chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after my injection, at 5:00 a.m. I got up to try to go to the bathroom but felt very dizzy - I had help to get to commode but had to lie on floor to stop from passing out, was sweating profusely.  Did not feel well between 5 and 8 am. I think I had 2 vasovagal episodes during this time brought on by needing to do a bowel movement but I had difficulty not passing out.  After second bowel movement - the dizziness and nausea and sweating subsided.  The rest of the day, I just had minor fever and minor headache.  By the next day I was normal.  I have had 2 or 3 vasovagal episodes in the last 15 years and so that is what I think it was but I assume possibly brought on by the vaccine.  My average sleeping heart rate that first night was 10 beats per minute higher than normal (I wear a Fitbit with a sleep app).
10/15/09 appox 1430 - given flu vax in right deltoid - IM. Felt initial "soreness" entire deltoid/shoulder in AM of 10/16/09. This soreness/stiffness remained for 3 days. 10/23/09 - again had significant soreness/stiffness at (R) deltoid and shoulder joint with difficulty raising (R) arm.
the pt got the covid vaccine and felt light headed and short of breath. I asked the pt if she wanted me to give her the epipen and she said no. So I paged a code white over the intercom so a manager would come to the pharmacy and he called 911 immediately.  After the paramedics came to the pharmacy and tended to the pt they connected her to the machine and all her vitals were normal. she wanted to be taken to the hospital so she was.
arm redness; arms swollen; Arms sore; Incredibly itchy; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain in arm and pruritus. On an unknown date, the outcome of the erythema of extremities, swelling arm, pain in arm and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second dose of Shingles vaccine and patient's arms red swollen and sore. The patient stated that he/she know that takes time but it was incredibly itchy. The patient asked if it was normal and how much longer would it that last?  Consent to follow up was not possible as no contact details were available.
A 2 year old developed a high fever 12/23 - 12/26 that ran up to 105.5. Patient was evaluated at an out of town clinic since family was on a trip. All test were within normal limits, patient was given Bettriaxone  IM. Follow up 12/25/04: Patient still febrile. On 12/27/04, patient developed a rash. The impression was that this was a viral illness versus vaccine fever. Follow up 12/28/04: Patient was afebrile.
This case was reported in a literature article and described the occurrence of facial palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed facial palsy. Serious criteria included GSK medically significant. The outcome of facial palsy was unknown. It was unknown if the investigator considered the facial palsy to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic facial nerve palsy in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 1-21 days after vaccination, the patient developed idiopathic facial nerve palsy. The case met the definition of Brighton level 1. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event idiopathic facial nerve palsy and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
sore arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Systemic lupus erythematosus.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-341218, MOD-2021-341213 (Patient Link).
TOOTHACHE; STRESS; INFECTION IN JAW AFTER ROOT CANAL; ANXIETY; DIFFICULTY IN SLEEPING; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: waldenstrom's macroglobulinemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: ibrutinib (tablet, oral, batch number: 1137534 expiry: -MAY-2023) 420 mg, 1 time every 1 day, from 01-FEB-2017 for waldenstrom's macroglobulinemia. No concomitant medications were reported. On an unspecified date, the patient experienced toothache, stress, infection in jaw after root canal, anxiety, difficulty in sleeping, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from infection in jaw after root canal, and headache, and had not recovered from toothache, stress, anxiety, and difficulty in sleeping. This case, involving the same patient is linked to 20210943562.
