chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injection site left arm. Temp 98.6 1/12: 0600am: Shaking chills, cold sweat, faint, nausea, headache, body pain, fatigue, skin sensitivity, pain injection site. 1/12: 0630am: Same as above, Temp 100.9, took Ibuprofen 3 tabs. 1/12: 0730am: Less of all symptoms, ate food. 1/12: 12:30pm: Headache, body aches and pains, weakness, fatigue, nausea, skin sensitivity, pain at injection site.  1/12: 1:12pm: Temp 99.5.  took ibuprofen 3 tabs.  1/12: 2:15pm-3:40pm: Breakthrough body aches, pains, headache, skin sensitivity, pain at injection site. 1/12: 7:40pm: Body aches, tired. Temp 98.3. took Ibuprofen 3 tabs. 1/13: 0800: Slept well, no further pain medication, no further side effects except mild soreness at injection site. 1/24: 0800: no soreness to injection site.
Night of injection, incredibly sore and heavy arm that kept me awake. Woke up with body aches, stiff and painful joints,  bottoms of feet hurt. Extreme migraine behind eyes and back of head with light and smell sensitivity. Tightness of chest with shortness of breath and racing heart.
Having really heavy menstral bleeding; Am not due for a period until the end of the month i had ended my last cycle on 28Jul; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself).   A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in the right arm on 05Aug2021 18:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies to Latex. The patient's concomitant medications received within 2 weeks of vaccination included diclofenac sodium (SPRINTEX) taken birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Covid prior to vaccination. The patient was not tested post vaccination. On 05Aug2021, the patient was vaccinated at 6:30 pm and at 7:30 (19:30) pm started having really heavy menstrual bleeding she was not due for a period until the end of the month she had ended her last cycle on 28Jul2021, and her cycles were never this heavy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient not received treatment for the events. The outcome of the events was not recovered.
pt recv vax 15JUN95 & 26DEC95 pt devel approx 12 vesicular lesions scattered all over the body;MD indicated that the rashes were considered to represent break through chicken pox & not causally related to the varicella vax
Patient presented with Vomitting and diarrhea. Has had a COVID exposure in which patient turned positive.
Vaccine administration error.  17 year old patient walked in to vaccination site with father around 2:35pm.  We were running Moderna at that time but still had a few doses of Pfizer left from the morning session so we registered patient for COVID-19 vaccine. During registration there was miscommunication due to language barrier and the father was registered instead of the 17 year old son.  Moderna vaccine was administered when it should have been Pfizer.   I as the clinical lead realized an administration error had been made when the wayfinder handed me a blue prevax form for Pfizer and there was no Pfizer on the floor (they were locked in the med room). We immediately brought the 17 year old patient and the father to an exam room and informed them about the error (wrong patient was registered and Moderna was given instead of Pfizer).  They were both very understanding and did not have questions or concerns.
Itchy arm.  Put some anti itch meds on it and it stopped itching.
Information has been received from a physician concerning a 14 month old female who was vaccinated PO with the second 2.0 ml dose of ROTATEQ.  While the patient was in the hospital for adenoidectomy the patient experienced vomiting, diarrhea and fever and remained hospitalized for 5 days.  The patient tested positive for rotavirus.  The outcome was unknown.  There was no product quality complaint.  No further information was provided.  Additional information has been requested.
Severe Pain, weakness in upper arm and shoulder. Severe range of motion along with sharp pain in shoulder and upper arm with weakness shooting down the left arm.
pt recv vax & 24hr later pt devel an inj site rxn characterized by redness, warmth, swelling & pain;the rxn resolved on it's own w/in 2-3 days;this is one of three patients, from the same site, reporting a similar rxn;
Extreme sore throat, body aches, headache, sinus congestion, lymph nodes swollen on neck. I basically have a horrible flu. I feel worse than when I got Covid!
