizzy,laid her head over the chair for few seconds, but didnt loose consciousness-she is alert,blood pressure was normal-15/80mm Hg.we reached out to emergency services but we never used them as she is alright by then. called the pharmacy back after reaching home.
Post Covid-19 vaccine (1st dose) to L Deltoid at 12:15. 12:30 Patient with c/o "dizzy, heart racing" Patient transferred to wheel chair by staff, team lead and BP taken to LUA 191/78 73 and O2 sat 00% ra. Patient given sips of water and BP retaken at 12:33 154/75 62 Patient stated that she normally has high BP however, she has taken her morning metoprolol. 12:38 Patient stated she started to feel better and requested back to be raised, BP 152/85 70. At 12:40 patient informs staff that she is feeling better and wanting to stand and ready to go. Team lead notice patient unstable gait and patient verbalized being dizzy and jittery. Patient return to clinic sitting back down in wheel chair. Patient called to daughter to inform her of her condition and meet at clinic. Team lead attempted without success to encourage patient to be evaluated in ER with transport by EMS. Patient agreed to be evaluated in ED and daughter to transport. BP upon discharge from clinic was 166/89 60 with c/o head ache.
Headaches for 4 days Over the counter medicine did not help Overall body aches for four days over the counter medicine did not help with that either
I26.99 ACUTE PULMONARY EMBOLISM 4/26/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA R09.02 HYPOXIA 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA I26.99 ACUTE PULMONARY EMBOLISM 4/26/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA R09.02 HYPOXIA 3/30/2022 ADULT T-CELL LEUKEMIA W LYMPHOMA
Swelling/redness at site of vaccination in left deltoid. Pt noted pain to shoulder and left claviate/upper chest on 5/24/03. Local erythematous induration at site of vaccination only.
1 of 2 pts who exp an adverse event following vax; pt recv vax 13SEP94 & was irritable & had a low grade fever; 15SEP DTAP site was red & swollen (6"x12") & warm to touch; tx w/ice; APAP given 16SEP MD visit-pt recovered;
Two weeks after booster, she started itching all over body; Two weeks after booster she had hives all over the body; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Two weeks after booster, she started itching all over body) and URTICARIA (Two weeks after booster she had hives all over the body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 031L20A and 034K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced PRURITUS (Two weeks after booster, she started itching all over body) and URTICARIA (Two weeks after booster she had hives all over the body). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) for Pruritus and Hives, at an unspecified dose and frequency. At the time of the report, PRURITUS (Two weeks after booster, she started itching all over body) and URTICARIA (Two weeks after booster she had hives all over the body) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient does not have any history of skin allergy . The  concomitant medications on use were not provided.  Patient visited a doctor and received Allegra 24 hour prescription medication.The symptoms were improving from 16-Dec-2021, hives was fading and the itching was better.
A pharmacist reported that a pt attending a health fair received an injection of Flu Shield. On 10/24/99. The next day, the pt developed an injection site reaction characterized by an area of redness, swelling and warmth up to six inches in diameter. She was treated with diphenhydramine  and applications of ice; She recovered. The reporter states that 6 pt's experienced this event; however, only one could be identified. All pt's were treated with diphenhydramine and applications of ice and all pt's recovered.
Patient experienced lightheadedness about 5 minutes following vaccination. Became warm and began sweating. Patient proceeded to faint for about 3 seconds and came to. Patient was slightly disorientated after fainting but soon recognized time and place. Patient placed his head in between his legs for several minutes. Patient rested in waiting area and was given water and peanut butter crackers. After a roughly 40 minute waiting period, patient felt okay to leave the premise.
AM - 10/6/10 - nausea; stomach griping - 1pm had BM - then diarrhea started and passing blood and continuing to have severe lower abdominal pain, blood went from red to burgundy color. 11pm - continuing to pass flatus. 10/17/2010 Continue with steady abdominal pain - 10/18/2010 still had abdominal pain - 10/19/10 Continues to pass blood (burgundy) in stool. Pt had colonoscopy 7/2010 and Barium Enema 9/2010 - which were negative. H/o GERD, HTN, Arthritis.
Dizziness; Flu- like symptoms; Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and FATIGUE (Tiredness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided  No treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: follow up received on 31st march 2021 contains no new information; 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.
Dizziness, back ache, soreness at sight of admin. Redness at sight, diarrhea.
