chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre syndrome; patient was paralised from the top of head to toes; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional via social media .   This case involves a patient of unknown age and gender who experienced Guillain-Barre syndrome and was paralyzed from the top of head to toes (paralysis), after he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain-Barre syndrome and was paralyzed from the top of head to toes (paralysis) (Unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Patient stated that  the reason she/he did not get a flu shot was it gave him/her a disease. Thank God it was temporarily. He/she would not wish this one anyone. The  Guillain-Barre syndrome can also have serious side effects after one gets well in two to three months. Patient requested to check it out and do some research before anyone got a flu shot. He/she never took the flu shot since then and that was 53 years ago. He/she wears a mask and washes hands a lot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient of unknown age who experienced Guillain-Barre syndrome and paralysis after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Pt recvd engerix-B & the next morning following dose 1 exp flu like sx, diarrhea & vomiting;
COVID-19; Reaction to covid-19 vaccine; Weakness; Vertigo; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), IMMUNISATION REACTION (Reaction to covid-19 vaccine), ASTHENIA (Weakness), VERTIGO (Vertigo) and ABDOMINAL PAIN (Abdominal pain) in an adult female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    The patient's past medical history included Herpes infection. Concurrent medical conditions included Hidradenitis suppurativa, Apnea, Upset stomach, Nasal allergy, Hypercholesterolemia and Blood pressure high. Concomitant products included SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for Blood pressure high, OMEGA-3-ACID ETHYL ESTER (LOVAZA) for Hypercholesterolemia, MONTELUKAST SODIUM (SINGULAIR) for Nasal allergy, OMEPRAZOLE for Upset stomach.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 10-Sep-2021, the patient experienced IMMUNISATION REACTION (Reaction to covid-19 vaccine), ASTHENIA (Weakness), VERTIGO (Vertigo) and ABDOMINAL PAIN (Abdominal pain). On an unknown date, the patient experienced COVID-19 (COVID-19). In September 2021, ASTHENIA (Weakness), VERTIGO (Vertigo) and ABDOMINAL PAIN (Abdominal pain) had resolved. At the time of the report, COVID-19 (COVID-19) and IMMUNISATION REACTION (Reaction to covid-19 vaccine) outcome was unknown.            Treatment medications were not reported. The reporter's causality for the events of weakness, reaction to covid-19 vaccine, vertigo and abdominal pain with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's causality for the event of COVID-19 was not provided for Humira. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up document included additional events of weakness and vertigo, event onset date updated.
Information has been received from a nurse concerning an 18 year old female who on 11-JAN-2007 received the first dose of Gardasil. Subsequently, the patient developed a rash on her arm and "had a temperature". On 15-MAR-2007, the patient received the second dose of the Gardasil. On 15-MAR-2007, the patient developed a rash on her arm and legs and "had a temperature". The patient sought unspecified medical attention. The patient recovered. It was also reported that the patient will not receive her "3rd dose" of the vaccine. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a registered nurse concerning an 18 year old female who on 11-JAN-2007 was vaccinated intramuscularly into the right deltoid with the first dose of the GARDASIL (Lot # 653735/0688F). On 12-JAN-2007, the patient developed "some rash on her arm" and an elevated temperature. On 15-MAR-2007, the patient was vaccinated intramuscularly into the "left upper quadrant" with the second dose of the GARDASIL. On 16-MAR-2007, the patient developed a rash on her arms and legs and an elevated temperature. Treatment included TYLENOL and BENADRYL. The patient recovered. It was also reported that the patient will not receive her "3rd dose" of the vaccine. Additional information is not expected.
Immediately following JANSSEN COVID-19 vaccine administration patient began to faint. 911 called immediately. The patient remained stable and alert until paramedics arrived. Upon arrival, paramedics stated patient adverse reaction most likely due to dehydration and low blood pressure. EMT administered fluids and patient was taken to a local hospital for further evaluation and monitoring.
Rash; swelling; small bruise; itch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), SWELLING (swelling), CONTUSION (small bruise) and PRURITUS (itch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LOSARTAN, AMLODIPINE, FENOFIBRATE, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM), ACYCLOVIR [ACICLOVIR], ESTRADIOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D) and BUSPIRONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (Rash), SWELLING (swelling), CONTUSION (small bruise) and PRURITUS (itch). At the time of the report, RASH (Rash), SWELLING (swelling), CONTUSION (small bruise) and PRURITUS (itch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I got shingles; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the second shot and week later got shingles. The patient stated that it was not a bad case.
