chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minor joint pain, mainly in knees; Minor headache; Feeling blah (washed out); Soreness in arm; This is a spontaneous report from a non-contactable consumer, the patient.  A 62-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in Aug2021, on day one, the patient experienced minor joint pain, mainly in knees that lasted one day, minor headache that lasted one day, feeling blah (washed out) lasted one day and soreness in the arm that lasted three days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events minor joint pain, mainly in knees, minor headache, feeling blah (washed out) were resolved on an unknown date in Aug2021, after a duration of one day; while that of the soreness in arm was resolved on unknown date in Aug2021, after a duration of three days.  No follow-up attempts are possible. No further information is expected.
pt recv vax 7MAR97 & that same day pt devel a light rash on arms;
from doctor notes: On Friday morning, she received her second dose of the Moderna vaccine. Starting Saturday, she began to have swelling in the region of the right deltoid. On Sunday night, she went to an urgent care where they drew a border around it. They started her on Keflex and Pepcid. Today, she noticed the erythema was worsening and growing past the border. The pain is worst at the deltoid, sharp, comes and goes, without aggravating or alleviating factors, radiates down her arm. No relief with Benadryl, Pepcid. Has had intermittent nausea but no vomiting. Denies fevers, chest pain, dyspnea. No family or personal history of DVT/PE.  started on bactrim, continued keflex  diagnosed with cellulitis
p/vax pt periods stop MAR96;1096 periods resume;MAY97 strep throat, loss of weight, sinus infect, 1st nose bleed ever, lost 15-20#;JUN98 eating again;AUG97 joint pain starts, dizzy, h/a, n, rxn to diary food, 2nd nose bleed, T,UTI,chills
Mother told her she was allergic to pertussis vaccine. I spoke with this patient and her mother (via phone with permission from patient) who advised after pt received 2 month vaccinations, the injection site on her leg was red, hot and swollen to touch (size of softball) with 4-6 hours of crying. She stopped crying within 6 hours and the leg swelling resolved within a few days (<1wk). At 4 months of age, she received her second set of childhood vaccines with MD giving pertussis alone (not combo shot). She again began to "scream" uncontrollably with mom being unable to comfort despite use of TYLENOL with site swelling and redness worse than first set vaccinations. Mom brought child to nearby ER and told to continue use of TYLENOL/ASA and comfort measures. Mom advised she was told child allergic to pertussis vaccine. Symptoms again resolved within 24 hours (crying) and <1 week for leg swelling/redness without sequela. At 6 months of age, pt received her third set of required vaccinations including pertussis vaccine. Mom reported redness and swelling extending from top of child's leg around to buttock. Child not moving leg due to pain and just kept still. Patient again screamed for 4-6 hours, was not eating, drinking, and was "Inconsolable". However, crying resolved after 6 hours using TYLENOL and she was wiggling about using legs normally without problems within 24 hours. Site redness and swelling again resolved within 1 week.
Fever of 99.5 to 100.4, chills, fatigue, slept a lot, arm really sore
Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt was lightheaded for about 5 minutes
I started getting symptoms of a cough and headache. I had the cough for a couple of days and took an at home COVID-19 test that was positive. I contacted my doctor and was prescribed Paxlovid. The Paxlovid helped my symptoms but the side effects from the bad taste was bad. I am a kidney donor and I have 1 kidney, I was within the boundary of taking the medication. I also had a runny nose and cold like symptoms. These symptoms lasted for 5 days.
A red rash that is painful to the touch has appeared on a few locations on my skin, each about the size of a silver dollar: (1) on my back at the waist behind my right hip; (2) on the front right upper thigh on the hip joint; (3) upper right groin. They appeared over a week after the first injection so I can't be completely sure they are related to the vaccine, but it seems like that is possible as I don't know of any other possible reason for the rash. I've had the rash for two days now, so I don't yet know how long it will last.
30 minutes after the vaccine. My tongue started tingling. It seemed like my tongue started to swell. I took 1 capsule of Benadryl. And went to the emergency room because I thought I was have an allergic reaction and to be safe. I waited in the ER for 2 hours and began to feel better. The Benadryl seemed to have worked. They evaluated me and I went home. It was pretty mild. I also had chills in the evening, muscle pain, for one evening. And nausea for 5 days. It was manageable. Nothing major.
