chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough  Pfizer Dose 1 6/18/21 (lot not listed in online system) Pfizer Dose 2 7/9/21 (lot not listed in online system) COVID Positive 8/29/21 Presented to ED 8/29/21  8/31/21:The patient is a 90-year-old female who presents the hospital via EMS with worsening dyspnea and feeling unwell for the past month.  Patient has a past medical history significant for essential hypertension, mixed hyperlipidemia, PAF on anti coagulation, nonischemic cardiomyopathy, chronic diastolic CHF, aortic stenosis s/p TAVR, CKD 3B, GERD.  Patient fully vaccinated for COVID-19. Of note, patient was seen in the ED on 08/29 for similar chief complaint, was hydrated with 1 L IV NS after being diagnosed with AKI, dehydration, virus, and discharged home with doxycycline, COVID-19 PCR obtained at that time resulted positive.   On arrival to the ED, the patient's temperature is 99.8° F, heart rate 79, respiratory 24, saturating 96% on room air with blood pressure 130/60 and 2/10 severity pain.  The patient's laboratory studies were significant for BUN 42, CR 2.06, AST 44, phosphorus 2.3, magnesium 1.6, proBNP 11825, troponin 0.09 then 0.08, COVID-19 rapid AG positive, CRP 7.3, ESR 52, D-dimer 0.62 normal for age adjustment, HGB 10.1, HCT 30.8% with lymphocyte count 0.94, VBG:  PH 7.41, pCO2 41, PO2 29, HC03 26, base excess +1, O2 sat 54%. Blood cultures obtained x2.  Chest x-ray shows worsening bibasilar infiltrates.  EKG shows normal sinus rhythm, heart rate 80, QTC 465 with left axis deviation and right bundle-branch block.  Patient was administered NS IV x1 L, Zofran 4 mg IV, levofloxacin 750 mg IV, ceftriaxone 2 g IV, acetaminophen 1 g p.o., and azithromycin 500 mg IV in the emergency department   The patient was seen in the emergency department laying in bed.  The patient is extremely hard of hearing and obtaining history was very difficult.  She is very leery of staying in the hospital, but we discussed that her grandson thought it would be best rather than her going home alone feeling this ill.  She seems to understand that her breathing is poor right now.  We discussed obtaining inflammatory markers and starting her on steroids if they were elevated.  We attempted to discuss code status, but patient did not want to discuss this at this time.  9/3/21: A 90-year-old lady presented to the emergency room with history of generalized fatigue, increased shortness of breath. Patient was noted to be COVID-19 positive, despite being fully vaccinated for it.  She was admitted for COVID-19 pneumonia.  Patient was treated with empiric antibiotic therapy, Decadron.  Patient's condition has improved, is much more alert.  Patient is more cooperative with physical therapy. Patient's medication has been adjusted.
Vaccine improperly stored, was kept in vaccine refridgerator beyond 72hrs. Patient did not indicate any reactions to the vaccine.
swelling, redness & hot ears, welts all over face, stomach, feet, back & diaper area, t99 @ ER per mom's report; pt recvd Epi in ER;
Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; aching teeth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:00 (Lot number: ER 8737) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Chronic Inflammation" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN. Past drug history included: Novocaine, reaction(s): "allergies". The following information was reported: FACIAL PAIN (non-serious), NECK PAIN (non-serious), FACIAL DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "Slight pain and discomfort up left side of neck and face"; TOOTHACHE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "aching teeth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial pain, neck pain, facial discomfort, musculoskeletal discomfort, toothache.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination: Nasal Swab on 22Apr202 was negative. Slight pain and discomfort up left side of neck and face; aching teeth with first dose.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493950 Same reporter/vaccine/patient, different dose/events
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 11-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
I woke up the next morning with a swollen throat. It was red and sore. When I open my mouth I saw a white spots on my tonsils. My left side of my jaw is extremely tight and hurts when I open and close it
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 20-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ;devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Moderate Headache with light sensitivity , body aches, lack of appetite, heart palpitations, extreme thirst,
Information has been received from a physician refers to a 10 months old male patient with a history of short bowel syndrome enrolled in a study. On 07-FEB-2012, the patient was vaccinated with first dose, ROTATEQ oral. On unknown date, the patient was vaccinated with second dose, ROTATEQ oral. On 05-JUL-2012, the patient was vaccinated with third dose, ROTATEQ oral. No other co-suspects were reported. No concomitant medications were reported. On 23-OCT-2012, the patient experienced vomiting and diarrhea. The patient had 3 episodes of vomiting, followed by one day of diarrhea. On 24-OCT-2012, the patient recovered from vomiting and diarrhea without treatment. This was an expected event in the normal course of childhood. The events of vomiting and diarrhea were not related to ROTATEQ. The events of vomiting and diarrhea were considered medically significant by the reporting investigator. Additional information is not expected.
Heavy and extended period with large and constant blood clots. I was at the end of my period when I got vaccinated and it is still going on. There was about a 24 hour break last Sunday-Monday.  It is so heavy there is no point in using a tampon and I have bleed through overnight pads in 1-2 hours at some points.
