chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 520 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Muscle weakness and joint pain. Somewhat improved but persistent 5 weeks after the first dose.  Digestive problems after the second dose: bloating and indigestion.
itchy rash at the site of her 1st shingrix shot; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On 1st February 2021, 3 weeks after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed an itchy rash at the site 3 weeks after vaccination. She showed it to a dermatologist who told her she probably should not get the 2nd dose. The reporter did not consented to follow up.
she administered an expired vaccine to a patient with no reported adverse event; Initial information was received on 27-Feb-2023 and live follow up received on same date both were processed together regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was treated with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 27-Feb-2023, the patient received total 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ613AA and expiry 25-Feb-23) (expired product administered, latency same day) (strength: unknown) via intramuscular route in the left thigh for immunization.   At time of reporting, the outcome was Unknown for the event she administered an expired vaccine to a patient with no reported adverse event.  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 the 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.
My blood pressure was dangerously high at 199/95;  the bottom went as high as 111.    Normally it is around 110/70.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 03-year-old, male child patient. On 08-Oct-2018, the patient (underage of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019) (explicitly coded as inappropriate age at vaccination). No adverse were reported after administration of the vaccine. This case 201804694 was cross-linked with original cases 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
None, just a sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient started to receive her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1685), intramuscularly on right arm at 14:45 on 22Dec2020 at single dose for COVID-19 immunization. Medical history included hypothyroidism and psoriasis, no allergies to medications, food, or other products. Concomitant medication included ibuprofen (MOTRIN). The patient experienced sore arm on 23Dec2020, event reported as non-serious. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of event was unknown.
During the night after receiving Prevnar 20, she developed right ear pain, right-sided throat pain, generalized bodyaches, malaise, and diarrhea. These symptoms were still persistent on 8/27/2023 when she sought evaluation at the Clinic. She was diagnosed with right otitis externa and prescribed otic antibiotic drops. She was advised to seek re-evaluation from her PCP in 1-2 days.
Patient had 3 prior Pfizer doses with mild aching, fever and headache at the third dose. This 4th dose was Moderna. 10 hours later she had onset of severe headache, nausea, repeated vomiting, fever, generalized abdominal pain, arm pain, and generalized myalgias. On neurologic exam she was normal, abdomen mildly tender, tender cervical chain  nodes, and heart tones normal, no rub.  Vomiting subsided in  few hours but the headache, myalgias, and nausea persisted strongly for 48 hours.  She was bedfast for 2 days which is very unusual for patient.  Five days later she still feels unwell, with loss of appetite, some nausea but is resolving and capable of usual activities. Treatment consisted of acetaminophen and rest.
7 x 3.5 cm area of erythema, warmth, and swelling, prob cellulitis. Rx's Cephalexin 500 mg TID x 7 d.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised which was given to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via The Agency (Reference number- 00303291) via call center and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310763, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310762, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (lot number: UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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.
Had swollen in the arm  in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Had swollen in the arm  in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049021a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GINKGO BILOBA (GINKO BILOBA [GINKGO BILOBA]) for an unknown indication.   On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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. In May 2022, the patient experienced VACCINATION SITE SWELLING (Had swollen in the arm  in the injection site). At the time of the report, VACCINATION SITE SWELLING (Had swollen in the arm  in the injection site) outcome was unknown.            Concomitant medications also included some other undisclosed medications.  It was reported that patient did not lost her vaccination card, but that in her vaccination card she had 4 shots when she only had 3 shots. On 13 May 2022 patient had first booster dose.  Treatment medication was not provided by the reporter.
