chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joints ache / pain in her hips; pain at the injection site; fatigue; severe aches and pains / extremely sore / getting out of bed is very painful; debilitating; pain from her shoulder to her elbows; getting out of bed is very painful; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number B49F7, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, injection site pain, fatigue, pain, weakness, pain in arm and activities of daily living impaired to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Reporter was the husband of the patient. The patient received a FLUARIX vaccine and following day, she experienced severe aches and pains, pain at the injection site and fatigue. The reporter also said that she was extremely sore and her joints ache. reporter said these effects had been very debilitating. The patient included that getting out of bed was very painful for her as she had pain in her hips in the morning and pain from her shoulder to her elbows. The reporter was given medical advice disclaimer and was referred to HCP. The reporter consented to follow up. This case is linked to the case US2021259937, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259937:Same reporter, same product
This spontaneous report as received from an healthcare worker refers to a patient of unknown age and unspecified gender. The reporter stated on an unknown date the patient was vaccinated with a dose of GARDASIL that past the recommended scheduled date. Lot# and administration route was unspecified. The reporter did not know if the patient was late for the second or the third dose. The reporter also didn't know the date of the vaccination. No adverse effect reported. Outcome of event was unknown. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
shingles, shingles pain, shingles blister; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm at age 57 years, on 24Feb2021 10:30 (Batch/Lot Number: EN6198) as 1st dose, single for COVID-19 immunisation. Medical history was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccination within 4 weeks. Patient reported that she got the first Pfizer COVID vaccine dose 24Feb2021, and a day after the vaccine (25Feb2021), she got shingles. Patient went to her doctor on Monday (01Mar2021) and was diagnosed with shingles. She clarified her shingles symptoms started on 25Feb2021. She said her doctor prescribed acyclovir 400mg, 1 tablet every 4 hours for 5 days. She said she had finished her acyclovir 400mg prescription that was dispensed in a pharmacy bottle. Patient was pretty much at the end of her shingles, but she still hurts once in a while. She said the shingles pain was so bad, the pain had woke her up at night. She said she did not have that many shingles blisters, and the shingles blisters were still there. She said her shingles pain and blisters are better now. Patient wanted to know if it was okay to get second dose and the doctor told her that is okay. Patient have heard a couple of people that have gotten the shingles after receiving the Pfizer and Moderna COVID-19 vaccines and was very worried about getting the second dose. She was scheduled to receive her second COVID-19 Vaccine on 17Mar2021. Vaccination facility type was other huge warehouse hospital, vaccine was not administered at military facility. The outcome of the event was recovering.
Body rash.  Numbness in left hand (Thenar area and the ring and pinkie down to the wrist). The numbness feels like it is about to go to sleep (no pins or needles feelings) I have feeling and grip strength, just feels like it is about to go asleep.    The body rash went away when I took Benadryl when I got home at 11:00 am.    I am still having the numbness in my hand and fingers but not as bad and not as long.  Off and on daily now (1 week out from the vaccine).
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter. The reporter reported that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date. The vials expired on 08-Oct-2021 and were left in the refrigerator past that date. The full 3rd dose of the Moderna COVID-19 vaccine as it was a clinic for immunocompromised patients.
lymph node is hard and painful; swelling of lymph node; extreme fatigue; she has experienced chills; This spontaneous report was received from a pharmacist referring to herself, a 39 years old female patient. The patient had eye swelling and "tickle" in her throat to influenza vaccine inact split 3v (AFLURIA) in 2020 and influenza vaccine (FLUZONE) in 2021 (Flu vaccines). The patient's pertinent medical history included narcolepsy. Information about concomitant therapies was not provided.    On 07-NOV-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # W011264, expiration date not reported, upon internal validation established as 05-SEP-2024, 0.5 milliliter, intramuscular in the left deltoid) for protection from HPV (prophylaxis).    On 08-NOV-2022, the patient woke up with extreme fatigue and swelling of lymph node above left clavicle. At that time, the lymph node was soft and "squishy". The lymph node was now (as of 11-NOV-2022) hard and painful. The patient denied fever but had experienced chills. The patient did not seek medical attention. The patient asked if these symptoms were expected and how long she should expect them to last. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Shingles that began the 24th of January, has spread from my back (left T4 dermatome wrapping around under breast) with fairly severe symptoms.  I am a physician, recognized it quickly and began acyclovir but blisters and pain still manifested badly.  I have no history of being immunocompromised but I will mention that after the first does of moderna I was extremely fatigued from when I received the shot to when my shingles began, and continue to be fatigued.  I am currently breast feeding.