Large, hard knot in injection arm - c. 3" x 1.5" (full shoulder), very restricted movement - can not raise. Throbbing preventing sleep.  Ongoing, have used Advil and ice with no improvement. Chills & Fever - starting c. 26 hours after injection, continuing to increase (now 30 hours post vaccine) Headache - onset c. 18 hours post injection General - Tired / achy. Back pain. Burning eyes.   All ongoing and worsening.
dose of 0.25 mL Fluzone Quad was inadvertently administered to a 3 yr 11 month patient, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 3 years and 11 month old female patient who was vaccinated with a 0.25 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent] (frequency once) lot UT6647JA, exp date 30 June 2020 via intramuscular route in the left thigh on 30-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to vaccine underdose.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
Information has been received concerning a pt who was vaccinated in 12/99 with varicella vaccine. In 06/2000 the pt reported tested positive for herpes.
Started experiencing ringing, pressure in my ears. Similar to to what one might experience on an airplane as cabin pressure changes and altitude increases. Feels very uncomfy.
This spontaneous report as received from a nurse via company representative refers to a 16 year old female patient. On 19-AUG-2013 the patient was vaccinated with RECOMBIVAX HB thimerosal status is not provided (dose 1, lot number 668558/0894AA exp 17-MAY-2013; route and dosage unknown). The nurse reported that the patient received the first dose of RECOMBIVAX HB that was expired. No adverse event reported. This case is related to MARRS case no 1308USA012700 (same reporter link; patient's brother). Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 24-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician concerning a 6 year old female who on 27-JUN-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 26-FEB-2008 the patient was seen in the office and the chickenpox was "visually diagnosed" by the physician. No further information was available. There were no lab diagnostic studies performed. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Vaccine for ages 5-11 was not diluted appropriately. Child reportedly was tired and had a sore arm for a few days after both the first and second COVID vaccine. No other adverse event.
Left ankle, right knee swollen and painful, Difficulty standing up Left Knee is swollen and painful. Injection sight left arm is very sore Fever: 101 Primary care physician contacted by phone. Maybe a flair up of gout or arthritis??  2/17/2021 - Fever gone. Walking painful but not as severe. 2/18/2021 - Ankles and knees still sore
3 minutes after receiving the first dose of Moderna, I tasted metal, experienced dizziness, narrowing field of vision, and reduced hearing. Blood pressure dropped to 75/35 and lower than normal heart rate, 45 bpm. Became clammy and sweaty. After this initial reaction, 12 hours later, I have fatigue and a slight headache.
Arm  is sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient received first Shingles shot yesterday and experienced arm sore but better than the alternative. Additional Supportive Information: Follow-up would not possible as no contact details were available.
PEDVAXHIB was administered post temperature excursion; no adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (dose and  route of administration were not provided, lot # T001207 with expiration date: 09-JUN-2022) for prophylaxis.The vaccine underwent temperature excursions. The vaccine was stored in temperature 9.2 Celsius degrees for a time frame of 9 minutes. There was no previous temperature excursions and data logger was not involved. No adverse events were reported.; Sender's Comments:  US-009507513-2012USA000976:
Information has been received from a nurse practitioner concerning a 21 year old female who on 19-AUG-2010 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # not reported). Shortly after 19-SEP-2010 the patient developed a rash that lasted for one week in which was really sensitive at the injection site. On 22-NOV-2010 therapy with GARDASIL was discontinued. After stopping therapy on 22-NOV-2010, the patient's outcome was recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sore arm following flu shot administration, still sore as of reporting on 12/14/17. Limited range of movement.
Have not had menstruated since I received my second shot.  I now have an ovarian cyst seen at my ultrasound in August on my right ovary which I did not have during the ultrasound in July.
stress; she was due to get the shingles vaccine; She stated she was due to get the shingles vaccine but did not have time to get it done; Shingles; This spontaneous report has been received from the 67-year-old female patient via Glaxosmithkline (manufacturer report number: US2021AMR226575) referring to herself. The first outbreak of shingles was in 2006, if her memory serves her right, when she was recovering form colon cancer treatment. Concomitant therapy was not reported.  Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine (zoster historical)) (strength, dose, route, lot # and expiration date were not reported) was administrated on 05-AUG-2016 (also reported as in 2016) for prophylaxis when she was there with-insurance.   The patient stated she had a history of cancer and the stress of everything caused the shingles to come out. Her recent outbreak of shingles was mild. She staled she started taking valaciclovir (VALTREX) for shingles on 19-OCT-2021 and finished the 7-day course on 26-OCT-2021. She stated she was feeling better noting that she knew valaciclovir (VALTREX) did not cure shingles. It was also reported that shingles symptoms were almost gone. She stated she was due to get the shingles vaccine but did not have time to get it done (extra dose administered and circumstance or information capable of leading to medication error).   The causality between the events and Zoster Vaccine Live (ZOSTAVAX) was not reported.; Sender's Comments:  US-009507513-2112USA002933:
Baby vomited after crying. Fever started. Baby was began to get fussy. At 2 AM baby was burning up. She had a 104 degree fever. Fever is still present at 101.5.
