chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Vaccine Administered to 4 People; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to 4 People) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to 4 People). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to 4 People) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.  On 11-JUL-2021 around 10AM, one vial of vaccine was  first punctured. The vial was kept at room temperature for more than 24 hours.  On 12-JUL-2021, four doses were withdrawn out of the expired vial and administered to 4 people.  Treatment information, if any, was not provided.
9-8-03 DTAP left delt. IPV left arm sq Sept 9th child developed fever of 103.5 with red rash 50 x 50 mm.
Patient developed redness and swelling at site of injection (left arm). Symptoms persists after 6 days of administration.
Doses were pulled from vials that were involved in temperature excursion; Doses were pulled from vials that were involved in temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Doses were pulled from vials that were involved in temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Doses were pulled from vials that were involved in temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Doses were pulled from vials that were involved in temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Doses were pulled from vials that were involved in temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Doses were pulled from vials that were involved in temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Doses were pulled from vials that were involved in temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. On Sep17-2021 our fridge that held one open partial box of MODERNA compressor died, fridge temperature went to a maximum of 57.28 degree's when the MODERNA vaccines were removed and placed in another approved vaccine fridge. Total time of out of temperature range was 2 hours and 15.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Upon follow-up receipt: 2nd dose number added. On 30-Sep-2021: Non Significant follow up
Chills; Low grade fever; Headache; Slight congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 05Apr2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced chills, low-grade fever, headache and slight congestion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was taken as a result of the event headache which included treatment with EXCEDRIN. The clinical outcome of the events chills, low grade fever, headache and slight congestion were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Within 15 mins of receiving vaccine client informed EMTs she was feeling itchiness around face. First vitals at 1630: blood pressure 138/89, pulse 129, oxygen 98%. PHN joined shortly after. Per client had anaphalaxis reaction to 1st dose Pfizer vaccine and was recommended to receive Janssen. Client with flushed face, rash on chest, neck and left arm. Client denied shortness of breath, chest pain, or trouble swallowing. PHN offered client Benadryl. Per client had pre-medicated with Benadryl 1.5hrs ago. Client informed she would we kept an additional 30 mins in observation. 1635 vitals: blood pressure 134/81, pulse 118, oxygen 98%. Client stated symptoms same, denied shortness of breath. Rash on chest, neck and left arm same, not spreading. PHN asked client if she had followed up with provider after first reaction. Per client did speak with provider and was given steroids afterwards. Medical history: Ehlers-Danlos Syndrome and mass cell activation. Current medications: Cromolyn Sodium, Clonidine, Corlanor, Klonopin, Hydrocodone, Flexeril, Metropolol, Microgestin, Singulair, Vitamin B, Vitamin B12, Claritin, Iron, Magnesium, Famotidone, Zyrtec, and Probiotic. Per client no past history of allergies to vaccines. 1640 vitals: blood pressure 123/93, pulse 108, oxygen 97%. Per client itchiness resolved, rash to chest, neck improving. Vitals at 1650: blood pressure 121/79, pulse 100, oxygen 98%. Per client throat felt "weird", denied shortness of breath, closing of throat, no swelling of tongue. Client able to answer all questions and breathing normal. Per client itchiness was resolved. Rash to chest and neck resolved, left arm with improved rash. 1655 vitals: blood pressure 110/80, pulse 95, oxygen 98%. Per client feeling much better. Denied shortness of breath, no itchiness, rash resolved. Client given ER precautions. Per client not driving, was getting picked up. Client left facility with steady gait at 1705.
Patient presented for Moderna Covid 19 vaccination. Patient received first dose of a 2 dose series on 4/22/21 at an outside clinic. Patient presented to the health department for the 2nd dose on 5/18/21, 26 days after the first dose was administered. According to CDC guidelines, patients receiving the Moderna covid-19 vaccination should wait 28 days between first and second doses. This RN, currently acting as screener/educator role during this immunization clinic, did not observe that the date of first vaccination administration was 26 days ago instead of the required 28 days. Vaccination was administered by another staff RN. The nursing supervisor was informed immediately upon discovery of the error.
Very red rash in AXILLA of the right arm, not painful or itchy, but very red covering whole arm pit and petechiae surrounding3-4 inches around the axilla area.  First noticed it 3 weeks or so after the first injection. Treated with benadryl spray/cream topically and oral to help with sleep. Not painful at first, but did develop an itching and painful area after a few days. It is now March 16th and right  arm pit is STILL red.  I had thought it was an insect bite, but did not act like that and it has  eased up, bit not gone away.  It was not until a week AFTER the Second Moderns shot in the opposite left arm  that a rash developed on the LEFT armpit/axilla area did it occur to me that it may be vaccine related and should be reported.  I have pictures.
