chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.; No adverse event; refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (refrigerated vaccine past its 30 day use by date was administered to a patient/given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 26-Aug-2022 and vaccine was administered on 27-Oct-2022.).    No concomitant medications were reported.  Reported that the vaccine was punctured for the first time then administered to a patient as first dose on 27-Oct-2022. The vial did not undergo any temperature excursions. Patient received the vaccine from red cap, magenta border vial.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2022: Live significant follow-up received patient identifier, indication and case narrative updated received.
ankles were just stinging and itching terrible/her wrists were doing the same things as her ankles; her right ankle and foot feels a little, she doesn't know how to say, tingly; spot on the inside of her right knee and one below her shoulder that would itch and sting; awful dreams; sick to her stomach; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 14:00 (at the age of 69-years-old) as single dose for covid-19 immunisation. Medical history included she had a very light case of COVID in Sep2020, couldnot smell. Concomitant medications were not reported. Patient stated that she got the shot on 15Mar2021, that day she was sick to her stomach and by 4:30 PM the next afternoon she was better, then she got a spot on the inside of her right knee and one below her shoulder that would itch and sting, like a bee stinging her, and that was in the afternoon on 16Mar2021. She had terrible dreams the night of the 16Mar2021 and the 17Mar2021. Patient stated that her ankles stinging and itching terrible went away, her wrists were doing the same things as her ankles, this was last night, her right ankle and foot feels a little, she doesn't know how to say, tingly, but other than that, it's not as bad. States the itching of the ankles started last night and went away. She stated that has to go, she will call the doctor office, and see what he thinks, she thought she will get some advice. On an unspecified date in Mar2021, ankles were just stinging and itching terrible/her wrists were doing the same things as her ankles was recovered. The outcome of the event spot on the inside of her right knee and one below her shoulder that would itch, and sting was recovered on 16Mar2021. The outcome of the event sick to her stomach and awful dreams was not recovered while the outcome of the event her right ankle and foot feels a little, she doesn't know how to say, tingly was unknown.  No follow-up attempts are possible. No further information is expected.
Muscle weakness, prolonged muscle soreness (>5 days) after moderate exertion; elevated blood pressure (160/130 when pt normal is 12/60)
Incorrect Tdap vaccine was given instead of intended newborn Hep B. Pharmacist, provider and nursing manager were alerted. No adverse reactions observed at this time. Error was discovered 19 hours after administration. Parents made aware. Given the option for delay of discharge. At this time unsure of decision.
Fatigue Headache Fever Chills  Disorientation  Arm soreness  Weakness  Nausea
Sciatic Pain; Injection site is very red and feels like she has 5 different beestings in her arm; Injection site is very red and feels like she has 5 different beestings in her arm; Coughing up phlegm; Fever of over 100 degrees; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 56-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. The patient medical history was not reported. The concomitant medications of the patient included risdiplam, loratadine, ursodiol, colecalciferol (REPLESTA), l-methylfolate and salbutamol sulfate (PROAIR), all taken for an unspecified indication, start and stop date not specified. On an unspecified date the patient experienced sciatic pain, injection site is very red and feels like she has 5 different bee stings in her arm, coughing up phlegm and fever of over 100 degrees. The patient underwent lab tests and procedures which included fever of over 100 degrees. The outcome of all the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
DIZZINESS, MUSCLE WEAKNESS, RAPID HEART BEAT, DRY MOUTH, OVER THE COURSE 26-27 HRS. SHOT ADMINSTERED AROUND 6 PM, SYMPTOMS STARTED AT 2 AM.
Nausea, vomiting, fevers, chills, myalgias, arthralgias, severe fatigue, severe headache, muscle stiffness, blurred vision, dizziness,
Shortness of breath, Throat tightness and chest tightness,  Burning in arms
HYPOTENSION 2/15/2021 ATRIAL FIBRILLATION, UNSPECIFIED  HYPOTENSION 2/15/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Information has been received from a health professional concerning a 34 month old male who on 07 Mar 2006 was vaccinated with a dose of Variavax (Lot # 646539/0551R). On 17 Mar 2006 the patient developed 5 vesicular lesions around the injection site. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Burning feeling in left knee very sensitive and rash in left and right thighs. Rash not itchy just bumps. Took benedryl and burning feeling is going away
ALLERGIC REACTION, INIT 4/1/2023 HTN (HYPERTENSION)
Patients right thigh had a raised thickened dark pink-red area approximately 1"long on area where 2 of 4 vaccinations were given on 12/15/06.
Soreness at injection site Fever 99-100.3 Aches  Weakness
Severe allergic reaction that led to a hospitalization; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 57-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2017-2018 season) (batch number DM9N3, expiry date 30th April 2018) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2017, the patient received FluLaval Tetra 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to FluLaval Tetra 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient himself. The patient suffered from the severe allergic reaction that led to hospitalization. The reporter did not consent to follow up.
