chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Complained of a headache on Fri., was lethargic and fell asleep while playing in playroom at daycare. No fever. Mother noticed child scratching site of injection. Fri. at bedtime, checked and the site was red, swollen, itchy approx 3" Wx 4" L red area. On 03/18/2002 redness subsiding-lump still present at injection site.
Lichen Planus; This is a spontaneous report from a contactable consumer (patient). This consumer reported in response to non-health care professional letter sent.  A 60-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 06Apr2021 at 14:30 (at the age of 60-years-old) as dose 2, single for covid-19 immunization. Patient medical history including any illness at time of vaccine was none. Concomitant medications included vitamin d3. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 13Mar2021 at 15:15 PM (at the age of 60-years-old) as dose 1, single for covid-19 immunization and had a feeling of lesion in the lower left area of mouth. On 07Apr2021, right after second shot the patient experienced lichen planus. Patient started feeling a lesion in the lower left area of mouth in front of the lower teeth. Reporter stated the day after the 2nd shot of the vaccine on 07Apr2021 went to dentist, they photographed it. Thought it was an allergic reaction to vitamin D3 that patient was taking, but stopped that and it got worse, went to dentist a few weeks later then lesion got larger and there were more. Dental hygienist said they never saw them in the mouth in the 6 years while cleaning teeth. Surgeon suggested a biopsy and they removed a portion from upper right side inside mouth near jaw in cheek area. (6 stitches). Confirmed Lichen Planus "Possibly due to vaccine". The patient underwent lab tests and procedures mouth lesion biopsy which included a result of non-cancer lichen planus on 28Jun2021. Reporter considered the event as non-serious. Therapeutic measures were taken as a result of the event. The clinical outcome of the event was not recovered at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
My reaction to the shingles vaccine was shingles; My reaction to the shingles vaccine was shingles; I am in terrible pain; meds to treat it make me extremely tired; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My reaction to the shingles vaccine was shingles) (serious criteria GSK medically significant), shingles (Verbatim: My reaction to the shingles vaccine was shingles) (serious criteria GSK medically significant), pain (Verbatim: I am in terrible pain) and tiredness (Verbatim: meds to treat it make me extremely tired). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and tiredness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient's reaction to the shingles vaccine was shingles.  The patient was in terrible pain and the medicine to treat it make him/her extremely tired. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
chronic back pain; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "chronic back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash, swelling,heat and itching at local injection site. Pt took OTC BENADRYL.
Woke up with hives on my arms and legs, very itchy everywhere including insides of my ears
Swelling, redness and itching of injection site  roughly 5?x 4? welting.
uncontrolled bowel movements before reaching toilet; diarrhea; pain in arm; headache; fatigue; malaise; At the height feeling of impending doom; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), ANXIETY (At the height feeling of impending doom), ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (pain in arm) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069h22a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-May-2023, the patient experienced MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet). The patient was treated with ACETAMINOPHEN at a dose of 1000 milligram; ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE) at an unspecified dose and frequency and LOPERAMIDE at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient had pain in arm immediately increasing over 4 hours requiring 1000 mg acetaminophen, at 24 hrs headache and malaise, at 48 hrs severe unrelenting diarrhea lasting 4 plus days. Diarrhea uncontrolled by diphenoxylate/atropine. Severe fatigue, headache and diarrhea for 48 hrs then moderate for 24 hrs and now mild but unresolved. Loperamide also ineffective. Over 10 uncontrolled bowel movements before reaching toilet. At the height feeling of impending doom. It was unknown if the patient experienced any additional symptoms/events.
A FEW MINUTES AFTER THE SHOT WAS GIVEN, THE PATIENT COMPLAINED OF DIZZINESS AND FEELING LIKE HER "BODY IS ON FIRE, AND TIGHT IN THE CHEST." PATIEN WAS GIVEN 50 MG OF LIQUID DIPHENHYDRAMINE AND A BOTTLE OF WATER. AFTER ABOUT 15 MINUTES, SHE FELT FINE AND LEFT THE AREA, SAYING THAT HER ROOMATE IS HERE TO PICK HER UP.
Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine
Full body muscle aches, joint pain, chills, nausea, swelling and redness at inj site, standing difficulty.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 22 February 2008 from a health care provider.  A female patient, age not specified, had received a right deltoid injection of Fluzone SV 2007-2008, lot number U2443AA, on 21 February 2008.  The patient had received a left gluteal, intramuscular injection of Tetanus Toxoid Adsorbed Preservative-free, lot number U1715BA, on 05 February 2008.   Fourteen hours following the 21 February 2008 vaccination, the patient experienced facial swelling and urticarial lesions of the right upper thigh and right elbow.  "Blotchy patches" were also reported.  The patient was evaluated by a physician and treated with intramuscular Benadryl, intramuscular Solu-Cortef, and subcutaneous epinephrine.  All symptoms resolved within 60 minutes.  Diagnostic testing was none.  The patient was discharged with Allegra D and prednisone.  At the time of this report, the patient had recovered.
Post vax, the pt developed a large circular area of erythema around injection on left upper arm. Treated with Benadryl.
This report was received from Pfizer and was assigned manufacturer report number 2011090133 concerning a 21 weeks female with relevant drug history unknown and relevant medical history unknown who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) instead of PREVNAR through unknown route at 14:30 pm on unknown site Relevant drug history was unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Hib conj vaccine (unspecified carrier). Vaccines taken within the last four weeks were unknown. Relevant lab date was unknown. Conflicting information at the time of reporting, the patient was not taking PREVNAR and it was unknown if she was taking PNEUMOVAX 23. This was originally reported by consumer. All telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested.
Arm started hurting at injection site about 2 hours after administered. Next day, my whole arm hurt, injection site was swollen, red, and hot. 2 days after injection, arm was really painful, red, swollen and injection site was hot to touch, developed fever of 102.4. Tylenol and ice packs; fever broke at about 1 AM; arm still painful.
Quarter size red area with knot, warm to touch 1/2" away from injection site of left thigh.  Benadryl, Tylenol, Motrin to be given as needed.
SWELLING AND REDNESS AT AND AROUND INJECTION SITE. LEFT ARM VERY SORE AND HARD TO LIFT. PATIENT EXPERIENCED NAUSEA AND POSSIBLY FEVER.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset Jul2022, 1 week after the suspect product(s) administration, outcome "unknown", described as "migraines". The event "migraines" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that patient had booster shot 1 week ago now patient had migraines per doctor in ER due to shot. Had cat scan all was fine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
lower right sided abdominal pains that moved to trunk area then back within 4 days of receiving vaccine. Then rash appeared on waist on 10-27-07 and back pain that would awaken patient from sleep.
Pt in a SNF; pt had a positive COVID test in the facility on 1/24/22; treated with 10 days of ABX for COVID pneumonia; pt passed away in the facility
Patient stated he experienced soreness in his arm the next day and for many days.  Since then he has experienced and continues to experience muscle weakness in the arm the shingrix was given.
She experienced muscle cramps/soreness on side of vaccination only. She couldn't lay down on that side. She had to take ibuprofen for the pain which resolved after 1 day. She experienced pain a few hours after vaccine.
Information has been received from a physician concerning a 13 year old male who on 04-MAY-1998 was vaccinated with the first dose of MMR II vaccine. On 19-JUN-2001 the patient was vaccinated with the second dose of MMR II vaccine. On 12-JAN-2010 the patient developed mumps. On 14-JAN-2010 lab test results revealed IgM 0.26, IgG 2.35 and serum amylase 54. The patient was diagnosed with left parotitis on the same day. It was reported that the patient had exposure to others with mumps. The outcome was not reported. No further information is available.
