chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 71 year old female patient concerning herself. Patient's medical history included psoriasis. None drug reactions or allergies were reported. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were not reported). Other suspect therapy included influenza virus vaccine (manufacturer unspecified) also reported as "FLU shot" (dose, frequency, route of administration, lot # and indication were not provided) administered on the same day. Concomitant therapies included LEXAPRO and SYNTHROID. On 08-JAN-2015, the patient developed injection site reaction and she experienced muscle and joint pain. The patient stated that she was uncomfortable, tingly (no further specified by the reporter) and hot (no further specified by the reporter). She had a fever as well. The patient sought medical attention during a scheduled office visit and received a treatment which included prednisone (manufacturer unspecified) and KEFLEX. Unspecified laboratory and diagnostics tests were performed on an unknown date. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and ZOSTAVAX was not assessed by the reporter. Additional information is not expected, as no contact details were provided by the reporter.
After I received the first dose of the COVID-19 Moderna vaccine on 8/2/21 I began to experience hip pain, extreme headaches, inability to leave my bed, insomnia, hot/cold flashes, and restlessness. On 8/11/21 after my symptoms went away gradually I began to get a red hot rash on the injection site it was swollen and hurt more than words can describe. On 8/30/21 I received the second dose of the COVID-19 Moderna vaccine and the symptoms were even worse than the first shot. I got an extreme headache for days and began to hear water faucets in my ears causing me to collapse. I was unable to move at all without being super dizzy and seeing black. My eyes began to see white flashes and I was diagnosed with Vestibular Neuritis as a side effect from the vaccine. I was then put on a steroid and anti vertigo medication to combat the Vestibular Neuritis and upon finishing the medicine I began to feel somewhat normal. After the second dose I noticed intermittent lower abdominal pain and on 10/6/21 I began having a headache that was exactly like the headaches I got after each dose of the COVID-19 Moderna vaccine. The headaches felt like I had water between my brain and skull. This particular headache lasted for four days then turned into spinal pain. My spine and ribs could not be touched or they would cause excruciating pain to be felt. My primary care provider ordered a blood test to be done and the D-DIMER was elevated at a 603. Which I was told is indicative of blood clots present in my body. I will now be getting an ultrasound of my lower abdomen and a ct scan of my brain to rule out clots in those areas.
Hypersensitivity reaction; raised; hot to touch; Itchy "like poison ivy"; rash at injection site 4 x 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), RASH PAPULAR (raised), VACCINATION SITE WARMTH (hot to touch), PRURITUS (Itchy "like poison ivy") and INJECTION SITE RASH (rash at injection site 4 x 3 inches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Drug allergy (zosyn).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced RASH PAPULAR (raised), VACCINATION SITE WARMTH (hot to touch), PRURITUS (Itchy "like poison ivy") and INJECTION SITE RASH (rash at injection site 4 x 3 inches). On 27-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved and RASH PAPULAR (raised), VACCINATION SITE WARMTH (hot to touch), PRURITUS (Itchy "like poison ivy") and INJECTION SITE RASH (rash at injection site 4 x 3 inches) outcome was unknown.            No concomitant medications was provided. Treatment information include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: final AE diagnosis with start date, and event outcome, Product information was updated, event was updated, medical history was updated
Patient started to have left leg pain. Presented to facility  on 4/26/21. Ultrasound examination  showed DVT
Initial unsolicited report received from a healthcare professional on 11-Nov-2016. This case involves a 25-year old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza Vaccine) (manufacturer: unknown, batch number, expiry date, dose, dose in series were not reported) via intramuscular route in right deltoid on 10-Nov-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) includes allergy to Zantac. It was also reported that patient had no illness at the time of vaccination. Concomitant medications was reported as Lexapro for depression. On 11-Nov-2016, one day following the vaccination, patient woke up with swelling in right wrist and tingling in the fingers of the right hand and after evaluation carpal tunnel syndrome was reported. Patient required emergency room (ER)/ doctor visit. Laboratory investigations was performed which confirmed the carpal tunnel testing was positive. Corrective treatment was not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
arm is red and swollen at the injection site; arm is red and swollen at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2021, the patient received Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient's arm was red and swollen at the injection site.  The patient asked if an ice pack can be put on arm to help the swelling go down.
