chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 39 years old female patient who received vaccine ACT-HIB that was reconstituted without the diluent provided (lot UJ055AA, expiry date 17-Nov-2020) via intramuscular route in the gluteal muscle on 04-Mar-2019 prior to a splenectomy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BEXSERO; and FLUBLOK 0.5 ml on the same day. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Started wheezing, became SOB. Weak, malaise - difficulty breathing lasted several days - weakness.
Pain in arm, much more than a normal shot. Tiredness, ache ness, chills, tenderness on scalp. Lasted for 3 days
Pt was presented to ER after receiving injection. The pt experienced a large area of tenderness and redness on the left deltoid area. This is the third reaction reported at this facility since 6/7/00. All three appear to be different lots.
Patient felt dizzy after initial 15 min waiting time. Vitals taken, rested an additional 15 min and dizziness improved
After receiving vaccine went to lobby to wait 15 minutes, within 10minutes got lightheaded and near passed out.  Husband got nurse.   Nurse found patient sitting in chair with head between knees face flushed.  Lowered patient to ground on back and raised legs.   Gave juice and water. Patient states gets anxiety and did not taker her medications this am.   B/P   67/40.    EMS activated and took to ER B/P at this time has gone to 124/76
Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0196) and on 02Jul2021 as dose 2, single (Lot number: EW0198) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Got covid twice after getting Covid Vaccine. Clinical course: She later added, she got Covid a year after the inoculation and she had been fully vaccinated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201318929 same patient/drug, different dose/event;US-PFIZER INC-202201318928 same patient/drug, different dose/event;
Tinnitus - Sever ear ringing, throbbing head, was told there is no cure for tinnitus :(
Started around 6:00 pm on 1/7/2021 with headache, body ache, on  1/8/2021!i still had aches but started with 101.5 temp.  Now on 1/9/2021 I feel fine.
04/18/2022 Vaccination 06/27/2022 I had sinus drainage, cough, body aches, chills, fatigue. COVID-19 testing x2 NEGATIVE 06/30/2022 PCR test COVID-19 POSITIVE  Was prescribed Albuterol but I didn't use it much. They did also give me something for cough but I can't remember the name.  I am presently feeling better.
Severe case of hives 5 hrs post-inject; Treated w/antihistamines, hives subsided w/no further problems; 1st shot;
3JUL midday temp of 103.5 aural;105.6 aural @ noc;6JUL neck rash w/sl swelling of neck;seen by MD dx rxn to vaccine;7JUL light, prickly rash like rubella) develops;lasting 203 days;temp low grade cont;11JUl wheal;
Swelling at painful lump at patient's Right thigh at site of Pediarix vaccine. Lump continued and grew slowly for 2 months, finally after U/S and MRI imaging, was given Dx of venolymphatic malformation, but then had spontaneous drainage and near resolution of Sx. Another similar lump occurred after vaccine (Infanrix) 10/13/2014, and now again on 7/30/2015 (Pedvax) both at Left leg.
Swollen lymph node in neck (left side).  No treatment given.  Lymph node swelling resolved 16Mar2021.   Extreme fatigue - start 16Mar2021 - on going as of this report.  No treatment given.
Pt. received Johnson & Johnson vaccine 05/24/2021 suffered flu-like symptoms following. Diagnosed with Shingles 07/02/2021. Doctor called in prescription for Shingles.  Stating Physician informed her to let them "scab-up" and let them go away.
Right upper arm erythema and warmth circumference of upper arm from deltoid to bicep and where PREVNAR 13 admin 1 week ago. Treat with BENADRYL and KEFLEX.
Patient Came into observation and said she felt like she was going to have a seizure, subject layed down and complained of feeling dizzy, blurry vision, stiffness and both arms are numb. Empress transported to hospital.
got really weak; hard time getting up and hard time walking; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (got really weak), GAIT DISTURBANCE (hard time getting up and hard time walking) and CHILLS (chills) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included DIGOXIN, LEVOTHYROXINE, FUROSEMIDE, METOPROLOL, ROSUVASTATIN, WARFARIN, GABAPENTIN, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and CENTRUM SILVER +50 for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (chills). On 11-Mar-2021, the patient experienced ASTHENIA (got really weak) and GAIT DISTURBANCE (hard time getting up and hard time walking). At the time of the report, ASTHENIA (got really weak) and GAIT DISTURBANCE (hard time getting up and hard time walking) outcome was unknown and CHILLS (chills) had resolved.            Treatment information was not provided.
