chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose was given on 03Nov2020 and third dose on 04Dec2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 26-year-old male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HBV (Engerix B).   On 4th December 2020, the patient received the 3rd dose of Engerix B. On 4th December 2020, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received an early third dose of Engerix-B.  Second dose was given on 3rd November 2020 and third dose on 4th December 2020 earlier than recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
approx 1mo p/vax pt devel a rash that looked like tiny dots, the following day it was almost gone. addl info req
She started to feel nauseated and she vomited; She started to feel nauseated and she vomited; Her arm was swollen from the side; very swollen; She is being having a stomach pain and all of those avail all the side effect and stuff like that; Till the day her headache is still constant; She started to have diarrhea and the diarrhea is still going on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 05:30 (Lot number: FC3180) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "Till the day her headache is still constant"; DIARRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "She started to have diarrhea and the diarrhea is still going on"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 15Aug2021 05:30, outcome "unknown" and all described as "She started to feel nauseated and she vomited"; PERIPHERAL SWELLING (non-serious) with onset 10Aug2021, outcome "unknown", described as "Her arm was swollen from the side; very swollen"; ABDOMINAL PAIN UPPER (non-serious) with onset Aug2021, outcome "unknown", described as "She is being having a stomach pain and all of those avail all the side effect and stuff like that".  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Large knot (2 1/4 x 2 1/4), warm and red at injection site.  started to itch on the 5th, didnt think too much about it then got progressively worse on the 6th w the knot developing and red/warm.  today 1/7, the knot is reducing slightly but the redness is spreading.
severe rush type of rxn;feeling of anxiety & hyperactive shortly p/3rd dose;driving home p/inj had abd pain, nausea, vomiting;resolved 48hrs but cont to reoccur;attacked by rabid raccoon on 26AUG94;
p/recv vax pt rpt whole body rash w/lesions in mouth. treated w/benadryl
01/03/18 = received vaccine for pneumonia, and around midnight, I woke up with chills and fever. Took TYLENOL for fever and muscle pain for 4 days. Right arm is swollen to date 01/08/18. Flu-like symptom.
In an hour time I feelt an electric shock ( Like a live wire) travel up my back into the top roof of my mouth,  My mouth muscles tighten down, my lips started to tingle and swell.  The fever hit me 20 minutes later.  I took allergy pills and ibuprofens for two days straight.  I fell asleep right after I took the first set of allergy pills.  I would wake off on on for the next three hours to chew on ice for my lips and mouth.   These symptom last for two days.
16 month old was given Adacel instead of Daptacel/No AE; 16 month old patient was given a dose of Adacel/No AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 10-Oct-2019, the patient received a fourth 0.5mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5566AA, expiry date- 13-02-2021 via intramuscular route in the left thigh.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme fatigue starting around 2/3pm  Upon waking from sleep around 7pm extreme chills and muscle aches had set in.  Fever reached 102 around 10pm.  Terrible sleep through the night, jittery and painful  Woke to less severe chills, body aches and migraine. Lymph node tenderness. Fever of 100  Symptoms have not improved as of 1:30pm the next day following my injection.
