chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stomach cramps; diarrhea; lower back pain; constant nausea; lymph node under left armpit swollen; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea) and LYMPHADENOPATHY (lymph node under left armpit swollen) in a 52-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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea), LYMPHADENOPATHY (lymph node under left armpit swollen), CHILLS (chills) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea), LYMPHADENOPATHY (lymph node under left armpit swollen), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Pt recvd pneummococcal vax following vax pt devel a local reaction measuring 7-9" & 3"; the reaction was characterized as being indurated, hot, erythematous & lasted for about 4-5 days; tx was nonspecific; no further details were provided;
Mother reported that soon after the administration of the immunizations infant began to have fever, increased respiratory rate and some abdominal distention.  Mom started to give Tylenol at that time.  The symptoms worsened and mom brought the infant to the emergency room on 7/18/10 for evaluation and treatment.
Day two cough begins and tendon below deltoid(4 inces below vaccination site) red, very tender, itches and shows some inflammation burning to nerve pain at surface with clothes rubbing on it hurting. Continued for four days Day three all the above but increased cough that night dramatically effecting sleep.  Chest pain and tightness. Day four still all above checked blood pressure twice 158/90 and 148/78 post med Day five cough subsiding, taking 800mg of advil and double dose of lisinopril for relief and stabilization.  Day 6 began numbness and tingling in left toes and left fingers.  Worsened two days later adding bottom of left foot, back of calf(lft) and side and left elbow. Faded by day 13 and as of report date 11/9 continued tingling in middle three left toes and ring and middle finger left hand.
My son had his first major seizure (full body) the day of his 4 month vaccination shots. He has had 7 seizures within the last 3 months, varying from focal to full body. He currently is on Phenobarbital medication. The spinal tap, CT Scan, MRI and his first EEG were all clean. The second EEG did show seizure activity.
Information has been received from a school nurse concerning her 12 year old daughter who on 22-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # 666733/0066Z). On 22-JUL-2010 the patient experienced redness and swelling at the injection site. On 26-JUL-2010 the patient came down with bad fever blister and her physician put her on ABREVA. The patient went to the doctor's office. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-MAY-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 24-MAY-2012, the patient was treated for the onset of a vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir for management of his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a register nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported). The register nurse mentioned an unknown number of patients may have received GARDASIL that were improperly stored. No adverse effects reported. Also the register nurse reported that current stock of GARDASIL (in fridge at 34F for 5 months (150 days or 3600 Note: hours) due to a problem with the min and max thermometer not being reset. At the time of the report the outcome was unknown. Additional information has been requested. These case is one (1) of two (2) reports form the same reporter (1404USA013469).
Parent brought 2 sons together, one was 10 years old, one 12 years old to the pediatric vaccine clinic.  12 year old received pediatric 5-11yr old dose of Pfizer (10mcg) instead of 12+ dose of 30 mcg.  Mother was notified, as was pediatrician.
patient reported low grade fever, aching all over, "just like I was getting flu" about 24 h after admin lasting for 12-16h relieved with ibuprofen
As of 8/16/15, patient's left upper arm, about 5 inches between deltoid and elbow area, was red and warm to the touch and she was complaining of itchiness. No pain. Her symptoms started on 8/12 and 8/13. Advised to use a cold compress and watch if the redness spreads. As of 8/18/15, itchiness has subsided but redness has spread. She feels weaker than usual.
This spontaneous report was received from a respiratory therapist refers to a 26 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patients were vaccinated with PNEUMOVAX 23 (route, strength and dosage were not reported), which was improperly stored. The possible lots involved: H002280 expiration date 16-JUL-2014; T004196, expiration date: 06-DEC-2014; T013345, expiration date: 11-JAN-2015; and T015866, expiration date: 25-FEB2015. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot; Both ears itched, felt warm to the touch and were pinker.; Welt on the spine; Itching; Both ears itched, felt warm to the touch and were pinker.; Soreness; Facial tightness on left side of face down to neck shoulder and arm; Couldn't lift her arm above hip that evening; Couldn't sleep.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening), INSOMNIA (Couldn't sleep.) and PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ) in a female patient of an unknown age 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening) and INSOMNIA (Couldn't sleep.). On an unknown date, the patient experienced PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ), SKIN DISCOLOURATION (Both ears itched, felt warm to the touch and were pinker.), URTICARIA (Welt on the spine), PRURITUS (Itching) and FEELING HOT (Both ears itched, felt warm to the touch and were pinker.). At the time of the report, PAIN (Soreness), MUSCLE TIGHTNESS (Facial tightness on left side of face down to neck shoulder and arm), MOBILITY DECREASED (Couldn't lift her arm above hip that evening), INSOMNIA (Couldn't sleep.), PRURITUS (Both ears itched, felt warm to the touch and were pinker/ another popped up and itched/ had itching on and off since her shot ), SKIN DISCOLOURATION (Both ears itched, felt warm to the touch and were pinker.), URTICARIA (Welt on the spine), PRURITUS (Itching) and FEELING HOT (Both ears itched, felt warm to the touch and were pinker.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Vaccine lot # GJ6665 was received in our office on 10/19/2022 and placed in our vaccine refrigerator therefore the expiration date for that vaccine was 10 weeks out which would be 12/28/2022.  We administered this vaccine after that expiration date.  Patient reported no adverse reaction.