2/4  upset at bedtime which was unusual 2/5 slept longer during night, didn't wake up until 5 am, usually up at 3 am,  only took 1 oz, usually 4 oz,  2/6 dec intake, only 1 oz per feeding, q 3-4 hrs, projectile vomiting, sleeping more, when awake lethargic, cold hand and feet, purple, spit bubbles around mouth,  More spit up than nl, color same,  Dec UO, stool dec, Dark brown, not normal color Didn't notice abd distention was more than usual  2/7 talked to triage nurse, went to ER in the afternoon,Transferred to hosp ER overnight.    Received 1x NS bolus.  Extensive work up in ED including CBC, CRP, ESR, CMP, coags, UA, hepatitis panel, CT head, and US pylorus which were all unremarkable except for ascites noted on US.   + rhinovirus/enterovirus, coronavirus, rest of respiratory panel neg including covid 19, flu, RSV abd U/S: Likely ileocolic intussusception seen in the right hemiabdomen, reduced with contrast enema,  Pt immediately better, happy, po nl, UO and stool nl  D/c home later same day 2/8
Developed exercise induced urticaria. Develops total body hives, sob and feeling of throat closing. Has recently begun having sx even when exposed to hear. Hospitalized, on multiple meds now. Symptoms: Hives, angioedema, chest tightness, wheezing. 10/27/05 D/C summary records accompanying report were reviewed. Additional symptom was exercise-induced anaphylaxis. Per follow up dated 1/3/06 Although urticaria and anaphylactic SX have resolved, pt is now experiencing chronic fatigue and daily intractable insomnia, and headaches, etiology unknown. Above SX probably R/T the TX for the adverse event, prednisone, multiple meds, stress of decreased quality of life or immune complex D/O. C3D event still elevated 101, initial spec scan of bran abnormal.  Follow-up Info: Still experience periodic flushing and hives. But major problem is the chronic fatigue & ongoing headache syndrome-pain level6/10/C3D level stil elavated. Medically discharged from the Marine Corps for the above-receive 60% disability.
Syncope after receiving GARDASIL 9 vaccine/ the patient passed out/ black out for a couple of seconds; This spontaneous report was received from a nurse via company representative referring to a 12-year-old male patient. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 15-MAY-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number 1602283 and expiry date 16-AUG-2021 (upon internal validation established as 18-AUG-2021), first dose of hepatitis a vaccine, inactivated (VAQTA) lot # s002439 and expiry date 15-MAY-2020, second dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number r030487 and expiry date 22-OCT-2020 (dose, route not reported) for prophylaxis and other vaccines included meningococcal acyw conj vaccine (crm197) (MENVEO) (dose, route, frequency, lot number and expiry date were not reported). Immediately after vaccination (15-MAY-2019), the patient experienced syncope and it lasted for less than a minute. The patient was sought for medical attention. The patient received granola bar and water. The nurse reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the most painful injection of all injections. Outcome of the event syncope was fully recovered within 20 minutes. It was reported that, the patient was not returned to the office after the event. Causality assessment for the event was not provided by the reporter.  Upon internal review, the event syncope was considered to be medically significant.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1908USA005384: US-009507513-1907USA011407:
Arm at site of injection became swollen, hard, red and painful. The area that was swollen has peeled but continues to be red and painful.
Arm weakness/leg weakness; Little irritation at the injection site; Minor headache off and on; Leg pain/really bad arm pain in the left arm with lifting and movement/arm pain; Itching on chest and arms; Tenderness in injection site; Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955; Expiration date was not reported) on the left arm on 27Mar2021 (19:55) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). The patient had no relevant medical history. Concomitant medications included cetirizine hydrochloride (ZYRTEC). On an unspecified date in 2021, the patient had neuropathy. On 27Mar2021, the patient had minor headache that was off and on; leg pain and really bad arm pain (left arm) with lifting and movement; itching on the chest and arms; and a little irritation at the injection site. On 28Mar2021, the patient had arm and leg weakness. In Mar2021, the patient had tenderness at the injection site. The patient had received diphenhydramine (BENADRYL) as treatment for the itching on the chest and arms. The patient's x-ray was normal on an unspecified date in 2021. The outcome of the events was not recovered for 'arm and leg weakness'; recovered on 27Mar2021 for 'itching on the chest and arms'; and was unknown for all the other events. The patient was scheduled to receive the second dose of vaccination, but did not want to risk having the same effects in the right arm.