Received another vaccine instead of the Bivalent Booster; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received another vaccine instead of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received another vaccine instead of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received another vaccine instead of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided Patient said she went to her vaccination provider to receive the Covid-19 Bivalent 5th booster and instead she received another vaccine, they switched lot numbers in her vaccination card and they did not know what they gave her. No treatment information provided
Anxious; Tired; Blood clots in left leg, right leg and brain; A spontaneous report was received from a consumer who was also a 66-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood clots in the left leg, right leg, and brain, anxious and tired.  The patient's medical history was not provided.  Concomitant medications reported included vitamin D, magnesium, lisinopril, and vitamin B12.  On 14 Jan 2021, approximately 3 days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced immense pain in the middle of the night, and subsequently saw her primary physician. An ultrasound revealed blood clots in her left leg, right leg and brain. A hematologist and vascular surgeon were consulted. Patient was treated with apixaban while they are doing blood work. The patient also became tired and anxious. She noted that she never had comorbidities before and was upset that her life has completely changed. A repeat ultrasound was scheduled for 19 Feb 2021.  The mRNA-1273 dose was discontinued in response to the event of blood clots in the left leg, right leg, and brain, anxious and tiered.  The outcome of events, blood clots in the left leg, right leg, and brain was considered unknown at the time of this report. The outcome of the events, tired and anxious were considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Got 1st shot on 10/12/21 in left arm.  On 10/13 right arm started having numbness and pain from shoulder to wrist. It was continual and daily.  On 10/24/21 in evening I experienced heavy chest pressure, sharp pain in back between shoulder blades, more numbness and pain in right arm.  Worse pain with deep breathing. Worse when lying down.  Called 911. Medics ran ekg several times.  It was normal. BP elevated. Brushed off as panic attack.  No trip to ER.  ON FRIDAY 10/29/21 I woke at 4:45 am to the exact same symptoms as stated on 10/24.  911 called and this time my husband had them transport me to Medical Center ER.  labs drawn showed enzymes at 117.  Dr. diagnosed pericarditis and was prepared to send me home.  2nd labs came back as he was preparing to send me home.  Heart enzymes shot up to 282.  Had to have angiogram done, which was all clear.  I was able to come home later that evening.  Angiogram was done by Dr.     I have a follow up appointment with their partnering ANRP on 11/5/21
immunization reaction  ldt red hot swollen , 3 days, use ice pack and otc bendryl, rtc if pain or swelling persists
Ear pressure and  humming sound, in right ear.  Felt like I was in high elevation could not get ear to ? pop?.  After two weeks finally starting to feel better.
5/1 Development of lip numbness with progression to lower extremity weakness with inability to walk. Patient required extended hospitalization with further facial paralysis, lower extremity paralysis  and debility. Multiple test and neurological consultation performed with finding of Guillain-Barre. Treated in hospital setting with IVIG and subsequent discharge to inpatient rehab facility.  Patient is currently home recovering and continues to require outpatient physical therapy and speech therapy and use of wheeled walker for ambulation.
Patient has painful burning sensation and red inflamed area that started slowly in muscle at injection site. Burning sensation, and red, inflamed area described as pain level 7 or 8/10, and has slowly moved from whole tricep down arm, and is currently affecting bicep area. No other area has been affected thus far.
Approximately 4 hours after receiving the vaccine I started to experience tinnitus (ringing) in both ears. It is now Monday, April 19th and the ringing has not gone away.
Injection site warm to touch; Injection site red; Injection site itchy; Soreness at the injection site; A spontaneous report was received from a consumer concerning a 55-year-old, male patient who received Moderna's COVID-19 vaccine and experienced pain at site of injection, redness, itchiness and warmth at the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient felt soreness at the injection site.   On 31 Dec 2020, the patient noticed that the injection site was red, itchy, and warm to touch. No treatment information was reported.    Action taken with mRNA-1273 in response to the event was not reported.   The event, pain at the site of injection, was considered resolved on 23 Dec 2020. The outcome of the event(s), redness, itchiness and warmth at the injection site, was unknown.; Reporter'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.
3 brief sz, facial muscles & eyes startle type rxn w/upper  extremities occurred roughly 6hr p/vax;
Patient reported face burning, throatt feeling dry and "taste weird" BP 143/85, HR 74, RR 22, O2 Sat 100%; MD consulted & recommended J&J on 6/8/21.  Pt felt better & was discharged.
Patient was administered ROTATEQ on 4/1/08 and developed intussusception in 5/08 requiring surgical repair at hospital. 8/11/08-records received for DOS 5/26-63/08-DX: Intussusception. Presented to ED  crying, vomiting green colored emesis and blood in diaper. On 5/25/08 had bowel movement of mucus and blood. Stomach pain for past 2 days. Air reduction enema unsuccessful reduction of ileocolic intussusception. 8/26/08-records received-open reduction to reduce intussuception.