pt recvd vax; devel a local rxn described as cellulitis manifested by erythema, induration & a warmth; tx w/ Keflex; rxn resolved w/in several days;
reddish rash and swelling on arm, on my left arm; reddish rash and swelling on arm, on my left arm; reddish rash and swelling on arm, on my left arm; This is a spontaneous report from a contactable other HCP.  A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: EW0217), via an unspecified route of administration, administered on 19Jun2021 as single dose for covid-19 immunisation. Medical history included neck pain from an unknown date, (At one time, I was having like neck pain on left side but that subsided), blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included Dyazide 37.5/25 (Hydrochlorothiazide, Triamterene) taken for blood pressure measurement, start and stop date were not reported. Date schedule to receive second shot: Consumer stated, second shot is 10Jul2021.The patient experienced reddish rash and swelling on arm, on my left arm, reddish rash and swelling on arm, on my left arm on 27Jun2021.Consumer stated treatment was not taken. Verbatim event relatedness: COVID-19 Vaccine: reddish rash and swelling on arm, on my left arm - Related. The events reddish rash and swelling on arm, on my left arm was reported as worsened. The outcome of all event was not recovered.
no adverse event; patient was accidently was given both PNEUMOVAX23 and PREVNAR 13 on the same day; This spontaneous report was received from a registered nurse referring to a 65-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 12-OCT-2021, the patient was accidently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # U002528, expiration date on 13-SEP-2022, for prophylaxis (strength, route of administration and anatomical location were not reported) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) 0.5 ml, lot #CK0842, expiration date on 01-FEB-2022 on the same day (accidental overdose). At the time of report, the patient had not experienced any additional adverse event (no adverse event). Vaccines were administered together and there was no guidance on the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) in the prescribing information for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
shooting pains in arms, legs, feets, hands; spasm  in arms, legs, feets, hands; Intermittent weakness in arms, legs, feets, hands; Shooting pains on face; Face spasm; Face weakness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 13Apr2021 at 14:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex type 1 (HSV type 1), migraines, irritable bowel syndrome (IBS), headaches, post-traumatic stress disorder (PTSD) and tinnitus. Patient reported at Clinic for treatment as MC is too far( reported by patient). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) from unknown date and for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Mar2021 at 09:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 20:00 the patient experienced shooting pains, spasm, intermittent weakness in his arms, legs, feet's, hands and On unspecified date in Apr2021, the patient started to feel it on face. Comes and goes, started to become unbearable. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as the result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shooting pains, spasm, intermittent weakness in arms, legs, feet's, hands and on face were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
flu like symptoms - fever, chills, headache, body aches and pains. increased redness and soreness at injection sight. Skin is hot to the touch, painful, and about 6" X 4". The redness started on 09/28/2019
2 days after receiving vaccine patient developed a rash that was itchy and tingling at the injection site. The rash cleared  at that area but redeveloped  about a week later under her breast moving around to her spine. The rash is not painful but is itchy and tingling.
12-15-17 Parents of pt. notified that KINRIX was expired by 2 days. Discussed drug company info, CDC and ACIP. No problems but achy arms. 12-7-17 Mother called to say rt deltoid had red area about 2 inches in diameter. No complaints from child, no fever or breathing difficulty. 12-8-17 Spoke to mom. Redness decreasing.
On 10/22, patient developed cough, weakness, shortness of breath, and nasal congestion. On 10/26, patient was seen in urgent care and diagnosed with COVID-19.  Additionally, he was found with new onset atrial fibrillation with RVR so was sent to the ED for further evaluation.  Patient was admitted 10/26-10/27 for evaluation of new onset atrial fibrillation and COVID-19 pneumonia. Per chart review, provider suspects atrial fibrillation was likely precipitated by COVID-19 infection. Patient has been vaccinated with the COVID-19 primary series and one booster.
Pt complains of pain in left arm when lifts arm up to shoulder height or higher. Pain started same day as injection. Pt saw dr on 10/9/10 and explained problem to dr - no treatment given.
Received a flu and pneumonia shot on left. Arm became red and swollen, also had emesis and high fever.
