chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 7/31/21 around 8pm that evening, I had a spontaneous bloody nose. The worst one I have ever had in my life. It took a whole roll of toilet paper to shove in my nose, apply pressure and stop the bleed. It was bleeding so bad, I couldn't keep up with the flow and thus got blood all over my new leather chair. When it was done after about 45 minutes, it looked like a murder scene that I had to clean up.  On 8/3/21 around 8am, I woke up in the morning with an extremely painful back spasm. I immediately laid on a heating/massaging pad and took 2 Advil for 3 hours. When I tried to move the pain was still there. I took more Advil and continued the heating/massage pad. I fell asleep until 4pm. My back was still in tremendous pain. It was my my lower back, just to the left of my spine. At this time, I took 250mg of Soma and rested more on the heating/massage pad. Around 8pm, I tried to get up and walk a little. the Soma (muscle relaxant worked on the paid about 50% bringing the pain level down from a 9 to about a 6. I took another Soma and got back on the heating/massage pad. Around 10pm, I took another 250mg Soma as my back was still spasming and still in pain.  Needless to say, I couldn't go to work today, it was too painful to move. I was unable to eat because the pain was too much. I was able to drink a small amount of cold water. I have never had any back pain, problems or spasms in my entire life. This pain was highly unusual and very scary. I have determined by talking with other health care professionals that my nose bleed and back spasms were directly related to the 1st dose of the Covid vaccine, Moderna that was administered on 7.30.21.
Fever of 101, body ache, headache, loss of taste and smell, congestion, cough.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # M042171 with expiration date of 07-JUN-2018 and lot# M042822 with expiration date of 19-JUN-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001009: US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001230: US-009507513-1705USA001232:
At minute 12 after injection (8:31am on 1/5/20), the pruritis started on my scalp and my back. I informed the volunteer at the end of the drive line. She offered to have EMS evaluate me, however I declined as I thought the reaction was mild. Over the next 10 minutes, after being released from the driveline, I was so itchy I wanted to literally rip all of my skin off. The back of my throat started to itch, but never felt tight or swollen. No SOB or chest tightness. I checked my temp at 8:45 and I was at 101.0 and HR was 110bpm. I am a PA working in dermatology and got to work and took 50mg of diphenhydramine PO but was not improving. One of the doctors I work with and I decided it was best for me to get checked out in urgent care. I had my MA drive me there and was seen immediately. I had a blotchy rash over my entire body, but not raised or hived. Temp was 100.6, HR 86 and BP 127/78, respirations 16/min O2 sat 98% and the itchiness was still severe but I could tell the diphenhydramine was kicking in. I was then given 40mg of famotidine PO and 10mg Dexamethasone IM in the right buttocks while in urgent care. After about 15 minutes, my symptoms were improving, but not resolved. I was released and went home to rest. Throughout the day yesterday (1/5/20) my heart rate would spike as high as 130bmp (my normal is 60-70bpm). Then it would come down within a few seconds to about 100bpm and steadily stay between 90-100bpm all day. Last night I was woken up at 3:30am (1/6/20) with a HR of 132bpm and O2 at 97%. I took a few deep breaths, and it slowly started to drop to 100bpm. Since 6:00am, I am steady at 70-80bpm with occasional spikes of 96-100bpm and I can feel when my heart is starting to race. I have my pulse ox on for the day and will continue to monitor my symptoms. I still have occasional pruritis, but it's tolerable. I was discharged from urgent care with PO Prednisone tapered dose, however, I am very shaky already and do not want to make it worse, so have not started it yet. Not sure if I should? And I would like to know if I should receive the second dose? If so, should I pre-medicate? Please let me know if you have any further questions about my event. Thanks.
Employee states with pain to upper (R) arm (injection site) on movement. Also with movement limitation - difficulty of dressing/undressing due to movement limitation and pain on movement.