This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 02-NOV-2006 was vaccinated intramuscularly in the right arm with GARDASIL (Lot # not provided). Concomitant therapy included Yasmin. On 14-JAN-2007 the patient received her second vaccination of GARDASIL (Lot #653735/0688F) intramuscularly in the left arm. On approximately 09-NOV-2006 the patient experienced a lighter coloring of the skin at the injection site. It was reported that the patient did not experience any itching or swelling. On approximately 21 Jan 2007 the patient experienced lighter coloring of the skin at the injection site. Follow up information confirmed that on 01-FEB-2007 the patient experienced lighter coloring of the skin at the injection site. At the time of this report the patient's skin discoloration in both arms had not resolved. Additional information has been requested.
Terrible leg pain on both legs, especially at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible leg pain on both legs, especially at night) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Terrible leg pain on both legs, especially at night). The patient was treated with PARACETAMOL (TYLENOL) for Leg pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Terrible leg pain on both legs, especially at night) outcome was unknown.            No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-JUL-2021 contains No New Information.
Breakthrough case admission after 3 vaccines Pfizer 3/19/21 lot# Er2613;  Pfizer 4/9/21 lot# Ew0162;  Pfizer 1/7/22 lot# FL3209
Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 69 years of age, the patient was administered the ZOSTAVAX vaccine at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a physician's office for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
About 10 minutes after shot patient vomited and felt dizzy  Dizziness lasted about half hour Gave patient chips and donut and water  Patient admits to eating a very small bowl of cereal and taking metformin previous night at 7pm  Also admits to not taking high blood pressure the e medication this day  Patient blood glucose was 202 right before eating chips  Patient felt much better after about 40 minutes late Was sent home in a car service and confirmed her got home Also we stated if situation worsens to seek medical attention ASAP hr representative called his emergency contact and informed this person of incident and told to monitor patient
Passed out on sidewalk in parking lot of the clinic about 15 min after vaccine was administered, immediately came to but hit nose and lip causing bleeding and elbow during fall, did not try to catch herself. Went back into clinic, saw a nurse who took name and number, no ice pack or treatment was given, patient stayed for about 10 min before nurse told her she could leave, and patient drove herself home.
Narrative: COVID infection following COVID vaccine series 03/09, Moderna , dose #1 04/06, Moderna , dose #2 12/01 COVID swab, result: detected 11/27 pt  cc: cough, fatigue, headache, myalgias, rhinorrhea exposure: unknown 12/01 SARS-COV-2 Variant Sequencing results: pending
Patient deceased 02-02-2022. Covid pneumonia, respiratory failure, and cardiac asystole.
Afib suddenly worse and very difficult to control. Multiple ER visits and cardiology appointments for medication adjustment before Afib was finally able to be controlled.
Breakthrough case admission after 3 vaccines Moderna 3/6/21 Lot# 030A21A;  Moderna 4/3/21 Lot# 018B21A;  Moderna 11/19/21 Lot# 012H21B
Information has been received from a physician concerning a 6 month old male who on 14-MAY-2007 was vaccinated with the third 2 ml oral dose of Rotateq (Lot # 656385/0030U). Concomitant therapy included DTaP (+) Prevnar. On 26-MAY-2007, the patient experienced intussusception. An abdominal x-ray was performed in the emergency room. Intussusception was located in the right upper quadrant and was reduced via of air enema with no difficulty. On 26-MAY-2007, the patient recovered from intussusception. Intussusception was an other important medical event. In follow-up, the physician reported that the patient was "doing fine." The patient started vomiting and went to the emergency room and was diagnosed with intussuception which was reduced successfully via air enema. The physician did not know if the intussusception was related to therapy with Rotateq. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.  6/19/07 Received vax record from PCP which confirms RO lot number but was 2nd dose, not 3rd.  VAERS database updated w/same. 6/19/07 Received hospital records via fax from CDC which reveal patient admitted 5/26 & d/c on same day for persistent vomiting & dehydration. FINAL DX: Intussusception, reduced by air enema.
OCT94 pt w/abn rt lower extremity;MRI nl;EMG & nerve conduction studies were performed;1AUG98 child seen by reporter noted rt thigh & calf 2.5 to 3.5cm smaller in circumference than lt leg;dx paralytic poliomyelitis secondary to vax
Began feeling lightheaded on drive home, about 10-15 minutes after the injection. Breathing rate increased - I wouldn't describe it as shortness of breath, more like an anxiety reaction. Lightheadedness increased when I got out of the vehicle to swap seats with my wife so she could drive. I lost consciousness as I was reaching the passenger side door, regained almost immediately after hitting the ground. Paramedics arrived, took vital signs. Blood pressure was reading 127/89, blood sugar 68. Not sure what my resting heart rate was. Nothing was found to be alarming enough at the time to require transport or hospitalization, so I went home and rested. One additional dizzy spell occurred upon standing about four hours after the event, but cleared up after sitting down, and no further events occurred after that.
