chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion for Lantus, Toujeo, And Apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7F reported with no reported adverse event; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced temperature excursion for lantus, toujeo, and apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7f reported with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] And While Treated With Insulin Glulisine [Apidra], Insulin Glargine [Lantus] And Insulin Glargine [Toujeo] via solostar.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking Insulin Glulisine Unknown dosage unknown (lot - 0F789C), Insulin Glargine Unknown dosage unknown (with an unknown batch number) and  Insulin Glargine Solution for injection dosage unknown (with an unknown batch number).  On an unknown date, the patient received a  dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number not reported.  On an unknown date the patient developed a non-serious event  "temperature excursion for lantus, toujeo, and apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7f reported with no reported adverse event" (product temperature excursion issue) (unknown latency) following the first dose intake of INSULIN GLULISINE, (unknown latency) following the first dose intake of INSULIN GLARGINE of INSULIN GLARGINE and (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported "in a temperature excursion for Lantus, Toujeo, and Apidra. Excursion occurred on 12Feb2022 due to human error; total time out of range is 13 hours with a maximum temperature of 48.7F reported."  Action taken with Insulin Glulisine (Apidra), Insulin Glargine (Lantus), Insulin Glargine (Toujeo) And Meningococcal Vaccine (Menactra) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Temperature excursion for Lantus, Toujeo, And Apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7F reported with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion for lantus, toujeo, and apidra due to human error, total time out of range is 13 hours with a maximum temperature of 48.7f reported with no reported adverse event.
Immediately after being vaccinated (within 1 minute) he felt dizzy, hot, and light headed. He was lowered to the floor and given smelling salts. Ems evaluated, monitored for appoximately 30mins and then was felling better. Patient went home.
Case number PHEH2012US017186 is an initial spontaneous report received from a medical assistant on 29 Aug 2012. This case refers to a 1-year-old male infant. The reporter stated that this infant might have been vaccinated with MENVEO (batch number: A10132) intramuscularly on 22 Aug 2012. The reporter also stated that it is also possible the patient might have received Hepatitis vaccination and not MENVEO. This information was documented in patient's chart. No other information was available.
Arm soreness; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.  The patient had no known allergies to food, medications and other products. It was unknown if the patient diagnosed or tested positive for COVID-19. It was unknown if the patient had acute illness at the time of vaccination or up to one month before. Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension and Sleep apnea.   On 22-Oct-2021 at 7:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.  Patient has no known allergies.  No treatment medications were reported.  This case was linked to MOD-2022-522998 (Patient Link).
MUSCLE STIFFNESS IN LEGS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced muscle stiffness in legs, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle stiffness in legs, and tiredness. This report was non-serious.
Received vaccine on 10/27. The following morning she reported to work (in a lab). was standing when she felt vision go grey and had syncopal event (unwitnessed) striking head on floor. subsequent days reported mild "brain fog", difficulty concentrating when she reported to my office on 10/2 for evaluation. I felt she had a syncopal episode and a mild concussion from the floor strike (she doesn't recall if she ate that morning, just that she felt "unwell" the morning after the vaccine.
Approx 15 min after receiving flu vaccine, began to itch in lower (L) arm. Itching continued to spread to face and scalp, and the rest of body. Headache began approx 4 hours after vaccine was given.
Swelling, hardness, and bruising on left shoulder within the next 2 days. No other symptoms noted from patient.
When I woke up I had a migraine and I took some Tylenol and that did not cut it. I took some ibuprofen and that did not cut it. That stayed until 11 pm. I was getting nauseous. The next day I had a little bit of coughing so I went to get tested for Covid at the pharmacy. It came back negative. I did not know if that was related to the vaccine or just a bug I caught, Since then I have had a lingering cough but nothing too concerning.