This case was reported by a physician via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 31st December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, generalized rash and pustule. On an unknown date, the outcome of the injection site rash, generalized rash and pustule were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, generalized rash and pustule to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The reporter had no information of the patient. The patient received dose of SHINGRIX and experienced intermittent rash that look like chicken pox at vaccination site and other areas of the body, small pinpoint pustules. The reporter had no information on lot and expiration date.
Patient called clinic with c/o persistent L shoulder pain following vaccination. Pt states that her shoulder only hurts when she moves it and was not able to quantify the pain. Patient declined self-inspection for lumps, discoloration, or changes in temperature or skin texture. Pt also denies fever/chills. Nurse recommended that patient be seen in clinic by a provider. Patient has a history of shoulder pain and already has a PT and massage/chiropractic referral in place.
Progressive ascending weakness (R>L) with urinary retention. MRI spine showing T6-conus longitudinally extensive non-enhancing lesions and minimally enhancing 3x 2.3cm L thalamic lesion. Differential diagnosis includes post-infectious vs post-vaccine autoimmune demyelinating process such as ADEM-like picture with transverse myelitis vs paraneoplstic process. Lower suspicion for primary CNS lymphoma.  -s/p brain biopsy 4/7/21 -s/p 5 plasma exchanges with two more planned
Patient requested influenza vaccine and after administration they called a caretaker who reported they had alread received an influenza vaccine
Fever and shaking of whole body w/staring of sight and associated foaming. Patient stopped breathing with cyanosis. Mom gave CPR and after 4-5 mins, patient turned responsive and started crying, back to baseline except for discomfort. On arrival to ER, she was crying, active, no seizure activity, with spontaneous breathing without any distress. Overall, well-looking child with fever. Then she developed a second GTC seizure that lasted for 1 min, followed by post-ictal confusion. She received 0.7 mg of ATIVAN.
Pt says that she started itching every where.  She felt little pin pricks like i was sticking her with a pin.
Cellulitis on left arm-deltoid, about 4" area of redness, swelling and heat.
pt recv vax & devel an inj site rxn characterized by swelling & erythema;no further info was available @ the time of this report;
" I felt the needle go in but did not feel the usual full feeling as the shot was injected. Within an hour I had a headache and pain up the left side of my neck, then severe pain in my left shoulder area a short time later. "
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # L016429/expiration date - 09-AUG-2017 (incorrect product storage). No adverse event. Excursion temperature was 51.22 F and timeframe was 92 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same operator. Additional information has been requested.
11-year-old brought back with concerns of redness and swelling on the left upper arm. Had received vaccines on March 14. On the left arm he received the Tdap and meningitis vaccine. Has redness and swelling in the area feels warm since the last 2 days. The area of redness and warmth is increasing in size. Denies any respiratory difficulties, any generalized swelling, any difficulty with swallowing. Denies any previous reaction with the tetanus vaccine. No history of any fever. Has been having BENADRYL, TYLENOL and cold compresses to the local area.
MODERNA COVID-19 Vaccine EUA  On 2/4/21 I received my vaccination in my left arm. On 2/16/21 noticed a red hive like rash at the injection site that extended down to the  inside of my arm. No bumps, not itching,  just a red patch about the size of a half of chicken breast.  Applied Triamcinolone cream to the site. Saw Dr. on 2/17/21  and she said to monitor and apply the Triamcinolone cream.  If it worsened we may treat it as a skin infection.  The redness  lessened over the next few days and was gone by 2/21/21
This is the second dose and the adverse reactions duplicated the first back in October 2018.  Several hours afterward, I start to feel achy, then within an hour or two after that, I am fevered, chilled, achy all over. It lasts a day and a half. Fever usually breaks then comes back the evening of the next day, and residual headache and body ache continues for the 2nd day.
PAPULE & MACULAR RASH TO TORSO AND LOWER EXTREMITES - 7 TO 10 DAYS AFTER IMMUNIZATION.  TREATED WITH CIPRO 500mg, ATARAX 25mg AND ZYRTEC 10mg.
pt went to get 2nd dose of primary series (1st dose given 8/29/2022)  but was given bivalent booster as 2nd dose of primary series.  no known s/s to note as result of inappropriate dosing.
