chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This issue might/might not have impacted this individual. We identified a possible storage and handling issue of one particular vial of vaccine that might have made the vaccine less potent on June 16, 2022.  Doses from this vial were given to 9 children on the date June 16, 2022. 17 children were vaccinated that day and we have been unable to identify which 9 children received doses from the vial that was impacted.  The vaccine was reconstituted and replaced into the refrigerator for what inadvertently became too many hours before it was used. We did extensive research with Pfizer, the CDC and the local Department of Public Health and have received documentation back from the correct medical unit at the company Pfizer, who researched this vaccine being out of range for possibly 2 additional hours than what they had data for as of June 2022.  Each of the 17 children is being offered an additional dose now, 8 or more weeks after the possibly ?invalid? dose and is encouraged to discuss this with their pediatric primary care provider, who has also been notified by me. We suggested the 8 week delay to potentially reduce the risk of side effects including myocarditis in children after an mRNA if another dose was given sooner. It has now been 8 weeks since that clinic and this child has been offered an additional dose.
She has fainted and pass out; She has fainted and pass out; She fell down and hit her head and all of her left eye; She fell down and hit her head and all of her left eye; she was like in pain; she needs help with her balance, walking; This is a spontaneous report from a contactable consumer (patient's grandfather). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 17 years of age), dose 1 via an unspecified route of administration, administered in arm right on 27May2021 17:15 (Batch/Lot Number: EW0187) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history was none. Family history included her grandmother had diabetes. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant. The patient did not have any prior vaccines. It was reported that the patient received Pfizer vaccine. She was under 18, she was 17 and she had a very bad side effect from it. She got her first dose yesterday (27May2021) and she had a bad reaction and was rushed to the emergency room. She fainted and passed out and she was like in pain and she was out like about four minutes. Just all of a sudden and then after she got out of it and then they needed to rush into the emergency room. She fell down and hit her head and all of her left eye. They took her to the emergency room. They did every test, they checked everything, and they said it was a bad side effect from the vaccine. She got her vaccine around, it was like about 5:15 pm in the afternoon and the incident happened like about 7:20, 7:30. She was trying to recover, she needed help with her balance, walking. She was trying to rest. The doctor in emergency room said that she had to rest, if side effects continue or happen again then she had to go back to the emergency room. Not really. They did some lab tests yesterday (27May2021) in the hospital. They don't know what they did. There was complete blood, there was CBC done. They did CT scan of her head, X-rays for her arm. They have here PMP, the reporter was not sure as they have different kind of blood test. They have calcium level 1, glucose level, there are so many different test names such as WBC and RBC. When asked about treatment it was reported that 'No, they did not prescribe her any medicine'. They told her for any pain, from the fall she found hit her head she could take Tylenol regular'. The events occurred on 27May2021. The outcome of 'fainted and pass out' was recovered on 27May2021 (she was out like about four minutes); 'she needs help with her balance, walking' was not recovered; while outcome of other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
The pt experienced a fever, right arm swelling, redness and warmth to the touch. On 9/22/00, the pt's fever has decreased and the pt is much better.
Developed arthritic pain in my hands and feet and right elbow.  Also had pain in left foot that lasted for 16 hours then disappeared spontaneously.
Tiredness and body aches lasting from the morning after the shot through the following night 100 degree fever lasting 3 hours, nausea lasting about 5 hours
First day itchy rash appeared on medial side of right bicep Second day itchy rash appeared on top of right bicep Third day itchy rash appeared on lateral side of right bicep
30 minutes s/p vaccination developed scratchy throat, no other sx VSS Transported to clinic for observation
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # L039660 for prophylaxis. On an unknown date the patient experienced incorrect product storage, poor quality drug administered and no adverse event. The outcome of incorrect product storage, no adverse event and poor quality drug administered is unknown. The reporter considered incorrect product storage, poor quality drug administered and no adverse event to be not related to Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB).; Sender's Comments:  US-009507513-1706USA005754: US-009507513-1707USA000534: US-009507513-1707USA000535: US-009507513-1707USA000536:
Patient had increase in sleep day after immunizations afebrile upon awakening. Mother noted infant to be gray in color, glossy eyed and poorly responsive for several minutes same day as shots
I began to develop some rash on my lower right leg, but thought it was Poison Ivy at first as that was what it looked like to me (even though it really was too early for it to have begun to sprout at that point as well as having had long pants on when I had been out in the yard). My regular doctor prescribed a 10 day script of Prednisone and it began to get better. A week or so afterward was when I received my 2nd dose of Pfizer (4/9/21) and the rash suddenly got much, MUCH worse - and it was everywhere! Legs, arms, torso. It itched INCREDIBLY badly. I asked my doctor for another script of Prednisone, but evidently they are remiss to give too much of that out for very long. I then went to a dermatologist that prescribed some topical cream (Desoximetasone) that did and continues to help. They also began to give me UV light treatments 2-3 times a week at increasing time amounts. It initially seemed to help but then began to get too painful, especially when the rash was particularly raging, so I stopped doing those and asked for more Prednisone. They eventually wrote me up for another stint of it though it seemed far less effective at this point. I was able to get into a different dermatologist at this point and had them examine me too. They took punch biopsies in both my arm and torso, which showed positive for Chronic Urticara. They started me on a heavy rotation of various antihistamines (at one point I was at 12 doses of 24 hour tablets a day) which never really seemed to do much. Knocked the itchiness down at that point, but the rash was always present and flared on a weekly-ish basis. They then prescribed a multi-week prescription of Cyclosporin which also never seemed to do that much. It has been 9 months now, and it continues to be (on a semi-weekly basis) just as bad as it ever was.
Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient of an unknown demographics who experienced pain, swelling and redness at the injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (also reported as one week ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient developed a non-serious pain, swelling and redness at the injection site, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was pain, swelling and redness at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
Person received  Pfizer COVID vaccine as first dose. Came to vaccine clinic one week earlier than scheduled and received Moderna for second vaccine.  There were no adverse reactions to either vaccine.
No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) in an adult 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. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-2022, 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 30-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30-DEC-2022 beyond MFG Expiration Date).    No concomitant medications were reported.  Vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was 30-Dec-2022.   The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 4th of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694396:MASTER CASE
On 2/14/03 at 21:30, child complained of headache and temperature was 104.9F so mother gave Tylenol. A short time later, the child had a seizure. She was transported by EMS to ER. After 5 hours of observation, she was released to home. Dx'd and treated for viral influenza, febrile seizure and fever. Rx'd Tylenol and Motrin.
2 d after flu shot given developed enlarging nodes on (L) side of neck only, no pain except opening jaw wide came in office 10-31-13 o/c persistent enlarging nodes - no tender, no inflam - all firm mobile - largest approximately 2 cm each at tonsillar and parotid but many - less than or equal to 1 cm in all (L) neck chains.
Approximately 10 min after receiving the vaccine pt started feeling nauseated. Pt stood up to go to the bathroom and had a syncopal episode. Pt landed face first onto the hard floor. Pt was treated by medics on scene and was taken into a private waiting room. During further assessment pt had another syncopal episode with his hr dropping into the 40's. Pt became pale and diaphoretic. Pt transported to ER via ambulance
Pt described that she had never had any skin problems until after she took the 2nd dose of Moderna COVID19 vaccine. She stated that not long after having the 2nd dose, she started itching. Her skin was so inflamed that she was unable to sleep at night for itching. Her feet were so inflamed that she was unable to wear regular shoes and has work sandals for the entire time since this started. Pt has been on Dupixent for atopic dermatitis for 3 months now and remarked she is greatly improved, able to wear regular shoes and able to sleep. However, she said she still can feel the underlying inflammation below her skin and it is very difficult.
Extremely reddened to swollen arm painful, numbness of fingers tx w/ATB & analgesic;
I was extremely tired, I had a queasy stomach and a headache. This lasted approximately 48 hrs
Dysphagia since vaccine.  Intermittent chest discomfort since vaccine. Angioedema of lip and tongue (12/07) (12/09 when seen in clinic) Given steroid and antihistamine for treatment at walk in clinic
looks like lymphedema; stomach wasnt bad enough to feel like throwning up; progressing and getting worse, not getting any better; right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm; really tired / fatigue; HEADACHE / sever headche; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (looks like lymphedema), ABDOMINAL DISCOMFORT (stomach wasnt bad enough to feel like throwning up), CONDITION AGGRAVATED (progressing and getting worse, not getting any better), PAIN IN EXTREMITY (right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm) and FATIGUE (really tired / fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Metastatic breast cancer (Start date  on 10-??-2021). Previously administered products included for an unreported indication: XGEVA on 31-Mar-2021 and FASLODEX on 31-Mar-2021. Concurrent medical conditions included Blood pressure, High cholesterol and Diabetes (Diabetes-type 2). Concomitant products included ESTRADIOL (ESTROGEN), PALBOCICLIB (IBRANCE), METFORMIN, DENOSUMAB (XGEVA), LISINOPRIL, ROSUVASTATIN and FULVESTRANT (FASLODEX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (really tired / fatigue) and HEADACHE (HEADACHE / sever headche). On 17-Mar-2021, the patient experienced LYMPHOEDEMA (looks like lymphedema), ABDOMINAL DISCOMFORT (stomach wasnt bad enough to feel like throwning up), CONDITION AGGRAVATED (progressing and getting worse, not getting any better) and PAIN IN EXTREMITY (right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm). On 16-Mar-2021, HEADACHE (HEADACHE / sever headche) had resolved. At the time of the report, LYMPHOEDEMA (looks like lymphedema), ABDOMINAL DISCOMFORT (stomach wasnt bad enough to feel like throwning up), CONDITION AGGRAVATED (progressing and getting worse, not getting any better), PAIN IN EXTREMITY (right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm) and FATIGUE (really tired / fatigue) outcome was unknown. Not Provided      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.   Treatment includes softly massaging those areas.  For metastatic breast cancer CT scan was performed and showing changes.   This case was linked to MOD-2021-280024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow-up received on 06-AUG-2021 and added Race information, Ethnic group, Medical history and concomitant medication
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced pneumococcal pneumonia. The patient received the fourth dose on 03-Aug-2004. The nurse reported that the patient experienced pneumococcal pneumonia after receiving the completed immunization series of PREVNAR. The child experienced pneumonia 2 to 3 times and was referred to the hospital for evaluation. The evaluating physician suggested that the child have a blood test for immune response and a PREVNAR booster. At the time of the report, it is unknown if the patient recovered. See related case(s): US-WYE-H03100208 (overdose without AE, non-expedited). No additional information was available at the time of this report.
