chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a plenty of unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (route, dose, frequency and lot # not reported). On an unknown date, the patients experienced pain, swelling and redness at the injection site. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
I few hours after I received a shot my arm hurt, within 12 hours right above where I received a shot waas incredibly painful. I took Tylenol ,it subsided it has continued to hurt since then.  If I touch the spot above my shot it hurts worse. When I received a shot it did hurt when she stuck me, but I do have upper arm  muscles .I am in shape, no fat on my arm. Some wondering if injecting it into my muscle is the reason why my arm hurts so bad. I compared notes with my friend whose 40 also in shape and his arm hurts like heck also.
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves female patient (age unknown) who received vaccine ACT-HIB. The patients past medical history, concomitant medication and family history were not provided. On 07-Dec-2018, the patient received a first dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On 28-Feb-2019 she also received a second dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was an actual medication error due to inappropriate schedule of vaccine administered. It was reported that patient was administered the first ACTHIB on 07-Dec-2018 and the second on 28-Feb-2019. The reporter nurse stated that patient was given the vaccination earlier than the recommended intervals. It was unknown whether adverse event occurred after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
miscarriage of the 16-17 week fetus; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number : ER8730), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 16:30 as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medications included unspecified prenatal vitamins. The patient did not have other vaccines in four weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient had a miscarriage of the 16-17 week fetus. The patient had surgery to remove the fetus and tissue. The mother was due to deliver on 09Sep2021. The outcome of the event was recovering. The patient had a nasal swab COVID-19 test on 22Apr2021 with a result of negative. The event was reported as life-threatening.
PATIENT HAD LARGE RED, INFLAMED, WARM TO TOUCH AREA ABOUT 3 INCHES BELOW INJECTION SITE. IT STARTED AFTER RECEIVING INJECTION. SHE WILL USE ICE ON THE AREA, AND POSSIBLY BENADRYL. SHE WILL NOTIFY HER PRIMARY PROVIDER OF ADVERSE REACTION AS WELL.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
tendonitis appeared right away, within 1 month of first shot and has been there ever since.  Chest pain started 2 months after the vaccine.
Blood pressure has significantly increased / Started seeing high blood pressure after June 145/90 / seeing high from June; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included low blood pressure until Feb2021. On an unknown date in Feb2021, the patient had her physicals done and her blood pressure was normal 120/80 (unspecified units). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Jun2021, the patient's blood pressure had significantly increased and she started seeing high blood pressure; she had high blood pressure of 145/90 (unspecified units) after Jun2021; nothing else changed other than the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On an unknown date in Jun2021, the patient underwent blood pressure test and the result was 145/90 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blood pressure had significantly increased, she started seeing high blood pressure and started seeing high blood pressure of 145/90 (unspecified units) after Jun2021 was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever up to 105.7 and febrile seizure 9 days after MMR, VARIVAX, and Hib administered.
FROM ED physician; Sepsis, Respiratory   History: Patient presents today with fever, URI symptoms, shortness of breath, tachycardia.   A month ago patient was diagnosed with an E. coli GI infection.  He was then seen for upper respiratory symptoms on 9/23/2021 and treated for pneumonia with Omnicef.  Patient returned a week later finishing the Omnicef but then had bloody mucousy diarrhea, he was presumptively treated for C. difficile with oral vancomycin no testing done.  He then again returned with the diarrhea resolved but then having ear pain and upper respiratory symptoms.  There was some drainage so they decided to treat the patient with eardrops but normal oral antibiotics though they felt this with a perforated eardrum.   Patient presented to clinic today feeling shortness of breath and generally unwell.  Found to be febrile to 101.6 and was transferred over to the emergency department for further work-up and treatment.  They have given a DuoNeb and given 125 Solu-Medrol, patient does not have a history of chronic lung disease that they know of.  Antigen testing for Covid was negative.  10/21:  Diabetes Education   Assessment:  Referral to see pt with newly diagnosed pre-diabetes with hyperglycemia.  Pt received IV steroids on adm.  Pt now adm with bilat pneumonia, recent C diff. He was on oral steroids in late Sept for cough/wheezing. Pt resting in bed with O2 in place.  He states that there are no plans for dischg today-waiting to be seen by Infect Dis Doctor met with pt and wife to discuss normal blood sugar and AIC levels.  Pt has no hx of elevated blood sugars but he does have family history of diabetes in his father. Discussed symptoms of hyperglycemia and current use of Novolog insulin if blood sugars elevated.  Discussed plans for Endo to see and possible need for oral diabetes med. Discussed effect of diet, exercise and meds on blood sugars.  Pt states he hasn't been as active this Fall as he's been ill with "one thing after another." Written information provided for pt.  Will also ask dietitian to see.   To ED for : Pneumonia of both lungs due to infectious organism, unspecified part of lung  Note from SF nurse: Shortness of breath gettung worse over the past two weeks. Has had 3 covid nedative tests.. Has had  A combination of blood in stools and diarrhea.. also has had  ecoli which has been treated..  PER ED HOSPITALIST: Patient Active Problem List Diagnosis ? Elevated cholesterol ? Herpes simplex ? Prostate cancer ? Family history of colon cancer ? Pneumonia
Double Vison - Cranial Nerve VI Palsey - Lateral Rectus Palsey left eye
Vaccination was for the Flu (Fluad (65+) PFS 2020-21 INJ 0.5 ml   Serial # unknown  Swelling of the right side of the face.  Slight swelling still present after 72 hours.
