chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 vaccines given to this patient 11/06/2012 HPV Lot# H010649 MCV4 Lot # U4289AA Flu Lot # UH745AB. 5 minutes after injections were given patient felt lightheaded, fainted and became very pale. Initial BP: 90/50 mmHg. Patient assessed, assisted with head down, legs up and administration of fluids and sugar provided after the patient referred that his last meal was over 7 hours prior. Kept in observation for about 45 minutes and d/c home with BP 110/70 mmHg. Be aware that this was his last HPV dose and he did not have this problem in the past.
pt recvd vax;had fever 103x 3 days;running nose,cough & congestion;sent to er;given cold meds;PC to pt 15mar, has a cold otherwise returned to nl;
pain on the same arm (right arm)/right arm soreness; injection site pain; When she tries to raise it or go outward, she has to use left arm to help push her right arm; this has been going on for many days like a muscle pain; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021), dose 1 intramuscular, administered in Arm Right on 12Feb2021 08:00 (age at vaccination 68 years) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included rotator cuff injury from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient not visited emergency room or physician office or emergency room for reported events. The patient experienced injection site pain on 12Feb2021, pain on the same arm (right arm)/right arm soreness on 16Feb2021, when she tries to raise it or go outward, she has to use left arm to help push her right arm, She states this has been going on for many days like a muscle pain on 2021. Reporter stated, she started experiencing pain on the same arm (right arm) but is not specific to the injection site which is still ongoing. She mentioned that she can bear the pain but is uncomfortable with it. She is asking if this is normal and for how long should she expect it. She is concerned because she has to receive another injection in the same arm in 2 weeks because she cannot do it on the other arm because of a rotator cuff injury. She is getting concerned, is this to be expected before she gets the second dose. she received her first Covid vaccine on the 12Feb2021. The only thing she had, and it wasn't even as big of a deal as she expected, was pain at the injection site, which started the date she got the shot. She states the injection site had gotten sore, of course, but laying on it hurt. Next day injection site was improved. The next day she didn't feel anything when she laid on it. right arm was getting more sore, not at the injection site. Below the injection site, hurts to the elbow. But her right arm got progressively more sore. She is not that worried, a little concerned if it's nothing but if it's something she wants to know. Her right arm pain is not getting any better. Wants verification that this is an expected side effect. Patient received treatment for reported events She only took Acetaminophen on 2 separate days, one each time. Took one on 18Feb2021 before she went to bed, doesn't know if it helped because she went to sleep. Considered using heat or ice but a shower makes it feel better temporarily. The outcome of event vaccination site pain was recovered on 13Feb2021, pain on the same arm (right arm)/right arm soreness was not recovered, rest of all events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Began having runny nose and congestion. Tested positive on at home. Went to urgent clinic in Florida and was prescribe Paxlovid. After beginning Paxlovid around day 3 or 4.
Pt recvd 2nd dose of Engerix-B 4SEP92 & 10 mins later tongue got thick, had difficulty swallowing & dizziness; taken to MD office & sx progressed; devel SOB, chest pain, chills, cyanosis of fingers & lower extremities; tx w/DPH; taken to ER
Second dose not given in over 42 days since first dose on 3Mar2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not given in over 42 days since first dose on 3Mar2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given in over 42 days since first dose on 3Mar2021). On 03-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Second dose not given in over 42 days since first dose on 3Mar2021) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021 is not significant.
10/21/02-pt rec'd pneumococcal vaccine .5cc Rt arm IM approx 11am. SHe had the influenza vaccine week ago. 10/22/02 presented to office with tenderness and redness at injection site with fever of 100.9. Advised to go to hospital she refused. Dr started Keflex 500mg q 6 hrs x 10 days with f/u 10/25/02-fever gone, feeling be4tter, cont. Keflex.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.16  Concomitant products were not provided.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Slightly nauseous; Extreme dizziness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness) and NAUSEA (Slightly nauseous) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, VERAPAMIL, POTASSIUM CHLORIDE (KLOR CON), LEVOTHYROXINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ROSUVASTATIN, ZINC, VITAMIN D NOS, GABAPENTIN and HCTZ for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness). On an unknown date, the patient experienced NAUSEA (Slightly nauseous). At the time of the report, DIZZINESS (Extreme dizziness) and NAUSEA (Slightly nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, the patient was taking unspecified allergy pills as concomitant medication. She reported that after half an hour of the vaccine injection, she had 3 hours of extreme dizziness, to the point that she could not walk out of her car. Her oxygen stats were fine, she just drank water following which, her symptoms subsided (details not provided). The patient wanted to confirm if she required a medical emergency, or her reaction was a common side effect?   This case was linked to US-MODERNATX, INC.-MOD-2021-085925 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085925:Cross linked to Dose1
TOOK THE THIRD DOSE ON DAY 7/ DID NOT COMPLETE VIVOTIF DOSES PRIOR TO TRAVEL; TOOK UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-1751) was received from a consumer on 06-Jul-2019. It describes a female consumer who "took the third dose on day 7/ did not complete Vivotif doses prior to travel" (PT: Inappropriate schedule of product administration) and "took unrefrigerated doses of Vivotif" (PT: Product storage error). The consumer was receiving Vivotif (lot number: 3003242) for a trip.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 27-Jun-2019, 28-Jun-2019, 03-Jul-2019, and 05-Jul-2019 respectively. She had a power cut for 24 hours before starting Vivotif. She stated that she was not sure about what the temperature reached during the storage of doses. She had a planned trip on next Sunday.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took the third dose on day 7/ did not complete Vivotif doses prior to travel" and "took unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the third dose on day 7/ did not complete Vivotif doses prior to travel" and "took unrefrigerated doses of Vivotif" was considered as not applicable.
