chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: A certified medical assistant reported that a patient was erroneously given an expired dose of Havrix. Information found in medical information about vaccination and patient were disclosed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient was administered with Havrix vaccine, which was already expired, which led to expired vaccine used.
Received Shingles Vaccine ZOSTAVAX 7/21/09. After 48hrs, had rash on chest and under breasts. Returned to doctor 8/4/09. No diagnosis. Given fungal cream. Went to dermatologist 8-11-09 and diagnosed with pityriasis rosea. Given Hydroxyzine, Loratadine, and cream.
skin flare up; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (skin flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN LACERATION (skin flare up). At the time of the report, SKIN LACERATION (skin flare up) outcome was unknown.            Concomitant medication was not reported.  Skin flare up because she had not been able to get pen replaced it had been two weeks. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Event verbatim updated.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, PNEUMOVAX 23 was improperly stored outside the temperatures recommended in the product insert and was administered to an unspecified number of patients (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored GARDASIL (MARRS # 1407USA005269) and VAQTA (MARRS # 1407USA05270). Additional information has been requested.
tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) 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 concomitant medication was reported. The treatment information was unknown.
None known at this time. Error reported to this nurse per school nurse. DTAP was given instead of TDAP.
"Pimples", some with white pustules. Onset Friday, progressively worsening.
local erythematous painful rash at injection site started day 8 after injection. OTC treatment.  Seen provider 5 days after the initial event. Pt still has a large area of visible erythema and blaching rash. Pt reports her symptoms are getting better at the time of visit.
Low blood pressure, sweating, low blood sugar, lowered heart rate, tunnel vision.  On site EMS monitored blood pressure, heart rate and blood sugar. I ate some crackers/snacks and drank water. Lasted about 5 minutes until I was feeling better after a snack and water (I had eaten a normal lunch/breakfast, etc that day). Afterwards, I was lethargic for the evening and the next day. I also have a history sith similar reactions to giving blood and other similar instances.
Shingrix Injection 50/0.5ml - right arm became swollen, painful, red, with hot hard knot about 2" x 3" - wasn't too concerned because I saw that was a fairly normal reaction.  But, it took almost 2 weeks for the swelling and knot to go away.  As of today, 2-1/2 weeks later, there is still about a 2" x 2" pale pink area.   I did not contact my doctor, but I will probably do so because I am wondering if I should have the 2nd shot or not.
Pt c/o headache and nausea prior to injection.  Pt sat an additional 15 min  BP: 136/74.  Pt states she felt better,   Supervisor identified.
Shortness of breath, rash that covered entire body. Patient never seeked medical care nor informed our office at same of adverse reaction.
Left sided Chest wall and rib pain 2 days after immunization.  Seen in local ED and dx'd as possible pleurisy, then possible Pneumonia
Rett's synd-not dx until AUG98 though exhibited regression in verbal & motor skills prior to being dx;dec head circumference from 50th percentile to 25th now down to 5th;  Per follow-up, ongoing pervasive developmental disorder-symptoms consistent with RETT syndrome, but, genetic testing negative for RETT gene. Pt requires 24 hour a day assistance/care/therapies.
On the night I received the COVID-19 vaccine, I had a fever that went up to 103 degrees Fahrenheit. In the morning 24 hours after I had the second dose of the COVID-19 vaccine, I felt a little better from the night's fever and ate instant ramen, oranges, acetaminophen, and a vitamin C tablet. This was at about 8:45 AM. A few minutes or a minute after I swallowed the acetaminophen and vitamin C, I got a severe allergic reaction that led to me going to the Emergency Room. I have eaten these things before and am not allergic to acetaminophen, vitamin C, or anything in the instant ramen. The reaction was first felt by a shortness of breath and I could barely breath. Then, hives started to form on my face and my lips and face became extremely swollen. I then ended up throwing up after my mom gave be a Benadryl pill and I drank another Benadryl after.  My face had become less swollen but it was still difficult to breath and hives started to form all over my body so we decided to rush to the Emergency Room. We got to the Emergency Room at about 9:30 AM and the hives on my body were worse. They were able to calm down the reaction by giving me more Benadryl through an IV and steroids. They knew I had the second dose of the vaccine so they did not give me anything that would suppress my immune system. Timewise, it could be the acetaminophen, but I have taken acetaminophen in the past many times before without a reaction.
I had the normal sore arm. I ended up the next day with stuffy nose, sore throat, tired, weak. The next day I had the post nasal drip and really fatigue and my sugars were running high, cough and swollen glands. The third day I went to the Doctor to get Covid test, it was negative. The Dr. said I had a chest infections, post nasal drip.  It took about two weeks to go away, they didn't want to give me any medication because they didn't know about the shot. I had two Covid test and they were negative.
I woke up with dizziness/vertigo, and continued to feel it like motion sickness especially when going up/down stairs or bending over.  Never experienced this before.  This was day 2 of menstrual cycle and originally thought perhaps due to that, but not a heavy period.  This was 12th day after 1st COVID shot.  Severe the first half day.  Persisted several days, though gradually got a bit better.  Treated with Benadryl, iron, vitamin C/D/zinc, rest, etc.
