chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACHINESS; VERY COLD; DULL HEADACHE; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 12:45 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 20:00, the subject experienced achiness. On 08-APR-2021 20:00, the subject experienced very cold. On 08-APR-2021 20:00, the subject experienced dull headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achiness, very cold, and dull headache. This report was non-serious.
Side effects from SHINGRIX 500 mcg, Redness and swelling and muscle pain, headaches, fever, shivering, feeling tired and weak, felt so bad had to go to the doctor.
It?s been 10 years since I got a flu shot, and out of fear I got one 9/9/20.  Less than 24 hours later, as I was finishing an online yoga practice with a client, strange joint pain began (wrist, thoracic spine)  While I?m saying goodbye to my client, the chills begin along my arms. The  A/C was off which is usually the reason. BUT then the shaking and convulsions started. Within a matter of seconds, my entire body was uncontrollably shaking. It felt as if I was submerge in an ice bath ~ I was so cold, yet no fever. Temp was around 97 F. My words cannot describe how horrible this felt.  Had enough strength to go downstairs and get Hubby?s help. He got me in bed with a heating pad, my thermal blanket, hot massage rocks, and my night guard ~ I was chattering so violently, I thought I would break a few teeth.  Then the pain in my hips began. Felt similar to Labor pain, only 10x worse. I rolled to my side, along with the heating pad, and luckily that dissipated quickly.  Once the shaking stopped, I slept for a solid hour, yet woke to feel like I got run over by a truck. Was weak to rest of the evening and slept fairly well. The next day, Friday 9/11/20 I was sore, weak, and had what felt like a "flu headache" in my forehead area al day/night. Had a terrible night's sleep and woke up feeling as if I had a mild case of the flu. My temperature was 99.6 F most of day until bedtime, with chills, muscle joint ache, headache, fatigue, and no appetite.  I feel better today, although there is a lingering weakness, soreness, and faint headache.
urticaria, pruritis, local tenderness/induration @ inject site (lt deltoid);
weakness; diarrhea; no appetite; achiness; high fever; chills; I was tired; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (achiness) and INJECTION SITE PAIN (sore at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications reported.  The patient's past medical history included COVID-19. Concurrent medical conditions included Asthma.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (sore at the injection site). On 15-Feb-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (achiness), PYREXIA (high fever), CHILLS (chills) and FATIGUE (I was tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (achiness), INJECTION SITE PAIN (sore at the injection site), PYREXIA (high fever), CHILLS (chills) and FATIGUE (I was tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller received the 1st shot of the Moderna vaccine on 14Feb2021. Reports soreness at the injection site. Says she got really sick for 3 days with a high fever, chills, achiness, weakness, diarrhea, no appetite, & fatigue. Admits to being hospitalized with Covid-19 in Oct2020. Reports the symptoms after the shot were just like ones she suffered through when she had Covid-19. I took Tylenol. Admits that she's a severe asthmatic.
Patient received Johnson & Johnson COVID vaccine on 04/07/2021. Developed COVID symptoms on 05/18/2021. Tested positive for COVID on 05/24/2021.
Shingles breakout on face, severe fatigue, lung discomfort. Note: I am a medsurg nurse and had Covid in March/April, 2020.
chills; fever; real bad, shaking problem; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the BNT162B2 (Pfizer covid vaccine; Lot Number/Batch number: Unknown) dose 1 via an unspecified route of administration yesterday on 26Apr2021 09:30 as a single dose for covid-19 immunization. On 26Apr2021 (yesterday) at 13:15, he had a tooth extraction and picked up a prescription. Medical history included covid virus 4 months ago (had a mild case). Concomitant medication included amoxicillin 500mg 2 tablets first dose taken for tooth extraction from 27Apr2021 at 09:30. On 27Apr2021 (same day) at 11:30, patient experienced chills, fever and real bad, shaking problem. Patient wanted to know if any drug interaction occurred with Pfizer vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had reaction to COVID vaccine.   Caused swelling lips, hives around the around the mouth and mild numbness.  Was given benadryl  25mg,  PO and was advised son to take patient to urgent care for further evaluation.  Patient denied SOB and closing throat at the time of visited.  Patient was in stable health condition before leaving.