Vial is approved for storage at room temperature for up to 12 hours. The vial was stored at room temperature for 24 hours before the dose was administered.
She has slight swelling to the left axilla to the left side of the breast. No heat warmth or redness. The area is tender.
LACK OF SMELL; LACK OF TASTE; NAUSEA; VOMITING; SEVERE METALLIC TASTE; This spontaneous report received from a patient concerned a 35 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, rare form of gout, and immunocompromised due to chemotherapy infusions., and other pre-existing medical conditions included atromyocin allergy. The patient experienced drug allergy when treated with vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced severe metallic taste. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced lack of smell. On 08-APR-2021, the subject experienced lack of taste. Treatment medications (dates unspecified) included: ondansetron hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 07-APR-2021, and severe metallic taste on 08-APR-2021, and had not recovered from lack of smell, and lack of taste. This report was non-serious.
t101.2 & cried non stop for 5hr;saw MD in ER that evening;
Presents for COVID; states tested positive/diagnosed x1 wk PTA. Sx include fever, fatigue, cough, sore throat, chest congestion, SOB. RA sat 83%. Admit for pneumonia due to COVID w/hypoxia. Tx: O2 via NC, dexamethasone, zinc, vit c, abx, remdesivir. DC to home on O2.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar event for 14 patients. This is 12th of fourteen reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 as reporter/drug/event, different patient.
Redness and swelling and pain of right delt. and arm from shoulder to elbow.
Redness, swelling, itching to left deltoid.  Symptoms started 12-18 hours after vaccine administered.
Narrative:  COVID infection after completion of COVID vaccine series: 03/29/2021 COVID vaccine dose #1 04/26/2021 COVID vaccine dose #2 07/13/2021 Pt reported onset of cough, fatigue, loss of sense of smell, myalgia, and sore throat 07/14/2021 COVID positive per nasopharyngeal swab 07/15 2021 Pt reported no change in condition 07/16/2021 Pt reported improvement in sx 07/17/2021 Pt reported getting fatigued easily. Infrequent continuation of cough and rhinorrhea. 07/18/2021 Pt reported onset of HA 07/20/2021 Pt reported continuation of sx. Cough has become more frequent and accompanied by wheezing. Requested albuterol. 07/22/2021 Pt reported improvement of sx with use of albuterol. Had low BP earlier in the day. 07/22/2021 Clinical resolution of COVID infection (per CDC self-isolation guidelines) 07/26/2021 Pt reported continuation of dry cough. Requested speaking with PCP. Prescribed albuterol, APAP, DM/guaifenesin, and throat lozenges. 07/28/2021 Pt c/o consistent cough. Concerned he "now has bronchial infection." Advised to seek emergency medical care for any SOB/CP.
Patient had influenza vaccine on 10/02 on right arm. She then had a Pfizer COVID-19 dose #3 booster vaccine on right arm on 10/05. Mostly painless swelling of right axillary lymph nodes. No systemic side effects. - She was advised to take Advil 600 mg TID with food and ice/cool compresses. - She had a video visit on 10/07 and followed up in the office on 10/08.
Dizzy, Light Headed; Elevated Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy, Light Headed) and HEART RATE INCREASED (Elevated Heart Beat) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy partial (Right side of thyroid removed for cancer treatment) on 03-Mar-2021. Previously administered products included for an unreported indication: Cemotherapy (November/December of 2020) in 2020.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizzy, Light Headed) and HEART RATE INCREASED (Elevated Heart Beat). On 26-Mar-2021, DIZZINESS (Dizzy, Light Headed) and HEART RATE INCREASED (Elevated Heart Beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
5/29/09 COMPLAINED OF HEADACHE, LEG WEAKNESS, HIP JOINT PAIN, EYE PAIN UNTIL 5/31/09.  SORE THROAT AND CONGESTION 5/30/09-5/31/09. IBUPROFEN ONLY.
