chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inspection: faint pink appearance of skin left arm that has some blotchiness not circumscribed and warm but no induration or fluctuance.  Significant tenderness of deltoid muscle outside of the area where there is pink discoloration.; palpation: tender to palpation of most of the deltoid region on the left arm..
Refusal to eat and vomiting, taken to ER. Later transferred to another hospital where she was diagnosed with intussusception that was reduced by air contrast enema.
recurrent staph infections - ongoing for 14 months; took 4 rounds of antibiotics, but still going on
30 minutes after injection, arm started to swell and get red, and hot at injection site. That evening, heat and ring grew to 5 inch circle and swelled to about golf-ball size. Slight headache. Next morning, woke up tired, not feeling well. By 1pm arm swelled to soft-ball in size as did redness which became darker red and began to itch. (have picture) Throat scratchy. No fever by head reading but arm reading was 101.3 (where redness was) and circle enlarged and became more oval almost down to my elbow. Next morning woke extreme nausea, red arm still hot, still swollen. Chills all day, never vomited, just couldn't drink or eat anything. Next morning called Dr. Office and reported in. Same symptoms all day. Ice was applied to arm all days. Saturday had more headache than before, tired.  Arm began to go down in swelling and redness. Slight fever and diarrhea all day. Sunday still tired but was able to eat crackers. By evening redness gone, swelling gone. Woke this morning feeling nearly 'normal'.
moderna covid-19 vaccine eua- fever 102, in bed all day because of fatigue, sore muscles
This spontaneous report as received from a pharmacist refers to 2 unspecified infants of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 27-JUN-2015, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Shortness of breath was caused by movement; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 30Mar2021 12:00 (at 36-year-old, non-pregnant at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication was none. No other vaccine in four weeks. No other medications in two weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 09Mar2021 12:00 (at 36-year-old) as dose 1, single for COVID-19 immunization. The patient experienced shortness of breath on 12Apr2021 22:45. Seriousness criteria was reported as disabling/incapacitating. Clinical details: the patient started having shortness of breath two weeks after the second dose. Initially it was very severe. She spent that week mostly in bed. Shortness of breath was caused by movement. She was still having it. She still cannot do chores. Her doctors were having a hard time figuring out what has happened. Now they wanted her to see a heart specialist. The event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment was received. The outcome of the event was not recovered. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Had 4 booster shots on 3/29/19.   Started with spots on legs 4 days ago.  No change.  No itch.  No fever.  no blister. Today at school they have gotten larger.  isolated papules and tiny clusters of papules on both legs..
she's having a minor infection which is Urinary tract infection; This is a spontaneous report from a Pfizer Sponsored Program support via contactable Consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on 22Mar2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient had minor infection which is urinary tract infection, took antibiotics as prescribed by doctor. She wants to know if that affects a reaction while having the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever (106 max) 6 days after 1 y.o. shots given assoc. with body rash.  Patient otherwise well-looking during exam visit (had no fever).
Intense chills; Dizziness; Muscle soreness; Abdominal cramps; Lower back cramps; Headache; Fatigue; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 12:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. 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 COVID vaccine. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 as a single dose for COVID-19 immunisation. On 16Apr2021 at 21:00, the patient experienced intense chills, dizziness, muscle soreness, abdominal cramps, lower back cramps, headache, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 events. The clinical outcome of the events intense chills, dizziness, muscle soreness, abdominal cramps, lower back cramps, headache, fatigue and nausea was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of neck pain in a 18-year-old male patient who received BEXSERO (batch number 16A301, expiry date 1st January 2019) for prophylaxis. On 17th July 2018, the patient received BEXSERO. In July 2018, 2 days after receiving BEXSERO, the patient experienced neck pain and rash. On an unknown date, the patient experienced coldness of lower extremities, tingling of extremity and weakness in extremity. On an unknown date, the outcome of the neck pain, coldness of lower extremities, tingling of extremity and weakness in extremity were not recovered/not resolved and the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the neck pain, coldness of lower extremities, tingling of extremity, rash and weakness in extremity to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported, but it could be 17 years or 18 years. At the time of reporting, the patient was still experiencing neck pain and new symptoms have developed. Less than a month after receiving vaccination, the patient experienced weakness and tingling in the left leg and weakness and tingling in the right arm, and left leg also felt cold to the touch. The healthcare professional would not provide the patient information.
