chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling fingertips/gets bouts of tingling or being numb/neuropathy type, numb tingling sensation; like a traveling sensation; her joints, later clarified that she has to keep opening and closing her left hand; This is a spontaneous report from a contactable consumer.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 15Jan2021 10:00 at SINGLE DOSE, for covid-19 immunization. The patient is right-handed which is why she got the vaccine in her left arm. Medical history included ongoing high blood pressure since an unknown date in 2011 (diagnosed about 10 years ago).  There were no concomitant medications used. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient was experiencing numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling at her fingertips, her joints, later clarified that she has to keep opening and closing her left hand. All of these has been continuous, and it seems like it was getting worse not better. It was uncomfortable and hard to explain, it was weird. She describes that it was like "a pain that travels from her elbow to wrist but its numb at the same time". Her left hand gets bouts of tingling or being numb. She has to open and close her hand. Her left arm feels essentially numb from her wrist to the elbow region. She knew there was something going on the day of the injection like a traveling sensation, but she started to really notice the neuropathy type, numb tingling sensation on Saturday (16Jan2021). She clarified that she was not in pain. She did not have any of these symptoms prior to getting the vaccine She was hoping it will go away because it was concerning since it has been about a week since the vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
customer asked if pentacel given on a catchup schedule, would a 5th dose of the vaccine be needed to complete the series and if so when should patient receive the 5th dose with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who asked if diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] given on a catchup schedule, would a 5th dose of the vaccine be needed to complete the series and if so when should patient receive the 5th dose with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On an unknown date in 2017, the patient received a 1st dose of suspect Pentacel, On an unknown date in April 2019 received a  second dose, on an unknown date in February 2019 received third dose and on 31-May-2022 received a fourth dose of the vaccine (dose 0.5 ml, once, Lot: UJ612AAA, 28-Jan-2023 via intramuscular route at right leg strength: standard) for immunization.  On 31-May-2022 (Latency: same day) the customer asked if pentacel given on a catchup schedule, would a 5th dose of the vaccine be needed to complete the series and if so when should patient receive the 5th dose with no reported adverse event (product use issue). As per local labelling adverse event due to pentacel on a catchup schedule should be given to a patient after the age of 5.   Action taken was not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm red, hot, swollen from shoulder to elbow... Referred patient to family DR.
back pain; vomiting; site of injection is sore; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O26A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history not included .  relevant concomitant products usage were not reported by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 25-Mar-2021, the patient experienced BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills).  At the time of the report, BACK PAIN (back pain), VOMITING (vomiting), VACCINATION SITE PAIN (site of injection is sore), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.       No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Presented with weakness/fall; Covid + in ED; admit with Covid PNA; mild symptoms; room air, remdesivir and steroids not indicated; TX with monoclonal antibody, rocephin, doxycycline, Vitamin c, Vitamin D3, Vitamin B12, zinc; room air (no supplemental O2 needed). Patient was also treated with antibiotics for COVID-19 pneumonia. Patient did not need to be on oxygen. She was on room air during this hospitalization.
Writer had 10/6/22 Influenza vaccine visit with Patient and discussed vaccine reactions, Writer unsure if VAERS completed previously.  Day after vaccine 1/23/21 (not within 4 hrs) Patient call nurse triage reporting chills, fever 101.5F, vomiting x 3, stomach pains, diarrhea, headache, myalgias, managed at home but reported "feeling out of it." Patient reported husband had wanted to take her to ER but she declined. Tylenol was advised, started feeling better 5-6 pm 1/24/21, but still had body aches with Tylenol helpful. Then Patient proceeded to have Moderna COVID-19 Vaccine, 2nd primary series, Dose #2 (100 mcg/0.5 ml) Lot 024M20A with no problems. Proceeded to Moderna Covid-19 vaccine booster, dose #3 (50 mcg/0.25 ml) on 11/09/2021 Lot 004F21A missed dialysis day after 11/10/21, also headache and vision changes after vaccine reported. Managed at home, headache improved with Tylenol, had blurry vision before vaccine noted also that eye specialist had attributed to migraines. Patient had fall at home 11/11/21 (2 days after vaccine), did not hit head, husband had to assist up and then mentioned right knee pain but declined knee x-ray, managed at home. Reported a black pinpoint spot in her vision after fall, resolved after nap, advised to continue to follow with eye specialist. Proceeded with Moderna COVID-19 vaccine booster (50 mcg/0.25 ml) Dose #4 on 6/11/2022 Lot 054A22A, not within 4 hours but called nurse triage and reported nausea with vomiting, fever, chills, reported to nurse may not make it to dialysis 6/13/22 (2 days after vaccine) but Writer unable to confirm from chart review if Patient made it to dialysis. Writer confirmed with husband at influenza vaccine visit on 10/6/2022 that patient was "sick" after COVID-19 vaccine dose #1 and after COVID-19 vaccine dose #4.