I had BOTH the Shingrix vaccine and a flu shot (fluarix quadrivalent 0.5 ML INJ GLAX NDC:58160-0885-52) in the same arm at the same time. I took 2x 220 naproxin sodium about 30 minutes afterward. I had malaise and fatigue in the afternoon and retired early.  I awoke around 1 AM with a high fever (not measured), severe headache, intense fatigue, and skin painful and sensitive to touch and movement. I took 2 more naproxin. Symptom severity receded by about 3:30 AM. By morning my fever was 99F (measured) and headache and skin sensitivity lesser though not gone. I had 2 regular strength acetiminophen around 9 AM. By evening all symptoms other than fatigue and injection site sensitivity were gone.
Hives started in appearing in twos just on the side of my body where the shot was given. Every day for about a week two more would pop up and itch for a couple days. Now today, two weeks after the vaccine,  they are starting on the other side of my body.
C/O arm soreness and hand and fingers became tingling approx 1-2 hours after vaccine. Then tired and vomiting X2 at about 2-3 hours with headache, dizziness. Seen at ER received Sofran, Benadryl and Motrin.
Sedation, Myalgia, Diarrhea & NASAL CONGESTION
Knot at the anterior of the elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knot at the anterior of the elbow) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced JOINT SWELLING (Knot at the anterior of the elbow). At the time of the report, JOINT SWELLING (Knot at the anterior of the elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded
Temperature excursion with Moderna COVID-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 40-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 28-Feb-2023, 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 28-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with Moderna COVID-19 vaccine).    No concomitant medications were reported.  The temperature excursion occurred for both monovalent and bivalent. 9 doses of monovalent doses given. Multiple doses of 1st & 2nd doses administered. 27 total doses were administered post excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master case
The week prior to delivery (3/22), I started feeling shortness of breath and a headache. I thought it was just normal pregnancy symptoms. That Friday (3/26), I noticed swelling in my ankles. I am a teacher so I asked my school nurse to check my blood pressure; it was high (for me) around 144/88. She said I should call my OB and let them know. I did, and they said to rest for the weekend and they'd see me on Tuesday for my 29 week appointment.   We had a weekend trip planned. We took our son there. The next night, I didn't feel right. My belly felt hard to me and I wasn't feeling my daughter move as much, but soon after, I went to sleep. Our two year old son woke us up crying around midnight, and I noticed that I started bleeding when I went to the bathroom. My husband drove me straight to the emergency room. I was diagnosed with sudden and severe preeclampsia. My fibrinogen levels were 100% indicative of a placental abruption. They called the transport team in from hospital so they could transfer my daughter immediately after birth. At 5:57 am on 3/28, my daughter was born via emergency c-section. She is currently fighting everyday at the NICU in the hospital.  On Friday, 4/2 I was readmitted for severe preeclampsia to hospital. My blood pressure was 190/115. I had to receive another round of magnesium sulfate. I was released from the hospital on Sunday, 4/4.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient ws vaccinated with PNEUMOVAX23 (dose and route unknown). It was reported that the patient developed an unspecified rash at the injection site "shortly after" administration of PNEUMOVAX23 (onset date unknown). It was also reported as therapy discontinued and not reintroduced. The outcome was unknown. Additional information has been requested.
Severe onset flu s/s. Intense bone pain, muscle pain, weakness , inability to stand, legs buckled twice slipping to the floor, unable to think clearly, and generalized Bee Sting sensations, inj, site hard, red swollen. For the next three days following- hypotension- BP 100/60 ( meds held), continued symptoms, pale. Day 4- s/s lessening.  Day 5- able to return to normal activity. Day 13 - return on left arm inj. site redness & pain, return of fatigue, illness, weakness. Fingers and feet with same Bee Sting sensations with occasional generalized . Illness rebound for approx. 3 days.
Headache, slight nauseated feeling for 2 days.  Headaches lasted 3 days.      Tylenol
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 12:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 12:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received vaccine past its 30 day expiry date The vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose.  No treatment information was provided.
The vial was stored in fridge greater then 12 hours post puncture; No adverse event; Dose administered greater then 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture), EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2022 at 9:45 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022 at 9:45 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture), EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture) and EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture). No relevant concomitant medications were reported. It was unknown whether the vial was initially stored in the refrigerator. The vial was first punctured on 13-May-2022 at 8.15 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. It was unknown whether the vial was exposed to room temperature range (8° to 25°C, 46° to 77°F). Was stored in freezer until 13-May-2022 and then in fridge the entire time. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2022: Follow up received: no new information. On 16-Aug-2022: Follow up received: vaccination start date updated.
This spontaneous report as received from the patient's mother refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (Lot # not provided) (dose, route and frequency not reported). No other co-suspects were reported. No concomitant therapy was reported. The patient's mother reported that on an unknown date the patient experienced has been suffering "central nervous system adverse event" after vaccination with GARDASIL. The patient experienced psychiatric events, tachycardia, memory loss and vision problems. The outcome of central nervous system adverse events, vision problems, memory loss, tachycardia and psychiatric events was unknown. Additional information is not expected.
This spontaneous report as received from a nurse practitioner refers to a eight unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patient was vaccinated with improperly stored doses of VARIVAX (lot # M009768 and expiry date 23-FEB-2018) (dosing regimen unknown). The vaccine was exposed to temperature excursion of 20 F for 3 hours. Previously the vaccine was exposed to 34 F for 3 hours. The call was due to data digital logger. No adverse effects were reported. No product quality complaint (PQC) was filed. This case was cross linked with the case 1611USA010902 via same reporter link. Additional information has been requested.
I have had joint pain in my knees for many years, but the pain is bearable. After the shot, inflammation and pain in my knees was much worse. There have been days in the past four months I have not been able to walk, drive or sleep.
4 y/o female  had vaccines to bilateral thighs  on 4/25/22. C/O skin rash today. Pt had quarter sized area of erythema to left thigh. Tiny area to right thigh. DC home with no antibiotic.