Rheumatoid arthritis flare up; Rheumatoid arthritis flare up; This case was reported in a literature article and described the occurrence of rheumatoid arthritis flare up in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant) and rheumatoid arthritis flare up (serious criteria GSK medically significant). The subject was treated with glucocorticoids nos (Glucocorticoids). On an unknown date, the outcome of the rheumatoid arthritis flare up was recovered/resolved and the outcome of the rheumatoid arthritis flare up was unknown.   The reporter considered the rheumatoid arthritis flare up to be possibly related to Shingles vaccine. The reporter considered the rheumatoid arthritis flare up to be possibly related to Shingles vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of flare in a patient of unspecified age and gender, who was vaccinated with unspecified zoster recombinant adjuvanted vaccine (manufacturer unknown) for prophylaxis. The patient was part of retrospective chart review that aimed to study the impact of the new zoster recombinant adjuvanted (ZRA) vaccine in rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRD) patients and to measure the risk of flare and incidence of side effects between 01 February 2018 and 20 January 2019. The patient had rheumatoid arthritis. No information on patient's medical history, family history, concurrent condition was provided. On an unspecified date between 01 February 2018 and 20 January 2019, the patient received 1st and 2nd dose of unspecified zoster recombinant adjuvanted vaccine (administration route and site unspecified, batch number not provided). The age of vaccination was not provided. On an unspecified date, within 12 weeks of vaccination, the patient developed flare after 1st and 2nd dose of vaccine. Treatment was unknown. [In this study, all the flares were mild, self-limited, responded to treatment with low dose glucocorticoids, and did not warrant a change in immunosuppressive therapy].  The outcome of the event was not reported. The authors' stated, "In our experience with 300 patients who received the new ZRA (207 RA and 93 SRD) in 2018-2019, the incidence of disease flares was less than or equal to 3% and of side effects was 15% which is reassuring. Both flares and side effects were mild, self-limited, and did not require a change in disease-modifying anti-rheumatic drugs (DMARD) therapy.
I was 32 weeks when I got my 2nd booster. Completely healthy pregnancy. I was due October 2. The baby stopped moving 1-2 days after the shot was given. I went to the dr and was told there was no heartbeat. I delivered my stillborn a few days later- she weighed 5 pounds 3 oz.  this was my first pregnancy.
This case was reported by a physician via call center representative and described the occurrence of rash in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 66 or 67 years of age. The batch number was not reported. The doctor reported that about a week ago the patient received SHINGRIX and developed a rash. The rash was treated with Benadryl and has resolved. The injection was administered at a local pharmacy and not at the doctor's office. Because of this the doctor did not have the batch number or the exact date of administration.
A large (half dollar size), raised hive appeared to the right of my injection site. I do get hives but never on my arm and they disappear within hours. This one persisted for hours and left a faint red spot 24 hours later. It is no longer raised.
his mouth was real dry; he was real nervous when he got his COVID vaccine.; he could hardly sleep/ it was only that night except for now when he may wake up during the night and then it is hard to fall back asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: EN6199) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Taking Metoprolol for this for about 3 to 4 years. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal (ongoing). The following information was reported: DRY MOUTH (non-serious) with onset 10Mar2021, outcome "recovering", described as "his mouth was real dry"; NERVOUSNESS (non-serious) with onset 10Mar2021, outcome "unknown", described as "he was real nervous when he got his COVID vaccine."; SLEEP DISORDER (non-serious) with onset 10Mar2021, outcome "unknown", described as "he could hardly sleep/ it was only that night except for now when he may wake up during the night and then it is hard to fall back asleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event Details: Shortly after he got home, about half an hour after he got home, his mouth was real dry and then he could hardly sleep. Then the next morning the dry mouth eased up a little bit. When he would drink water, his mouth became dryer than it usually does, you would think it would do the opposite. It is not as dry as it was the first day, it has improved a little. The night of 10Mar2021 is when he could hardly sleep from his dry mouth, it was only that night except for now when he may wake up during the night and then it is hard to fall back asleep.   No follow-up attempts are possible. No further information is expected.