Erythema & swelling, 10cm x 10cm, (R) deltoid, 24-48 hours after Flu immunization. Pain, decreased mobility x 24 hours; resolving at 48 hours. No fever, no joint pain, no other rash.
Large welts on body approx. 1 day after Flu and Pneumonia vaccines. Rash spread throughout body (facial, skin erythema).
bleeding out of her left ear; The injection site feels like bruising; This is a spontaneous report from a contactable consumer (reporting for mother in law). A 90-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284, expiry date unknown), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. Medical history included patient was diabetic. The patient's concomitant medications included that patient was on blood thinner (unspecified). Reporter's mother-law (patient) received the Pfizer Covid vaccine yesterday (also reported as today), Jan2021. About 5 hours after receipt of the vaccine, patient was bleeding out of her left ear. It's been an ooze, like a capillary bleed. It's intermittent but it has not stopped. This was her first dose. She can hear OK and the ear was not painful. Her respiratory system seemed to doing fine. The injection site felt like bruising (Jan2021). The site looked fine, no bruising around the band aid and no swelling. She has never bled from her ear. There have not been any medication changes and no known damage to the ear. Patient asked if bleeding in the left ear been associated with the Covid vaccine. No treatment was received for the event bleeding out of her left ear. The outcome of the events bleeding out of her left ear and injection site felt like bruising was unknown.
Prior to receiving the Moderna vaccine, I had an extremely mild case of tinnitus (minor ringing in my ears that would typically go away after a few minutes).   Within a day of getting the vaccine the ringing in my ears is now constant, has increased several decibels and has resulted in some hearing loss.
Patient returned to pharmacy about an hr later with chief complaint of redness. Her arm did not present with severe redness.
I have a bubbly rash on the right side mostly on my arm, inside my elbow, wrist, upper thigh, back of calf.; This is a spontaneous report from a contactable Other HCP (patient) reported for herself that: A 53-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 14Jul2021 12:00 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 23Jun2021 12:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization(Age at vaccination 53 years). The patient past Medical history was not reported. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient experienced a bubbly rash on the right side mostly on my arm, inside my elbow, wrist, upper thigh, back of calf on 20Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: Nasal Swab negative on 04Aug2021. No treatment was received. The event outcome was not recovered.
Within 20 minutes of vaccine injection, feeling hot and feverish. That went away after a couple hours. 3 days later, the development of full body hives which were extremely painful and unbearably itchy to the point of not being able to sleep for a few nights in a row. Eventually after a few days, Benadryl was taken and the swelling and hives went down.
A non-serious spontaneous report of positive for influenza was received from a physician concerning a five-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 19-SEP-2009. Two days later on 21-SEP-2009 the patient presented with a fever of 103, headache, sore throat, sneezing and nasal drainage. He was being treated with various medications for these symptoms. The patient tested positive for influenza. No outcome was provided.
Family member came to visit with 12 year old son.  The day after arrival, his energy was low and he did not want to go out.  His mother thought it was a summer cold until receiving a call that kids he played with before arrival tested positive for Covid.  Two days after that I became lethargic and then tested positive.  My house is small and we shared space, to include my car, in enclosed space.
after a few minutes patient had tingling in the left deltoid injection site, fatigue and numbness in the left leg, and mild nausea. Vital Signs temperature 99.5, respirations 18, pulse 18, blood pressure 113/77, Oxygen Saturation 98% on room air. Water and a snack given, patient then felt better. reported to Dr. and to make f/u appointment, and to provide ER precautions to go to Urgent care or ER that night if symptoms worsens.
Day 8 post vaccine (4/1/2021), my left arm became sore again, had a rash, and was swollen. Along with the arm issues, I got diarrhea, burning throughout my body, neuralgia, headache, stiff joints, and aching muscles. April 7th, I started to get psychiatric symptom of mania. I HAVE NO HISTORY OF BI-POLAR ILLNESS, TAKE NO PSYCH MEDS, AND AM TYPICALLY EVEN-TEMPERED!!!!!My husband noticed pressure of speech, my not sleeping and eating, and I feel like a whoosh of energy courses from my feet to my head continually now. At times I feel panic, although I have nothing externally in my life that would cause such symptoms. I had to call al shrink at midnight on 4/10/21 to get an Rx for Ativan. I AM LIVID IN MY NEW MANIC STATE!!!! I hate taking drugs because another drug messed me up!