chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner and refers to a currently 17 year old female patient. There were not patient's medical history, concurrent conditions and concomitant therapies. On 06-AUG-2018, the patient was vaccinated with VAQTA intramuscularly, lot # R013858, expiration date: 12-JUN-2019, for vaccination (strength, dosage and frequency were not provided). The reporter stated that on an unknown date, the patient experienced headache that lasted for one month. Therefore, the patient saw an unspecified healthcare professional regarding the headache who prescribed unknown treatment. The patient's conditions was currently resolved. There were not laboratories diagnostics performed. The reporter did not provide causality assessment between the event and VAQTA.
I started feeling bad on Tuesday the ninth at 8 PM fever sweating chilling severe headache joint pain and I didn?t start feeling  Little better until Thursday  The 11th  at 10 AM but still having spells where I?m sweating and chilling I went to bed At 8 PM on Tuesday the ninth and did not get up until 10 AM on Thursday the 11th
After 2 hours had severe pain on left side; Threw up no less than 6 separate times; A spontaneous report was received from a consumer concerning a 70 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain and vomiting.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 19-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) route of administration unknown and anatomical location unknown for prophylaxis of COVID-19 infection.  On 19-JAN-2021, the patient experienced pain on the left side and vomiting. No lab or treatment details provided. Patient is enquiring about taking the 2nd dose safe or not. Agent called back reporter on 27Jan2021 at 11:02am EST and was unable to reach. Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event (pain and vomiting) was unknown.
Had shot and a year later had shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and a year later had shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and after a year later he/she experienced shingles so the patient stated that shingles can happen. 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.
This spontaneous report was received from a Pharmacist referring a female 50 year old patient. The patient's medical history and concurrent conditions were not reported. On 27-AUG-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection (dose, route of administration were not reported, lot # L040178 with expiration date 18-AUG-2017) because the patient was a smoker. EFFEXOR XR 75mg (manufacturer unknown). On the same date the injection site of the patient had redness, warmth to the touch, swelling and a knot was felt and there was pain in the armpit area; the arm had swelling around the arm and past the elbow. The events were recovered within a week, on approximately 03-SEP-2016. The reporter stated that a product quality complaint was not involved. The causal relationship between the events and PNEUMOVAX 23 was unknown. Multiple cases reported by primary reporter for PNEUMOVAX 23. Additional information has been requested.
Pt was sitting at a table and started to get up, suddenly collapsed and stopped breathing. Pt was a resident of an assisted living facility and was a  DNR so facility staff did not attempt CPR. Pt was transported to ER where he was pronounced dead.
This spontaneous report was received from a certified medical assistant and refers to a 20 month old patient of unknown gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose, site of administration were not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.
Vaccination at 3:00 PM on 1/28/2021. Woke up at midnight on 1/29/21 ( 9 hours later) aching all over with oral temp of 102.8 F. and aching all over. Took acetaminophen. The morning of 1/29 her left side hurt very bad and she still had a fever. At noon here temp was 100.6 oral and at 6:00 PM it was 101.7 oral. Continued achy and tired. On 1/30/21 continued with being tired with sore arm. Better by 1/31/21.
Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients received doses of RECOMBIVAX HB (route, lot#, dose and frequency unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
VERY WEAK; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a male 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very weak, fever, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, bad headache and very weak was not reported. This report was non-serious.
his arm was sore; little tired; arm is just tender to touch; This is a spontaneous report from a contactable consumer (patient) by a  Pfizer sponsored program.   A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 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 and concomitant medications were not reported. The patient received vaccine for pneumonia (shot too) and experienced sore arm and tiredness. The patient stated that his arm was sore, he felt a little tired (as for pneumonia shot) and arm is just tender to touch. Patient would like to know if taking amoxicillin would have any effect on the vaccine. Outcome of the event arm is just tender to touch was unknown while outcome of the other events was recovered (he is fine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 16-JUL-2013  the patient was inadvertently administered a 4th dose of GARDASIL (lot#, expiration date, dose and route not reported). No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Presented with full-body urticaria (hives); dermatographia (?skin writing?).  Treated with 10 milligrams (mg) of antihistamine (Zyrtec [cetirizine]) once-to-twice daily.  Symptoms have continued to-date for 19 days, as of this reporting (19 Dec 2021).
Onset of symptoms upon waking up the following day. Severe body aches, drowsiness/fatigued/tired, vomiting, shivers/chills. Symptoms persisted for about 24-48 hours.
