chrisvoncsefalvay/vaers-outcomes huggingface dataset:
found collapsed and very confused; found collapsed and very confused; unresponsive; difficulty breathing; blank stare; This is spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an 28Jan2021 (at the age of 67-years-old) at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient was found collapsed and very confused, unresponsive, and experienced difficulty breathing on 29Jan2021. The events caused hospitalization and were reported as life-threatening. The patient also experienced blank stare on 29Jan2021. The clinical course was reported as follows: The patient had a blank stare after receiving the first dose of the vaccine. The patient was later found collapsed and very confused. She was taken to the hospital, became unresponsive, and had difficulty breathing. The patient required intubation and sedation and remained in hospital. Therapeutic measures were taken as a result of found collapsed and very confused, unresponsive, and difficulty breathing as aforementioned. The clinical outcome of found collapsed and very confused, unresponsive, difficulty breathing, and blank stare was unknown.
Patient mistakenly received two DTaP vaccines; This case was reported by a consumer via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number ak443, expiry date 16th September 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th May 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 16th May 2022, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: The reporter was the patient's mother. The patient mistakenly received two DTaP vaccines (Kinrix and Infanrix) on the reporting day.  The reporter had nothing else to report. The reporter consented to follow up. Additional supportive information: The patient mistakenly received two DTaP vaccines which led to accidental overdose.
Adverse Events: Beginning in June 2019, extreme thirst, soaking diapers throughout day time, bed-wetting every night and nap time, lethargy and weakness, slow responsiveness, one seizure, vomiting,  inability to pass bowels from extreme constipation, intestinal pain, headaches, loss of appetite, dizziness and falling, weight loss of 6 pounds. Treatment: Admitted to hospital, diagnosed with type 1 diabetes, and placed on insulin. A few days later, a Celiac test revealed gluten intolerance.
I had stayed awake because I work nights and then I went to sleep. I woke up with excruciating headache - worst I've ever had. I checked my temperature - it was 99.4 and I had chills. I normally run cold.  I felt awful I took a couple of Tylenol and ibuprofen - waited for it to take the bite off so I could go to sleep. I called off into work. I waited until about 11:00 - 11:30 enough so I could go back to sleep. I took two more Tylenol and Ibuprofen and I took Benadryl. I woke up the next day and felt great when I woke up. Sometime in early-mid March, I had a flare up of pain. First it was my hands - from my elbows down to my fingertips - started to hurt. My hands were aching. It started spreading throughout my whole body - hands, knees, ankles, back - it was moving. One day, I couldn't even move. I was taking Ibuprofen non-stop, I was in so much pain. My hands were hot and throbbing like I was sunburnt. My knuckles and joints were aching - everything was swelling up. Mostly staying in the joints - felt hot and achy. I slept with ice on my hands. At work, I kept filling up plastic bags with ice and holding them on my hands. Symptoms were from neck to tailbone  - my whole spine - and my hips. Sometimes it was all the above - everything below my ears along with a very mild headache. And then it became focused in certain spots. It shifts up and down. It definitely stays in my sacral region and my greater trochanter in my hips; in my elbows and in my knees. It is now starting to get a bit better -  it's nothing like it was before.  It took awhile to reach my Primary Dr. to get a  referral for Rheumatologist. Had gone to Urgent Care on  April 7, 2021; Doctor visit 4/29/2021
Two days after getting vaccine I began having diarhea and it lasted for almost a week.  I am sure it was the vaccine because  did not eat or drink anything unusual or that would cause loose stools.
