chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and tenderness in the arm; Pain and tenderness in the arm; Diarrhea; Constipated; Legs above the knee are cramping and swelling; Legs above the knee are cramping and swelling; Lower abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Pain and tenderness in the arm), PAIN IN EXTREMITY (Pain and tenderness in the arm), DIARRHOEA (Diarrhea), CONSTIPATION (Constipated) and MUSCLE SPASMS (Legs above the knee are cramping and swelling) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Pain and tenderness in the arm), PAIN IN EXTREMITY (Pain and tenderness in the arm), DIARRHOEA (Diarrhea), CONSTIPATION (Constipated), MUSCLE SPASMS (Legs above the knee are cramping and swelling), JOINT SWELLING (Legs above the knee are cramping and swelling) and ABDOMINAL PAIN LOWER (Lower abdominal pain). At the time of the report, TENDERNESS (Pain and tenderness in the arm), PAIN IN EXTREMITY (Pain and tenderness in the arm), DIARRHOEA (Diarrhea), CONSTIPATION (Constipated), MUSCLE SPASMS (Legs above the knee are cramping and swelling), JOINT SWELLING (Legs above the knee are cramping and swelling) and ABDOMINAL PAIN LOWER (Lower abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
One to two days after receiving SHINGRIX vaccination, patient experienced upset stomach, chills, and muscle/joint aches w/o fever. Symptoms have since lessened with time.
Patient received the influenza vaccine on Sept. 13, 2021 at flu vaccine clinic. On the morning of Sept. 21, 2021, Patient developed tingling, numbness, and weakness in both arms which was bilateral and ascending. It progressively became worse through the morning hours. His wife drove him to the local emergency department. He was transported to a higher acuity hospital and was diagnosed with Guillain-Barre Syndrome. Shortly upon transfer, the tingling, weakness and numbness began in both legs. He spent several days in an acute hospital setting and then in a rehabilitation unit. He is currently receiving out-patient OT and PT. He has regained the ability to walk, but still has leg weakness. He still has substantial weakness and loss of control of both hands.
Day following immun sl soreness @ site; 2nd day following immun whole arm sore; has gotten progressively worse; 0 edema, 0 discoloration, 0 heat @ site; Entire arm sore & weak; can't raise arm;
Swelling to right side of face within 1 hour of receiving vaccinations. Treated with over the counter benadryl. Symptom subsided by morning per client's mother.
diarrhea; stomach ache; headache; muscle pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received Shingrix (left arm). On 02-AUG-2023, 1 days after receiving Shingrix, the patient experienced diarrhea (Verbatim: diarrhea), stomach pain (Verbatim: stomach ache), headache (Verbatim: headache) and muscle pain (Verbatim: muscle pain). The outcome of the diarrhea, stomach pain, headache and muscle pain were not resolved.   It was unknown if the reporter considered the diarrhea, stomach pain, headache and muscle pain to be related to Shingrix.     It was unknown if the company considered the diarrhea, stomach pain, headache and muscle pain to be related to Shingrix.   Additional Information: GSK receipt date: 02-AUG-2023 The reporter was the wife calling on behalf of her husband who received a Shingrix shot (unknown if 1st or 2nd dose) and on day of reporting, the patient started having muscle pain, headache, stomachache, and diarrhea. The reporter did not have any information about the vaccination facility other that the patient went to his doctor a day before and was given the shot.  The reporter did not have lot/expiry information. The consent to follow up with Healthcare Professional (HCP) was not asked.
Pt had postmenopausal bleeding starting on 3/30-4/3.  Workup with u/s was negative.  Pt had burning with bowel movement on 3/29, felt like a "habenero pepper."  Also had itching and rash of chest wall, right breast, back.  Received her shot in the left arm.
Patient recieved Moderna instread of Pfizer as a second dose. Moderna was given 21 days after 1st Pfizer dose.
Pt reported noticing onset of symptoms - tightness in throat and difficulty swallowing. Took Benadryl with no relief. Then took a dose of her own EpiPen 2:10pm. Arrived at ER at 2:30pm.
Pt vax 4 doses; seroconverted but is not seroprotected. Pt is a non responder;
Pain in her left jaw in the hinge area; she opens her mouth too wide, she gets a sharp pain almost like it's tearing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain in her left jaw in the hinge area) and ORAL PAIN (she opens her mouth too wide, she gets a sharp pain almost like it's tearing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, 117B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   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 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Pain in her left jaw in the hinge area) and ORAL PAIN (she opens her mouth too wide, she gets a sharp pain almost like it's tearing). At the time of the report, PAIN IN JAW (Pain in her left jaw in the hinge area) and ORAL PAIN (she opens her mouth too wide, she gets a sharp pain almost like it's tearing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose (lot 011A21A) of Moderna COVID19 Vaccine on 02Mar2021 and second dose (lot 117B21A) on 30Mar2021. All doses were given in her left deltoid. She did not have this jaw pain after the first two doses.   No concomitant medications or treatment details were reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (bosster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Early stage glaucoma" (unspecified if ongoing). Concomitant medication(s) included: LATANOPROST. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Negative, notes: Re bound of  symptoms after course of Paxlovid. Antigen negative 3 days after end of Paxlovid course; (25Jun2022) Positive, notes: antigen positive test 6 days after end of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
(R) arm injection site redness and sore. No temperature/fever. Patient states was fine day of, felt sore following morning then noticed redness came in to pharmacy on 6/3/15 at 9:30 AM. Patient had 2nd dose Hep B on 6/1/15 (L) arm which was stated on 6/1/15. On 6/3/15 patient said she felt lightheaded during Hep B shot which was not mentioned on 6/1/15 during VARIVAX apt.