My arm hurt a little bit.; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (My arm hurt a little bit.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm hurt a little bit.). At the time of the report, PAIN IN EXTREMITY (My arm hurt a little bit.) 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.   Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt was given vaccine by Dr. nurse 2-2-12 was seen in our clinic 2-3-12 with (R) leg swollen, red, hot, fever and unable to bear weight.
Appendicitis; Flu like symptoms; Pain on Right (R) side; Tired; Nausea; A spontaneous report  was received from a consumer concerning a 50-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced appendicitis, flu like symptoms, pain on right (R) side, tired and nausea.  No medical history was reported. The current condition included thyroid. Concomitant medications included thyroid medication.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, Friday, the patient was tired, nauseous, had pain on right (R) side and flu like symptoms. On 06 Mar 2021, Saturday, the patient went to emergency room (ER) where a scan was performed and the patient was diagnosed with appendicitis. On the same day, the patient was sent to a hospital where an appendix surgery was performed. On 07 Mar 2021, Sunday evening, the patient was discharged.  Treatment information included surgery, appendix removed and pain medicine after surgery.  Action taken with mRNA-1273 in response to the events was unknown.  On 07 Mar 2021, the event of appendicitis resolved, while the outcome of the events of flu like symptoms, pain on right (R) side, tired and nausea was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Client received extraneous and unnecessary dose of hepatitis B vaccine by RN on 09/07/23 at 1702.
Arm got really red; Arm seemed to be swollen; Arm itched / Small itching spots (forehead & back & arm); Shivering; Just water; Throwing up; Been sick; Sweats; Cold; This case was reported by a consumer and described the occurrence of erythema of extremities in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2018, the patient received Shingrix. In October 2019, less than a year after receiving Shingrix, the patient experienced sickness, sweating, cold and vomiting. On an unknown date, the patient experienced erythema of extremities, swelling arm, pruritus, shivering and unable to eat. On an unknown date, the outcome of the erythema of extremities, swelling arm, pruritus, sickness, sweating, cold, shivering, vomiting and unable to eat were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pruritus, sickness, sweating, cold, shivering, vomiting and unable to eat to be related to Shingrix.  Additional details were provided as follows: The patient's arm was red and seems to be swollen for around week and half. The patient stated that, past weekend from the date of reporting, had been sick, sweats, cold and shivering and then started throwing up, just water. On 28th October 2019, the patient finally ate and on the day of reporting woke up it coming back up through last days. The patient had small itching spot on forehead, back and arm, but did not looks like chicken rash. The patient stated that it had been 29 days ago from the date of reporting and asked if it was due to vaccine. The patient was caretaker and had seen plenty such cases.
I felt fine after the vaccine. Did just have a little soreness at the injection site. Then a co-worker told me my voice was strange, was hoarse. I was feeling fine. The next day I lost my sense of smell. Talked to my PCP and he told me to get tested for COVID, to my surprise I was positive. That was on the 28 or 29 of December. I also developed a lump on my neck on the right side and my PCP prescribed a Z Pack. I finished it but it never went away. I developed another lump on my left side when I took the second dose and I am taking Doxycicline for it.
Lips and tip of tongue burning. Lips are cracked a little swollen. Very painful. Feels like razor cuts. Sometimes scratchy throat. Very small white spots on bottom lip
injection site reaction Narrative:  Patient had some arm soreness for 1 day after vaccination. Symptom has resolved.
Patient called 6 1/2 hours after receiving Hep A vaccine. Mother stated patient was covered in hives and having difficulty breathing. We instructed to call 911.
Patient go very pale and stated he felt like he was going to pass out and felt very nauseous.  Helped patient lay down on the floor, applied cold ice pack to back of his neck and took his vital signs.  Lung sound clear and respiratory rate normal non-labored.  Blood pressure normal, pulse rate 97 and pulse oximetry 99% on RA.  No signs of rash or hives.  Emergency services contacted and care transferred to EMTs at 1:45pm.
This spontaneous report was received from a pharmacist concerning a 77 year old female patient with chronic lymphocytic leukemia (CLL). On 08-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J002968; expiration 14-JUNJ-2014) in the right arm. No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that on 08-OCT-2013, the patient wanted to get the tetanus, diphtheria and pertussis vaccine but there was a miscommunication and she requested ZOSTAVAX instead. She was not aware that ZOSTAVAX was for shingles. After ZOSTAVAX was administer, the patient realized that ZOSTAVAX was not what she wanted to get because of her history of CLL. Relevant laboratory data was unknown. The outcome of ZOSTAVAX administration in a patient with CLL was unknown. Additional information has been requested.