COVID-19; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J (Dose 1 with unknown batch number). Past adverse reactions to the above products included No adverse event with J & J. Concurrent medical conditions included Hypercholesterolemia and Drug allergy. Concomitant products included SIMVASTATIN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from May 2022 to May 2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            The patient was on other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received COVID-19 Vaccine. It was stated as, 48 hours after finishing Paxlovid, Covid-19 symptoms returned and were much more severe than initial symptoms.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving second dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid and 48 hours after finishing Paxlovid, Covid symptoms returned and were much more severe than initial symptoms. Patient was noted to have received a dose with J & J prior to current vaccination (Interchange of vaccine products). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving second dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid and 48 hours after finishing Paxlovid, Covid symptoms returned and were much more severe than initial symptoms. Patient was noted to have received a dose with J & J prior to current vaccination (Interchange of vaccine products). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
In February, I had blurry vision in my right eye. I went to the eye doctor and was diagnosis with a blood clot on my retina. I was referred to a retina specialist and haven't been prescribed any care and only being evaluated. I also went to my primary care physician regrading my blood pressure and was prescribed a higher dose of maintenance medication: Lisinopril 10mg.
Edema, redness, swelling of arm, developing to cellulitis. Treated with cephalosporin antibiotic.
SICK ON 1-20-22 WITH LOW GRADE FEVER, WEAKNESS, VOMITING AND A FALL. TESTED + FOR COVID-19 AT THE ER ON 1-21-22. ADMITTED TO ICU ON 1-21-22. DISCHARGED ON 1-24-22
CHILLS, NAUSEA, HEADACHE, ACHY FEELING -BACK AND LEGS MORE SO THAN THE REST OF HER, INSOMNIA.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with pneumococcal vaccine 23 polyvalent two days after it had expired. Subsequently, the patient experienced a headache, felt tired and experienced a local reaction. Unspecified medical attention was sought. No further details were provided and at the time of this report, the outcome of the events was unknown. Additional information has been requested.
Dose 1, headache.  DOSE 2  Five hours later severe headache, extensive heat being generated from head, body not, then followed by high fever 101.8 with heart rate going up to 155, followed by twelve hour later breaking fever. Extensive headache continues. At 24 hour mark hives on face under eyes, big welts and red. Continued migraine. This is not safe!!!!!!  I will sue the agency for this product, emergence use yet mandate by colleges and employers. SOMEONE NEEDS TO PAY FOR THIS!!!!! I WILL CONTACT A LAWYER.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient reports pain/discomfort in chest and abdomen shortly after vaccine.  States she experienced shortness of breath, headache, and fatigue for 2 weeks after vaccination.  A day after vaccine, reports multiple episodes of subjectively bloody diarrhea.  An evaluation by GI showed now abnormal findings.  Patient tested for COVID and was negative.  Advised not to get second dose of vaccine.
Information has been received from a consumer concerning her daughter (age not reported) with a history of hernia when she was 4 or 5 years old and who on 13-Aug-2007 was vaccinated with the first 0.5 mL dose of Gardasil (lot # not provided).  There was no concomitant medication.  The daughter's mother reported that "since August 2007" her daughter has not received her period.  The daughter's last menstrual cycle was on July 31st and was over on August 7th.  "Caller stated that she is positive her daughter is not having sexual contact."  Laboratory blood work was performed (date unspecified, results not provided).  Additional information has been requested.
Admitted to L&D, delivered baby 8/11/2021.  Asymptomatic for COVID SxS
This case was reported by a nurse and described the occurrence of anaphylaxis in a female patient who received Flu unspecified for prophylaxis. The patient's past medical history included hysterectomy (In 1982), tubal ligation (In 1980), gallbladder operation (In 1987) and migraine (In December 2017). Concurrent medical conditions included hypertension, diabetes mellitus and drug allergy (Sulfa (Rash), Doxycycline (Sick), XOLAIR (Anaphylaxis)). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported.
Left upper arm erythema at injection site from upper arm (top of humerus) to elbow covering 3/4 circumference of arm, warm to touch, soreness & pain, swelling +1 causing skin to be firm to touch
Within 3-4 hours post vax, the pt experienced a golfball-sized knot at the injection site that was hot, swollen, and red, as well as nausea, vomiting several times, and a fever of 102.6. The pt was also crying. The pt was seen by the physician. At that time, the site was swollen but only minimally with a little tenderness. He had no fever and was eating well. The pt recovered from the symptoms within 48 hours of onset.