Rheumatoid arthritis flare up; Flu like symptoms; This is a  report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1160362) at unk (cf) and second regimen since 2015 (Lot number: 1160362) at weekly (unk unk, weekly (cf dose increased (1 in 1 wk))), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". The action taken for adalimumab was dosage increased.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flu like symptoms" related to BNT162b2.  Clinical Course: On unknown dates, the patient experienced Rheumatoid arthritis flares and flu Like symptoms with covid vaccine. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of rheumatoid arthritis flares and flu like symptoms with Humira vaccine was not provided. Causality for covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) of rheumatoid arthritis flares was not provided and for flu like symptoms was provided as Possible with covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of rheumatoid arthritis flare up" ,flu like symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Crabby day p/vax & next 3 days 4-5 days following vax broke out w/a few pimple-like spots on various parts of body; no temp; MD not called;
Patient began having increasing shortness of breath about a week after receiving first dose of Pfizer COVID-19 vaccine.  Symptoms worsened and persisted to the point where patient called her PCP on 1/26/2021, who advised her to report to ED if experiencing worsening symptoms and/or low oxygenation.  Patient reported to ED on 1/29/2021 due to tachycardia and O2 sats <90%.  On presentation, patient was found to have bilateral pulmonary emboli involving the upper and lower lobe regions bilaterally  including segmental branches without evidence of right heart strain.
This non-serious medically confirmed report (initial receipt 10-OCT-2014) concerns a 84 year old female patient. No additional medical history was provided. Concomitant medications were not known. It was unknown whether the patient had received and tolerated the influenza vaccine in the past. On the 10-OCT-2014, the patient received AFLURIA (batch number T58106) 0.5 ml once. The vaccine was received via the subcutaneous route in the abdomen, a medication error. No adverse reactions were reported. Outcome was reported as recovered. Reporter comments: The reporter stated that the case was non-serious and a medication error.
Two days after my second COVID vaccine I felt pretty bloated although my fatigue/chills/aches from the previous day had subsided.  That night I got hives on my neck, shoulders, chest, breasts and upper abdomen.  They were not itchy and went away without treatment that night but I got up in the night to go to bathroom and had small amount of blood from rectum.  The blood from rectum and bloating has continued.  It is only a small amount of bright red blood but has occurred about 5 times since that second dose of vaccine.
Rash, eczema. Finally was given hydrocortisone around age two. Child still suffers from eczema.
High fever for 48 hours (102 degrees)  mild fever after for 24 hours after the initial 48  (100 degrees).  Very achey all over and lathargic.
23JUL92 pt recvd 1 dose of Engerix-B & 96 hrs later during the evening of 27JUL92 devel nausea, chills, lowgrade fever, soreness/redness @ inject site; 28JUL92 was feeling better but still had some sx;
Pfizer 3/24/21, 4/14/21. Positive on 12/25/22
hives/rash on lower back and right elbow. didn?t get confirmation until 3:30 that same day there was hives (can?t see my elbow or back, had to have someone else look)
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Information on patient diagnosed with/tested positive for COVID-19 was unknown. It was reported that the vaccine was stored in an ultra cold freezer at minus 82 degrees Fahrenheit. It was reported that the storage condition at the  time of temperature excursion was frozen storage. Maximum temperature reached was reported as negative 82 degrees Fahrenheit. The excursion duration was 1 month. It was reported that the Moderna COVID-19 vaccine vials were moved from super cold freezer to the refrigerator on 19-Nov-2021. It was reported that 70 vials were still in ultra cold freezer and 8 vials were in the refrigerator. It was reported that no vaccine state changes were noticed and the vaccines were never refrozen. The proposed desired Use by date was 07-Dec-2021.  No concomitant medications were reported.  No treatment medications were reported.
Ambulance had to be called on patient around 11:30 pm he was hallucinating and foaming at the mouth, he was hospitalized for a week in our county with altered mental status, went home one night, ended up in another hospital, took over a month to diagnosed patient, after he lost his ability to walk, talk, eat, and swallow his own spit, multiple test, MRI'S and spinal taps were done before being diagnosed with nmda receptor encephalitis. We spent 70 days in hospital, and are currently in a third hospital. Patient has had plasmaphersis, retuxamab, heavy doses of steroids, and IVIG and still being treated.