Sore arm, swollen, sensitive, dry mouth, chills, respiratory problems worsened to the pint that had to use a nebulizer and Mvcinex, flushed face. Today still has hard time breathing.
Immediately following injection: sore arm, ?fuzzy? head, mild syncope, hot and cold flashes- all resolved after about 20 minutes minus arm pain.  Approximately 7am the next day overall muscle soreness- especially spinal area,  dizziness,  nausea, bruised arm at injection site, generalized weakness
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient (age not reported) who received a dose of FLUZONE QUADRIVALENT lot UT6290MA, expiry date: 30-Jun-2019, via intramuscular route in the deltoid NOS on an unknown date, which was not stored correctly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the vial of FLUZONE had taken 5 days in shipping instead of 2 days of shipping and was warm to the touch before injecting. The patient did not experience any adverse effects following the vaccination. 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 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 the sender: none.
Reported symptoms of: Chills, Fatigue, Fever, Headache, Muscle/Body Aches, Runny Nose that lasted 10 days.
Approximately 10 minutes s/p vaccination, employee became sweaty, c/o tingly hands, low BP, c/o nausea.  Medical assistance team called, patient transported to ED.
03/11  Headache and Woozy 03/12 and 03/13  Woozy and Nearly Fell 03/13 and 03/14  At 3:00am woke up with phantom smells of burning meat, Very unpleasant and lasted an hour each time. 03/11 03/21 All over muscle and joint pain, headaches, and intense pain at the base of the skull and down the spin, intermittant nausea and loss of appitite. Taking Aleve 24/7 to help with the pain Sleeplessness due to pain Taking Aleve and have increased Low-Dose Naltrexone for pain at night.
A consumer report has been received. The report concerns a female patient. Patient relevant history, concomitant diseases and concomitant medications were not reported. Patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on 06-Nov-2014. Patient said she received FLUMIST QUADRIVALENT on 06-Nov-14. Two weeks after vaccination she started symptoms of swelling of tongue, difficulty breathing, shortness of breath. She also felt tingling on her hands, legs and head which were more increased close to bedtime. She went to her HCP/MD and to ER due to symptoms. She was told it was probably related to food allergy or anxiety. She was given anti-allergy medication and noticed this meds did not have effect on her symptoms. Then, MD said that her illness was not an allergy reaction or food allergy or anxiety. The symptoms lasted two weeks. After that she noticed that she presents shortness of breath on and off/occasionally. She also confirmed this is the first time she has received FLUMIST QUADRIVALENT. FLUMIST patient reported that after administration in Nov-2014 she developed symptoms of being hard to breathe and feels like something heavy on her chest. She also had a headache. These started 2 weeks after FLUMIST administration and are still occurring. The doctor tells her that everything was normal when they examine her. At the time of reporting, the event of shortness of breath and headache was ongoing and the outcome of the event of swelling of tongue and tingling of hands, legs and head was unknown. The reporter considered the events to be non-serious.
Pt. was given 0.25mL of Afluria, Influenza. Pt is 10yo's and was given a 6-35mo influenza vaccine. Pt was given only half a dose;was supposed to get a total of 0.5mL. No signs, symptoms of anything happening afterwards.
dose from vial missing NDC; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT IDENTIFICATION NUMBER ISSUE (dose from vial missing NDC) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT IDENTIFICATION NUMBER ISSUE (dose from vial missing NDC). At the time of the report, PRODUCT IDENTIFICATION NUMBER ISSUE (dose from vial missing NDC) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  It was reported that vials with missing NCD came from another location since they would not use them, so the exact shipping information was unknown.  Upon visual inspection the vials  were fine and were transfered with the proper storage and arrived frozen.  No treatment information was provided.