feeling some significant headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 24Mar2021 for covid-19 immunisation. The patient called to advise that she was feeling some significant headache after getting her second dose of the vaccine this afternoon, 14Apr2021 around 4 pm, because of this she took 2 tablets of Tylenol about 25 minutes ago and asking if she should continue using the Tylenol since someone advised her not to. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax 18SEP95 & 30SEP95 exp confusion, agitation & T101-102;adm to hosp lab work-up revealed white count of 16,000/cumm which inc to 20,000/cumm;dx brain stem infarction vs encephalopathy d/t flu shot vs meningitis
Exposed, below freezing, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152065:Same reporter US-GSK-US2022151428:Same reporter
Tight chest; Coughing; Sweating; Body spasms; Slept for over 24 hours; Really sick; Rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight chest), COUGH (Coughing), HYPERHIDROSIS (Sweating), MUSCLE SPASMS (Body spasms) and HYPERSOMNIA (Slept for over 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (Rash on arm). On 05-Mar-2021, the patient experienced CHEST DISCOMFORT (Tight chest), COUGH (Coughing), HYPERHIDROSIS (Sweating), MUSCLE SPASMS (Body spasms), HYPERSOMNIA (Slept for over 24 hours) and ILLNESS (Really sick). On 06-Mar-2021, HYPERSOMNIA (Slept for over 24 hours) had resolved. On 07-Mar-2021, CHEST DISCOMFORT (Tight chest), COUGH (Coughing), HYPERHIDROSIS (Sweating), MUSCLE SPASMS (Body spasms) and ILLNESS (Really sick) had resolved. At the time of the report, RASH (Rash on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure, ATORVASTATIN for Cholesterol, METFORMIN for Diabetes.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Teatment given included Benadryl and Lisinopril.   This case was linked to MOD-2021-138107 (Patient Link).
Headache and backache that lasted for about 24 hours and recently I noticed my period stopped.
Patient reported facial flushing and red injection site and injection site hot to the touch. Requested treatment at clinic and was given RX for Triamcinolone .1% twice daily for 2 weeks and instructed to get OTC ZYRTEC once daily. Facial symptoms resolved with TYLENOL at home on 04/16/2019.
Patient developed 8x10 cm reddish discolorization around injection site. Irregular configuration. No warmth non tender. Seen 1/2/07 some on 1/10/07.
This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range of unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Onset of low grade temp and rash on trunk on day 7 after immunization.  Worsening each day with fever 103 and rash entire body. Patient had MMR and VARIVAX vaccine on March 30, 2010. She broke out in rash 6 or 7 days later. It is now 3 weeks since the rash started and it is worsening. Fever is up again to 102 with no obvious source of infection. Plan another visit to pediatrician.
Extreme pain in left lung and fatigue. Temperature of 102f for three days Visited Urgent care and later prescribed inhaler Next day prescribed steroids for a week
History of questionable immunodeficiency, recurrent pneumonia given Prevnar 2 years ago.  Received Pneumovax as part of Polysaccharide Antibody workup on 11/10/03 in 24 hours developed pain/swelling at site, fever to 103F, myalgias.
Received TDAP 12-8-11 rt. deltoid - knot came up next day at injection - not visible to naked eye - no redness - swelling - started draining 3 days ago - reddish yellow discharge - arm and neck aching. Noted 2 knots around area 3 days ago. No fever.
Headache, Myalgia, SkinRash, FATIGUE; CHILLS Narrative:
Within the hour of vaccination arm felt heavy and tight. Numbness and tingling in arm and hand. Soreness in arm. Took Ibuprofen. Day 3 reached out to physician and was told to continue with ibuprofen, likely lymph node swelling putting pressure on axillary nerves causing numbness/Tingling. Soreness resolved in a few days. Numbness/Tinging/tightness in approx 1 1/2 weeks. On day  7 notes severe lower back pain but was intermittent and worse with certain movements, lasting a few days. Day 9 noted fatigue during work hours, in the evening noted body aches/muscle fatigue/headache. Day 10 tested (PCR) for Covid which was negative. Day 14 extreme fatigue and intermittent headache still persist. Examined by PCP who wants to test again for Covid as well as do antibody testing. Also test to rule out flu and mono to be scheduled.
No Adverse Event; Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna; Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna), COVID-19 IMMUNISATION (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 19-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 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 19-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna) and COVID-19 IMMUNISATION (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna), COVID-19 IMMUNISATION (Got dose of Pfizer Covid 19 Vaccine as second dose, but his first dose of Covid 19 Vaccine was Moderna) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received: updated reporter information.
Pt presented at pharmacy with following complaint, Soreness at injection site, fever, sore throat, Headache, malaise, and a localize rash on her face. She stated she had done nothing different since vaccine and developed these symptoms.