Child received Hep A vaccine & PREVNAR on 6-4-12 at 11:00AM (approx). 3-4 hrs later developed abd pain, vom. Seen at hospital -> ileocecal intussusception reduced w/ air enema.
PAIN IN ALL FINGER JOINTS AND DIZZINESS. PATIENT ALMOST FAINTED AND ENDED UP IN THE ER. STILL IN PAIN 4 DAYS LATER.
Did not see any change in temperature, however the evening following the vaccination he was quite diaphoretic, and weak that evening and the following day.
Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diarrhea and vomiting and headache.
COVID 19 Treatment; COVID 19 Treatment; Drug as reported; Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Aug2022 at 12:00 as dose 5 (booster), single (Lot number: gh9703) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 at 15:00 as dose 1, single (Lot number: en9581), in left arm, on 23Feb2021 at 14:00 as dose 2, single (Lot number: en6198), in left arm and on 30Aug2021 at 15:00 as dose 3 (booster), single (Lot number: fd8448), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jul2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "previous lymphoma" (unspecified if ongoing), notes: Other medical history: previous lymphoma. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Jul2022 at 12:00, outcome "unknown", described as "Drug as reported; Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; positive, notes: rebound test positive; negative, notes: several days after last negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient is a 72 y.o. female with PMHx significant for CAD, HTN, HLD, COPD, tobacco use disorder, vitamin D deficiency, and insomnia who presented to DH on 1/12/2023 with syncopal episode.  Initial work-up concerning for septic shock secondary to underlying colitis.  There was initially concern for C. difficile colitis and patient was on oral vancomycin and IV Flagyl due to possibility of fulminant C. difficile.  Patient was also briefly on a bicarb drip due to worsening AKI and acidosis.  Patient was found to be COVID-positive, but without COVID-pneumonia.  Infectious disease was consulted and started the patient on remdesivir.  C. difficile testing and stool PCR testing came back negative and patient was transitioned to Vanco and Zosyn. However, due to no obvious infectious etiology, antibiotics were initially discontinued. Subsequently 1/2 Bcx turned out to be positive for GNB without any further confirmation. Patient was there fore treated with IV antibiotic and transition to oral for total 7 days as recommended by infectious disease. Patient has finished remdesivir, improved respiratory status, on RA, diarrhea resolved, ambulating on her own with plans to discharge home with family.    Septic versus hypovolemic shock-resolved Diarrhea Off pressors, BP stable. AF, on RA LA 4.6>1.7. Leukocytosis at 16>13K CTA C/A/P suggestive of possible diffuse colitis. C. difficile testing and stool PCR negative, blood cultures negative today  Imodium prn given ongoing diarrhea. Diarrhea improving BP stable, good urine output Discontinued IV fluid stable   COVID-19 infection Suspect incidental COVID infection, on RA COVID test + on 1/12/23 Not requiring oxygen and no pulmonary infiltrates on CT Procal markedly elevated at 86.5 finished remdesivir per ID recommendations Improved overall   Positive blood culture 1/2  GNB 1/12 Unclear significance, ID PCR inconclusive Clinically looks better, afebrile, no leukocytosis Abx transitioned to Augmentin for 5 more days per ID. Anemia normocytic normochromic Hb on arrival at 12.1>10.7>7.3 Check iron panel and stool occult. Transfuse for Hb <7.0 No active bleeding at this time Iron studies consistent with iron deficiency anemia Patient not allergic to iron,  discussed with her IV iron x  3 doses Outpatient work up for anemia Hgb stable at 7.7  B12 and folate adequate   Hyperlipidemia Lipids 6/20/2022: TC 179, TG 79, HDL 89, LDL 74 Continue home atorvastatin 80 mg daily  Hypertension Home medications: Amlodipine 2.5 mg daily and losartan 25 mg daily BP meds held in the setting of shock BP now elevated Resumed amlodipine at 5 mg daily 1/16 BP elevated, resumed losartan 1/17 Increased Losartan to 50 mg daily for better BP control  Vitamin D deficiency Vitamin D 6/20/2022: 22 Ergocalciferol 50,000 units weekly   Insomnia Continue home zolpidem as needed   Tobacco abuse On Chantix at home Encourage continued cessation
Client called to report an allergic reaction to the influenza vaccine received on 11/07/2005 reported 3 - 4:30 on 11/7/2005 headache, nausea, 6 pm, Body aches 6:30 - 7pm difficulty breathing, vomiting arms numb, face numb, left leg numb, her mother took her to ER. States recovering still difficult walking. To see MD 11/09/2005
Large area of swelling and redness around injection site.  Fatigue and light-headedness.