Pt given Engerix-B 30Nov89, developed painful elevated, hard nodules that looked like purpura with lumps on both legs & arms/hands. C/O severe pain & swelling from knees down, could not stand or walk, palms were tender. Extensive text WORM
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/5/2021 and 3/26/2021. Patient presented to emergency department from nursing home after cardiac arrest x 10 minutes. According to nursing home patient was COVID-19 positive. Patient GCS was 13 on arrival with positive FAST exam. Patient expired 1/7/2022 at 0929.
A hard painful knot developed at the injection site; surface of skin became pink. General malaise,
BAck pain, chest pain, headache, muscle/joint aches, fever 1/31/03 late pm. Blue and purple spots in vision, lip swelling, upper, one side 2/1/03. Went to ER 2/1/03 no treatment given. 3/3/03 appears well.
when pt presented for 2nd series mom reported prolonged 3-4 hrs crying that parents were unable to stop; pt did not report this to MD; phoned MD office & recvd order for ped DT; mom reported no crying p/receiving ped DT;
Blurry vision; Really tired; Arm a little sore; Headache; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (Lot number: ER8735) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for anxiety; DIAZEPAM. Vaccination history included: Bnt162b2 (First dose, lot: EP6955), administration date: 31Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Blurry vision"; FATIGUE (non-serious) with onset 21Apr2021, outcome "recovering", described as "Really tired"; PAIN (non-serious) with onset Apr2021, outcome "recovering", described as "Achy"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "recovering", described as "Arm a little sore"; HEADACHE (non-serious) with onset 21Apr2021, outcome "recovering", described as "Headache".  Additional information: The blurry vision started about an hour after both shots. The patient had a headache on 21Apr2021 and on 22Apr2021 morning.  No follow-up attempts are possible. No further information is expected.
Chills (shaking so hard I could barely walk), mild fever (99.9 to 101.7), body ache, headache. Lasted from 2:00 am on 1/29 til roughly 6:00 pm  1/29.
Sore L arm: at the injection site through the bicep. Lumbar back and bilateral knees also are sore and painful. Treated with ibuprofen. First day pain was worse than the following day.
Patient was sitting in a chair after the vaccine was administered, stated she was feeling well then fainted onto the floor.  Assistance provided by nursing staff, noted to be pale, given water and stayed sitting on the floor (declined transfer to cot).  She then felt intermittent nausea, had numerous emesis when attempting to stand 30" after initial fainting.  Able to stand at 2015  and tolerated well.  Able to ambulate to car, stated she felt better, accompanied by her father.  Mother reported intermittent nausea and vomiting continued until 4/26 when seen in the ER, given IV fluids and antiemetics
head aches, vomit,high fever,rash all over the body(red spots)
gave first dose at 0805, pt noted itching of throat at 0815, given Benadryl 50 mg IM at right deltoid at 0823
Chest pain, phlegm in throat, cough, wheezing. 50MG DIPHENEHYDRAMINE HCL at 1130 IM. 125mg Solu Medrol IM.
7/15/10 went to ER for upper arm swelling. 7/16/10 went to ER for worsening extending to whole arm. Hospitalize till 7/19/10. Got IV antibiotics.
Vesicle along with fever started on right ankle and then enlarged and spread up toward his thigh. Was painful. Seen by dermatology who diagnosed on 8/25/2016 shingles confirmed by PCR (Herpes zoster infection). Treated with acyclovir for 7 days.
Did not take fourth dose of Vivotif on time; Spontaneous report received on 12DEC2019.  A female consumer reported that she "did not take fourth dose of Vivotif on time" (PT: Product dose omission). She was receiving oral Vivotif for typhoid fever prophylaxis. It was reported that the consumer completed 3 doses of Vivotif every other day, but she forgot to take her fourth dose, which was due on 10DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer forgot to take fourth dose of Vivotif on time (missed dose). Considering the nature of the event, the causality of the event is assessed as not related with Vivotif.; Sender's Comments: It was reported that a consumer forgot to take fourth dose of Vivotif on time (missed dose). Considering the nature of the event, the causality of the event is assessed as not related with Vivotif.
On 11/26/2022 I received my Covid-19 vaccine. On 02/10/2023 in the afternoon I had a feeling of unwellness. I started to get chills, fever, and fatigue then went to bed. The next day I started having sore throat, fever, sinus congestion following with a lip and tongue swelling. I reached out to the hospital after symptoms got worse with severe body ache. I was given Pepcid, Toradol,  Methylprednisolone. I was diagnosed with Covid 19. Symptoms lasted 1 week. Ongoing hoarse voice.
Patient received the Moderna COVID19 for the 1st dose and was inadvertently given the Pfizer COVID19 vaccine for the 2nd dose.
Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for approx. 36 hrs.
fever of 105-106f, and convulsion.  2/4/93: admitted to medical center. treated with amoxicillin for possible uti.