Shortness of breath, swelling of tongue and throat, tingling of hands and arms, lightheadedness, dizziness, increased heart rate. 11/19/09 and 11/20/09 Medical records received for date 11/13/09. DX: Anaphylactic rx secondary to H1N1 vax vs. sushi. Pt. presented w/ c/o receiving H1N1 vax same day and later c/o SOB, tongue "fullness" after consuming sushi. Pt states allergic to clams and muscles. Assessment: pharyngeal swelling, SOB.
heavy during the first few days after vaccine; I also discharged heavy blood clots on some days; Since then I have been bleeding every day/ But even after 35 days i spot daily/ It is not stopping even after 35 days; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 09:00 (at the age of 44-years-old) as second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The second dose was taken during the patient's period. On 09Apr2021, the patient experienced been bleeding every day, heavy during the first few days after vaccine, even after 35 days the patient spot daily, discharged heavy blood clots on some days and it was not stopping even after 35 days. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event been bleeding every day, even after 35 days the patient spot daily day and was not stopping even after 35 days was not recovered; while outcome of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High fever of 105, vomiting, sweats for multiple days. Then after that, my taste and smell have been strange for months. Constant heart pain, fast heartbeat, fatigue, out of breath
Lt arm extremely swollen, red and hot to touch. Ibuprofen Tab., 600mg. 1 Tab Every 8 h. Clindamycin cap. 300mg, 1cap. PO every 8h, x 10 days. Diphenhydramine cap. 25mg, 1cap, PO TID, x7days. Mupirocin 3xaday.
11/10/21 - 3:35pm Client's age at time of vaccination is 11 years and 11 months. Client and client's mom informed vaccinating nurse that client was 12 years old and nurse inadvertently vaccinated client with adult dose of Pfizer not realizing client's actual age. Client exhibited no s/s of any immediate adverse effects from vaccine. Follow up call placed to client's mom to check on client. Client's mom reported that client was doing ok with no issues or concerns. No reports of any headaches, dizziness or lightheadedness.
pt recvd vax & 13SEP93 exp nausea & also exp anorexia which resolved p/1 wk; approx 1NOV93 devel sprue like sx; stools were less formed than nl & greasy in appearance; pt did not exp diarrhea; lab eval revealed sl evelated amylase @ 100;
6 days after vaccines (10/14/2009), developed fevers to 102, then rising to 104 with back arching; at height of fever, had "jerking" movements both arms while nursing--just 5-10 secs, then stopped and happened again for few seconds; over that night, seemed uncomfortable, arching back a lot, crying a lot with an uncharacteristic shrill cry; next AM, seemed better, but stumbling/not walking well; wanted to be held rest of day; fevers then resolved over next 24 hours; then mom noticed large bruise on gum (called dentist, likely eruption hematoma); next day, had more episodes of shrill cry; by 10/19/2009 seems much better, no fever, walking fine, acting much better; has had no other sx's except minimal runny nose and minimal cough; examined on 10/21/2009 with normal exam except for eruption hematoma of maxillary molar, enlarged tonsils with small amount white exudate, mild splenomegaly (spleen tip palpable 1-2 cm below left costal margin)
29JUL97 raised red spots-no fever, no itchy; tc from mom;no known exposure to chickenpox or shingles;6AUG97 contacted mom today pt doing well rash has nearly disappeared-did not reach vesicular stage;
Patient had requested Pfizer bivalent and nurse accidently gave Moderna Bivalent. Correct vaccine, wrong brand.
Pfizer-BioNTech COVID-19 Vaccine   Symptom: Talking out of one side of my mouth
This spontaneous report was received from a nurse practitioner refers to a 19 years old patient who on 29-AUG-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
per parents pt seems pale & floppy since recvd vax earlier today on eval is hypotonic;
pt recv vax 3DEC96 fever to 104 w/no other sx;10DEC96 atypical rash appeared 11DEC96 appetite dec, sl dehydration;fever persisted till 13DEC96;rash fading 14DECi6;
-cough -SOB -Chills -body aches -headaches Sore throat
Left arm started to tingle. Then skin started to get very sensitive. By 8 PM on 10/9/2012, I had a full blown fever, aches, pains, extreme fatigue. No vomiting or diarrhea. Symptoms still ongoing as of 10/11/12 and visiting doctor this afternoon.