This spontaneous report was received from the Vaccine Coordinator referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
SOB, Itching in throat  Resolved by PO Benadryl-50mg  Negative for Hives  Pt. Left Via Personal Vehicle
No Adverse Event; Caller reports that improperly stored vaccines were administered. No other adverse events reported. No product quality complaints. No further information.          ?    Names of vaccines involved (including lot/exp) GARDASIL 9 (lot: U031056 exp: 06; This spontaneous report was received by customer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAR-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #U031056, expiration date: 16-JUN-2024, (, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  Administered dose of vaccine experienced the temperature excursion of - 40.0 degrees Fahrenheit for 70 hours and 5 minutes. No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2305USA008276
syncopal reaction directly after administering vaccine.  patient was seated, did not hit his head, and came to within 30 seconds
he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail.; sensation as if you had oil on your skin.; he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail.; This is spontaneous report received from a contactable consumer (patient) via medical information team. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on thursday, on the same side he received the injection he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail Mar2021. Patient describes the pain as not severe, only noticeable when he touch something with his finger, he also called this symptom "jalapeno finger" from what he found on the internet and mentioned it was a sensation as if you had oil on your skin. Referred patient to his HCP. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
7 days after injection,  arm swollen and hard to touch. Painful,  tender, hot, small rash. Swollen area circular about 5 inches in diameter
Shaking of extremities; Fever 100.8F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking of extremities), PYREXIA (Fever 100.8F) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced TREMOR (Shaking of extremities), PYREXIA (Fever 100.8F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking of extremities), PYREXIA (Fever 100.8F) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-067030 (Patient Link).
Patient has a red, raised rash with itching that is present at site of injection that wraps around to back of arm - rash is still present 14 days later.
Came down with the shingles; pain went from my arm into my chest; pain went from my arm into my chest; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Came down with the shingles), pain in arm (Verbatim: pain went from my arm into my chest) and chest pain (Verbatim: pain went from my arm into my chest). The outcome of the shingles, pain in arm and chest pain were not reported.   It was unknown if the reporter considered the shingles, pain in arm and chest pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain in arm and chest pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by patient via interactive digital media. The patient stated that he/she had heart attack, infact that was what the patient thought he/she was having, the pain went from patient's arm into his/her chest, and patient had the shingles shot and came down with the shingles the very next day. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Pharmacist told him that the injection had been subcutaneous; Has a large knot that he can move around, it is posterior to the deltoid; A spontaneous report was received from a health care professional concerning a 50-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced a has a large knot that he can move around, it is posterior to the deltoid (Injection site mass) and  pharmacist told him that the injection had been subcutaneous (Incorrect route of product administration).  The patient's medical history was not provided. Concomitant medications were Amlodipine and Descvy.   On Unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19-Jan-2021, the patient received the second dose of two planned doses of mRNA-1273 (Lot Number: 028L20A) subcutaneously in the right arm for prophylaxis of COVID-19 infection.  On 19-Jan-2021, after receiving the vaccine, the patient experienced large knot that he can move around posterior to the deltoid. Treatment for the event was not provided.  On 21-Jan-2021, the pharmacist told him that the injection had been given subcutaneously. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, large knot that he can move around, posterior to the deltoid is unknown. The outcome for the event, pharmacist told him that the injection had been given subcutaneously was considered resolved on 21-Jan-2021.; Reporter's Comments: This case concerns a 50 years old male patient, who experienced incorrect route of product administration, and a non-serious unexpected event of injection site mass. There were no reported AEs associated with this case of incorrect route of product administration. The events of injection site mass occurred 1 days (same day) after second dose of mRNA-1273, lot # 028L20A. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events (injection site mass) a causal relationship cannot be excluded.
Patient received vaccine on 5/21/2018 and came to clinic on 5/24/2018 to have PPD read and stated would like for me to look at arm where got vaccine at, states is tender and red but states arm is better than it was yesterday (5-23-2018). NP also look at arm, was instructed to apply warm compress to it and if worsens or feels hard to return to clinic. Patient voices understanding.
fifty cent piece size red area, warm to touch of lt thigh;not painful to palpate;
Upon leaving the hospital, I felt very lightheaded and nauseated.  On my drive home, I was forced to pull over because I felt that I could not take a deep breath and my heart was beating very fast.  The dizziness and nausea continued, but the breathing issues was not severe and I continued home.  For the next three days, the nausea was constant and I had severe brain fog such that I could not concentrate or focus.  I called in sick the following day as I did not feel that I could safely do my job as an ICU nurse.  It eventually all passed, but took many days to feel normal again.