A red splotch developed about  30 hours after I had the vaccine. The red splotch was roughly  8cm x 4 cm , and it was warm to the touch and painful .  I took 25 mg of Benadryl at that time. The next day after it had been about 56 hours since their vaccine, I generously covered it with aloe vera gel. [It was fruit of the earth brand. ]About an hour later it felt significantly better. It feels better today, although I can still see the splotch, and it?s still warm.  When I had the vaccine and even 24 hours later although it was painful there was no visible red splotch. You cannot even really see where the vaccine was given. Splotch did not develop until sometime about 30 hours after I had had the vaccine. By the way, if you really want people to report adverse events, your website should be much more user-friendly.
On 1 Jun 2018, patient experienced left shoulder pain limiting range-of-motion x 7 days s/p Anthrax inoculation left arm. On-set of symptoms of pain and limitation of motion within 24 hours of receiving injection but did not present to clinic until today as he expected symptoms to resolve. Physical Exam: Musculoskeletal: Left shoulder skin intact without erythema, edema or ecchymosis, small palpable nodule on lateral deltoid, ROM in abduction/external rotation and adduction/internal rotation limited by pain. Patient was instructed on home exercises including stretching and light weights (2 pounds). Stretches included cross body arm pull, overhead arm pull, cross back arm pull, neck stretches, starting with 2 sets of 10 reps and increasing to 3 sets of 10 reps. Shoulder pain completely resolved by 5 Jul 2018.
pt recv vax & 2wk p/vax pt devel a rash which consisted of a few small bumps;it was reported that subsequently  the pt is feeling fine & the rash is gone;
Headaches, sleep deprivation, stomach pain (daily), arm swollen, red & sore, muscle aches and nausea. Pt partially recoverd - headaches, muscle and joint aches not as often as in the past. Pt missed 4 work days due to this event. At time of evaluations I wasn't sure it was ANTHRAX. Pt did not received any furtheer ANTHRAX shots since the reported event Per follow-up: 7/25/00 1601 - 1st attempt to reach pt - message left on answering machine requesting a call back. 7/26/00 1520 - 2nd attempt to reach pt - message left on answering machine requesting a call back. 7/27/00 1355 - Call back from pt - she continues to have severe heaaches and has been seen by doctors - Consent form sent for medical records.
Injection site and around the injection site on arm became red, warm, and swollen on Day 8 after the injection. The redness started in two localized areas on the upper left arm. The redness continued to grow from a small circular area to a much larger area covering almost the entire upper arm area. Patient experienced itching, pain, and discomfort in the area. The symptoms decreased by day 11 and was completely gone by day 14.
Onset of warmth, dizziness, sweating after the vaccine. No Syncope. Felt better quickly when supine. VSS      No orthostasis before dismissal.  Self resolving vasovagal reaction.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The patient vital signs were taken and within normal limits (WNL).It was reported that the patient denied any signs/symptoms of distress at the time of report. The patient was not diagnosed with COVID-19.This case was linked to MOD-2021-391981 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: included patient information and suspect details.
Miscarriage - cramping, bleeding. Doctor visit the following morning determined pregnancy no longer viable. 12/1/09 Medical records received for date 11/2/09. GYN DX: threatened AB vs missed AB. Pt presented w/ c/o vaginal bleeding/cramping states positive pregnancy test approx 6wks pregnant. 12/2/09 Medical records received for date 10/29/09. Pt given H1N1 vax and seasonal flu vax. Presented ot office w/ c/o possible pregnancy has c/o breast tenderness, fatigue urinary complaints.