PT WAS GIVEN THE INJECTION AT AGE 1O, PT DID NOT HAVE REACTION, PARENT AWARE
10/7/16 6 p.m.-Bodyaches and low-grade fever. 10/4/16 8 p.m.-10/8/16 6 a.m.-Bodyaches, chills, high fever, headache. 10/13/16-Mouth full of canker sores developed.
The patient bad blood titers drawn three weeks ago, and is showing no titers for the mumps only; Information has been received from the patient's mother referring to a 29 years old male patient who was severe sulfa allergy. The patient had none concomitant medication or medical history.    In 1992 (reported as about 27 years ago), the patient received the full series of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, schedule, lot# and expiration date were unknown) injection in the arm for prophylaxis.  On 11-JUL-2019 (reported as three weeks ago), the patient bad blood titers drawn and was showing no titers for the mumps only (mumps antibody test negative). Unspecified lab studies performed: lack of mumps titers. The outcome of the event was reported as not recovered. The patient did not seek medical attention and no treatment was given for the event.  Causality assessment was not provided.
Muscle pain when muscle (where shot was given) is used to lift and or twist. Sharp pain when used only. This is report only; no visit to PCP. Pain noted next day and has stay the same .
headache was on the right side of head going  towards eye- this was off and on pain in arm pain in underarm at top of chest
The ninth day after receiving the vaccine I developed swelling, redness, itching, and soreness at the injection site.
Patient was given the Janssen vaccine and fainted just a few seconds after injection.  She awoke shortly after after and was given some water and was monitored by pharmacy and store staff until she felt normal, about 30 minutes.  Her boyfriend drove her home.
2 vesicles appeared on roof of mouth; Red bumps (rash) appeared in mouth; Left arm also very stiff/sore; Left arm also very stiff/sore; This is a spontaneous report from a contactable other healthcare professional (HCP). This 35-year-old female HCP reported for herself that she received BNT162B2 (lot number EH9899) 1st dose Intramuscular at left arm on 27Dec2020 at 12:00 PM for Covid-19 immunization. Medical history was not provided. Concomitant therapy included birth control. The patient experienced red bumps (rash) appeared in mouth, and 2 vesicles appeared on roof of mouth within 24-32 hours after receiving vaccine. Left arm also very stiff/sore for 24 hours after receiving vaccine. Event onset time was reported as 12:00 PM on 28Dec2020. No treatment was received for the events. The outcome of the event was resolving.
Administration error: full Pfizer vaccine dose administered to pediatric patient. Diluted 12+ Pfizer (purple cap vial) with 1.3 mL diluent and administered 0.2 mL dose. Total dose administered was approximately equivalent to the full dose for ages 12 and older (about 30 mcg). No immediate adverse events were observed following administration, however the patient and her parent left the facility prior to completion of the 15-minute observation period.
I believe the Covid vaccinations caused my blood sugar to rise causing a TIA  on March 15, 2021, and loss of peripheral vision in my right eye, as well as mild changes in my close-up vison.  Ater experiencing confusion and disorientation, a friend drove me to my doctor's office. From there, I was sent to the emergency room.   I do not remember the exact number, but the next day I returned to my doctor's office for lab work. My blood glucose was 475 and my AiC was +14.
Patient had varicella and hep b vaccine administered at hospital - pt developed itchiness and redness to face, sore throat, and low grade fever. Pt seen at clinic on 2/6/17 and told to take Benadryl and Claritin. Rapid strep completed and negative.