Pt received dose #1 Moderna COVID vaccine 1/22/21 @ Vaccine clinic. 1/24/21 scheduled virtual urgent care visit reporting generalized fatigue and malaise/myalgias as well as some nausea and headache. Intermittent for months, was feeling better, then recurred after COVID vaccine. Provider indicates this may be related to the vaccine. Plan to treat with OTC Tylenol or Motrin and increase her fluid intake over the next day or 2. Presented to ED later the same day for workup. "Pt reports weak, low energy, nausea, headache, dizzy at time, chills, malaise, weakness, feelings of hypoglycemic." Workup negative, discharged home without treatment or escalation of care. Entered by PSS for tracking.
8 pm, 8/17/21 Left foot 'falls asleep' - I noticed numbness and tingling in the top lateral side of my left foot, and radiating up into the lateral side of my left calf.  Over the next hour, numbness radiates up lateral side of left leg, into left thigh.  Numbness and tingling woke me up 2-3 times that night.  Around 4 am, 8/18/21, woke up with numbness and tingling in left forearm and hand affecting left thumb, pointer finger, middle finger, and lateral forearm.  9 am, 8/18/21 Numbness and tingling continues in Left foot, thigh, forearm, and hand, and has now affected left side of scalp surrounding left ear.  Numbness and tingling continues for several hours and fades from head after several hours.  Numbness and tingling has continued in left foot, leg, hand and forearm continuously, but fading to less intensity, and including this moment when this was written 2 pm, 8/22/21
Same day: fatigue, nausea Next morning: swollen, tender, red, warm at injection site  2.5x3 inches
Patient with 5mm pustule on right cheek, pustule appeared 5 days after smallpox vaccination given. Pt had temprature of 100.3 at time of outbreak.
Patient has about a 5 inch red circle around the injection site and heat in that area. She said it was not painful.
Initial and follow up information has been received from a pharmacy student and a physician respectively, refers to a 61 year old male patient with medical history of chicken pox as a child, high blood pressure and hyperthyroidism. Drug allergies/reactions included: LIPITOR caused elevated liver function tests, simvastatin (manufacturer unknown) caused felt poorly, CRESTOR caused muscle and headaches and LIVALO caused felt poorly aches. On 12-FEB-2010, the patient was vaccinated with ZOSTAVAX lot # 665521/1226Y expiracy date 27-FEB-2011, 0.65 ml, subcutaneous in the left arm. No rash occurred at the site of injection post-vaccination. Concomitant therapies included fenofibrate (manufacturer unknown), lansoprazole (manufacturer unknown), fluocinonide (manufacturer unknown), ergocalciferol (manufacturer unknown), multivitamins (manufacturer unknown), compounded testosterone (manufacturer unknown), LEVITRA, LEVOXYL, aspirin (manufacturer unknown), VALTREX, fish oil (manufacturer unknown), DIOVAN and ADVAIR Diskus. In 2011, the patient experienced herpes zoster outbreak every three to four months, lasting through 2012. The patient was treated with VALTREX. On 19-NOV-2013, the patient was diagnosed with another zoster outbreak and would begin therapy with VALTREX. On 21-NOV-2013, the patient experienced rash on the left side of his neck, one lesion (also reported as patient experienced pain in the neck going up towards the facial region and was followed by the ras on the neck). The patient sought for medical attention (saw primary health care provider). VZVIP specimen sample was collected from a vesicle/lesion (no results were given). The patient had no recent exposure to chickenpox or shingles. The outcome of another zoster outbreak was reported as not recovered. This is one of two reports from the same patient (MARRS # 1312USA004011). Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+  hours as well.
patient reports having lymph node swelling affecting neck, supraclavicular region and left axilla after vaccination.  symptoms persisted for more than 6 weeks after vaccination and patient pursued medical evaluation given persistent lymph node swelling.
fever for 5 days after vaccination, then developed leg swelling and weight gain with profound proteinuria. Kidney biopsy revealed minimal change disease
Patient noted that she was beginning to have symptoms of a reaction at around 0910 with facial flushing and tingling. She self -administered a dose of Benadryl PO but stated she did not need epinephrine or further intervention. At 0920 she noted her symptoms were progressing with some itching and a "funny feeling in my stomach like I might pass out." She was transferred to medical where she was given Epi IM 0.3 mg in clinic then transferred to ED.
PROVIDER HIT THE BONE/BONE HURTS; SORE ARM NEAR SHOULDER; PROVIDER HIT THE MUSCLE; INJECTION SITE PAIN STILL HURTS SINCE 4 WEEKS; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18050221 or 1805022) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced provider hit the bone/bone hurts. On 19-MAR-2021, the subject experienced sore arm near shoulder. On 19-MAR-2021, the subject experienced provider hit the muscle. On 19-MAR-2021, the subject experienced injection site pain still hurts since 4 weeks. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm near shoulder, injection site pain still hurts since 4 weeks, and provider hit the bone/bone hurts, and the outcome of provider hit the muscle was not reported. This report was non-serious.