First ever episode of atrial fibrillation with rapid ventricular response (160 bpm). Acute onset while at rest with palpitations. Patient documented atrial fibrillation with consumer grade ECG (Kardia). (Patient is a cardiologist). Arrhythmia resolved 10 min after taking 6.25mg of Coreg. No recurrence.
Sunday 7/25 pt was noticed itching scalp later developed hives scattered throughout body, itching. Seen in our office 7/27. Dx Urticaria/Tx BENADRYL.
About 1 hour after shot, I had a coughing fir that felt like I could not recover breath. Then, eyes began to itch and swell. I thought I had something in them, and rinsed them well. Got worse with redness and itching. Progressed to irritated throat, inside mouth, and down to throat. My cough caused pain that felt like a radiating pain on each side of throat-this was not esophagus pain-just pain on coughing. I began to have a very flushed face, heat and pinking. I called the pharmacy and was advised to go to an emergency room, which I did. I was evaluated, EKG, throat Xray, and they pushed Benedryl, Prednisone, and Pepcid. I was observed for over 4 hours, as my blood pressure needed to come down-Sent home w/prednisone - still not symptom free after 7 weeks, totally.
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 65 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered, (dose number in series:1) for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered (dose number in series:2) on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose. On 01-DEC-2021, the patient experienced off label use.(dose number in series:2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209551, 20211209843, 20211210058, 20211210588, 20211210610, 20211210159, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211209775, 20211212088, 20211212082, 20211209679, 20211210549, 20211210610, 20211210159, 20211209706, 20211209798, 20211209874, 20211209884, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210141, 20211210112, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210590, 20211210670, 20211210824 and 20211210662.
SWEATS; INCREASED IRREGULAR HEART BEAT; COULDNOT SLEEP/TROUBLE SLEEPING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, and other pre-existing medical conditions included patient no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced sweats. On 15-JUN-2021, the subject experienced increased irregular heart beat. On 15-JUN-2021, the subject experienced couldnot sleep/trouble sleeping. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, and couldnot sleep/trouble sleeping on 16-JUN-2021, and increased irregular heart beat on 15-JUN-2021. This report was non-serious.
Around 7 p.m. patient felt chest weakness & minor SOB. Took Ibuprofen 400 mg PO. Woke up in middle of the night, had increased SOB and chest weakness. Describes as felling "Not well." Drank water. Felt better. Went back to sleep.  2/4: Patient c/o nasal congestion, slight blurred vision, increased SOB/chest weakness, had body aches, slight swelling in neck lymph node (hx of swelling due to abscess). Felt better as day progressed but in afternoon @ 3:30 p.m. while at store with family, had to leave to sit in car due to fatigue and reoccurring SOB. Minor SOB episode throughout the day. Slept well at night. Took Ibuprofen 400 mg PO x1 which improved body ache.
Low grade fever,chills, headache, body aches, especially in legs,and soreness at injection site.
Developed a vesicular rash on right thigh 6 months after varicella vaccine times 4 days. Skin culture positive for varicella zoster virus. Given 5 day course of oral Acyclovir to treat, recovered without difficulty.
Two days after receiving the 2nd Pfizer dose of the Covid-19 vaccine, my heart started beating irregularly.  I didn't feel pain and it was late at night so I postponed going to the doctor.  The next day I felt better with no irregular heartbeat.  The following night my heart continued to beat regularly, but it would occasionally sound different then usual.  The following day (05/28/2021) I went to the Urgent care.  They did the following tests: X-ray Chest PA/AP and Lateral for Palpitations POCT - CBC for Palpitations POCT - I-STAT CHEM 8 for Palpitations POCT - I-STAT TROPONIN (cTnI) for  Palpitations ECG 12 lead for Palpitations  They didn't find any symptoms.  The following day I tried to exercise and again felt an irregular heartbeat so I stopped exercising.  I took it easy for the following week and slowly started doing exercise again.  I felt no further irregular heartbeats.  After about a month, I went to a cardiologist.  Since my medical tests from the urgent care didn't show anything wrong, he advised me that I wasn't in any danger at the moment from these heart problems.
4" x 3 1/2" hot to touch, slight edema at IZ site (L) deltoid. C/O pain.
Coughing, wheezing, trouble breathing, tightness in chest, called a nurse & took 50mg Benadryl, reduced wheezing and coughing.  Around 3 am, slight trouble breathing, bloodshot eyes, facial swelling.