Chills; Extreme exhaustion; Cognitive memory issues/Forgetting how to do a task; Saying words backward; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 16:15 (Lot number: EWO176) at the age of 49 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Chills"; FATIGUE (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Extreme exhaustion"; AMNESIA (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Cognitive memory issues/Forgetting how to do a task"; SPEECH DISORDER (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Saying words backward"; FEELING ABNORMAL (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "brain fog". The events "chills", "extreme exhaustion", "cognitive memory issues/forgetting how to do a task", "saying words backward" and "brain fog" were evaluated at the physician office visit. Therapeutic measures were taken as a result of chills, fatigue, amnesia, speech disorder, feeling abnormal.  Additional information: Patient did not receive any other vaccine in four weeks of vaccination. Other medications in two weeks included prescribed medicines. Facility type vaccine was Pharmacy or Drug Store. AEs resulted in the doctor or other healthcare professional office/clinic visit. AE treatment included consultation. No covid prior vaccination. Patient was not covid tested post vaccination.  No follow-up attempts are required. No further information is expected.
Patient received Monovalent for his booster when according to guidelines starting 09/01/2022 the patient should have received Bivalent .Patient called with no answer, message left notifying patient and to call to schedule Bivalent vaccine in 2 months .
After receiving my shot on the 26th, my arm was sore as is standard for vaccinations. I was fine the next day. When I woke up on the morning of April 3rd, my arm was swollen, sore, and itchy around the injection site. I tried taking some acetaminophen to help with the swelling and soreness, but it didn?t change. Icing it helped with the swelling.
an allergic reaction; she had trouble moving her tongue to speak; increases thirst within 5 minutes of shot; awareness of throat; creeping headache starting at the base of the neck across the entire head; along with lowering blood pressure; I started feeling floaty; my motor skills decreased; I had trouble standing up; I had trouble standing up & walking; I had trouble speaking forming the words & sentences; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection, Lot number: EW0153), via an unspecified route in the right arm on 14Apr2021 at 12:45 (age at vaccination: 42-year-old), as a single dose for covid-19 immunization. Medical history included covid prior to vaccination. Known allergies included Biaxin and penicillin. Concomitant medications included Vitamin D and Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was tested for covid post vaccination. On 05May2021 at 00:45, after the first shot, patient experienced increases thirst within 5 minutes of shot, awareness of throat, creeping headache starting at the base of the neck across the entire head. The throat/headache, along with lowering blood pressure was how she react during an allergic reaction, so she asked the nurse to check her blood pressure. She checked every 15 minutes. Instead of going down, it steadily went up. At this time, she started feeling floaty, her motor skills decreased (She couldn't aim her hand in my bag, she had trouble standing up & walking, and she had trouble moving her tongue to speak), and she had trouble speaking forming the words & sentences. When her blood pressure got to a certain level, the nurse called the paramedics. She was brought to the ER. The patient underwent lab tests and procedures which included blood pressure: it steadily went up and went down, bloodwork, a chest Xray & a CT scan with & without contrast. Patient blood pressure went down as she waited & the results of all tests taken didn't have anything that were of concern to the doctors, so she went home. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
A spontaneous, non-serious event of asthma attack has been received from an office manager, concerning a five-year-old male patient subsequent to receiving FLUMIST. Medical history included asthma. Concomitant medications were not reported. On an unknown date in October 2009, the patient received FLUMIST. In the evening on the day the patient received FLUMIST, the patient experienced a severe asthma attack. The patient was not hospitalized but required nebulizer treatments for a few days. The patient was currently doing well. The outcome of the event, asthma attack, was resolved.
Child received an adult dose of Pfizer vaccine for her 2nd dose of the series.  No adverse events reported.   Mother filled out vaccine consent form and documented that the child was 12.  When the vaccination was entered into system the clerk noticed that the child was in fact 11 yrs and 9 months.  Have attempted to contact the parent and will continue to do so.  No adverse effects have been reported.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 January 2002, 5 March 2002 and 15 August 2002 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (20 mcg, unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy. The healthcare professional reported no titer levels detectable, absence of expected effect.