Aching in bilateral joints.  Had not had this at all previously.  Joints effected, knees, hips, shoulders, elbows, wrists, spinous process of C7.   Was seen by my doctor who prescribed prednisone and an anti-inflammatory diet.  The prednisone only helped temporarily.  Aching joints have significantly impacted my activities of daily living such as my sleep, dressing, bathing, etc.  It has been difficult to turn in bed, move into a sitting position, reach for things etc.  My knees are slightly better in the last month.    Lab tests were done and were all negative. See below. My doctor referred me to a rheumatologist, who I am waiting to see.
Pain to lower back and down left leg. Same as before L4-L5 Disc surgery
approx 1715 mom went to check pt; pt was limp, eyes rolled back, not responsive-pale did not start really crying until arrived @ office limp in car on way to office; irritable & t100.9l
initial sx which started a couple weeks after vaccination: repeating himself, mild short term memory loss sx escalated and peaked at full mania a couple months later: aggressive behavior, confusion, mania, irritability, inability to stay on task, inability to perform day to day tasks such as turning on water for shower or how to measure a board (he is a wood worker), psychomotor agitation (walked for 4 miles in he woods and injured himself in the night and called wife, then pusher her down on the ground at 3 am as he was 2 miles from home - lead to psych admission).
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958371, 20210958806, 20210958566, 20210959351, 20210958518, 20210959620, 20210959581, 20210958977, 20210958348, 20210958321, 20210958525 and 20210959909. This case, from the Others is linked to 20210958366.
This spontaneous report as received from a healthcare worker referred to a 69 year old female patient with medical history of hyperglycemia, irritable bowel syndrome, hypertension, rheumatic fever and with drug reactions/allergies to NORVASC(caused peripheral edema in lower extremities). On 14-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot#J000432, exp date 10-APR-2014, 0.65 ml, subcutaneous). Concomitant therapies included DITROPAN XL, potassium and LASIX. Patient was seen in the office on 16-MAR-2013 because she had developed an induration of 5 cm and erythema of 10 cm surrounding injection site. She stated that there were no lesions at injection site, declined VZV packet. No lab diagnostics studies performed. The outcome of events were unknown. Drug relationship was not provided. Additional information is not expected.
Patient came to pharmacy 9-28-13 to let me know she reacted to the Fluzone HD shot within 2 hours of recieving the vaccination.   She has yearly recieved the regular dose flu shots but never before the high dose flu shot.  She requested high dose since she is now 65 years old.  She said her symptoms consisted of headache, body aches, chills, fever, vomiting and diarrhea, loss of bladder control.  She described her headaches as sometimes at the base of her neck and usually aroung her eyes and temples.  She is currently still having some headaches.  She also said she had notified her doctor of her side effects.  Better but still has periodic headaches and still feels tire and achy.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later on or about 31-OCT-2011, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Patient with redness, swelling from injection site to mid forearm. Given BENADRYL 50 mg by mouth and ice packs, and swelling/redness improved.
Immediately complained of nose "feeling weird", then at about 3:45 PM started saying eye was itching, by 4:15 left eyelids were swollen, almost shut and red.  Had noticed when administered, most was given in left nostril.  Went to emergency room, arrived at 4:30, she was also complaining of dizziness and "being tired".  ER gave her Orapred, Bbenadryl and Pepcid.  Symptoms resolving over next 12 hours.
injection site reaction. hot, swollen, itchy visited urgent care. Inspected,, temp taken(98.4) given prescription
fever diarrhea now dark forest green a week later also sometimes just mucus in pamper only shaking head back and forth he is wheezing coughing constant
Patient presented with red, swollen, itchy arm at the injection site. This was 3 dose post injection.
On 3/4/08 at 1140 am patient presented at this dept. with complaint of left upper arm and shoulder being very sore, beginning 3/2/08. Upon observation left upper arm and shoulder area appear edematous, feel warm to touch and are very tender to touch. Some redness noted, around deltoid area.
4/27/18 received SHINGRIX vaccination. 5/23/18 came down with Bell's Palsy.
Initial fatigue and chills 18 hours after the dose. They subsided within 48 hours. Subsequently five days post vaccine palpitations, DOE, chest pain w any activity where heart rate went over 80. Symptom reached peak on days 9-10 post vaccine, and began dissipating slowly. Fatigue persisting now into week 4 post vaccine. Also BP elevated starting 5 days post vaccine until 3 days ago.
Patient reports back pain chronically, but worsened on the left side and felt "inflamed" for 24 hours. Patient also reported hand shakiness and was unable to write for 24 hours. Patient reports he had balance issues.