This spontaneous report was received from a pharmacist referring to a 66 years old female patient. The patient's concurrent condition included high blood pressure. The patient's concomitant therapy included unspecified high blood pressure medication. The patient had no drug allergies. In December 2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. On 22-JAN-2019 (reported as "about a week ago") the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # R000692, expiration date 09-SEP-2019, intramuscularly for prophylaxis. On 28-JAN-2019, the patient returned to the pharmacy and reported that since receiving the second dose of PNEUMOVAX 23 she experienced soreness in the vaccinated arm. No treatment was given to the event. No lab diagnostics and studies were performed. The outcome of the event was unknown. The causality between the event and the suspect vaccine was not reported.
hives/itchy on L upper arm/shoulder. Negative resp. distress negative angioedema
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # not reported) that were exposed to 47 F for 168 hours. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Student was given a 3rd dose of the H1N1 Nasal Mist--was only supposed to receive 2 doses.
body ache; having fever of 100 degree temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PYREXIA (having fever of 100 degree temperature) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (body ache), PYREXIA (having fever of 100 degree temperature) and CHILLS (chills). The patient was treated with Ibuprofen for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body ache), PYREXIA (having fever of 100 degree temperature) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 °F (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Ran fever. Couldn't walk up and down stairs. Tingling in hands and feet.
SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH
Information has been received from a 74 year old female consumer who on an unspecified date in December 2006, was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  Unspecified medical attention was sought.  No further information was provided.  Additional information has been requested.
First dose: No soreness or any other symptoms experienced.   Second Dose: Sore arm, back pain, dizziness, nausea
I began getting dizzy and fatigued a few hours after receiving the vaccine, around noon. Arm pain seemed to be getting worse throughout the day. On Saturday, arm pain had gotten significantly worse and continued to worsen throughout the day. On Saturday evening, had uncontrollable shakes and chills. I went to bed early and had sweats and shakes throughout the night, sweating through two sets of clothes. Was awake much of the night Saturday - Sunday with extreme arm pain. Sunday morning arm pain was excruciating and I had lost almost all mobility in my left arm due to pain (could not even dress myself). I was concerned due to the level of pain and the fact that it was worsening so I went to the ER where I was treated.
April 9, excrutiating pain in Left foot.  April 10, excrutiating pain in right foot.  April 11, pain in both feet.  Can hardly walk, all of a sudden out of nowhere!  Went to Urgent care April 12th.  Unknown.  Podiatrist April 14th, Unknown.  Another Podiatrist April 21st, Unknown, but orders X-Rays.  Show nothing.  Walking like a crippled person in pain.  Again, all of a sudden out of nowhere!. Sunday, April 25, excrutiating pain, weight-bearing on right foot.  Husband carries me to the car and drives to ER .  NOTE: All physical exams did not cause pain when manipulating joints.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4390940-00 (Agency).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Arrived in observation at 1:16pm. complained of shortness of breath, wheezing at 1:35pm. Pulse regular at 92. Resp. rate 22 SPao297, BP 150/86. Diminished breath sounds, clear. Negative for stridor. After removing mask, patient stated wheezing subsided. 1:40pm - patient refused medical treatment and EMS. Denied shortness of breath at this time. 1:41. patient used her Pro Air rescue inhaler with relief. No stridor. No angioedema. No redness to throat or swelling. No nausea or vomiting. Patient did state that she had wheezing approximately 15 minutes after 1st Moderna dose. She did not report. Also when asked pre-vaccination (to dose 2) if she had any allergic responses to dose 1 she stated no.
