chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 17 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 84 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. ; Sender's Comments: US-009507513-1705USA014053:
Information has been received from a physician concerning a 19 week old male with no pertinent medical history and no drug reactions or allergies who on 05-AUG-2010 was vaccinated orally with the second dose of ROTATEQ (lot # 668036/0594Z). The patient was vaccinated orally with the first dose of ROTATEQ (lot # is 665275/0301Z) on 03-JUN-2010. Concomitant therapy on 05-AUG-2010 included PENTACEL and PREVNAR. The physician reported that there were no problems with the patient after receiving the first dose of ROTATEQ (lot # 665275/0301Z). The patient developed diarrhea and was diagnosed with rotavirus gastroenteritis on 15-AUG-2010, 10 days after receiving the second dose of ROTATEQ (lot # 668036/0594Z; otherwise asymptomatic. The physician reported that the culture of the stool revealed rotavirus. The patient had been treated with PEDIALYTE at home because of the potential for life-threatening dehydration. At the time of reporting, the patient was fully recovered. The physician felt that rotavirus gastroenteritis was not related to therapy with ROTATEQ, and reported that "condition would have been worse without the vaccine". Rotavirus gastroenteritis was considered to be immediately life-threatening by reporter. The lot check has been initiated. No further information is available.
The patient developed high fever about 5 min. after flu vaccine administered. Symptoms lasted about 10 hours. No GI illness or rash developed after vaccinations. No increase in URI Sx's developed (Temp reached 106 deg)
This case was reported by a health care professional and described the occurrence of injection site redness in a 20 year old female subject who was vaccainted with Engerix B for prophylaxis. Medical history included not allergic to yeast. On 06 June 2006 the subject received 1st dose of intramuscular Engerix B in Unknown deltoid (lot AHBVB248AA). The health care professional reported that on 06 June 2006, less than one day after vaccination with Engerix B, the injection site was swollen to the size of half dollar and hard. The red area became the size of a tennis ball. The subject also reported to the healthcare professional that the site was tender to the touch with itching and burning occurring. The subject was seen at a physician's office. At the time of initial reporting, 08 June 2006, the events were ongoing. The healthcare professional considered the events were probably related to vaccination with Engerix B. Follow up information received on 03 July 2006 indicated that the events resolved by 09 July 2006. In the reporters opinion, the events were possibly related to vaccination with Engerix B. No additional information was reported.
pt was fussy w/in an hr of vax; By 12AM mom states pt had fever of 105 ax; seen by md 29MAR93; fever cont for approx 1 wk off & on-sometimes as high as 102 ax; MD records state probable viral infection; had elevated white count;
Patient presenting with complaint of swelling of face and tongue numbness. Vital signs at 9:24 BP: 142/78 HR:72 RR:20 02:95%  Provider assessed patient noted likely environmental allergies, no sensory motor deficits cranial nerve intact. Explained red flags and when to go to ER. Patient sent home with no further complaints.
As shot being injected, immediate swelling approximately 1 inch laterally. 1 cm welt with surrounding erythema. Welt & redness increased for first 15 min, then started to fade. No respiration sx.
I was going in for a routine lung scan. An adrenal mass was found on a CAT scan. I had surgery on March 2, 2023, to have to have the mass surgically removed. The doctors are unsure how long it has been there. A biopsy was performed, the mass was tested and found to be an adenoma.
Patient presented with frequent falls and left sided weakness with severe headaches for greater then 24 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose number unknown, single (Lot number: 0810234) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 27Aug2023 to 31Aug2023.
On the 17th of august I started getting a red rash on my elbow area of my left arm. Wouldn't go away and I made a doctors appointment where my doctor diagnosed me with having shingles. I received a PCR which came back positive for shingles. Two weeks later I woke up with a pain in my neck, I took a motrin, and shortly after I experienced a muscle spasm and the pain moved down to my left arm and I started experiencing numbness in my fingers of my left hand. I made an appointment and  pcp  prescribed me a muscle relaxer and gave me a steroid shot. They wanted to get a few more test done to see what was causing this pain and sent me to a neurosurgeon. The neurosurgeon did a ct scan of my brain and decided to prescribed me more muscle relaxers and another steroid shot for the pain to get some improvement, I am currently waiting on my results.