Patient was given adult Vaqta dose instead of pediatric dose.  No signs, symptoms or adverse effects noted.
Patient fainted onto the floor within 15 minutes of vaccination.  Patient transported to ER by EMS.
Chills; Myalgia; Low-grade fever (100.4F); Headache beginning 8 hours after 2nd dose administration; This is a spontaneous report from a non-contactable Nurse (patient). A 28-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation, lot number: EL5247. Medical history was reported as none. Concomitant medications were not provided. Patient had no known allergies (NKA). Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation, lot number: unknown. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date patient experienced Low-grade fever (100.4F), chills, myalgia, headache beginning 8 hours after second (2 nd) dose administration. Resolved in 48 hours. No treatment was received for the events. Patient was tested for Covid post vaccination with Covid_test (Other) with negative result on 20Jan2021. Patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Blood clots; 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 THROMBOSIS (Blood clots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT CALLED THIS MORNING REPORTING SEVERE PAIN IN RIGHT ARM THAT HAS CAUSED LIMITED MOBILITY IN THE ARM. PATIENT SAID PAIN STARTED UPON RECEIVING VACCINATION AND HAS CONTINUE THROUGHT THE WEEKEND TIL TODAY 7/2/19. PATIENT HAS CALLED HIS ORTHOPEDIC DOCTOR AND AWAITING REPLY.
rash on injection site and knee pain and leg numbness(right side) and swollen lymph nodes on both armpits and light headache still present. rash lasted 3 days pain in knee and  armpit still present
Mom gives hx of pt having continuous cry most of night p/immun given; mom states high pitched & continuous;
MD rpt pt recv 2nd dose varivax 3//98 & 12/29/98 pt became preg, took vitamin during preg & delivered normal healthy baby. 12/30/98, lab test on pt 12/29 revealed WBC (high) RBC (low) hem (low), hematocrit (low)
Vertigo starting at 4 am on 3/15 and lasting all day. Had 2 quick episodes of vertigo (30 seconds) on 3/17.
On March 5, 2008 patient called pharmacy to say she had developed a rash on her legs about 4 to 5 days after receiving vaccinations.  The rash stopped on her legs but continued up to her trunk. She described the rash as tiny, bumpy with pustules.  She said it did not bother her but I informed her she could use diphenydramine (Benadryl) cream or hydrocortisone cream on any "closed" pustules.
Information has been received from a nurse practitioner concerning a female with retinopathy, blindness, developmental delay, and hypothyroid and a history of premature birth (25 weeks) who on 3/1/98 was vaccinated with varicella virus vaccine live (lot # 624724/1327E). Concomitant therapy included levothyroxine Na. On 5/10/04 the patient developed vesicles. On 5/13/04, the patient was seen with 75-100 lesions and was afebrile. The patient was diagnosed with varicella. Medical attention was sought. The patient was treated with Aveeno as needed. No product quality complaint involved. The reporter noted that this was the third case of varicella in a week after receiving varicella virus vaccine live (WAES0402USA00595 and 0405USA00765). Additional information has been requested. Additional information received. The patient's age and date of birth have been added.
1649 Pt received dose of Janssen (Johnson & Johnson) vaccine today approximately around 1440. Pt states she is "feels like I'm going to throw up". Pt brought back to AR triage for observation. Pt states feeling lightheaded and feels tingling and itching around lips.    Vital signs at 1652: BP: 160/103 (Map: 133) HR: 73  SPO2: 99% Temp: 98.2 F RR: 21   1658: Spoke with emergency department Dr.  about patients situation. Dr. advises that 911 be called and patient be taken to emergency department, due to high blood pressure and itching around face.    1702: 911 called. Pt still feeling itching around lips and face.    Vital Signs at 1702: BP: 212/106 (Map: 139) HR: 67 SPO2: 93% Temp: 97.4 F RR: 22   1720: Pt states itching around lips, face, and now throat. Pt also states "It's hard to swallow and my tongue feels big". Paramedics arrived and administered IM epinephrine. Pt was taken to ER by paramedics