had a side effect; just slept for a whole day, he just slept; got a headache with both; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had a side effect), SOMNOLENCE (just slept for a whole day, he just slept) and HEADACHE (got a headache with both) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Overweight.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (had a side effect), SOMNOLENCE (just slept for a whole day, he just slept) and HEADACHE (got a headache with both). In 2021, SOMNOLENCE (just slept for a whole day, he just slept) and HEADACHE (got a headache with both) had resolved. At the time of the report, IMMUNISATION REACTION (had a side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not recall what dates the patient had the vaccine, it was a week or 2 after her son so sometime in May-2021 and the 2nd she thought the end of May-2021. The patient got the vaccine at 4 in the afternoon and was just feeling off and then got a headache and then fell asleep at 6pm and woke up the next day at 6am. Reporter would like to say it was totally gone and felt fine the next day. He got the Modena vaccine and had the best sleep he had ever had, he slept 12 hours with both and loved it, he said he would take it again so he could sleep. He was taking medications and had a couple that blood pressure medication and some for his stomach and something else. They were monitoring his heart and he was overweight.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Live significant FU appended( events added) On 05-Aug-2021: Non-significant FU appended On 16-Sep-2021: Live significant FU appended(patient race, events added)
Chills; Fever; Nausea; Headache; Redness; Swollen Arm; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced chills, fever, nausea, headache, erythema and swelling arm. Shingrix was discontinued. On an unknown date, the outcome of the chills, fever, nausea, headache, erythema and swelling arm were unknown.   It was unknown if the reporter considered the chills, fever, nausea, headache, erythema and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. On the following day after vaccination with Shingrix, the patient experienced chills, fever, headache, redness, nausea, and swollen arm. The pharmacist asked if patient could be reimbursed because, the patient did not considered to receive 2nd dose of Shingrix.
Pt allergic to Latex, used latex bandaid after administration --- realized this after placing bandaid on patient. Removed Bandaid personally, cleaned area with alcohol swab. Had patient stay in waiting area for 15 min after Adverse event and gave a BENADRYL 25mg. Rash started to dissipate soon after and patient stated she was fine.
Pt received Pfizer primary series dose instead of Pfizer bivalent booster. Pt stable and released from the vaccination site.
Soreness in arm; Fever; Chills; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 20-Jan-2021, PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided      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.   No concomitant medications were provided No treatment information provided    This case was linked to MOD21-11658 (E2B Linked Report).; Sender's Comments:  MOD21-11658:Crosslinked: Same reporter
No adverse event; Expired vaccine given to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     The patient's past medical history included GERD and Stroke. Concurrent medical conditions included Coronary artery disease, Hyperlipidemia, Hypothyroidism and Hypertension.    On 05-Jan-2023 at 10:57 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 05-Jan-2023 at 10:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient).    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Swollen Lymph Nodes near armpits,lasting approximately 36 hours; This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Nodes near armpits,lasting approximately 36 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. In December 2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes near armpits,lasting approximately 36 hours). In December 2021, LYMPHADENOPATHY (Swollen Lymph Nodes near armpits,lasting approximately 36 hours) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.  The physician reports receiving 50 mcg vaccine booster dose in December and experiencing swollen lymph nodes near armpits, lasting approximately 36 hours. Resolved without further complications.
Blood Clot blocked oxygen to the brain. Suffered a severe stroke  Was hospitalized  Suffered brain swelling  Lost brain function Died.
Swelled Joints that were sore & stiff, headaches, lethargy, and hot/cold chills over 8 days.   As days progressed  from 8/31/2021 to 9/08/201 symptoms lessened.   Appetite good and maintained fluid intake.  Used ibuprofen for headaches and swelled joints that were sore/stiff followed by long 7-8  periods of sleep.  Lethargy symptoms diminished over time.
MOTHER REPORTED SWELLING IN ARM AND BROUGHT CHILD BACK TO HEALTH DEPARTMENT. DTAP/IPV (KINRIX) WAS GIVEN IN RIGHT ARM. NOTED MODERATED SWELLING AND WARMTH IN DELTOID AREA IN THIS ARM. CHILD COMPLAINED OF PAIN.  FINGERS IN THIS AREM ARE WARM AND FLEXIBLE WITH GOOD MOBILITY AND RADIAL AND BRACHIAL PULSES FELT. ORAL TEMP 93.3 F. INSTRUCTED TO CONTINUE TYLENOL AND APPLY ICE PACK TO AREA PER DR'S ORDER. PATIENT DID NOT COMPLAIN OF ITCHING.