lady who injected the patient was a little upset since it bleed a little after being injected; bruise on her arm/Injection site bruising; she felt a little light headedness; little nauseated; Slight 'tenderness'; This is a spontaneous report from a contactable consumer (female). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry not reported), as second dose via an unspecified route of administration on the arm on 11Feb2021 at single dose for covid-19 immunization. Medical history included slow clotting problem (when she was little/was never diagnose with a disorder) and first vaccination (she did not have any bruise). The patient's concomitant medications were not reported. It was reported that the patient had the second dose of the Pfizer COVID-19 vaccine yesterday (11Feb2021). The lady who injected the patient was a little upset since it bleed a little after being injected. The patient stated, "You are very good that did not hurt. She said not that good. You are bleeding. You should not be bleeding but I do not even know she said you should not be bleeding but she said and then she kept patting my arm on the spot that it was, where she injected me and she said yeah that is right where I should inject you". The patient said that she was fine and was not concerned with the AEs but she wanted to know if the vaccine was still effective even though she bled. She also said that she developed a pretty big bruise on her arm/injection site bruising. The patient was injected in the deltoid muscle. She said when she removed the band aid there was only little blood transferred there. The patient said that her doctor when she was little told her that she has a slow clotting problem but was never diagnose with a disorder. The patient said that she felt a little light headedness or a little nauseated after being injected. The patient's concerns were not to the bruising, did not concern her at all. Her main concern was to make sure that she did not have symptoms and she wondered afterwards, the patient ended consoling her. The lady was concerned that may be the patient was on blood thinners. The patient said that she was not on blood thinners. The patient had a slight 'tenderness' never really caused her a problem. Just breathe a little bit easier and when she got home and took off the Band-Aid there was really hardly any blood there but she had the first vaccination she did not have any bruise. The patient have a huge bruise on her arm this time and that was okay. The patient bruise equally too. But she just wanted to make sure that since they really did not have symptoms that the vaccine was really injected into the area where it was going to be affected for her. The patient assessed the case as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
SM reports having large local reaction following receipt of AVA #4 in his right upper arm on 25OCT04. The evening of 27OCT04 he noted pain and swelling of the area that progressed to between 50-120 mm with some induration at injection site. SM also reports feeling of malaise, muscular aches and a scratchy throat. He denies headache, chest pains, fever, generalized rashes, nausea or vomiting. He did not receive any additional immunizations at that time. 10/26/2004: erythema start. 10/27/2004: fatigue , malaise <60days start. 10/27/2004; edema and injection site 50-120mm start. 10/27/2004: muscle pain start.
Mother refers the patient presented with lesions on the skin on the third day after the immunization shot. Dr. prescribed Benadryl and Caladryl topically.  12/18/08 Reviewed PCP medical records. FINAL DX: Impetigo Records reveal patient experienced macular rash w/some crusts.  Treated w/antivirals, antibiotics & labs.  Records partially in Spanish. No other records available.  1/27/09 Reviewed hospital records of 8/21-8/25/2008. FINAL DX: Impetigo reaction to varicella Records reveal patient developed skin lesions s/p 2nd dose of varicella which progressed to oozing crusty lesions.  Tx w/IV antibiotics, improved & d/c to home on continued oral antibiotics.
Fever 102, left arm red, hot and tender. Treated w/ Augmentin and cool compress.
On 4/23, Developed sinus/cold issues that did not respond to any of the medicines that usually work. Starting on 4/25, Initial round of antibiotics and steroids had no effect on the symptoms. Breathing increasingly  became more difficult and for the first time in my life, my emergency inhaler didn?t have any effect. On 4/27, went to doctor, who was concerned it might be pneumonia or blood clots, since none of the traditional treatments helped me breathe more easily. She prescribed a stronger dose of antibiotics and steroids, which did seem to help the sinus issues, and the breathing has only improved if/when I?m moving as little as possible. I am still struggling to catch my breath.
pt recv vax 20JUL95 & 30MAR96 pt devel 2 chickenpox lesions;1 on cheek & 1 on leg;had no other sx;lesions resolved w/in 5-7 days;MD reported the pt 3 siblings;
Fever, Headache, Rashes, Extreme Fatigue and Extreme low blood pressure. 77/44. Heart palpatations, coughing, Purple eyes, Swollen eyes, throat and lymph nodes. Sore throat. My HRT pellets migrated around my body that were inserted in my buns.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Approx. 3 minutes after injection patient had itching and hives on arm of injection and right side down to her waist.  administered 50 mg benadryl orally.  Approx. 3 to 5 minutes later patient started coughing and was having trouble swallowing.  911 was called.  no Epipen was administered on site.  Follow up with patient, she was discharged to home same day within 5 to 6 hours of reaction.
Came in a few days after vaccine and showed redness and swelling in left arm. After one week, patient came in with big red area, but no swelling and no pain. Patient said she can't hold glass of water because her arm shakes.
SICK AS A DOG FOR ENTIRE MONTH OF APRIL; AWFUL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-2021, the subject experienced sick as a dog for entire month of april. On APR-2021, the subject experienced awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick as a dog for entire month of april and awful was not reported. This report was non-serious.