Initial unsolicited report received from a pharmacist on 08 Aug 2016. This case involves a 55-year-old female patient who was vaccinated with ADACEL (batch number: U1558AA, expiry date: 10 Apr 2018) (dose, dose in series not reported) (route: intramuscular) in right deltoid on 08 July 2016. Patient had medical history of allergy to erythromycin. Concomitant medications were not reported. On 08 July 2016, on the same day following the vaccination, the patient experienced severe pain in right arm. It was also reported that, pain has continued to today. 08 Aug 2016, one month later and patient was also experiencing decreased mobility of that right arm which limits her activity. Patient required ER/doctor visit. X-ray of arm was done and result was negative. Other lab test was not reported. Patient had been treated with Ibuprofen. The outcome of the events was reported as not recovered. Documents held by sender: none.
2:05 p.m. c/c headache and dizziness approx 2 after getting H1N1 mist. Provided rest. Sent home with sister.
Right lower pulmonary embolism. Patient admitted to ICU and started on enoxaparin.
No adverse event; Past lot that had been expired, administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient).    ID number was reported as 80777027399. Patient age was reported as 63 years and 06 months. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt developed red, raised rash about 24 hours following pneumococcal vaccine. Rash on arm just below injection site.
Slow regression into autism. Acting deaf, not social, spinning, Coxsackie virus, lost words, pectus excavatum, bowel problems, loss of eye contact, temper tantrums, hearing became very sensitive. 12/2/08 Reviewed PCP medical records of 3/15/04-5/17/2005. FINAL DX: autism Records include developmental peds eval of 4/27/2005 which revealed speech loss & regression of skills since 2.5 yo.  Sterotyped repetetive play behaviors, reduced eye contact, picky eater, hyperactive, tantrums, underweight,   Had been in early intervention program & receiving PT/OT/ST since 1/2005.
Information has been received from a county health registered nurse concerning a patient (age and gender not reported) who in 2006 was vaccinated intramuscularly with Pneumovax 23.  Subsequently, the patient developed a local site reaction post vaccination. The patient sought unspecified medical attention.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Woke up with Itching on my back / Am I contracting Chickenpox or Shingles?; Woke up with / red spots/dry / on my back / Am I contracting Chickenpox or Shingles?; Woke up with / red spots/dry / on my back; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date, refer case US2021AMR079010).   On 6th April 2021, the patient received the 2nd dose of Shingrix. On 8th April 2021, 2 days after receiving Shingrix, the patient experienced pruritus, red rash and dry skin. On an unknown date, the outcome of the pruritus, red rash and dry skin were unknown.   It was unknown if the reporter considered the pruritus, red rash and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient was a healthcare worker and reported for himself/herself. The patient stated that this morning he/she woke up with Itching on back with red spots/dry. The patient was asking if it was contracting Chickenpox or Shingles. The patient stated that he/she just had routine side effects until this.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR079010:Same reporter.
Presented with CP, cough, fever; DX: sepsis due to PNA, LLL bacterial PNA, + Covid but noted to "likely be carrier"- tx with remdesivir as high risk for Covid PNA, Decardron, Merrem, Vanc, Singulair, Zinc; Home on O2
sore arm at injection site ib 10/8,10/9 and 10/10 on 10/9 ached all over my body and felt like I had the flu
Starting the next morning, I had heavy vaginal bleeding for 9 hours, then stopped and it was not time for my period
Patient called 2 days after the vaccinations and said her arm was red and swollen with a "ridge" around the area. She also stated she was nauseous and had vomiting that day. I spoke with her again 4 days after the immunization. She said her arm was getting better and she was not nauseous any more. She had gone to urgent care. They told her it was probably an "allergy" to the flu shot and gave her something for nausea, but she did not need it anymore.
small blistery rash on her upper buttocks/rash; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 54tf4, expiry date 18th May 2023) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was recovered/resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The reporter stated that patient experienced a small blistery rash on her upper buttocks after dose of Shingrix. The rash appeared within the first week.  The reporter did not consent to follow-up.