This spontaneous report as received from a registered nurse refers to a 76 years old male patient with no drug allergy and a concurrent condition of high blood pressure. The patient was vaccinated with a dose of ZOSTAVAX on approximately 03-OCT-2012 (reported as "last week"). Concomitant medications were unspecified high blood pressure medication. On 08-OCT-2012 the patient noticed rash around groin area and was experiencing pain. The patient came into the office on 09-OCT-2012 and was seen by the physician who confirmed diagnosis of shingles. Patient sought medical attention and VALTREX and VICODIN were given to patient as treatment. There was no lab diagnostics performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Shots on October 3, then on 4th and 5th fever of 102.0F.  One the 3rd and 4th he would not eat anything.  Pedialyte given.  One or two bowel movements the rest of that week.  Gradually been getting worse, 48 or more hours between each bowel movement. On Oct 6 went to Dr., scheduled checkup.  Finally seen on the 16th for constipation.  Used suppositories 1/2 supp.  On the 23rd put on prescription colace stoolsoftner and x-ray done with mild gas build up noted.  Put infant on gas drops then.  No bowl movement since October 21, around 3PM, after warm bath.  No assistance needed at that time.  Very large and runny.  Mom feels that the baby is uncomfortable and gets fussy if his stomach is touched to much.  Seems happy but eating a lot less now.  Only on breast milk. No formula or diet change, no cereal.  Suppository tried today, but no BM as of yet.
Congestion in lungs; Chronic obstructive pulmonary disease; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose 2, single (Lot number: EW0186), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood in sputum", start date: 09Feb2021 (unspecified if ongoing), notes: None urgent care; "Blood in sputum", start date: 12Apr2021 (unspecified if ongoing), notes: None hospital. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Time: Afternoon, Anatomical Site of injection: left upper arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer BioNTech EW0186), administration date: 26May2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Jun2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 11Nov2021, outcome "unknown"; PULMONARY CONGESTION (medically significant) with onset 12Nov2021, outcome "unknown", described as "Congestion in lungs". The patient underwent the following laboratory tests and procedures: Chest X-ray: (09Feb2021) Negative, notes: Negative for Pneumothorax; (11Nov2021) Follow up suggested, notes: Chronic obstructive pulmonary disease.  Follow-up attempts are completed. No further information is expected.
consumer reported that after first dose, she felt unwell; had headache; body pain during 3 days; This is a spontaneous report from a contactable consumer or other non hcp. The consumer reported about the first dose administered.  A 76-year-old female patient received 1st Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Batch/Lot number was not reported ), via an unspecified route of administration on an unspecified date (Age at vaccination 76-year-old) as dose 1,single for covid-19 immunisation. Medical history included hypersensitivity. The patient's concomitant medication included unspecified profilactic medication. Reporter states during the call patient mentioned she had chronic allergy and prior to first dose administration she took profilactic medication as her physician recommended. On an unspecified date, during the call consumer reported that after first dose, she felt unwell, had headache and body pain during 3 days. She mentioned taking Tylenol for management symptoms subsequently to vaccination. Reporter wanted to know about whether she could change appointment hour for second dose administration. The outcome was resolved on an unspecified date.  Information about lot/batch number has been requested.
Pt had a little redness below the injection site after the COVID-19 vaccine that came and went. On 2/20/21 (a week after the vaccine) redness was more prevalent and pt had soreness,  some swelling, itching, burning sensation,  and warm to the touch.
Pt reports going into Pre-term delivery 5 days after vaccine was given. Baby died about 1 month after delivery. Delivered 11/23/09.
Developed fatigue and indigestion, rash over arms, chest, back and legs, extremity and facial swelling, wheeze at night-placed on steroids.
24-year-old male presents with nondescript anterior chest pain and shortness of breath that is worse with breathing. He states this started acutely this morning. He reports 3 days prior he got his second dose of Moderna Covid vaccine. He reports a sensation of chills as well. He denies any fever, abdominal pain, exertional shortness of breath. Reports no cough or hemoptysis. Echo more procedure the patient's troponins were significantly elevated and had diffuse ST elevations throughout.  Was given aspirin and Toradol with no relief.  Was transferred to Hospital for further evaluation.  Patient was evaluated by her interventional cardiologist and had a bedside echo obtained there is no wall motion abnormalities and this was like bleed thought to be secondary to his recent Covid vaccination.  Will be admitted with a diagnosis of pericarditis for monitoring overnight.
RT ARM WITH 10 CM ERYTHEMATOUS MACULAR CIRCULAR AREA WITH HYPERTHERMIA AND MINIMAL PAIN TO PALPATION. TREATMENT WILL BE TO F/U AS NEEDED.
Most likely patient has gotten COVID from exposure; Side effects she experienced from vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Most likely patient has gotten COVID from exposure) and VACCINATION COMPLICATION (Side effects she experienced from vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION COMPLICATION (Side effects she experienced from vaccine). On 11-Jan-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Most likely patient has gotten COVID from exposure). At the time of the report, EXPOSURE TO SARS-COV-2 (Most likely patient has gotten COVID from exposure) and VACCINATION COMPLICATION (Side effects she experienced from vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: positive (Positive) Possible.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 contains significant information: The patient took 2nd dose of vaccine on FEB-2021. The outcome of the events changed from unknown to resolved.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
A nurse reported that a 41 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 8/29/00. The next day, the pt developed a fever and achiness. On 9/7/00, he developed right arm pain extending from shoulder to elbow. He was dx'd with right arm peripheral neuropathy. The pt was treated with ibuprofen, Medrol (methylprednisolone), and Soma (carisoprodol).