Fever, Chills, Body ache, sweating, shaking, vomiting, headache, nausea,
Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at time; This is a spontaneous report from a non-contactable consumer (patient) reported for herself that: A 36-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jun2021 11:15(Age at vaccination: 36-years) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient past Medical history included, food allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication and iron (IRON) taken for an unspecified indication. The patient previously took pcn 200 and experienced drug hypersensitivity, diflucan and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. 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 vaccine within 4 weeks prior to covid-19 vaccination. On 25Jun2021, at 23:00 the patient experienced Headache for 5 days starting 12 hours after vaccine.  Hot flashes, cold sweats, muscle aches and generalized malaise for 3 days after vaccine.  Currently breastfeeding and 5/8 weeks postpartum at times of vaccine. No treatment was received. The event outcome was Recovered on unspecified date.  Device Date: 01Jul2021  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021823853 same reporter/drug, different patient and event
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        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.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
This spontaneous case was reported by a patient and describes the occurrence (Left and right breast center of nipple has developed melia cysts.) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced  (Left and right breast center of nipple has developed cysts.). At the time of the report,  (Left and right breast center of nipple has developed  cysts.) had resolved.          Treatment medication information was not reported.
After second shot, my ears started running. I have been to three doctors because I'm suffering from Tinnitus. There is no help for Tinnitus; There has been many days where I don't even get in the car because I can't concentrate; I am very angry. Your covid vaccine has ruined my quality of life; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Sep2021 as dose 2, 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 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "unknown", described as "After second shot, my ears started ringing. I have been to three doctors because I'm suffering from Tinnitus. There is no help for Tinnitus"; IMPAIRED QUALITY OF LIFE (non-serious) with onset Sep2021, outcome "unknown", described as "I am very angry. Your covid vaccine has ruined my quality of life"; DISTURBANCE IN ATTENTION (non-serious) with onset Sep2021, outcome "unknown", described as "There has been many days where I don't even get in the car because I can't concentrate". The events "after second shot, my ears started running. i have been to three doctors because i'm suffering from tinnitus. there is no help for tinnitus", "there has been many days where i don't even get in the car because i can't concentrate" and "i am very angry. your covid vaccine has ruined my quality of life" required physician office visit.  Additional information: It was reported that the patient was very angry as the Pfizer's covid vaccine had ruined the patient's quality of life. After second shot in Sep2021, the patient's ears started running and have been suffering since then. Patient should be compensated for the misery and not only the one that is suffering from this and also reported as Pfizer make billions from just the Covid vaccine. Patient went to three doctors because of the suffering from tinnitus and there is no help for it. There had been many days where patient don't even get in the car because the patient can't concentrate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reported having dizziness, light headedness, and shortness of breath.  Patient was brought in to the exam room.  Vitals obtained, patient assessed by doctor, and observed by nurse.  After approximately 30 minutes symptoms improved and the doctor discharged patient to home.
Patient is a 57 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience itching.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and skin changes.   PMH: prediabetes, copd.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of itching of skin   Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, eye redness, cough, chest tightness, shortness of breath, wheezing, rash and dizziness       Previous Reactions: none. Did well with 1st dose of Pfizer but did have a headache that lasted for 5 days.     Objective    Vitals Vitals:   03/08/21 0906 03/08/21 0916 BP: 136/88 120/76 BP Location: Right arm   Patient Position: Sitting   Pulse: 97 90 SpO2: 96% 96%            Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not diaphoretic.  HENT:     Mouth/Throat:     Pharynx: Oropharynx is clear.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.     Findings: No rash.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: antihistamines pepcid and zyrtec Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Generalized itching.    She was observed in the medical bay for approx 15 minutes. She responded really well to the antihistamines. No further itching reported. No rash or other symptoms noted. She feels well to go home. Given handwritten instructions on medications received and when she can repeat if needed along with benadryl use.  Pt voiced appreciation of her care today. PT walked out by pharmacist.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021 at 9:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 72.34 for dose administered on 17-Feb-2021. No concomitant medications were reported. Batch number 022M20A administered on 17-Feb-2021 underwent temperature excursion with temperature of 22 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 11-Feb-2021 and beyond use date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I had arm sore at shot sight fever chills ache and pain tingling in hand and feet
Pt recv vax on 4/23/98; on 4/29/98 pt exp swelling, bubbling of    3 cm red, round circle w/ black&blue bull's eye at the injection site.  On 5/21/98 pt was recovered from exp.
Patient presents to the ED on 8/12/2021 with a temperature of 104F.  She also reports intermittent shortness of breath and cough for 1 week.  She also complains of some abdominal pain, nausea, and vomiting.  She was found to have a ureteral stone with pyelonephritis and was COVID positive.  For the COVID treatment, she required oxygen, dexamethasone, and remdesivir.  She received oxygen via nasal cannula from 8/12 through 8/16/2021, received 10 days of dexamethasone and 4 days of remdesivir.  The pyelonephritis was treated with antibiotics.