Painful knot under left arm for a week; muscle pain in left arm, upper right side back pain, overall weakness, tiredness all of which lasted over a week.
Pt had redness and swelling around injection site.  The swelling was warm to the touch.
Myalgia for ~2 months since getting first dose. Am a college tennis player, but am unable to perform essentially any exercise more intense than a few miles of walking and biking for 10 minutes.
Information has been received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-SEP-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (strength, route, lot# L005298 and expiration date 17-FEB-2017). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Numbness and paralysis right side of face. ER visit on 4/28/2021 confirmed diagnosis of ER.
"Myocarditis" as reported by patient's mother, currently hospitalized. Have not spoken to patient.
Anaphylactic reaction after vax. Hypotension, chills, nausea, weakness, and prolonged sleepiness.
Developed 'classic' ezcema on antecubital fossa and chest 7 days after multiple vaccines including smallpox prior to deployment. Denied history of atopic derm but has had outbreaks of other types of rashes on chest. Symptoms: Dermatitis, focal.
cold sweat; hot sweat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweat) and HYPERHIDROSIS (hot sweat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweat) and HYPERHIDROSIS (hot sweat). At the time of the report, COLD SWEAT (cold sweat) and HYPERHIDROSIS (hot sweat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
A week after the 3rd dose, I got full body hives. They are still happening. I am only taking ZYRTEC to subdue the itchiness. I did see Dr. on December 30, 2021, she recommended higher dose of ZYRTEC and recommended PEPCID and she did prescribe Prednisone. Prednisone did not help. She has recommended to continue the higher dose of ZYRTEC 3-4 OTC 10mg so 30 mgs daily and continue taking PEPCID. I will schedule a follow-Up soon. I still have the hives.
Patient told doctor that his blood sugar went up (>400) after his first COVID-19 vaccine and he was hospitalized.
Pt arm is red and warm to touch, redness has hard tissue under the skin (hard as a golf ball). Red site is 70mm horizontal and 60mm vertically. Site is tender to touch.
Patient reports of having arm swelling, sweating, chills, swollen face, pain, weakness, and fatigue
Patient hospitalized for having C-section on 4/11/21. Patient's baby was 7 lb 14.5 oz. Apgar was 8 at one minute and 9 at five minutes.   Patient also presented to the ED and was subsequently hospitalized on 4/29/21 within 6 weeks of receiving COVID vaccination.
Pt woke up Saturday 11/9 complained of spot on (L) breast that went away (not colored - just a spot). Top of shoulder ached and back of neck. Pt took 2x TYLENOL Extra strength; felt better; woke up Monday 11/11 aching all over; took additional TYLENOL.
Soreness and pain at the site of injection and on my shoulder blades since the injection day until today
Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/31/2022 Discharge Date: Aug 4, 2022  PRESENTING PROBLEM: Hypoxia  COVID-19  Pneumonia due to COVID-19 virus    HOSPITAL COURSE:   Patient is an 87-year-old female with a past medical history with rheumatoid arthritis on methotrexate comes in with shortness of breath and fatigue.  She was found to have COVID-19, she was not hypoxic but very dehydrated.  She was started on low-dose Decadron and remdesivir and responded well.  She worked with PT/OT and did if finding.  Recommendation was home physical therapy which was set up.  Patient's septic workup was negative.  She tolerated diet well.  Hemodynamically stable for discharge
Got mild case after having 2 shot and a booster/suspected Vaccination failure; Got mild case after having 2 shot and a booster; Still have 2 numb fingers and top of hand was also numb; having 2 shot and a booster; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got mild case after having 2 shot and a booster/suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got mild case after having 2 shot and a booster), numbness in hand (Verbatim: Still have 2 numb fingers and top of hand was also numb) and extra dose administered (Verbatim: having 2 shot and a booster). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported and the outcome of the numbness in hand was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and numbness in hand to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and numbness in hand to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023 The case was received from the patient via interactive digital media. The patient got mild case of shingles after having 2 shots and booster. That was 3 months ago. The patient still had 2 numb fingers and the top of hand was also numb. The patient stated that it was not fun and advised to get the shot as a full blown case of shingles was horrible and very painful? This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient had three shingles shots, which led to extra dose administered. The follow up would not possible as no contact details were available.
