chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). The subject was a former marathon runner. At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, muscle weakness, loss of stamina, extreme fatigue, pains in her hands, feet, and neck, and difficulty lifting her arms and legs. It was reported that these problems affect her activities of daily life and her ability to participate in physical activities which were an important part of her life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 14 November 2008 via an interview between lawyers and the subject. The subject was vaccinated with LYMERIX in April 1999, May 1999, and April 2000. In late-summer  or fall of 1999, the subject developed fatigue, muscle fatigue, joint pain and stiffness, swelling of extremities, water retention, hot sweats, fevers, Raynaud's syndrome, "total lack of circulation", cracks in her fingertips, and "hand bleaching". In January 2004 she developed stage I breast cancer. In the summer of 2006 she developed sciatica. Other events included jaw pain and trouble speaking and swallowing. All of the reported events were attributed to LYMERIX by the subject. Treatment included chemotherapy and radiation therapy, thymus removal, antibiotics, and other unspecified medications. With the exception of breast cancer and sciatica, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed to be medically significant by GSK.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 20-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested
Patient has a 3 inch by 8 inch area of erythema with mild raised area to right deltoid. First noticed swelling to area "knot" two days after receiving AVA vaccination which progressed to a large red area with itching four days post vac. Denies any SOB, fevers, weakness, fatigue, or paleness. No difficulty swallowing. No paresthesia.
shortly after the vaccine she started to fill tightness in her chest and not feeling well. The paramedics were called but she started to fill better and didn't want further care. We monitored her for another 1/2 hr and she started to fill better. We recommended she go to the hospital if she has any other symptoms.
DAY FOLLOWING INJECT PT COMPLAINED OF STINGING, ITCHING AND BURNING AT SOI. WHEN SEEN BY DR, SHE HAD SHINGLES LIKE ERUPTION OF THE SITE
Patient was inadvertently administered SHINGRIX instead of Yellow fever vaccine at first. The nurse grabbed it from the fridge reconsituted (presuming it was YF) and administered SQ. Upon documenting vaccine noticed it was in fact Shingrix. Patient noified of the issue, and was informed of local reaction. Due to patient departing our area for her travel, still wished to receive her Yellow fever vaccine in the other arm.  Patient does report redness in area of her arm where she received the shingrix vaccine.
Patient received Pfizer COVID vaccine on 4/28/21 and 5/19/21. On 12/28/21, patient admitted with cholelithiasis and gallstone pancreatitis to undergo laparoscopic cholecystectomy and cholangiogram. Patient was found to be COVID positive upon admission, but asymptomatic from respiratory point of view throughout the hospitalization. Patient was discharged home on 12/30/21 after recovering from surgery.
Blurred Vision, Vision totally blurred at a slight distance (less than 20ft!!) and I had just gotten my eyes check with new contacts a month prior.  My vision was so good prior that I was telling everyone I could not believe how could I was seeing.  NOW!!  I am almost afraid to drive because my distance vision is so blurred!!!  This is AWFUL!!!  No WAY am I getting the 2nd DOSE - No FREAKING WAY!!!
Patient started to feel dizzy, blurred vision and pounded headache from 1/17/21 to now.
Felt flush, light headed, tongue swelled was like that for a minute or two then symptoms subsided. Currently left with slight headache, dizziness, and sleepy.
Chest pain, elevated heart rate, elevated blood pressure, palpitations, skipped beats. Symptoms continuing for at least 2 weeks following vaccination. So far visited ER and symptoms continuing.
Began feeling lethargic and had a bad headache at 6pm on April 1st. I took ibuprofen to tame it. Began having cold chills 10pm. Took more ibuprofen to tame. Went to bed around midnight. Woke up at 10:30am feeling miserable. Very bad cold chills, painful headache, and body aches. I took Dayquil and covered up with lots of blankets and went back to sleep. Did not sleep well and sweated off the blankets. Woke up at 1:30pm feeling slightly better. The rest of the day I experienced mild headaches and slight chills in the evening.
Hearing problem; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Hearing problem) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Hearing problem). The patient was treated with PREDNISONE for Hypoacusis, at a dose of 2 weeks. At the time of the report, HYPOACUSIS (Hearing problem) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs details not provided.
Approx 1 1/2 hrs post immun pt cried unconsolably w/high pitched crying for approx 1hr; Mom called MD did not talk w/him for 3-4 hrs during which time pt continued to cry but could be quieted some; Would not eat;
Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Extreme pain in both upper legs. Feel it when standing from sitting position and vice versa. Standing from sitting position is worse. It?s almost debilitating. Can barely bend down to the ground. Went to my doctor. Prescribed steroids and anti inflammatory cream. Did NOT tell me about this site. Just found this site from a friend after telling her about my pain and my belief  it being a COVID-19 vaccination side effect.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 14-SEP-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-OCT-2016, the patient was treated at an Emergency Department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir, gabapentin, and oxycodone-acetaminophen for management of her painful condition. As a direct and proximate result of these malfunctions, 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.
Joint Pain in Fingers; This is a spontaneous report received from a contactable Consumer via system.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Family history included: "Joint Pain in Fingers" (unspecified if ongoing), notes: Brother also got Joint Pain in Fingers but no neurological issues. The patient's concomitant medications were not reported.  The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain in Fingers".  The lot number for BNT162B2 was not provided and will be requested during follow up.