Information has been received from a physician concerning a 10 year old white male with no past medical history who on 12-Aug-1997 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot #633680/0086E). Concomitant therapy that day included measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live, diphteria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified). There were also no other medications at the time of immunization. There were no significant illness at the time of immunization or immediately before or after immunization. On 08-May-2003 the patient was sent home from school with a fever and frontal headache. That evening he developed a pruritic rash which started on his upper torso. In the office, he had a vesiculopapular rash on his face, scalp, torso, and extremities that ultimately totaled about 50 to 100 lesions and group A streptococcal pharyngitis. The patient reportedly had a varicella infection. His VZV IgG antibody was 2.0 with 1.1 or greater indicating immunity and his VZV Ab IgM, EIA was .18 which was well within the negative reference range. The patient was treated with a 10 day course of cefasorxil (Duricef). On 04-Jun-2003 the patient returned for a follow-up visit. He had a few scabbed lesions remaining on his head and upper torso. His VZV IgG had increased to 4.6 and his VZV Ab IgM, EIA had increased to 2.50 which was also well within the positive reference rang of greater than 1.1. The patient reportedly recovered. I was noted that the patient did not experience any adverse events following prior vaccinations. It was reported that the patient's brother had been exposed to natural chicken pox in April 2003, and on 23-Apr-2003 had developed symptoms (WAES #0305USA02850). Subsequently, the patient's other siblings also developed symtpoms (WAES #0304USA2704, and WAES #0305USA02849). All were previously vaccinated. No further information is expected.
Initial solicited report received on 08 May 2015 from a consumer. This is a retrospective pregnancy registry case for Study QIVO8. A female infant born with congenital anomaly of patent foramen ovale i.e. days after (subject) received first intramuscular dose of FLUZONE QIV on 25 October 2014 in left arm (batch number: U173AA). The event appeared after visit was not reported. Ultrasound performed on mother of the subject on 34th weeks of gestation showed baby had irregular heartbeat with Premature atrial and Ventricular contractions (PACs and PVCs). Concomitant therapies were not reported. The lab data and corrective treatment were not reported. The outcome of the event of patent foramen ovale was unknown at the time of report. The investigator's causality assessment was not reported. Relationship to investigational product according to Company: associated. It was not reported if the serious adverse event led to the termination of the subject from the study. List of documents held by sender: none. This case was linked to case# 2015SA047942 (Pregnancy case).
Patient states he was fine when he left pharmacy, he went shopping at different pharmacy and while he was checking out his groceries in line he got really itchy on his arms and chest. He took off his coat and saw he was covered in hives just on his chest and arms. It lasted for 20 minutes and then disappeared. States at this time he is currently fine and no longer has the hives.  States he did not feel need to go to ER when he had them (he worked in emergency medicine for 40 years so he said he didnt feel need at that time).
DEVELOPED PHN (POST HERPETIC NEURALGIA) SECONDARY TO SHINGLES INFECTION IN SCALP. NO RASH OR BLISTERS. PAIN IS ON LEFT SIDE OF HEAD (PARIETAL OCCIPITAL AREA.)
Patient developed red, 2 inch wide whelp halfway around arm and lymph node of side of body which received shot. She said 4 days after shot she developed itching, which she treated with OTC cortisone cream. She consulted her Dr Tuesday (the day after the shot). Resolving as of 1/26/13.
4 hrs. after immunization - symptoms of fatigue slight cough, fever 102-103 F, night sweats, chills, rash (Sunday AM 1/13/13).
she did not feel that great (congestion, tired); she did not feel that great (congestion, tired); she did not feel that great (congestion, tired); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 40's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), NASAL CONGESTION (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "she did not feel that great (congestion, tired)". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Additional Information: The patient was in her mid 40s. The patient did not feel that great (congestion, tired) after her Pfizer bivalent booster. It was reported by patient neighbor.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Bruise about 3x4 Seemed like the guy put it very high on my arm
Dizziness and lightheaded when getting out of bed to walk to the restroom 17 hours post-vaccine. Fever present. Nausea and then lost consciousness for approx. 30 seconds. Treated with rest and fluids.