Skin is tight; Skin is hot; Rash on my whole left shoulder; Lymph nodes under my arm are painful; Lymph nodes under my arm are swollen; A report was received from a consumer concerning a 37-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced rash on my whole left shoulder, skin is tight, skin is hot, lymph nodes under my arm are swollen and lymph nodes under my arm are painful.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  31 Dec 2020 and a little bit on 01 Jan 2021, the patient had a rash on her whole shoulder, noticed the skin was tight and hot, and the lymph nodes under her arm were swollen and painful. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe diarrhea for 1 1/2 months until I started budesonide
The patient should have received 0.5 ml as the second dose of the series, but the technician administering the vaccination drew up and injected 0.25 ml, the dose of a booster. The patient was contacted to notify them of the error. They reported they were experiencing general fatigue similar to their first dose but no other symptoms
Incredibly stiff and sore neck. Hurts to move in any direction and cannot move very far at all in any direction.; Incredibly stiff and sore neck.; Hurts to move in any direction and cannot move very far at all in any direction.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included ethinylestradiol, levonorgestrel (LEVORA) from an unknown date for unknown indication. The patient previously took nitrofurantoin on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 16:30, the patient experienced incredibly stiff and sore neck, hurts to move in any direction and cannot move far at all in any direction. The patient had a slightly sore neck this morning like the patient had slept on it wrong or something, but it wasn't very bothersome at all. About an hour after the vaccine, the patient felt the neck get very stiff and by two hours after the patient was in intense pain. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events incredibly stiff and sore neck, hurts to move in any direction and cannot move very far at all in any direction were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Patient experienced high fever (did not remember exact measurements), violent chills, sore throat, and severe headache for 5-7 days after receiving vaccine. She also stated she had hallucinations and nightmares the first two nights after receiving the vaccine. She called her primary care provider and was advised to take tylenol, stay hydrated, and seek help if symptoms worsened. No antivirals given, no hospitalization.
blood pressure 160/50, looked terrible; Dizzy; dizzy spells lasted for 1 -2 minutes; dizzy while walking, can't walk in a straight line; 2-3 hot flashes almost every night lasting 30 seconds to 1 minute; pretty hot; shoulder and chest creating perspiration; occasionally having a chill; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure 160/50, looked terrible), DIZZINESS (Dizzy), VERTIGO (dizzy spells lasted for 1 -2 minutes), GAIT DISTURBANCE (dizzy while walking, can't walk in a straight line) and HOT FLUSH (2-3 hot flashes almost every night lasting 30 seconds to 1 minute) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure low. Concomitant products included LOSARTAN for Blood pressure.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received 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 BLOOD PRESSURE ABNORMAL (blood pressure 160/50, looked terrible), DIZZINESS (Dizzy), VERTIGO (dizzy spells lasted for 1 -2 minutes), GAIT DISTURBANCE (dizzy while walking, can't walk in a straight line), HOT FLUSH (2-3 hot flashes almost every night lasting 30 seconds to 1 minute), FEELING HOT (pretty hot), HYPERHIDROSIS (shoulder and chest creating perspiration) and CHILLS (occasionally having a chill). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure 160/50, looked terrible), DIZZINESS (Dizzy), VERTIGO (dizzy spells lasted for 1 -2 minutes), GAIT DISTURBANCE (dizzy while walking, can't walk in a straight line), HOT FLUSH (2-3 hot flashes almost every night lasting 30 seconds to 1 minute), FEELING HOT (pretty hot), HYPERHIDROSIS (shoulder and chest creating perspiration) and CHILLS (occasionally having a chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/50 mmHg (Low) 160/50.         Patient has not taken any medication as treatment.  Patient takes losartan for his blood pressure once a day or every 2-3 days.  Patient reported that 2 to 3 days after the second dose, he was scheduled to continue his therapy on his lower spine and had 3 sessions left to go.   Reporter did not allow further contact
Severe anxiety surrounding receiving the vaccine. Patient unable to stand after receiving the vaccine without falling. Hypotensive with an initial BP 76/45. Mild diaphoresis. Suspected vasovagal syncope. All symptoms/blood pressure resolved after 20 minutes of observation.