COVID-19 positive after booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive after booster vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive after booster vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive after booster vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported
received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 24-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml). At the time of the report, ACCIDENTAL OVERDOSE (received a third Moderna dose of 0.5 ml instead of the booster of 0.25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-366705 (Patient Link).
the tingling numbness in her left hand got worse; tingling numbness moved into her left leg; the tingling numbness moved into her left arm and moved into her whole left side; numbness in her left hand; felt totally wiped out; pain in her left hand; tingling in her left hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her left hand), PARAESTHESIA (tingling in her left hand), HYPOAESTHESIA (the tingling numbness in her left hand got worse), HYPOAESTHESIA (tingling numbness moved into her left leg) and HYPOAESTHESIA (the tingling numbness moved into her left arm and moved into her whole left side) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052CorE21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in her left hand) and PARAESTHESIA (tingling in her left hand). On 06-Sep-2021, the patient experienced FATIGUE (felt totally wiped out). On 07-Sep-2021, the patient experienced HYPOAESTHESIA (numbness in her left hand). On 08-Sep-2021, the patient experienced HYPOAESTHESIA (the tingling numbness in her left hand got worse), HYPOAESTHESIA (tingling numbness moved into her left leg) and HYPOAESTHESIA (the tingling numbness moved into her left arm and moved into her whole left side). At the time of the report, PAIN IN EXTREMITY (pain in her left hand), PARAESTHESIA (tingling in her left hand), HYPOAESTHESIA (the tingling numbness in her left hand got worse), HYPOAESTHESIA (tingling numbness moved into her left leg), HYPOAESTHESIA (the tingling numbness moved into her left arm and moved into her whole left side), HYPOAESTHESIA (numbness in her left hand) and FATIGUE (felt totally wiped out) outcome was unknown.            Patient had reported that she tested negative twice then but felt all the symptoms and felt the worst in the house as other in the house were Covid positive and sick. Patient also reported that on 06-SEP-2021 she felt worse with the vaccine than she did in July of 2020. On Tuesday she got better but had numbness in her hand that got worse and radiate to her left arm, then left leg and to the whole left side of body.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Scratchy throat; Swelling of lymph nodes (collar bone, jaw, ribs); Soreness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), LYMPHADENOPATHY (Swelling of lymph nodes (collar bone, jaw, ribs)) and MYALGIA (Soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C27A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Scratchy throat), LYMPHADENOPATHY (Swelling of lymph nodes (collar bone, jaw, ribs)) and MYALGIA (Soreness). At the time of the report, THROAT IRRITATION (Scratchy throat), LYMPHADENOPATHY (Swelling of lymph nodes (collar bone, jaw, ribs)) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Approximately 10 minutes after receiving the vaccine patient became dizzy, lightheaded, felt like she was  going to pass out, upper extremities bilaterally had tingling, then lower extremities bilateral had tingling, nausea.
Information has been received from a physician concerning his "about 6 year old" nephew who on an unspecified date was vaccinated with a dose of Varivax. "Around last week", in October 2006, the patient "experienced a serious break out of chickenpox". The patient visited the ER though he was not hospitalized. At the time of the report the patient was recovering, it was reported that the patient improved, however it was not known if the patient was on or off therapy. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Within 2-3 hours, onset of extreme arm soreness in injection location.  12 hours after injection (2am), awoken from sleep with a low grade fever, severe  body aches and chills.  12+ hours after injection, Insomnia and depression due to severity of body aches and chills.
Next morning noticed that site of injection was red, area 1/2". By Wednesday night rash spread 3x1 1/2" was hot and itching. Went to ER on 1/7 and doctor specified it was vax reaction. They thought it was blood poisoning at one point. Prescribed BENADRYL. On 1/8 follow-up with doctor. By 1/9 area no longer hot/red. Redness still there but not hot or itchy.