One week after second Moderna shot, patient began low-grade fever, loss of appetite, foggy thinking, fatigue, general malaise.  She was treated with three different meds for a possible UTI.  All symptoms except fever continued for 10 days, and on March 25, she suffered a TIA.  She went to the ER and stayed in the hospital for 36 hours.  MRI showed no lasting damage.  She is improving but is still fatigued.
This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 76-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 20th June 2018, 1 days after receiving SHINGRIX, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the day of reporting, the patient woke up with facial and cheek swelling on the opposite side of the injection site. No further information was reported regarding the event.
Fever 1 day after vaccination then erythematous rash developed over entire body 2 days after vaccines given.  Coalescing papules/plaques involving face to legs.  Not itchy.
If COVID prior vaccination: Yes; If COVID prior vaccination: Yes; This is a spontaneous report from a contactable healthcare professional (patient) received via Regulatory Authority. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 22Sep2021 at 11:00 (Batch/Lot Number: FC3183) (at the age of 55 years old) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient was not pregnant at time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks. The patient experienced COVID-19 and Drug Ineffective on an unspecified date in 2021. The patient underwent laboratory tests and procedures which included: COVID-19: positive on an unspecified date in 2021. The outcome of events was unknown. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 13Oct2021 at 10:00 (Batch/Lot Number: 301308A) for COVID-19 immunisation and experienced vision became blurry, could not focus on objects, could not read at all (It lasted about 15-20 minutes), a severe sinus headache came on shortly after her vision recovered, lasting approximately 24 hours.; Sender's Comments: Based on the reported information ,a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.
Upper arm swelling with rash and itching at site of injection.   Swelling is approximately 2 inches wide and 3 inches long. Rash is slightly red with about 3 groups of minute red scabs which may be due to scratching.  Symptoms are minor, but I have not had reactions to other vaccines before - except for the first Shingrix shot received on 12/16/2020.  Waiting for second Shingrix shot until 14 days after this second Moderna COVID-19 shot.
Mom reports pt devel fever shortly p/receiving immun; t102 responded to APAP; Also "harsh" cough; Taken to clinic 1JUL91, given ATB for ear infect; MD advised DT in future;
This spontaneous report as received from a physician refers to an unspecified patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (intramuscular injection, strength, dose number, route, lot # and expiration date not reported). Concomitant medications were not reported. The reporting physician informed that he overheard a patient experienced a change in personality and had an unknown neurological type reaction after receiving GARDASIL. No further information was provided. Outcome of the events and causality assessment were not provided by the reporter. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX early in the morning and experienced flu like symptoms until the same time the following morning. It was verified verbally that the vaccine was given intramuscularly.
About 8 hours after the vaccine, Ppt experience extreme fatigue, dizziness, and loss of appetite. She continued to be lethargic and feeling unwell until about Monday morning (March 22).
They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the sixth of six reports. A patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot number: EP8573), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the nurse reported that they had 7 to 8 patients positive of COVID-19 and out of which 6 were given Pfizer vaccine and they got infected. The patient tested positive for COVID-19 on an unknown date in 2021. The events were assessed as medically significant. The outcome of the events was reported as unknown.  Investigation Results for Lot Number: EP8573: Conclusion of Previously Completed Investigation : The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up (19Aug2021): New information updated. This is a follow-up spontaneous report received from a Complaint Group. This report included Lot number: EP8573 was updated.   No follow-up attempts are possible. No further information is expected.  Follow-up (01Sep2021): This is a follow-up report to notify that the case 202101065553 and case 202101138804 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202101138804.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Covid 19, Drug ineffective and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-202101058200 Different patient, same drug/event.
Pfizer-BioNTech COVID-19 Vaccine 0.2 ml administered on 4/13/2022, Beyond Use Date (BUD) was 4/12/2022. Vaccine left in refrigerator passed BUD, not separated from vaccine inventory. Vaccination team scheduled for the date, failed to verify BUD. Routine BUD check and separate expired and/or vaccines, and past BUD vaccines and label do not use.
I'm having fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient asked could he/she take Tylenol after the Shingles vaccine shot because patient was having fever. Additional supportive information: The follow-up would not possible as no contact details were available.