2/13/21 - Urgent Care visit for extreme dizziness, brain fog, imbalance and difficulty breathing.  Recommendation for sinus medication. 3/9/21 - PCP visit,  Difficulty breathing, wheezing, coughing up green phlegm.  Prescribed medrol dose pack, antibiotics and albuterol inhaler. 3/23/21 - PCP follow up visit, diagnosed with bronchitis (no previous history).  Difficulty breathing, wheezing, coughing up green phlegm.  Prescribed medrol dose pack and antibiotics. 4/11/21m- ER visit for heart attack like symptoms.  Led to admission to hospital overnight.  Stress test.  Referred to Cardiologist for follow-up. 4/23/21- Cardiologist follow-up, post hospitalization.  Prescribed 81 mg aspirin daily 7/13/21 - PCP visit for extreme pain in right hip, NO previous history.  Referred for xrays, toradol injection administered.  Lortab prescribed. 7/14/21 - Xrays of lower back and right hip completed. 7/16/21 - PCP for toradol injection. 7/20/21 - PCP for toradol injection. 7/23/21 - MRI of lower back at request of PCP. 7/28/21 - PCP office visit for extreme pain in both right and left hips.  NO previous history prior to Pfizer vaccine.  Referred for MRI of pelvis, Pain Management, Orthopedic Surgeon and administration of toradol injection.  Lortab prescribed. 8/3/21 - MRI of pelvis completed.  Diagnosis Avascular Necrosis of right and left hip.  Again, no previous history prior to Pfizer vaccine. 8/6/21- Pain Management visit.  Toradol injection, lortab prescription, and further follow up for injections in one week. 8/11-21 - Orthopedic Surgeon.  Pending bilateral hip replacement due to AVN (on hold pending Covid upsurge).  Prescribed Tramadol.  PENDING SCHEDULING OF SURGERY!!!
Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who on 19-MAR-2007 was vaccinated with the first dose, IM, of Gardasil. The physician reported that "approximately 3 minutes after receiving the first dose of the vaccine, the patient passed out," and then "experienced a seizure that lasted approximately 2 minutes." The physician stated that the seizure was probably related to pain or anxiety, and indicated that the patient's status had improved after she received therapy (therapy unspecified). Seizure was considered to be an other important medical event. Additional information has been requested.
Site: Pain at Injection Site-Severe, Additional Details: Patient reports that he has experienced very sore arm continuously since roughly three days after receiving vaccination (too sore to raise arm above head).  He reports soreness in both arms, not just the one that received the injection.  Reports no swelling, just pain. Unclear if due to vaccination.  Advised to use pain medication and ice packs and follow up with physician.
One week after receiving first dose I started having severe itching at the injection site, followed by a raised red area  3 inches in diameter that is hard and sensitive. Some small pustules appeared within the red area and bled when scratched.
Allergic reaction, hives over abdomen, bilateral axilla area , back. Extreme itching
Severe chills, breathing issues / hyperventilating, headache and ear pressure / ringing; most lasting approximately three hours. Had Tylenol and water; most symptoms faded away, however still having severe headache.
wrong vaccine administered; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergies, and bnt 162.  On 05-AUG-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210811474.
Pt had severe pain in the lower back 5 to 10 minutes after a flu & pneumonia injection. Pt could not move.
Initial unsolicited report received from a consumer on 30 Nov 2016. This case involves a five years old female patient who was vaccinated with a dose of Fluzone QIV (batch number-UI724AA, expiry date- 30-Jun-2017; dose in series- unknown) via intramuscular route in left deltoid on 21 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient was previously vaccinated with at least three doses of Fluzone QIV. The patient had similar vaccination site reaction with previous vaccination of Flu vaccine on 2015. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 21 Nov 2016, at night following the vaccination, the patient developed red, swollen, itchy and hard lump (3 inch by 3 inch) at injection site. On the next night area enlarged and on 23 Nov 2016, hard lump increased to 5 inch by 5 inch and painful at injection site. On 30 Nov 2016, area around injection site is still red but is no longer swollen and hard lump has disappeared. Laboratory investigations were not reported. The patient corrective treatment were Benadryl and Tylenol. The patient outcome was not reported. List of documents held by sender: none.