3/18 vaccination 3/21 bleeding 3/22 Ultra sound with low fetal HR.  3/22-/3/23 passing of gestational sac I went back Wed and had another lab work done  to compare the levels from Monday to Wed. No other lab work done.  2nd pregnancy, 1 live birth, DOD 11/5/2021
9x5cm red, warm area rt upper arm; put on Keflex 250mg TID x 10days;
Blurred vision, dizziness, itching, tightness of chest, headache.1340 c/o itching nose/chest tightness along with anxiousness BP 124/80, HR 60, RR 18, SpO2 98% RA.  Resp. easy/even.  Denies difficulty with swallowing. C/o Blurred vision at this time. 1349 States that chest tightness is resolved.  Continue to c/o blurred vision.  States that after receiving vaccination she almost immediately had an instant headache.  1356 States that itching is now resolved, along with tightness of chest/blurred vision. States that her headache remains.  1408: BP 116/76, HR 68, RR 18, Continue c/o headache.  No other complaints at this time.  Staff nurse suggested pt get a ride home.  Pt denied need for a ride stating that she was fine other than the headache.  1413 Pt released to go home.  Pt reminded to call PCP for any further adverse reactions.
Headache and fatigue 2/11 and 2/12 followed by itchy rash on left front chest 2/13. Rash spread to back and became painful on 2/14. Got diagnosed with shingles at Urgent Care on 2/15.
Cellulitis 7cm diam total 11cm diam vesicles, warmth right thigh. ABT Keflex 250mg PO tid x 7 days.
Information has been received from a certified medical assistant concerning a 25 year old female patient who on 17-APR-2009 received the first dose of GARDASIL (lot#661531/1311X) IM in her left arm. Concomitant therapy included NASONEX, hormonal contraceptives (unspecified) and ZYRTEC. On 17-APR-2009 the patient experienced hot flashes. The patient sought medical attention through an office visit. The patient's hot flashes persisted. Follow up information was received from a certified medical assistant on 27-MAY-2009. It was reported that the patient "would go ahead with doses #2 and #3." No other information regarding the AE was reported. On 28-MAY-2009, the certified medical assistant reported the following additional details: the patient had an allergy to ALUPENT, dust and pollen; no pertinent medical history; no other vaccines given at the time of the GARDASIL vaccination on 17-APR-2009; exact adverse event onset date was unknown, the patient simply reported at the 18-MAY-2009 office visit that she had been having hot flashes; some routine labs (not specified) drawn that day were all normal; hot flashes coincided with a new work-related stress, but did not go away when the work situation resolved; physician indicated that there was no correlation between the hot flashes and GARDASIL use; patient had to go to the office soon for the second GARDASIL dose; the patient after speaking with a co-worker, was interested in learning her "sugar level" so would see her primary physician. Additional information has been requested.
Zoster like lesions on Left Low back and Left Anterior and lateral thigh.  mildly pruritic and mildly uncomfortable.   no other systemic symptoms
11/04/08 Information as contributed by patient's mother:  30 minutes post vaccine on 9/26/08 Head tremor, behavior change, also observed by others.  Resolved quickly, (Review of symptoms neg; family history - negative)
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: On 5-28-21 the patient was given the COVID vaccine, following the vaccine he passed out.  When the patient came to he said he must have gone to sleep.  The patient stated he passed out the week before and thought it was due to not eating.  EMS checked vitals, and all vitals were good.  Pt refused to go to the hospital, he left with his wife and she drove.  I told the patient I would follow up with him via a phone call to see how he was feeling.  I called pt at 5 pm on 5-28, he stated he was fine
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included shoulder replacement (In February 2018) and multiple allergies. In September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season and the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX, the patient experienced vomiting. On 29th September 2018, the patient experienced swelling arm, chills, fever and feeling bad. On an unknown date, the outcome of the swelling arm, chills, fever and feeling bad were recovering/resolving and the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the chills, vomiting, fever and feeling bad to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she received SHINGRIX (right arm) and a flu vaccine (left arm) on either on 27th September 2018 or on 28th September 2018. On 29th September 2018 (1 or 2 days after vaccination), around evening she started feeling bad. Her right arm, where she received SHINGRIX, swelled up and she also had fever and chills. The patient had some vomiting, but she said she had that periodically due to her bad allergies. The patient had started feeling a little better on the day of reporting. The patient had denied permission to contact their physician.