Significant vaginal bleeding and vaginal blood clots. Extremely heavy bleeding during mid-cycle (between periods). No prior history of heavy bleeding nor any vaginal blood clots. Started approx 24 hours after first shot and continued for several days, with bleeding and clots. Scheduled virtual doctors visit immediately and followed up with in-person pelvic exam and ultrasound. Normal ultrasound results. Stopped birth control pills for several days, then restarted, then soon after changed to new birth control.
I noticed a slight red circular ring about the 4th day (February 14, 2021) but it was so slight, i couldn't tell if it really was a ring or not.  I didn't really pay attention or notice it was "blotchy" and "red" with some small red areas feeling slightly warm to the touch until February 19, 2021.   I took a picture of my arm on February 20, 2021 for documentation purposes.  Today, February 21, 2021,  the red blotchy patches/uneven circle looks lighter in color.   I had a headache on February 18 and 19, however, I can't positively say it was from the COVID vaccine.
2/8/23 started having stiffness in both hands while driving home from a restaurant.   2/9/23 throughout the day hands and arms started feeling sore and stiff,  by 3:30pm could barely make a close fist with both hands.  Wrist started to feel sore and swollen.  Hands were not able to grasp anything and skin showed inflammation.   2/10/23 not able to move left arm at all could not put arm away from side of body.  Fatigued and not able to move well or put on clothes by myself, went to ER  Treated me with Ketorolac and prednisone and was released 2/13/23 saw GP Dr who ran blood test and referred me to Rheumatologist  2/28/23 Diagnosed with Rheumatoid Arthritis
1 Year baby girl who developed macular rash secondary to vaccination. with rash over whole body spring palms and soles. Treatments given at ER was Solumedrol 30mg, IM, Benadryl .
A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that two patients accidentally received expired FLUMIST Quadrivalent. (Lot no. CJ2005) which started on 17-DEC-2014. The outcome of the event of two patients accidentally received expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
Pale, limp, hypotonic, hyporesponsive very inactive since vax; persistant crying; stared from 1130AM to 8PM on 11MAY92;
Inside of thighs felt irritated by underwear. When I checked, inside of thighs were discolored reddish purple. Then I found a spot on my stomach, and in my left  and right armpits, red spots on my back, very bright pink on inside of both arms,. Through these days and still today, though reddish purple areas are quite diminished, I still have much itching and backs of knees, thighs and calves are very pink, blotchy and itchy. Nothing raised like hives would do.  Under breasts and to nipples are very itchy, though not red or pink. I spoke with pharmacist, spoke to a nurse at my primary care facility and spoke to a pharmacist at my pharmacy and all have noted in my file my severe allergic reaction.  Did not go to ED as I did not have any trouble breathing and the skin discolorations did not go above my armpits.
Information has been received from a registered nurse who on 23-FEB- 2007 was vaccinated SC with a 0.5 ml dose of Zostavax (lot# 656413/1477F). There was no concomitant medication. About two weeks post vaccination, on approximately 09-MAR-2007 she experienced 4 itchy, non-vesicular bumps on her forehead and on the side of her nose. Medical attention was sought. The nurse reported that she was treated with valacyclovir hydrochloride (VALTREX), and the bumps resolved. A product quality complaint was not involved. Additional information has been requested.
Administered to a 9 month old.; Patient did not need the Hep B but needed the IPV component.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th May 2022, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's Comment: This case was reported by the certified medical assistant (CMA). Kinrix was administered to a 9 month old patient. She stated that all they had in stock was the DTap-IPV-Hep B and the Dtap, but the patient did not need the Hep B but needed the IPV component.  Additional Suportive Information: The patient received Kinrix at 9 months age and did not need Hep B component, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Patient called Pharmacy and reported the following on 3/16/2019:  Patient experienced fever starting the day after injection of second dose. The fever lasted about 3 days. She then developed a rash on her back and stomach which spread to the tops of her shoulders. She described the rash as itching and burning. She continues to have pain on her shoulders. The pain has spread to her neck and head.
coughing w/in 4hr, laryngitis, rhinitis 2 days later low grade fever;
Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.