Heart is weak; heart stop; collapsed in the kitchen; fever of 103°F; 2 inches redness around the shot site; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC DISORDER (Heart is weak), CARDIAC ARREST (heart stop) and LOSS OF CONSCIOUSNESS (collapsed in the kitchen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to COVID-19.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced PYREXIA (fever of 103°F) and VACCINATION SITE ERYTHEMA (2 inches redness around the shot site). On 01-Oct-2021, the patient experienced CARDIAC DISORDER (Heart is weak) (seriousness criterion hospitalization), CARDIAC ARREST (heart stop) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (collapsed in the kitchen) (seriousness criterion medically significant). The patient was hospitalized on 01-Oct-2021 due to CARDIAC DISORDER. The patient was treated with Manual therapy (CPR compressions on their chest till the paramedics arrived) for Cardiac arrest. At the time of the report, CARDIAC DISORDER (Heart is weak), CARDIAC ARREST (heart stop), LOSS OF CONSCIOUSNESS (collapsed in the kitchen), PYREXIA (fever of 103°F) and VACCINATION SITE ERYTHEMA (2 inches redness around the shot site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Body temperature: 103 (High) 103°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient collapsed with stopped heart in kitchen, parent performed CPR compressions on chest till the paramedics arrived. Patient was now hospitalized and intubated doctor diagnosed as weak heart with no inflammation.  It was reported that the Patient was not on any medication and had not been diagnosed with any heart conditions before and has not had covid.19.  Patient has no history of COVID-19 and heart conditions. Concomitant medications were not provided. Treatment information was not provided.  Company Comment: This case concerns a 35 year-old female patient with no reported medical history, who experienced the unexpected serious events of Loss of consciousness, Cardiac arrest, and Cardiac disorder. The events occurred 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 35 year-old female patient with no reported medical history, who experienced the unexpected serious events of Loss of consciousness, Cardiac arrest, and Cardiac disorder. The events occurred 3 days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Yesterday evening I experienced three episodes of hearing loss/ringing in my left ear. The longest episode lasted for probably about a minute (which is way longer than I've ever experienced before).   After the hearing loss, I noticed my eyes became a little more sensitive to light and I felt dizzy and a pressure/tickle sensation in my head which then became more focused towards the back of my left eyeball and a little of the back of my left upper arm & left wrist (very strange). No pain or numbness. I wouldn't describe it as tingle as it was more of  tickle.   Hearing has not gone out again since last night but I have some constant ringing/tinnitus and still feel tickle sensation in my left arm and behind left eye.  I couldn?t find much about the tickle online but came across a user who had COVID who literally described a ?ticklish pressure? in their ear,  so I know I can?t be the only one to have noticed this!!!
mild local cellulitis @ inj site about twenty five cent-fifty cent size rt thigh;
Temperature of 99 by 11:00 PM on 1/8, had a fever of 101.1 by 5:00 AM on 1/9, fever of 100 continued until 8:00 PM on 1/9
Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty,Pfizer-BioNTech COVID-19 Vaccine (Previous dose, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine). Past adverse reactions to the above products included Allergy to vaccine with Comirnaty andPfizer-BioNTech COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines). At the time of the report, ALLERGY TO VACCINE (Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Reported mentioned that there was one person who was severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines.  No treatment medications were provided by the reporter.
She said that she rarely gets sick; A soreness in her throat and it was hard to swallow; A soreness in her throat and it was hard to swallow; The feeling of a tooth ache/ having a toothache currently; Felt like someone punched her arm; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in upper right arm on 21Jan2021 at a single dose  for COVID-19 immunization. Medical history included seasonal allergy. There were no concomitant medications. The patient experienced a soreness in her throat and it was hard to swallow, in which she had to get ice to help alleviate the pain in her throat. The pain in her throat resolved a couple of hours later (as reported). She wanted to know if these side effects were from the vaccine. She also reported the feeling of a tooth ache today (26Jan2021), in which she tried to medicate with Tylenol, but was not able to access any while at work. Patient asked what symptoms do people experience within 15 minutes if they have an allergic reaction to the vaccine. The patient got the vaccine 5-6 days ago, but today (26Jan2021) she was on the job in a group setting and was having difficulty swallowing and had a sore throat. She said that she treated it with ice and it is slowly subsiding. She noticed she almost had a like a headache type thing, but it was in the back of the throat. She has had tingling in the back of her throat from seasonal allergies, but nothing like this. Her temp was 97.9 and it was now 98.3. As she swallows, she is feeling pain. She said that the ice helped out. She is having a toothache currently too and stated that she needs to go to the dentist. She noticed her sore throat while she was talking and noticed the sore throat and it hurt and when swallowing. She said that after the injection, she felt like someone punched her in the arm the next day on 22Jan2021. This has resolved at this time. She said that she rarely gets sick. This is the second time she has had some type of symptoms within 2 years. She said that she has not been around anyone and is social distancing. Treatment received for "a soreness in her throat and it was hard to swallow" included ice. The outcome of the events "a soreness in her throat and it was hard to swallow" was recovering (as reported), for event "felt like someone punched her arm" was recovered on an unspecified date and the rest of the events was unknown.  Information on the Batch/Lot number has been requested.
I had a severe hives; sudden dizziness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I had a severe hives) and DIZZINESS (sudden dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (I had a severe hives) and DIZZINESS (sudden dizziness). At the time of the report, URTICARIA (I had a severe hives) and DIZZINESS (sudden dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.