This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced little sore on arm (a little blue and black) on an unspecified date. Caller would like to know if taking Tylenol was allowed after the Pfizer COVID-19 vaccine. Caller also wanted to know if experiencing no side effects after the 1st dose of the Pfizer COVID-19 vaccine means she will not have side effects after the 2nd dose as well. The outcome of event: unknown. Follow-up attempts completed. No further information expected.
Immediately after injection, pt felt odd heaviness pain in upper arm/shoulder. This intensified through the night and by bedtime pain 10/10 - tylenol helped some but not much. Had a spell of numbness & tingling in hand x1 last night. (None today). No weakness. No fever. Some bodyaches. Today pain 5/10 in upper arm. Feels better with meds and if arm is splinted. Exam normal apart from intense pain throughout deltoid and mild-med pain in brachioradialis area. strength 5/5. Strong distal pulse. Skin cool but color normal with rash. ROM of deltoid, but with pain
Right arm hurting - Tue 9/27 night. Itching, fever - Wed 9/28. Shortness of breath - Thurs 9/29. Seen by MD on Fri, MD given Rx for MEDROL dose pack 4mg.
Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021; Received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 12:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 12:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. No treatment medication was reported by reporter.
Information has been received from a registered nurse concerning a 47 month-old male patient with no known drug allergies who on 01-Aug-2002 was vaccinated subcutaneously in the right upper arm with a first dose of varicella virus vaccine live (Lot number 642680/0479M). on 01-Aug-2002 concomitant therapy included an intramuscular fifth dose in the left arm of diptheria toxoid (+) pertussis vaccine (+) tetanus toxoid  (batch #541T9) (Infanrix), a subcutaneous second dose in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (639984/1383L), and a subcutaneous fourth dose in the left arm of poliovirus vaccine (IPOL) (batch #U0908). On 19-May-2003, the patient developed a generalized vesicular rash of 20-30 lesions. On 21-May-2003, the patient was seen in the office and was diagnosed with chickenpox. It was noted that no other symptoms were noted and no treatment was required. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint reported. No further information is expected.
one fourth to half of the vaccine leaked out/no AE; there was liquid dripping down both sides of her arm/no AE; one fourth to half of the vaccine leaked out/no AE; Initial information was received on 20-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves an patient of unknown demographics who experienced liquid dripping down both sides of her arm (occupational exposure via skin contact with product) and 1/4-1/2 of the vaccine leaked out (underdose and device leakage) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of occupational exposure via skin contact with product, underdose and device leakage (latency- same day).  It was reported call received from Pharmacist reporting a patient received partial dose of FLUZONE QUADRIVALENT PREFILLED SYRINGE on 17Sep2021. Caller reporting vaccine was administered and discarded in the sharps box when the patient noticed there was liquid dripping down both sides of her arm. Caller reporting she would estimate 1/4-1/2 of the vaccine leaked out. Caller with question on whether vaccine needs repeating and in what time frame to repeat dose. Caller also with question on whether we have any information on patient receiving over the recommended amount when repeating the full dose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no available information on lot number for this case.
Herpes zoster diagnosis in herpes zoster vaccine recipient. Diagnosed by hospital dermatology. Painful rash in one dermatome. Lasted less than 4 weeks. Treated with Valtrex. History of cancer.
This spontaneous report as received from a registered nurse refers to a 72 year old female patient. The patient had sulfa and BIAXIN reaction/allergy. On unknown date in 2012 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX (dosage information unknown). No concomitant medication was reported. The nurse reported that patient experienced shingles on two occasions after the vaccination. The first occurrence was on an unknown date. The second occurrence was on 11-JUL-2014, when patient presented with vesicular outbreak on the left side of her face and ear. The outcome and causality of the events were unknown. The patient was treated with VALTREX and sought medical attention (saw nurse practitioner). A product quality complaint (PQC) was not involved. A voice message left for return call from nurse to give permission for VZVIP (Varicella Zoster virus) packet to be sent. Additional information has been requested.
03/11/2021-4:40pm-Pt called-rec'vd Pfizer vac at 1:15pm, in observation area L arm felt heavy, didn't tell anyone, left the clinic, 3 pm, tingling up L arm, collarbone sore,  4pm mouth tingling, tongue numb/swollen, states same reaction w/ shellfish yrs ago, no shellfish since. Pt took fish oil, B12, Magnesium /Calcium citrate supplements for first time this am, instruc Pt to call 911 immediately, Pt called a clinic instead, has epi pen at home, decided to take Benedryl. 5:30pm tongue less swollen, Pt to consult with PCP re 2nd dose. 3/19/21- tongue remained swollen thru day 5/6. PCP told Pt reaction not vaccine related, ok'd to get 2nd dose. Pt plans to consult with son's allergist, will report back to PHN.
Patient father report that she has broken out in hives on her arms and legs... it comes and goes...
SOB, numbness, tingling lips. Evaluated by EMS-Transported to Emergency room/department or urgent care.