Diarrhea, fever and decreased appetite. No testing done for occult blood and no obvious blood in stool.
DTAP/HEP B - PED / IPV vaccine given in RA 12/15/09.  12/17/09 mom returned to clinic w/child w/ c/o right elbow to upper shoulder swollen/ red / hard/ tender to touch (twice size of arm) mom applied ice.  Seen 12/18/09 w/ decreased swelling & decreased tender to touch.
Menstrual period was supposed to start on April 17, it is now May 5 and still not started; This is a spontaneous report from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19262) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 22Jan2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient's menstrual period was supposed to have started and until 05May2021, it had still not started. Her cycle was generally very normal and she had taken 3 home pregnancy tests and all were negative. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent SARS-COV-2 test via nasal swab and the result was negative. The clinical outcome of the event menstrual period was supposed to have started and until 05May2021, it had still not started was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
DVT, positive anti-cardiolipin antibodies found, unknown if had prior; on eliquis now
Immz given 4/10/06 fever started 4/16/06. Few shots on 4/17/06. Dr saw pt on 4/21/06 all over body macular rash. Rash resolved 4/25/06.
This spontaneous report as received from a physician refers to a 19 years old female patient with none pertinent medical history and none drug reactions/allergies. The patient was vaccinated with the GARDASIL the first dose on 17-JUL-2007 (lot # (656049/0187U, Expiration date 29-SEP-2009), the second dose on 21-SEP-2007 (lot # 658560/1062U, Exp date 15-APR-2010) and the third dose on 23-JAN-2008 (lot # 659653/1448U, Expiration date 01-AUG-2010) (doses and routes not reported). No other co-suspects were reported. No concomitant medications were reported., On 31-JUL-2012 the HPV was discovered when the patient had her annual pap smear. The patient sought medical attention by office visit. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
Headache about 23 hours after injection, described by patient as severe but improved with water intake. Still lingering on 2/7/21 at 12:30pm.  Injection site redness, swelling, warmth, and itching that started 2/6/21 around 3pm. Itching is radiating to chest and neck. No other systemic symptoms. Still present on 2/7/21 at 12:30pm.  No SOB, chest pain, tightness, difficulty breathing or angioedema.
This is a spontaneous report from a contactable consumer. A 67-year-old female patient received PREVNAR 13 (batch, lot and expiry date was not reported), via an unspecified route of administration on 06Oct2017 at a single dose for pneumonia prevention, given at a pharmacy. The patient's medical history was and concomitant medications were not reported. On 06Oct2017, the patient received the vaccine which she thought was a good idea but since then she has had intermittent problems with her left arm. The patient stated that a physician did not suggest she get it or tells her what to get or where to get it. It was not prescribed to her, she received it on her own at a (pharmacy name withheld) and she felt safe enough that the method and way in which it was done was good. The patient added that she put herself in kind of a Zen mode to make herself relax while she got the shot. The outcome of the event was recovering (reported as improved but are persisting). The patient had no lab work in response to getting the shot. The patient reported that she was still able to use her arm.
No other adverse events reported; The patient received GARDASIL 9 in Jan 2021 and Mar 2021 and had yet to receive third dose; This spontaneous report has been received from a pharmacist referring to a 21 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On an unknown date in January 2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. Then, on an unknown date in March 2021, she was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. At the time of reporting, the patient had yet not received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The reporter stated the patient's other information was unknown, as she had not come in yet. There were no other adverse events reported.
I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful.  The following AM, I felt exhausted, dizzy, had mild headache,  thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested.  I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement,  I went to see my internist.  Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal.  So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.
Pt received Hep A shot in left deltoid on 2-6-17. States 24-48 hours after shot became severely tired, nauseated and developed a headache. States at the time of this report 2-10-17 he is still feeling fatigued, which was his initial reason for being seen by provider on 02-06-17.