Pt recvd 3 doses of Hep B vax 1st dose unspecified was given on 14NOV90; 2nd & 3rd dose w/Engerix-B 17DEC90 & 17MAY91 & it was determined that pt did not seroconvert;
After the first shot was fatigue, her heart was beating fast, chills, fever, abdominal pain and her body was aching. On April 2nd was having severe abdominal pain, felt weak, had an headache, and was tire. Went to urgent care the next morning. Abdominal pain was worse and was feeling very tired her symptoms wasn't going away. Seen a cardiologist on April 19th did some lab work to check for an auto immune. Gave her meds to slow the thyroid hormones. Her symptoms has gotten worse since both shots still shaking.
Severe headache that lasted 8 days, then it  went away for 2-3 days and came back very strong headache and spinal pain that lasted for about one more week, i went to the doctor and dr prescribed pain medicine and anti-inflamatory meds for 7 days.
Rash very itchy; Heat is felt when touching the area; On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length; Noticed a rash at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of RASH PRURITIC (Rash very itchy), SKIN WARM (Heat is felt when touching the area), RASH (On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length) and VACCINATION SITE RASH (Noticed a rash at injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and PROGESTERONE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced RASH (On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length) and VACCINATION SITE RASH (Noticed a rash at injection site). On an unknown date, the patient experienced RASH PRURITIC (Rash very itchy) and SKIN WARM (Heat is felt when touching the area). At the time of the report, RASH PRURITIC (Rash very itchy), SKIN WARM (Heat is felt when touching the area), RASH (On her back/all over her body/rash moving down her arm towards her hand/ the rash went from 2inches to 4inches in length) and VACCINATION SITE RASH (Noticed a rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment information not provided.    This case was linked to MOD-2021-228293, MOD-2021-229879 (Patient Link).
body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt came to ED on 12/27 and expired in the ED after testing positive. Came in with hypoxia and had multiple cardiac arrests
This case was reported by a healthcare professional via a sales representative and describes the occurrence of limb swelling in a subject of unspecified age and gender who was vaccinated with Infanrix for prophylaxis. Initially the healthcare professional reported "six to seven pts, however, no pt identifiers were provided. On an unspecified date in "April 2005 and before 6/24/05" the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in "April 2005 and before 6/24/05", at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on 6/24/05, the event was resolved. The healthcare professional considered the event was possibly related to vaccination with Infanrix.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of ROTATEQ orally (dose and lot number were not provided). No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
Initial and follow up information has been received from a certified nurse midwife for the Pregnancy Registry for GARDASIL, concerning a 22 year old white female with bipolar disorder and allergic reaction to KEFLEX and no previous pregnancies who on 03-OCT-2007 was vaccinated with a first dose of GARDASIL (lot # 658558/1061U).  On 04-DEC-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (lot # 659437/1266U).  Concomitant therapy included SEROQUEL (lot # not reported) and ABILIFY for the treatment of bipolar disorder.  The patient's LMP was reported as 15-FEB-2008.  The patient's pregnancy was verified with an office pregnancy test during an office visit on 24-MAR-2008.  An ultrasound performed on 01-APR-2008 revealed a 6.4 week intrauterine pregnancy.  On an unspecified date in April 2008,  therapy with quetiapine fumarate and aripiprazole was discontinued.  The patient sought unspecified medical attention.  No problems were reported.  Follow up information has been received from a certified nurse midwife concerning a female patient concerning a female patient (Rh negative) who was vaccinated with a first and the second dose of GARDASIL on 03-OCT-2007 and 04-DEC-2007.  Concomitant therapy included WELLBUTRIN SR, SEROQUEL (reported) and ABILIFY.  The patient was treated for pre-term labor (2008) with TERBURALINE and was also treated for an urinary tract infection (2008) with MACROBID and AMOXICILLIN.  On 27-OCT-2008 (36 weeks from LMP) delivered a healthy female baby (7 lb 8 oz, 20 in length, head circumference 13.75 cm and APGAR score 8 at 1 minute/ 9 at 5 minutes).  The patient had not had a Group B strep test done so she was treated with AMPICILLIN 2 grams IV one time dose .  She also received a dose of RHOGAM.  Additional information is not expected.  (Rh negative)