Booster dose Rapid Heart Rate, Difficulty walking, mental changes, New onset A-fib
Achy feeling, site red on evening 10/08/2013. 10/09/2013 Site red, warm to the touch, swollen. Itchy feeling on head first then over entire body. Blotches noticed 10/09/2013 per teammate.
pt recv vax; 15jun started fever of 105 R; leg swollen, 1/2 knot noted; fever until 17jun; no oth sx noted;tx w/ apap;
Hospitalization for acute hypoxemic hypercarbic respiratory failure (likely due to COVID-19) on dates 12/7/22- 12/16/22. Treated with dexamethasone, prednisone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient had diffuse fatigue, myalgia, arthralgias, and leg cramping associated with purpura on her right lower leg
Less than 26 days for administration of second dose; This spontaneous case was reported by a physician assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 939906) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Had flu shot 11/10/03. On 11/11/03, mom reported pain, redness, swelling and warmth. Examined by Dr 11/11/03. At that time, no warmth, 4 x 5cm area, slightly firm/indurated area of left upper arm. Placed on Keflex 250 mg/5ml 1 1/2 tsp tid for 10 days. Rechecked on 11/12/03 by PAC, noted erythema at left shoulder. No hardness or tenderness.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. Patient's concrurent conditions and relevant medical history was not reported. On 13-APR-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K007983 with expiration date of 03-JUN-2016), 0.5 ml, subcutaneous. Concomitant medications were not reported. No adverse events were reported. The outcome of the events were unknown. The causality of the events with (Oka/Merck) was not reported. Product quality issue was not involved. This case is linked to # 1505USA007262 via same reporter link. Additional information has been requested.
When using my muscle in left arm, it throbs/spasms uncontrollably until I stop using arm.; This is a spontaneous report from a contactable consumer (Patient). An 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Apr2021 13:00 (Lot number: EW0153) as dose 1, single and intramuscular, administered in arm left, administration date 29Apr2021 13:00 (Lot number: EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset 08Apr2021 14:00, outcome "not recovered", described as "When using my muscle in left arm, it throbs/spasms uncontrollably until I stop using arm.". Therapeutic measures were not taken as a result of muscle spasms.   Additional information: When using my muscle in left arm, it throbs/spasms uncontrollably until I stop using arm. It is not painful, but it's odd that it spasms so much and so often. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/ Administration facility. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Antibiotics. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? No. Prior vaccinations: None, Concomitant drugs: none, Patient medical history: none, relevant tests: None. Adverse event: muscle spasm, onset date: 29Apr2021 02:00, Seriousness criteria: Not serious, AE outcome: Not recovered, Treatment AE: No. After my second dose, my muscle at injection site spasms when I lift something. Problem still persists almost 2months after injection. No pain but very annoying.  No follow-up attempts are needed. No further information is expected.
Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.
I have been itching all over my body for one week now.  It is not getting any better.  I have welts all over even in myhead.  I cannot go to work or do anything else.
Pt got shot on 8/1/2012, redness, swelling and warmth sensation developed that same evening. Pt saw her doctor the next day and was given acyclovir. Pt did not take it though. Day 3, pt's symptoms progressed, so pt went to ER, received SEPTRA DS. Day 4, symptoms progressed, went back to ER, got KEFLEX added to SEPTRA DS and was told to start acyclovir. Patient has been on Prednisone therapy since 2005. The current dose of prednisone is 3 mg po qd started 6 months ago.
The patient had first dose of Moderna COVID-19 vaccine on 05/04/2021. On 05/08/2021 the patient began having cramping abdominal pain. He was seen in his primary office and the ED once before ultimately being admitted with a portal vein thrombosis and mesenteric vein thrombus. His only risk factors for blood clots are obesity. He has no family history of significant blood clots (except for father who had PE in setting of COVID infection). He has no history of malignancy or family history of malignancy at a young age. He is now being admitted for anticoagulation.
Approximately 2 minutes after injections the patient stood up to walk out of room and said she didn't feel good.  I sat her immediately in chair and she fainted.  After a few seconds she was alert and said her ears were ringing and her eyes seemed blurry.  Her pupils were dilated.  She was not sweating but said she felt really hot.  After a few moments her pupils were normal size and she was able to sip on some water and felt much better.  She did not have shortness of breath.  After about 15 minutes she was able to stand and felt back to normal.  Her family doctor was contacted and the situation explained to him and he felt she was fine to leave the pharmacy.