CUSTOMER NOTICED ITCHY PALMS AND SOLES OF FEET A DAY AFTER RECIEVING VACCINE, CLAIMS IT IS SUBSIDING
HYPOXIA 3/4/2023  &  1/29/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA) Patient contacted on 12/4/2021 and no adverse effects reported.
C/O myalgias in joint.  W/U by rheum/neuro.  ANA-Neg, Lyme-Neg, B12-Normal, Sed rate-26.  9/23/08 Reviewed PCP medical records of 2/25-7/17/2008. FINAL DX: lymphadenopathy; allergic urticaria; acute sinusitis; allergic rhinitis Records reveal patient experienced tender lump on throat, sore throat & difficulty swallowing, frequent HA x 1 week on the day of vaccination.  Exam revealed swollen turbinates, shotty tender cervical lymph nodes.  RTC 6/14 w/itchy rash all over x 2 days.  Had started Topamax 2 wks prior & was on accutane as well.  Tx w/steroids.  RTC 7/9 w/dysuria, hematuria & lower back pain x 4 days.  Tx w/antibiotics.  RTC 7/17 w/allergy s/s, sinus congestion.  Reported having myalgias & athralgias s/p 1st HPV injection 2/21/08.  Tx w/antibiotics & received Menactra that day.  10/3/08 Reviewed neuro medical records of 6/5-8/5/2008. FINAL DX: none provided Records reveal patient experienced multi neuro symptoms: sleep disturbance since childhood, mild sleep apnea, excessive fatigue x 1 year, chronic nausea, HA, tremor, joint & muscle pain, feeling out of it, depression, anxiety & mood disturbance.  Stated contraception 1 year prior.  Referred for MRI, EEG & labs.  Responded to tx w/meds.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain, it was very intense in the waist), PAIN IN EXTREMITY (lot of pain, it was very intense in the legs), LYMPHADENOPATHY (swollen lymph nodes in the injection arm), JOINT SWELLING (interior parts of both elbows were swollen) and PAIN IN EXTREMITY (intense pain in the forearm up to the fingers) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (lot of pain, it was very intense in the waist) and PAIN IN EXTREMITY (lot of pain, it was very intense in the legs). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in the injection arm), JOINT SWELLING (interior parts of both elbows were swollen), PAIN IN EXTREMITY (intense pain in the forearm up to the fingers), BREAST PAIN (pain in the breast), PAIN IN EXTREMITY (pain in the legs, specially in the interior part of the knees), PARAESTHESIA (tingling sensation in the body), FATIGUE (tired) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (lot of pain, it was very intense in the waist), PAIN IN EXTREMITY (lot of pain, it was very intense in the legs), LYMPHADENOPATHY (swollen lymph nodes in the injection arm), JOINT SWELLING (interior parts of both elbows were swollen), PAIN IN EXTREMITY (intense pain in the forearm up to the fingers), BREAST PAIN (pain in the breast), PAIN IN EXTREMITY (pain in the legs, specially in the interior part of the knees), PARAESTHESIA (tingling sensation in the body), FATIGUE (tired) and PYREXIA (fever) outcome was unknown. Not Provided          This case was linked to MOD-2021-092168 (Patient Link).
Pain at injection site. Chills.  Body aches.  Fever (100.1).  Chills ended after about 3 hours. Temperature returned to normal by following morning. Body aches similarly went away by following morning.
fatigue, weakness, malaise, n/v, joint pain, chills, diarrhea, anorexia.  Treated with ondansetron and NS 1L.
1 1/2 - 2 hours after receiving first BEXSERO developed headache, chills, upper body aches and neck pains. Mild soreness at injection site. Then shortly after felt tired and throat felt "funny" with difficulty swallowing. No lip or face swelling but his chest felt a little tight. Similar to a past reaction to Motrin for which he has an epi-pen. He did not take epi-pen but did take Benadryl and Tylenol.
Pt found sitting on chair, A&OX4, stable skins Pink/warm/dry, pupils equal and reactive to light, lungs clear. Pt complaining of rapid heart rate. pt states that this happened last time when she received her first vaccine. Pt vitals at 1615 were 162/110, HR 140, RR 22, SPO2 94% and at 1628 was BP 154/100, HR 124, RR 20, SPO2 93%. Pt was advised to go to urgent care for 12 lead ecg, due to no cardiac monitor being available at clinic site. Pts husband was called, advised of the situation and asked to come pick up patient and take her to urgent care.  Pt left with husband, A&OX4 stable.
1.  Rash developed about 90 minutes after the vaccine across my neck, up onto my left side of my jaw, and up through my left temple area.  The rash also started to appear in the middle of my back.  This rash started to feel tight and felt my throat tightening. 2.  26 hours after the vaccine-I spiked a fever.  My regular temperature is 97.4.  My temperature climbed to 99.9 for 6 hours. 3.  The redness on my neck, face, and middle of my back.  The bumps have not reduced after 6 days.  I have a burning sensation all over my face, neck, back, and now my legs and arms.  It is spreading.
Patient came in to get Moderna Primary series (first dose), but technican gave Moderna Bivalent booster .