symptom onset at 10:00 a.m., pt states her left arm became sore, developed a mild headache.   2:00 pm-mild generalized itching, with small red "bumps" on abdomen, and upper and lower extremities. does not know if rash was on her back. Swelling at injection site. Pt took a Benadryl and states the itching and rash resolved. She denies any swelling of her face, lips, and denies shortness of breath. Pt states she is slowing improving, her arm remains sore, but rash has resolved
Extreme dizziness; couldn't walk without help; Unable to get out of a chair; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness), GAIT DISTURBANCE (couldn't walk without help) and DYSSTASIA (Unable to get out of a chair) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness), GAIT DISTURBANCE (couldn't walk without help) and DYSSTASIA (Unable to get out of a chair). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Extreme dizziness), GAIT DISTURBANCE (couldn't walk without help) and DYSSTASIA (Unable to get out of a chair) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported.    Reporter did not allow further contact
Patient became dizzy and shaky within 7 minutes after getting first dose. She stated her hands were tingly and that she felt like she would pass out. The paramedics were immediately called. Paramedics took about 15 minutes to arrive and they attended to the patient. Patient was believed to have a panic attack but they recommended patient to see a md just in case its something different. Patient was able to walk out the store fine after about 40 minutes after the paramedics arrived and helped her out.
My husband & I both received our Covid-19 vaccines between 26Mar-01May2021. We both tested positive for Covid-19 last week; My husband & I both received our Covid-19 vaccines between 26Mar-01May2021. We both tested positive for Covid-19 last week; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient and his wife both received COVID-19 vaccines between 26Mar2021-01May2021. They both tested positive for COVID-19 last week, on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101193383 Same reporter/drug/AE, different patient
Injection given high in upper arm, possibly injecting serum into shoulder joint.  Intense throbbing pain began around 6:00pm same day (Thursday, Jan 21) and lasted four days (into Monday).  Ibuprofen and Tylenol taken in maximum allowable doses offered mild relief but was insufficient.   Arm became unusable during that period, losing all motion.  Sleep almost impossible over that period.  Mild redness and little or no swelling as was commonly reported by others; pain was deep in shoulder joint and radiated from neck to elbow.
all over body rash; vasculitis; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 75 years old male patient who experienced all over body rash and vasculitis, after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed all over body rash (rash) and vasculitis (unknown latency) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.
Patient hit the wall while looking at the cell phone and fall backward on the floor.  Call 911 and monitoring him until EMS arrived.  He was advise to sit and wait for 15 minutes but he decide to walk around right after the covid shot.
No additional AE reported; 13 Year Old' Patient was administered PROQUAD; This spontaneous report was received from an advanced practice nurse (APN) and refers to a 13-years-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-MAR-2022 at 15:00, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human Albumin (rHA)) (PROQUAD) vial, lot number: U030588, expiration date 29-MAR-2023 (dose, dosage schedule and route of administration were not reported) for prophylaxis, due to having no prior immunization with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age). No additional adverse event were reported.
The person received Pfizer Covid Vaccine on 4/22/21.  We administered based on the information received from patient. The person denied received any previous Covid vaccines prior to 4/22/21 appointment. Upon investigation of the this person had received two doses on 3/15/21 and 4/5/21. We attempted to contact the patient to determine whether or not this patient had indeed received a third dose and to check if they had any adverse events. After multiple attempts person was not able to be reached.
Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
Left ear pain started 2 weeks after shot.  3-4 days later started to develop Bell's Palsy.
(R) arm swelled from injection site to fingertips. Red. Hot. :for 5 days.
Inventory discrepancy. Based on the inventory review from the health care center. I was given 2 pediatric Pfizers and 4 adult Pfizers Unfortunately protocol was not followed on receiving the vaccine for clinic that morning and employee did not count the vaccine prior to transporting to clinic. Becuase of the discrpency in the inventory we are operating such that an adult Pfizeer was diluted and the child received a dose. On 3/17 post vac he was monitored for 15 minutes and had no reacction at that time. Left clinic aaox3  speaking and running around.  Mother instructed to monitor child for encourgae fluids and arm movement due to arm might experince soarness the next couple of days. At this time there has been no contact from us or any information from the family that a problem occured after the child received the dose.
Stabbing pain in abdomen, as if someone was stabbing my abdomen and moving it up and down; This is a spontaneous report from a contactable consumer.   A 19-year-old adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0178), via unspecified route of administration in the left arm, on 13Jun2021, as dose 2, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Spironolactone and Estradiol.  The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0173), via unspecified route of administration in the left arm, on 23May2021, as 1st dose, single for COVID-19 Immunisation. On 14Jun2021 at 13:00, the patient experienced stabbing pain in abdomen, (Reported as: as if someone was stabbing his abdomen and moving it up and down). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.
Pain at injection site. pain in shoulder and elbow. Bleeding enough to soak bandaid and shirt sleeve about 3 inch oval down arm. Pain continues to present 11/29. Bruise started within 24 hours. Spreads to encompass 5 inches. 11/29 bruise still visible about 2 inches and still blue. Not fading to green like normal bruise. Sharp pain at injection site when move elbow/wrist.