A week later had a small red spot size of a qaurter that was raised on same spot that shot was done on arm.  It was also little itchy and lasted maybe 48 hrs than went away.
I went to the outpatient clinic for a COVID-19 test and came back positive. It happened in August, or September. I had flu like symptoms. I was not prescribed any medication; I just took Tylenol.
Blisters on left side of face, in nose and mouth, tingling nerve pain, severe stabbing headaches, ear pain, teeth pain. Went to Urgent care facility and diagnosed with shingles. Prescription for valtrex and OTC motrin taken routinely for over a week.
horrible dry mouth conditions for 6-7 weeks; He has only been able to sleep on average 3 to 4 hours a night; awoken every 20 minutes all night long and many times had to urinate; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that caller is a 65 year old male who states that "almost exactly" 3 weeks after receiving his second dose of the Pfizer BioNTech COVID-19 vaccine, he started experiencing "horrible" dry mouth conditions for 6-7 weeks. He states that due to this persistent dry mouth, he has only been able to sleep on average 3 to 4 hours a night for the past 6 to 7 weeks. Caller reports that he had just come back from an ENT specialist regarding this and was told by this doctor that he has seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination and/or COVID-19 itself. Caller states that his doctor also referenced an article in a British journal that came out a few days ago that stated COVID-19 is shown to infect the salivary glands. He states that his doctor is unable to give any further recommendations other than give him things to keep him comfortable such as Salagen. Caller also mentions that after receiving the vaccine, he was being awoken every 20 minutes all night long and many times had to urinate but reports that this side effects has subsided. He states he read on Twitter about a woman who also had COVID-19 who reported having "bad" dry mouth and "was urinating more often than she had in her whole life." Caller would like to know if there have been any reports similar to his side effects that he experienced after the vaccine. Caller is concerned about whether they could be related to the vaccine or to having COVID-19 (which he does not state that he has). Outcome of the events was recovered.  No follow-up attempts needed. No further information expected.
Extreme pain and swelling at injection site, pain into lower arm and arm pit. Extreme exhaustion, body aches and slight headache.
No symptoms but blood tests showed greatly abnormal Myeloperoxidase which is high risk for blood clots ,stroke or heart attack.
approx 4min p/vax & w/in 1min of vax pt had an anaphylactic rxn;pt given epi, ventolin puffs, Solumedrol IV, 02 & was sent to hosp via amb for further w/u;
Pt recv vax on 1/10/97; on 2/5/99 pt exp varicella breakthrough
Subject in pneumococcal vaccine trial, with severe COPD, was scheduled with PCP visit. PCP ordered PET scan and MRI; results showed abnormalities in R lung. Lung specialist performed biopsy and Stage 3A carcinoma was diagnosed. No hospitalization or emergency department visit associated with this event. We would be happy to forward the Study's SAE Report Form upon request.
Mother reported child c/o pain in right upper arm, noticed swelling, reddness.  Gave Tylenol and this AM noticed it was worse, and swelling around to side of arm.  Tylenol did not help pain and swelling is getting worse.  Instructed to put ice on it and mother stated she had been.  Instructed to call physician.  Mother stated she would.  Called back and mother reported she was taking child into clinic.  Reported to mother that child had received Dtap/IPV and MMRV both in the right arm.
Patient has an egg shaped red patch on her left arm. Patient says she's experienced itching. She used Benadryl and Hydrocortisone 1% cream over the counter. Patient stated this happened to her before a couple years ago, she went back to that doctor's office and they administered a steroid shot. Patient report event to pharmacy today 9/24/2017 around 3pm. Patient was advised to continue taking Benadryl and Hydrocortisone 1%. Pharmacy provided more OTC medication to patient at no charge.
This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received first dose of TRUMENBA, at single dose and second dose of MENACTRA, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms on an unspecified date for 3 days with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2019170863 Same reporter/products/events, different patients; US-PFIZER INC-2019170864 Same reporter/products/events, different patients.
Was given my first set of Covid Vaccines april 9th and 30th 2021. Since then I had longer period cycles and missed periods. I have always been on a 28 day cycle since I was 14.   Got boosted on December 21st and have not had a cycle since novemever 15th