No other issues or concerns noted.; Medical assistant calling to report that a adult was given a pediatric dose vs the adult dose. Patient is almost 30 years of age. Admin on 9/20/2022 VAQTA:  LOT: U012007 EXP: JAN 18, 2023 NO PQC No other issues or concerns noted.; Medical assistant calling to report that a adult was given a pediatric dose vs the adult dose. Patient is almost 30 years of age; This spontaneous report was received from a medical assistant and refers to an adult (almost 30 years old) patient of unknown gender. The patient's medical history, concurrent conditions concomitant therapies were not reported.  On 20-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, lot number U012007, expiration date: 18-JAN-2023, administered for prophylaxis (dose, strength, and route of administration were not provided). The patient was given pediatric dose instead of the adult one (product administered to patient of inappropriate age, incorrect dose administered). No other issues or concerns were noted (no adverse event).
Mom reports inflammation at vaccine injection site x few days. Examined 5/24/2023 nothing R erythema, swelling and tenderness at R anterior thigh (~quarter sized). Rx for Cefdinir and advised warm compresses and ibuprofen PRN.
This case was reported by a nurse and described the occurrence of injection site cellulitis in an 18 month old pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date, the pt received Infanrix. At an unknown time, post immunization, the pt developed a type of cellulitis or swelling of the arm. The outcome of the event is unknown.
left arm felt sore after second Covid-19 vaccine; stiff neck; Foggy feeling; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (left arm felt sore after second Covid-19 vaccine), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING ABNORMAL (Foggy feeling) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm felt sore after second Covid-19 vaccine), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING ABNORMAL (Foggy feeling). At the time of the report, PAIN IN EXTREMITY (left arm felt sore after second Covid-19 vaccine), MUSCULOSKELETAL STIFFNESS (stiff neck) and FEELING ABNORMAL (Foggy feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.   This case was linked to MOD-2021-391809, MOD-2021-391816 (Patient Link).
Tetanus shot on 11-15-10. Came in today red, round 2 x 2 in diameter spot on right deltoid, warm to touch. Take TYLENOL, compresses, & come back on Monday if still there.
Initial report received from a health care professional on 17 May 2010: This patient, with an unknown medical history was inadvertently administered a dose of expired FLUVIRIN; (Batch no. 1013291P), intramuscularly on 13 May 2010. The outcome of the event was not reported. No other information was provided.
ARMS ACHE, BILATERAL HAND SWELLING, BLISTERING ON HANDS, FATIGUE.
Pt recvd vax 31JUL92 & approx 1 wk following vax devel pruritic rash; 2 wks postvax exp joint pain in elbow & wrist; joint pain lasted 3 days, rash lasted 2 wks, wrist pain subsided p/1 mo; pt decline to receive addtl doses of vax;
This spontaneous report was received from a pharmacist refers to a 62 year old female patient. On 30-JUL-2013, the patient was vaccinated with ZOSTAVAX lot # J005850 (Expiry: 17-AUG-2014), 0.65 ml, subcutaneous. On 01-AUG-2013, 3 days after onset of therapy, the patient experienced a rash at the injection site that was 2-inches in diameter, was red, painful, itching and burning with a hive after receiving ZOSTAVAX. The patient sought medical attention and saw the pharmacist on 01-AUG-2013. The patient received BENADYRL. On 01-AUG-2013, the patient went to an unspecified urgent care when rash increased to 5-inches in diameter and received cephalexin. It was reported that on 02-AUG-2013, the patient returned to the pharmacy and rash had decreased in size to 2-inches. The outcome of the events at the injection site that was 2-inches in diameter, was red, painful, itching and burning with a hive was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
I tested positive for COVID-19 on 07/22/2022 at 5:00PM. My COVID-19 symptoms started with a sore throat; Body aches; elevated temperatures 99.8 degree Fahrenheit; runny nose; and cough. I did a tele health on 07/22/2022 at 6:13PM. They told me that they can't prescribed PAXLOVID because it can interact with the medication I am currently taking. I took TYLENOL and ibuprofen alternately as needed over the course of 4 days. As of today 08/02/2022 I am not noticing any symptoms.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the RECOMBIVAX HB administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.52. Concomitant products were not provided. On 17-Feb-2021, Excursion time was 09 AM, temperature was 22, total doses given for the day was not provided, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021. On 17-Feb-2021 no hourly temperature recordings available. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pt reported pain the day of the injection (7/10/17).  The following morning the arm was tingling, difficult to move (7/11/17).  This resolved after about 4 hours.  Stated arm was white.  Today, 7/12/17, she came to the office because her arm was red, swollen, warm to touch from 4 cm below injection site to the elbow.
This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
1st dose in 2018 but has NOT received 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called on behalf of a patient and was a caregiver to the patient. The patient received first dose of Shingrix in 2018 but had not received the second dose till the time of reporting, which led to incomplete course of vaccination. The reporter did not give a consent to follow-up with HCP (health care professional). Therefore, HCP contact information was not collected. The reporter did not provide the following information: lot or expiry date, patient's initials, date of birth, gender, the date and route of administration, and dose. This case has been linked to US2019120355, reported by the sam e reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019120355:Same reporter
Extremely swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer, the parent. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included methylmalonic acidemia. The patient had known allergies to eggs and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills (MANUFACTURER UNKNOWN) taken from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 23:15, the patient experienced an extremely swollen lymph node under the left arm pit, approximately the size of a golf ball. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event extremely swollen lymph node under left arm pit was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
rheumatoid arthritis; This is a spontaneous report from a non-Contactable consumer. This consumer (patient's husband) reported for a female patient (wife) of unspecified age that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The medical history and concomitant medications were not reported. Consumer said his wife was scheduled to receive the 2nd dose next week. He said his wife had rheumatoid arthritis with outcome of unknown, and was currently taking methotrexate and abatacept (ORENCIA) infusion.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Flu like symptoms, achy, fatigue, short of breath even at rest, brain fog,