Return to clinic 1 1/2 wks. after receiving pneumococcal vaccine on 12/1/11 with Hx of (R) UE erythema & local swelling starting 12/2/11 which spread across entire UE; was "cherry red" initially but has decreased in last 1-2 days. Pt. uses arm normally & has no fevers.
Patient developed explosive, mucousy diarrhea approximately 3-4 hours after 1st dose of ROTARIX. Stool cultures, c. diff toxin by PCR, and Rotavirus Ag. were all negative. Three months of diarrhea, seen by Pedi GI who recommended probiotics and diarrhea resolved.
Red,  hot, itchy lump at injection site starting over a week following vaccine. Also known as "Covid Arm"
Patient developed intense bilateral leg pain, right greater than left.  Physical exam consistent with acute arterial thrombosis of both lower extremities.
Hives on torso, bilateral legs, swelling of lips left side. Denies trouble breathing or sob. C/o itching. ER visit no MD visit-all symptoms resolved.
No adverse event; administered a pediatric dose of VAQTA; This spontaneous report has been received from a nurse, concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 13-MAR-2023, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection at a dose 0.5 milliliters (ml) as prophylaxis (lot number w028555 has been verified to be valid; expiration date reported and established as 10-JUL-2024) (strength, route of administration, and anatomical location were not provided) (incorrect dose administered). No additional adverse events were reported.
This case involves patients with an unknown age and gender who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event (expired product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7035NA and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "The caller stated that there were several employees that received the expired dose of FLUZONE QUADRIVALENT Prefilled syringe (PFS). The caller estimated about NINE employees, but did not have any patient specific information to provide. The caller did not know the date of administration." At the time of reporting, 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 the Directive 2001/83/EC and Module VI. 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.
Pain in my upper neck and shoulder; Headache; Pain in my upper neck and shoulder; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer reported that:  A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: Aug2021), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in my upper neck and shoulder, headache, pain in my upper neck and shoulder. When probed for the concern, consumer stated, he had called because he took the first shot of the Pfizer Covid vaccine and have two questions. He had wondered if that was a normal side effect. My second question was, what were the rules about taking Advil, Ibuprofen and Tylenol. Consumer was informed about Pfizer Medical Information Department. Consumer was informed about the Role of Pfizer Drug Safety. When paraphrased the concern, consumer stated, "I have not taken (Advil) since I took the vaccine, I have not taken anything. I am just saying normal in life medication, in general I say from time to time take Advil for Headache." The clinical outcome of events were unknown.  Information on lot/ batch number has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 01-DEC-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
"hardly lift the hand"; lymph nodes near neack and right arm swelling; left side "spleen" pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (left side "spleen" pain), MUSCULAR WEAKNESS ("hardly lift the hand") and LYMPHADENOPATHY (lymph nodes near neack and right arm swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (left side "spleen" pain). On 16-Mar-2021, the patient experienced MUSCULAR WEAKNESS ("hardly lift the hand") and LYMPHADENOPATHY (lymph nodes near neack and right arm swelling). On 20-Mar-2021, MUSCULAR WEAKNESS ("hardly lift the hand") outcome was unknown. At the time of the report, ABDOMINAL PAIN (left side "spleen" pain) and LYMPHADENOPATHY (lymph nodes near neack and right arm swelling) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-068276 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068276:
Mom states on the 12th pt began with a "white bump" to the injection site. Bump worsened to the point of a "knot under the skin" and the "bump bleeding on and off" with redness around area per mom reported on 2/20 via phone call to the clinic. Mom instructed to come in to an office visit. CPNP found pt to have cellulitis of the right thigh and prescribed BACTRIM and BACTROBAN ointment. Mom presented with pictures of area which CPNP noted pt to have had a vesicle at the injection site. Mom says pt was playing last night and area opened and blood and "white stuff came out." Per CPNP open sore noted with surrounding redness, firm. No discharge now.
Less than 5 minutes following vaccine administration patient slumped forward in chair with apparent loss of consciousness.  Patient regained consciousness within 30 seconds and was aware of self and surroundings. EMS was called. Patient appeared diaphroretic and slightly shaky and endorsed mild dizziness. EMS team responded and transported patient to emergency room for further evaluation.
Roughly 8/9 hours after the second modern dose PT experienced drowsiness, headache, and nausea. PT fell asleep in an uncommon manner/unexpectedly. PT woke up 5 hours after falling asleep and had 101 fever/intense/crippling migraines, vomiting, and severe lower back pain (site of prior bulging discs). PT took Tylenol and maxalt, neither of which assisted with symptoms. PT maintained intense back pain and muscle tension in legs. PT was unable to walk because of the back/leg/migraine pain. PT fell asleep abruptly after four hours of being awake, similar to first. PT woke up 12 hours later with no fever and less severe back pain/migraine. PT took additional Tylenol and maxalt, was still not able to move well. PT fell asleep 3 hours later. PT woke up 9 hours later with no symptoms and has had no reoccurring symptoms since.   While symptoms were present PT was alone and was not aware/lucid enough to contact friends/family/medical assistance.