4/29/21 hpi admission to inpatient: 80 y.o. male with a past medical history notable for  Diabetes, history of CVA, arthritis, reflux, BPH, hyperlipidemia, hypertension. The patient presents for evaluation of  Worsening issues of weakness and hyperglycemia in addition to being worsening itchiness. Patient states he has had some issues with worsening reflux. Patient has not any emesis. Patient's wife thinks he may be slightly jaundiced. Upon further evaluation patient was found to have pancreatitis. Patient was placed in-patient will hold patient NPO and provide IV fluids. Patient has had pancreatitis previously. Patient's itchiness is probably due to elevated transaminases. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.  Transferred to hospital  5/1 HPI: 80 y.o. man with a history of type II DM, hypertension, and remote h/o CVA who presented to hospital following transfer from another hospital for acute pancreatitis.  Patient was initially admitted to their facility on 4/29, treated for pancreatitis with IVF, pain medication, and antiemetics.  He LFTs failed to improve.  RUQ US with no evidence of gallstones.  Transferred here for MRCP/ERCP.  He currently denies any abdominal pain.  No chest pain.  Breathing stable.  No fever or chills.  He states he has been having some belching and acid reflux for the last 1-2 weeks, worsening after a trip 1 week ago.  5/17/21 radiology: Malignant neoplasm of pancreas Admitted  5/20 - 5/24:  Open biopsy of liver/Pancreas, ECRP  6/14 Office Vist : oncology, pancreatic carcinoma metastatic to liver
On 1/12/09 pt received a Tdap inj booster in L deltoid in belly of the muscle. Several hours later she developed swelling and pain in the deltoid. No discomfort initially. No systemic sx's such as fever or malaise. Over the next 12-24 hours the L deltoid progressively got more swollen and painful and stiff. She developed dysesthesia over the ulnar distribution including the fingertips of 4 and 5 of that side. No weakness. Could not abduct her arm past about 45 degrees prior to or less than 45 degrees.
Approximately 3 1/2 inch diameter knot around injection site (red, swollen, hard to the touch) with approximately 2 inch diameter area with small blisters in the center. Patient had been putting alcohol on it. Recommended hydrocortisone cream and BENADRYL.
2in red itchy raised area where injection was given. Started about 2 days after injection was given  and still experiencing side effect a week after injection
Rash at injection site started late in day of injection. Rash red, warm to touch, itching and pain. Rash continued to spread, around and under arm. Has not started to improve even at 9+ days later.  Also on and off pain at back and both sides of neck ("stiff neck".)
HAD yellow fever INJECTION ON 6/10/09 DEVELOPED A 4 INCH RED BLOTCH ( NO FILLED) ON LEFT BACK OF ARM AND FELT MALAISE x 1 DAY.
~3 hours after injection: chills, sweating, heart rate increase.  10 hours after injection: 102 degree fever, nausea, vomiting, chills, headache. 30 hours after injection: fever lowered to 100 degrees and nausea subsided.
Left axillary lymphadenopathy; fever/rigor; fever/rigor; fatigue; mental fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:00 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LORATADINE; ACETAMINOPHEN, start date: 14Nov2021, stop date: 16Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Left arm), administration date: 28Dec2020, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "Left axillary lymphadenopathy"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 18Nov2021 20:00, outcome "recovering" and all described as "fever/rigor"; FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "fatigue"; MENTAL FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "mental fatigue". Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, chills, fatigue, mental fatigue.  No follow-up attempts are possible. No further information is expected.
Redness, Swelling, Pain  Hydrocortisone Cream, Oral and Topical Benadryl, Ice Applications