A large rash that was hot to the touch, appeared about 8 days after the vaccine.  It seemed to be going away after a few days and then it appeared for a short time again.  It was aso a little itchy.  So far today there is nothing.
Case number PHEH2014US020653 is an initial spontaneous report received from a nurse on 13 Oct 2014. This case refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: not reported) intramuscularly on 13 Oct 2014. No adverse event was reported following this administration error.
Muscle,joint pain Skin tenderness  Tiny runny nose  Run down Low fever 99.4 Feel hot
PFIZER VACCINE GIVEN BEFORE 5 MONTHS OF THE LAST VACCINE. LAST VACCINE GIVEN ON 10/28/2021
Joint aches with chills, tightness and burning of chest, headache, duration of 20 hours began 1 day after vaccination.
2 RNs I work with got their 2nd dose and tested positive for COVID the same week.; 2 RNs I work with got their 2nd dose and tested positive for COVID the same week.; This is a spontaneous report from a contactable nurse. This was the second of two reports. This patient of unspecified age and gender received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), with the first dose and second dose; both doses via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not provided. The reporting nurse posted that 2 RNs the nurse worked with got their 2nd dose and tested positive for COVID the same week. Event took place after use of product. Lab data included COVID-19 test was positive on unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 use.,Linked Report(s) : US-PFIZER INC-2021328440 same reporter, drug and AE, different patient
Uterine bleeding started 15 April - 20 April  No history of uterine bleeding since 2014 since insertion of IUD Fatigue
pt rcvd vax; pt felt sick to her stomack & exp'd a real sore arm w/ 1st dose; pt had no problems w/ 2nd dose; pt exp headache & felt sick to her stomach w/ 3rd dose;
pain and agony; pain and agony; This is a spontaneous report from a contactable consumer (patient).   A 77 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ),  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced pain and agony on an unspecified date with outcome of unknown.  .  Therapeutic measures were taken as a result of pain and agony (pain), pain and agony (depressed mood).The case was reported as non serious.The clinical course was reported as follows:the patient received the 1st dose of the Pfizer covid vaccine as scheduled and was advised not take Tylenol or Ibuprofen for the next 24 hours. However, she was in such 'pain and agony' that by 4:00 AM that night, she took an Ibuprofen. Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Headache while taking pills on Friday 5/16/08 lower jaw pain both sides to ear.
Rash developed on the 3rd day, both arms, face, head, ears, stomach. Large rash spots with hives, itching .  Was given a steriod shot, and three prescriptions a cream, Pepcid prescription strength and  Vistaril.
Approx. 24 hours after immunizations 4-5 blisterlike lesions appeared on child are are still present.
Shingle Shot;It was not until 3rd day of the Shot . The area of the vaccination became very hot, ached and red.(Felt inflamed)  Two days later the problem subsided. Two hours after the shot was given I developed hives itching on the other side of my arm. This lasted for a day and a half.
Both the first night and second day I had a fever of up to 103, chills, vomiting and fatigue.  Today on day 3 I just have fatigue.
Subq back of left arm became irritated and itchy June 23, 2010. Vaccine administered on June 21, 2010 @ 14:11.
Shingles; This is a spontaneous report from a contactable physician reporting same event under the same suspect product for 6 patients. This is one of the 6 reports. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date after the use of product. The outcome of event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
PATIENT RECEIVED PFIZER COVID 19 VACCINE AT THEIR FIRST OUTREACH WHICH WAS NOT WITH OUR CLINIC . TODAY SHE AND HER FAMILY CAME IN OUR CLINIC DURING A MODERNA CLINIC AND ONE OF OUR VACCINATORS GAVE HER A SHOT WITH MODERNA FOR THE SECOND DOSE COVID 19 VACCINE.
Fever, intense joint pain, chills, sweating, loss of appetite, tiredness, and weakness, beginning seven hours after injection and lasting for two days.
Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 300 next morning in hot sweat. Next day 1/12, body tension from chills precious night- relieved by advil. fatigue from poor nights sleep.
Large itching plaque about 3 inches below injection site, measuring about 2"x3".
High fever after first dose for 8 hours straight. Could not lift arm, from pain for 4 days. Hearing my joints cracking whenever I would move
Very sore arm; redness at injection site; fever of 100 degrees for less than 8 hours; and chills/sweats, muscle aches and pains for 12 hours. (On day three, arm is still sore and there is still some redness at injection site).
Swollen lymph node in the neck.Congestion and mucus green and yellow?s color
Patient developed Henoch Schonlein Purpura 1 days after receiving the H1N1 Influenza vaccine.
Onset chills and fever starting 9hrs post injection, 103F+ fever even after taking Tylenol 500mg every 4hr. Fever, chills, lethargy continuing to present (25hrs post injection)
Patient reported soreness & redness at the site of the injection beginning the evening after the injection was given (8/28). Also reports shivers and a "cold core" beginning that same evening. She discussed with her husband going to the ER, however they did not seek medical treatment at the time. The next day (8/29), the left arm (injection arm) became real swollen. Today (8/30), a rash developed  on her injection arm and down her left torso area; and was just developing to a lesser extent on her right arm. Seeking medical treatment was advised (and her PCP, Drs office was contacted).
Patient is fully vaccinated.    Hospitalized for 6 days. Admitted 12/15/2021 and presented to the ED after test positive for COVID a week ago and having worsening SOB and cough over the past couple of days. The patient denies any fevers, chills, nausea, vomiting, diarrhea, or any chest pain at this time.  He does have a history of diabetes mellitus 2, noninsulin dependent hypertension. Dx: COVID 19 viral pneumonia, acute hypoxic respiratory failure. CT PE: Negative for PE; Patchy bilateral airspace opacities.  Treatment:  oxygen, decadron, vit D, remdesivir. discharged home.
Chills; Flu like symptoms; Fever; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, flu like symptoms and fever in Apr2021 after the first dose and would like to know how long symptoms were going to last. The events were reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
under the arm is a knot; Pain in neck; Ear ache; Arm swollen; joint pain; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache), PERIPHERAL SWELLING (Arm swollen) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021 at 10:25 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 10:00 PM, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache), PERIPHERAL SWELLING (Arm swollen) and ARTHRALGIA (joint pain). The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, NODULE (under the arm is a knot), NECK PAIN (Pain in neck), EAR PAIN (Ear ache) and PERIPHERAL SWELLING (Arm swollen) had not resolved, PYREXIA (Fever) had resolved and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications reported were blood pressure medication. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Action taken with the drug in response to the events was not applicable
Fever 101 degrees F, dizziness, nausea for 12 - 20 hours after initial injection. For Rabies vaccine on all injections 03/24/2003, 03/03/2003, 03/17/2003
Pt reports feeling a hot, itchy sensation at time of vaccination, but that went away shortly after. Then about 10-14 days later patient reports feeling a burning itchy unbearable feeling all over her body and it is still continuing to this day. Pt reached out to her PCP and they prescribed her an allergy medication (cetirizine) to help with the symptoms, but patient still states that she is feeling uncomfortable. Pt. reported that in the past when she's received flu vaccines she has gotten lumps in her nodules after receiving the vaccine, but those would go away in a few days. This is the first time she had this type of reaction.
pt had adverse rxn felt dizzy, light headeded, nauseous, and short of breath. we dosed her with 10 mls of benadryl, at 3:15pm, bp 68/49, pt felt better and went to leave at 3:40 but when she went to walk to front of store her tongue felt numb and swollen. we gave ibu suspension at 3:45 15 mls and monitored another 10 -15mintues and she felt better.