Client reported to EMT feeling "hot" while in the observation area. EMT escorted the client outside into the courtyard to cool down. RN responded and noted the client seated outside without her mask on. The client reported feeling "hot, nauseous, and like my left eye is closing." RN noted no swelling over the client's left eye. Pupils were equal round and reactive bilaterally. EMT provided the client with an emesis bag. RN recommended the client move inside onto the anti-gravity chair. The client agreed, ambulated unassisted with a steady gait into the observation area and sat in the anti-gravity chair in a high fowler's position. Vitals obtained at 7:37 PM were as follows: BP 148/96, HR 90, and O2 96%. The client reported a history of high blood pressure. She takes Lisinopril and Hydrochlorothiazide daily, and states she took her medications this morning. The client has a history of blurry vision, nausea, vomiting, and dizziness after taking Gabapentin. The client stated her current symptoms felt different than the symptoms she experienced after taking Gabapentin. The client has a history of blood shot eyes after utilizing a steroid inhaler. Lastly, the client reported flu-like symptoms after a previous flu vaccine that lasted a few weeks. The client had equal strength bilaterally in her upper and lower extremities. At 7:44 PM the client drank water and was provided an ice pack. The client placed the ice pack on the back of her neck. Repeat vitals obtained at 7:45 PM were as follows: BP 151/93, HR 96, O2 97%. The client stated she last ate chicken soup at 4:00 PM. At 7:46 PM the client stated her nausea had improved and that her eye "feels calm." At 7:51 PM the client reported "feeling tingling from the knee down" bilaterally. RN noted  2+ pedal pulses bilaterally. Sensation was intact to touch over her feet bilaterally. The client denied any itching. Repeat vitals at 7:53 PM were as follows: BP 143/91, HR 86, O2 97%. The client stated she was, "feeling better. The tingling is moving up my leg." RN did not visualize any signs of redness or rash on the clients ankles bilaterally or near the vaccine administration site. At 7:56 PM the client stated she was, "not feeling warm anymore." Repeat vitals obtained at 8:00 PM were as follows: BP 139/94, HR 86, O2 97%. The client stated she "feels much better." Repeat vitals obtained at 8:05PM were as follows: BP 147/88, HR 86, O2 97%. RN provided education regarding s/s of anaphylaxis, when to seek EMS, and to follow up with her doctor regarding her blood pressure. The client voiced understanding of this education. The client stood up without assistance at 8:08 PM and denied any dizziness. The client stated the tingling was "much better" and stated "I feel fine." The client was accompanied by her son, who was going to drive her home. The client ambulated unassisted out of the observation area at 8:08 PM.
About 5 minutes after patient was vaccinated with COVID-19 vaccine, he complained of feeling dizzy and lightheaded while still seated at the vaccination station. Patient was moved to floor and assessed. Lungs were clear, A x O x 3, pulse regular and steady. EMS was already present from responding to another emergency so patient was assessed by them. Pulse 80, RR 16. Patient likely had vasovagal reaction as per mother he had similar symptoms when he underwent an MRI in the past. Patient had resolution of symptoms and ambulated out of clinic in stable condition with his parents. No hospital transport.
The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as needed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.
My symptoms began in my lower back. I thought that I had pulled it. I had that for about a week and I noticed I was getting sharp prickly sensations in my lower, I looked at it in the mirror and I saw lesions. I thought they were bug bites, so I treated them with topical bug bite medication. I started to get burning sensations like hot needles sticking in my back. By Sunday I was in severe pain, and I called my primary care physician and they had me come in on October 31, 2022. He started me on antiviral medication acyclovir, prednisone with a reducing dose. I was given tramadol for my pain. It helped a lot but last night I started to get the prickly feeling which was more irritable. This morning I woke and the largest one had started to leak. I was diagnosed with shingles.
Client received Janssen dose with no adverse side effects. Upon system entry, it was noted that client was not yet 18 (the minimum age to receive the Janssen vaccine). Client's mother was notified by County Health Officer on 12/09/2021. Mom was informed of the vaccine error.
Little bit more sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit more sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little bit more sore arm). At the time of the report, PAIN IN EXTREMITY (Little bit more sore arm) outcome was unknown. Not Provided          No treatment medication information were not provided No concomitant medication  were not provided Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-065500 (Patient Link).
Patient informed paramedic of arm tingling, paramedic informed patient that he will check back with him in a couple minutes. 5 minutes after, paramedic witnessed the patient having a seizure for 10 seconds. During seizure, patient hit car in front of him. Paramedic stated that patient had flexion and eyes rolled back. Patient came to and asked paramedic what happened. Patient does remember seizing. Patient went into ambulance and was given snacks due to blood sugar of 95. Patient states he is currently on a keto diet. Patient informed staff that someone will be picking him up and refused to go to hospital with EMT.