Information has been received from a nurse concerning a 12 month old female with no allergies who on 4/14/2006 was vaccinated SC with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 651815/0950R). There was no concomitant medications. On 4/24/2006 the patient presented with a perfuse erythematous papular rash all over her whole body including in her mouth. She also had a fever. There were no labs or diagnostics per. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
About 12 hours after receiving the booster vaccination I became ill with chills, fever, aches and no appetite. I stayed in bed all day Thursday 11/17/22 and Friday 11/18/22. I started to become dizzy when standing and had unusual orange colored urine despite hydrating with water. On Saturday morning 11/19/22 I had been lying on the couch and upon sitting felt very odd. I could feel my heartbeat and it felt wrong, loud and I felt like my chest was vibrating. My husband (who has a medical background)checked my pulse with the pulse oximiter several times and it was going up and down in an irregular pattern so he called 911. The paramedics arrived and preformed an EKG, said I was having Atrial fibrillation. They advised recommended that I be transported by helicopter to the nearest hospital with a cardiology center. I was transfered to Hospital. IN the helicopter my pulse continued to be erratic reaching over 190 beats so they administered IV medication to lower it. At the hospital I was seen in the ER where they quickly (within 45 minutes) decided to admit me to their cardiology unit. I have no history of A Fib. The labs drawn in the ER showed Liver Test elevations I have monthly labs drawn at my home and I had those same labs drawn just a coupe of days prior to my vaccine (on 11/14/22) at that time all my liver values were normal.  Since leaving the hospital I have had to see a cardiologist , have had at least two more incidences of Atrial fibrillation and am now on 2 different doses of Diltiazem (one for daily extended release and one for emergencies).
Had hives around TB test site after 2 days, and at 3 days had red bumps on forehead and across nose and cheeks. No swelling or raised areas.
The patient presents with complaints of fever to 102.4 and a rash. He was given a tetanus shot and a pneumonia shot 2 days ago. The fever started yesterday. The rash is in the area of his shots. He started throwing up today x2. He always has abdominal pain and there does not appear to be any difference now than usual. He denies sinus pressure, ST, cough, sputum, hemoptysis, diarrhea, BRBPR, melena, dysuria, hematuria.
Severe Redness, Pain, Tenderness at site of injection for 10 days.  Severe headache.
Red itchy rash under the armpits of both arms, groin area, and under her breasts.; Red itchy rash under the armpits of both arms, groin area, and under her breasts.; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) and RASH PRURITIC (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) and RASH PRURITIC (Red itchy rash under the armpits of both arms, groin area, and under her breasts.). At the time of the report, RASH ERYTHEMATOUS (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) and RASH PRURITIC (Red itchy rash under the armpits of both arms, groin area, and under her breasts.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
fully vaccinated patient. Traveled by airplane 6/27/21. Symptom onset 6/29/21.  Tested on 6/30/21 - covid-19 detected.
Within 24 hours of receiving the first injection I experienced chills, fever , redness and swelling in my right arm (from injection site to elbow),  these symptoms lasted 72 hours with the exception of the injection site swelling that lasted 10 days.
This is a spontaneous report from a contactable consumer.  An adult (18-64 Years) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced slightly sore arm muscle on an unspecified date. The outcome of event was recovered. Patient did not received any treatment for the event. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
patient stated that his arm started to get tingly and numb and stiff a couple of days after he received the vaccine.  The patient stated that he has to squeeze his hands into a fist periodically in order to make it feel better.  The problem has remained consistent the past couple of weeks since he first experienced it until now with no improvement nor has it gotten worse, he said.
Mother of patient states patient received vaccine and then "slumped over in chair". Mother left room to get addional help. When mother returned to room, patient was lying on floor. Mother was told by nurse that she "had a seizure". Patient was "slow to respond and did not recognize" mom for 10 minutes post event.
This case was reported by a physician via call center representative and described the occurrence of erythematous rash in a 78-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 4 days after receiving Shingrix, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to Shingrix. Additional information was received as follows: The age at vaccination was not reported. But, it could be 77 or 78 years old. The patient received Shingrix on the left arm. The healthcare professional stated that the patient experienced a unilateral right sided bright red rash that went from her right arm down to her right breast. The healthcare professional did not have vaccine information, patient's date of birth and would not provide any more details about the patient's adverse event.
I lost the ability to form coherent sentences; On Friday morning the fever was at 103.2F and stayed high; strange tingling sensation in my right arm; strong headache; This is a spontaneous report from a contactable other hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 18Feb2021 at 1:45 PM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lost the ability to form coherent sentences, on Friday morning the fever was at 103.2F and stayed high, strange tingling sensation in right arm, strong headache. It was reported by the patient that "I received my second shot of the Pfizer COVID vaccine on Thursday at 1:45 pm. Approximately 12 hours following the shot I developed a fever. On Friday morning the fever was at 103.2F and stayed high until that evening. In addition, I lost the ability to form coherent sentences, had a strange tingling sensation in my right arm at times (but did not lose muscle control), and developed a strong headache (not a migraine, my migraines usually come with an aura). The fever started to recede by Friday evening, my speech seemed normal again Saturday morning and the headache finally receded by noon on Saturday." The patient underwent lab tests and procedures which included body temperature: 103.2 Fahrenheit on an unspecified date. The clinical outcome of "strange tingling sensation in my right arm" was unknown, while the outcome of other events was recovering.  Information about lot/batch number has been requested.