4/13/2021 EW0153 Pfizer, 5/4/2021 EW0173 Pfizer 9/2021 developed headache, double vision, diagnosed after MRI and LP with demyelination
Information has been received from a 62 year old female patient with an allergy to VICODIN and no other medical history who on 11-MAY-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) SQ.  Concomitant therapy included LEXAPRO and KLONOPIN.  The patient reported on 12-MAY-2009 the day after the vaccination she was "very weepy, like she was hormonal.  She would cry at the drop of a hat."  The patient reported on 15-MAY-2009 4 days after getting ZOSTAVAX (Merck) she had "trouble breathing" and "passed out".  The patient went to the Emergency Room (ER) and was admitted.  The patient usually had "really low blood pressure" but her blood pressure was high when she was in the ER.  The patient at the time of reporting felt "a little shaky."  At the time of reporting the patient was recovering from the adverse events.  A product quality complaint was not involved.  Follow-up information has been received from the office manager that the vaccine lot # was 663639/1707X and the expiration date of the vaccine was May 2010.  The office manager confirmed that the date the patient admitted to the hospital was 15-MAY-2009.  The office manager indicated that she was not provided the discharge date and she had labs that were taken no later than 16-MAY-2009.  After speaking with physician, the office manager said that it was their opinion that the events were not related to ZOSTAVAX (Merck).  Additional information has been requested.
she just feels bad; she's been having diarrhea; low grade fever of 100.9°F; experiencing severe abdominal cramps; dry heaves; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (experiencing severe abdominal cramps), RETCHING (dry heaves), FEELING ABNORMAL (she just feels bad), DIARRHOEA (she's been having diarrhea) and PYREXIA (low grade fever of 100.9°F) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ABDOMINAL PAIN (experiencing severe abdominal cramps), RETCHING (dry heaves) and PYREXIA (low grade fever of 100.9°F). On 03-Feb-2021, the patient experienced DIARRHOEA (she's been having diarrhea). On 05-Feb-2021, the patient experienced FEELING ABNORMAL (she just feels bad). The patient was treated with HYDROXYCHLOROQUINE at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (experiencing severe abdominal cramps), RETCHING (dry heaves), FEELING ABNORMAL (she just feels bad), DIARRHOEA (she's been having diarrhea) and PYREXIA (low grade fever of 100.9°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 100.9 (abnormal) 100.9°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Mild nosebleed; Mild headache; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Mild nosebleed), PAIN IN EXTREMITY (Soreness of arm) and HEADACHE (Mild headache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120MA) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). On 18-Feb-2021, the patient experienced EPISTAXIS (Mild nosebleed) and HEADACHE (Mild headache). At the time of the report, EPISTAXIS (Mild nosebleed), PAIN IN EXTREMITY (Soreness of arm) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
As per previous comment, patient with evidence of pancreatitis as well as acute PE with no other obvious precipitating factors
Patient was supposed to get moderna second dose and she got pfizer second  dose because of miscomunication
After 28 hours -Sudden uncontrolled Shivering, Chills, head to toe body aches x 2 hours,  then Feeling of core temp overheating, physical touch of a bed sheet touching skin felt like a burn x 45 mins,  head congestion, headache, runny nose, watery eyes, fatigue.  72 hours later only runny nose watery eyes
in menopause/went to the restroom and found light diluted blood discharge; I'm the last hour, I am experiencing more painful cramping.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER BIONTECH), dose 1 at vaccination age of 53-year-old via an unspecified route of administration in the left arm on 16Oct2021 at 15:30 (Lot Number: EW0168) as dose 1, single for covid-19 immunisation. Medical history included menopause from 14Apr2021. The patient did not have Covid prior to vaccination. The patient has no known allergies. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C); zinc; sambucus nigra fruit (ELDERBERRY); and colecalciferol (D3 VITAMIIN), all indication, start and stop date were not reported. The patient reported that she was in menopause and date of last period was 14Apr2021. On 18Oct2021 at 18:00 pm (also reported as 19:00), the patient went to the restroom and found light diluted blood discharge. Now in the last hour, she was experiencing more painful cramping. She has historically have never had cramping problems when she had her normal periods. The cramping is escalating now as she was typing this. The patient considered the report as non-serious. It was unknown if the patient received treatment. The patient has not been tested for covid-19 post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.