Patient was given the Covid 19 vaccine instead of covid 19 Bivalent . The incorrect vial (standard covid 19, 12 and up) was taken out of fridge and placed with the Bivalent vaccine bin. In error a fourth dose was given to patient. It was discovered half hour after patient left when going to use vial for another patient by reviewing lot number and description on vial
Fever,  chills,  extreme fatigue for 24 hours after injection. Fatigue lasted weeks.  Several outbreaks of herpes (both types 1 AND 2) since vaccination. Highly highly unusual for me.  Haven't had any issues for years previous to getting the shot.
Developed sore upper right arm and red rash at injection site by 03/20/2021. Arm became swollen and rash spread  to eventually cover entire arm from shoulder to wrist and down the right abdominal side to the waistline. By  03/22/2021 blisters formed and oozing of a mostly clear fluid occured on entire right arm. 03/22/2021 phone conversation with PA regarding condition. He was suspicious of an infection and ordered 5 day supply of Amoxicillin 500mg antibiotic pill to be taken 3x day. Next day, 03/23/2021 at 3:30pm office appointment at clinic with NP. Extended Amoxicillin for 5 days, and ordered Hydrocortisone Butyrate cream to apply 2x day.
Information has been received from a registered nurse concerning a patient who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose of PNEUMOVAX 23 (lot# 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patient developed cellulitis reaction on his/her arms. The patient had to go to an emergency room but was not admitted into a hospital. At the time of the report, the outcome of the patients was unknown. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The nurse contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, date of events and recovery status. Follow up information has been received from a registered nurse who indicated that the 63 year old patient with cough and cold at the time of vaccination and no pre-existing allergies or medical conditions on 11-MAR-2010 at 10:00 a.m. was vaccinated with a first dose of PNEUMOVAX 23 (lot# 664476/1190Y) in the left arm. On 13-MAR-2010 the patient experienced cellulitis of arm and required emergency room visit. The patient was treated with clindamycin for seven days. Subsequently, on 16-MAR-2010, the patient recovered from cellulitis of arm. No laboratory or diagnostic studies were performed. This is one of several reports received from the same source. Additional information is not expected.
When she looked at something, she had spots of blindness/seeing dots of light in her vision/ blind spots; she could not see the words/ When she closed her eye, she had a jagged line of light/vision is weird; field of vision was blurry/she had to concentrate really hard to focus on anything in her view; injection site hurt; having a hard time sleeping; headaches; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 30Aug2021 at 15:00 (Batch/Lot Number: FC3184) (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Vaccination facility type was pharmacy or drugstore. Medical history included heart palpitations and the patient had an adverse reaction to a vaccination as a young baby, but unsure which one. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medication included methadone for eight years but have never had any problems with vision or headaches. Methadone was taken for an unspecified indication, start and stop date were not reported (taken within two weeks). The patient did not receive any other vaccine in four weeks. The patient got the shot on Monday, 30Aug2021 at 3pm. That same evening, she noticed the injection site hurt. Then around 9:30-10 pm, she started seeing dots of light in her vision. When she tried to read something, she could not see the words. When she looked at something, she had spots of blindness. She could not see her significant others eye while looking at his face. When she closed her eye, she had a jagged line of light. After about an hour, the blind spots reduced, but around her field of vision was blurry. For two days after that, she felt as though she had to concentrate really hard to focus on anything in her view. That day was Thursday and she was having a hard time sleeping, headaches, and still feel as though her vision is weird. She went to the ER. The event resulted in Emergency room/department or urgent care. No treatment was received. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.