1st dose 15Oct2021, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: A pharmacist was looking for additional information for patient who wants to received Shingrix second dose after recommended Shingrix schedule. The reporter declined for the follow-up. This is for 2 of 2 linked patients reported by same reporter. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023014279:Same reporter
Red rash around injection site, later spread down toward elbow and up across left shoulder, strong itching. Persisted for approx 3 wks, lessening now. Did not seek treatment, self-treated with topical ointment.
Soreness under the arm from armpit of injection site.; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0187) via an unspecified route of administration in the arm right on 19May2021 at 09:30(at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included atomoxetine hydrochloride (STRATTERA) from an unknown date for an unknown indication. The patient had no known allergies. Prior to the 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 vaccination. On 20May2021 at 08:00, the patient experienced soreness under the arm from armpit of injection site. The patient received treatment for the reported events which included ice pack and was continued to monitor. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event soreness under the arm from armpit of injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt had fell forward and fainted after 8 mins of observation, also stated "has a history of fainting after getting shots" Pt had got an abrasion on nose @ 1758 and immedialtely brought to attention. We treated her with a cold compress, 500 ml water, and cleaned, and put band-aid on abrasion. Pt said she "felt better but still had a headache" initial VS 96/52, 56 HR, and 96 O2. VS before D/C 113/75, 77 HR, 97 O2. Pt was discharged said she felt better.
Got 2nd shot after 3 weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd shot after 3 weeks) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd shot after 3 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd shot after 3 weeks) had resolved.            No concomitant medications were reported.
it was rpt pt vax & on 8/21/98 pt exp right eyelid swelling, red w/dark coloration & red streak on cheek. treated w/atarax. sx resolved p/ 1wk. approx 3wks p/ initial vax pt exp vesicular rash, less than 20 lesions. f/u pt titer 0.44
~36 hrs after vaccines given, mom noted pt had redness, warm & slight pain of R deltoid area.  Pt came -> MD office that day.  Likely vaccine rxn secondary 5th DTaP.  However, sm exchar with one drop of pus expressed at site of injection.  Monitor clinically.  If increased purulent fluid/pain will start KEFLEX (250 mg/5 ml) 10 ml TID x 7 days.
BODY WEAKNESS....NO ARM DISCOMFORT...DIFFICULTY WALKING...EXTREMELY TIRED
Veteran scheduled for CT scan for screening for malignancy due to unintentional weight loss. Incidental finding of Tiny linear pulmonary embolus in lower lobe pulmonary  arteries on the right that is nonocclusive. Follow-up MRI negative for malignancy.  CT scan was completed 4/14/21.   Patient was asymptomatic in terms of PE symptoms
On 04/22/2001 the pt presented to the ER with a temperature of 104.9F and seizing. Seizure lasted 45 minutes. He was riding in the back seat of the family car when his father noticed stiffening of his limbs and an irregular breathing pattern. Did have 2 to 3 days of intermittent nasal congestion, rhinorrhea and cough. Intubated for subsequent respiratory failure using vecuronium and thiopental for 12 hours. Transported by EMS to PICU for stay overnight. Discharge dx: Status epilepticus, mechanical ventilation for less than 12 hours and probable complex febrile seizures. Treatment: IV antibiotics (lorazepam and fosphenytoin) and Neurology consult. Because of findings on the CXR, there were concerns about a possible aspiration pneumonia. The only neurologic finding was some wobbliness with walking consistent with postictal ataxia versus medication intoxication. Plan is to continue on Dilantin until follow-up with Neurology, 1 month post discharge. The Dilantin was discontinued about 1 week after discharge, with rapid resumption of his normal gait, mental status, and coordination. The patient developed another fever 2 weeks after discharge with the temperature ranging from 100F to 102F. This persisted for 3 days and was treated with alternating Tylenol and ibuprofen.
Painful  menstrual cramps and very  heavy period.  Menstrual period also started 5 days earlier than expected.
Pt recv  1 dose vax June1995. 23Feb98 pt devel a rash that "looks like flea bites". He had 7 lesions mostly on his genitalia w/no fluid. Pts brother also reported WAES98022065. Pts sister had active varicella at time of pts vax.