severe h/a & fever for 2-3 days;sore back of neck for several (203 days);c/o leg pain for 2-3 days bilaterally;sore inj site for 2-3 days;vomiting x 1 day;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015 06:45, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 9.8 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Vaccines given on Monday, July 18, 4:48pm. Next day felt "yucky". Tuesday evening arm red, painful, swollen. Wed pm LA much more swollen, red, hot, only painful when pressed on. Seen in office today, July 21, 2016, "much less red and swollen,",  per mother. Redness (L) arm measures 13.5cmx 11cm with induration
The first symptom was a pounding headache which got progressively worse and was also the longest lasting symptom. Fever of 102.5 degrees. Fever lasted approximately 12 hours, and included heavy chills and sweating. Extreme fatigue, weakness, and dizziness. Metallic taste in mouth. Body aches, and especially soreness in the left arm (injection site). Loss of appetite. By 24 hours after the vaccine injection, almost all symptoms were gone, but soreness in left arm persisted. About 26 hours after the vaccine, I had extreme acid reflux which lasted a few hours. In the two days since the vaccine I've experienced a ringing in my left ear.
16 yo patient was given a dose of shingrix; was given a dose of Shingrix instead of varicella vaccine; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 16-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The reporter stated that a 16 year old patient was given a dose of Shingrix instead of varicella vaccine. No other details were shared. The reporter consented to follow up. Additional Supportive Information: A 16-year-old patient was given a dose of Shingrix instead of varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
After my second Shingrix shot I got very ill, worse than the first time. I had shivering, upset stomach, body aches, throwing up, terrible headache starting about 6 hours after the shot. The next day still had terrible shivering, upset stomach, stomach cramps and headache worsened. Day 3 I have body aches and a terrible headache with lessened stomach issues.
First: Chills (severe) for 1 day; second: chills & slight fever; third: extreme exhaustion/tiredness; fourth: brain fog/wooziness.
heart racing & erratic; heart racing & erratic; urinated 7 times in 1 hour; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EL9261, Expiration Date: 31May2021) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pituitary Addinson's Disease", start date: Sep2016 (ongoing); "Stercotactic Radiosurgery at Emory of Pituitary Tumor", start date: 14May2015, stop date: 14May2015, notes: for Pituitary Addinson's Disease; "Heart Bypass surgery", start date: 08Dec2009, stop date: 08Dec2009; "blood pressure increased" (ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure increased, start date: 1995 (ongoing); AMLODIPINE taken for blood pressure increased, start date: 1994 (ongoing); LEVOTHYROXINE, start date: 2016 (ongoing); HYDROCORTISONE, start date: 2016 (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] (ongoing); FISH OIL (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); VITAMIN D [COLECALCIFEROL] (ongoing); CALCIUM (ongoing); ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID] (ongoing); MAGNESIUM (ongoing); MIRALAX (ongoing); METAMUCIL [PLANTAGO OVATA] (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EL1283 , EXP 30Apr2021, Anatomical Location: Arm Left), administration date: 16Jan2021, when the patient was 76 years old, for Covid-19 Immunisation, reaction(s): "heart racing and erratic", "urinated 9 times in the next hour". The following information was reported: PALPITATIONS (non-serious), HEART RATE IRREGULAR (non-serious) all with onset 13Feb2021 07:00, outcome "unknown" and all described as "heart racing & erratic"; POLLAKIURIA (non-serious) with onset 13Feb2021 07:00, outcome "unknown", described as "urinated 7 times in 1 hour".  Additional Information: The patient was vaccinated in a hospital. The patient also took multivitamin as a concomitant therapy. Events did not result to doctor or other healthcare professional office/clinic and emergency room visit. It was also reported that the patient took antipyretic 3 days before the second dose.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site soreness for 2 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025120-2A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness for 2 days). In February 2021, VACCINATION SITE PAIN (injection site soreness for 2 days) had resolved. Concomitant drugs were not reported. Treatment details were not given. This case was linked to MOD-2022-526433, MOD-2022-526483 (Patient Link).
Headache Fever, achy,redness at injection site, swollen lymp nodes, itching Narrative:
Patient was showering with her husband 6 days after he received his smallpox vaccination when water from his injection site splashed in patients right eye. Within 10 minutes of water hitting my eye it began to swell. At that time called the CDC and their on call provider. Resolved with hot/cold compresses follow up with provider. Swelling is now gone.
Fever, joint pain, headaches, fatigue, stomach issues (nausea, diarrhea), body aches
Vaccine administered 10:00 AM. Became itchy around 3:00 PM and developed welt on abdomen. Around 5:00 PM, she went to ER when she developed tongue swelling. Has history of 5 throat closures due to bee stings and other allergies. Received Albuterol, Prednisone and Benadryl from ER visit. Discharged without further complications 12/14/05.