Patient received J&J vaccine on 4/30/21. Presented to ER on 5/4/22. COVID positive 5/4/22. admitted on May 5th morning with COVID-19.  Patient was originally seen in Urgent Care but due to hypoxia she was sent here.  Patient started couple this with oxygen.  Start on IV dexamethasone.  Patient also found to have iron-deficiency anemia and IV iron was ordered.  Hematology consulted.  Patient will get 5 days of IV Venofer.  Patient currently needs couple L of oxygen.  Discharged on 5/9/22
Patient fainted 3min post vaccination, placed patients head between his legs, patient regained consciousness after 15 seconds.
patient was found passed out in the parking lot, patient received a laceration above his right eye with orbital swelling.  we administered first aid to patient and called 911. to my knowledge the patient proceeded to the hospital for additional medical attention.  we also gave pt water and crackers as they stated they were dizzy.
fussiness and flailing abut as in pain Left thigh  erythema beyond injection site spitting up
child reported injection site pain approximately 4 hours after receiving his bivalent booster (IM) in the left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 at 10:30 as dose 4 (orange cap, booster), single (Lot number: GK0876) at the age of 5 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer/BioNTech, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FT9142, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular, Prev dose administration date: 25Oct2022, Prev dose dose number: 3, DOSE 3 (MAROON CAP), SINGLE), administration date: 25Oct2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer/BioNTech, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FT9142, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular, Prev dose administration date: 29Aug2022, Prev dose dose number: 2, DOSE 2 (MAROON CAP), SINGLE), administration date: 29Aug2022, when the patient was 4-year-old, for COVID-19 immunization; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer/BioNTech, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: FT9142, Prev dose lot unknown: False, Prev dose administrator route: Intramuscular, Prev dose administration date: 08Aug2022, Prev dose dose number: 1, DOSE 1 (MAROON CAP), SINGLE), administration date: 08Aug2022, when the patient was 4-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11May2023 at 14:30, outcome "recovered" (12May2023), described as "child reported injection site pain approximately 4 hours after receiving his bivalent booster (IM) in the left leg". Therapeutic measures were taken as a result of vaccination site pain. Additional information: On 11May2023, child reported injection site pain approximately 4 hours after receiving bivalent booster (IM) in the left leg. No medicine was given at the time. Approximately 11 hours after receiving the vaccine, the event had not resolved and was given ibuprofen to help sleep through the night. The patient did not have any adverse events upon waking the next day (ie, the event resolved by 12May2023).
SCRATCH; RED; SORE; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender of Unknown ethnic origin born in 1998.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced scratch (preferred term: Scratch). On an unknown date, the patient experienced red (preferred term: Erythema). On an unknown date, the patient experienced sore (preferred term: Pain).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed.     At the time of reporting, the event of scratch, red and sore was ongoing.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event: red, scratch and sore.      The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event: red, scratch and sore.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
From initial info received on 6/17/05 from an RN regarding an adverse event occurring in the USA, it was reported that an 11 year old male pt received his 1st dose of Menactra vaccine, lot U1640AA, administered in the left deltoid on 6/13/05. Reportedly, 2 days later, on 6/15/05, the pt developed a rash on his face and hands. Two days later, on 6/17/05, the rash progressed to welts on his torso. He had no complaints of fever or itching. The symptoms were treated with Benadryl. The pt's recovery status was reported as not recovered.
Neuropathy in right hand has increased; persistent right muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Neuropathy in right hand has increased) and MYALGIA (persistent right muscle pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in June 2018, Colon cancer in August 2018 and Radiation exposure in January 2019. Concurrent medical conditions included Neuropathy (Neuropathy in right hand has increased) since June 2018.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HYPOAESTHESIA (Neuropathy in right hand has increased) and MYALGIA (persistent right muscle pain). At the time of the report, HYPOAESTHESIA (Neuropathy in right hand has increased) and MYALGIA (persistent right muscle pain) outcome was unknown.            No concomitant medication and treatment medication were provided.   This case was linked to MOD-2021-074793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non-Significant follow up information was added: Contact information updated, Address of reporter updated.