chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), ASTHENIA (Could not get up), VOMITING (Vomiting) and PYREXIA (Fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), ASTHENIA (Could not get up), VOMITING (Vomiting), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Severe chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VOMITING (Vomiting), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Severe chills) had resolved. At the time of the report, ASTHENIA (Could not get up) and HEADACHE (Headache) had resolved. Concomitant medicines include thyroid medicine, cumidine, advil, Zerculas (for allergy).
Information has been received from a nurse practitioner referring to an unspecified number of patients. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored VAIRVAX (Merck) (lot # L010145, expiry date 24-MAR-2017, dose and route were unspecified). The reporter stated that the VARIVAX (Merck) was exposed to the following conditions: Temperature: 12F for 90 minutes; previous temperature excursion: 24F for 8 hours. This report was because of a "data logger". No adverse symptom was reported. Additional information has been requested.
diarrhea; vertigo; dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness, diarrhea and vertigo. On an unknown date, the outcome of the dizziness and vertigo were recovered/resolved and the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the dizziness, diarrhea and vertigo to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine unknown date and experienced dizziness and vertigo for two days and had diarrhea.  The reporter was due for the second dose. There was no additional information reported. The reporter consented to follow up.
This is in follow-up to report (s) submitted on 2/11/2009. Information has been received from a receptionist in a physician's office concerning her daughter who on 28-JAN-2009 was vaccinated with the fourth dose of GARDASIL (lot # unspecified). In addition, the patient's arm is sore at the injection site. The outcome is unknown. It was reported that the  patient was vaccinated with the first, second and third dose of GARDASIL on 18-AUG-2007, 04-JAN-2008 and 14-MAY-2008 respectively. Follow-up information was received from teh physician reported that she does not have additional information. The patient sought unspecified medical attention. No further information is available.
Marble sized lump above clavicle; lump right above his collar bone from on the same arm that he had the vaccine; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer Sponsored Program COVAX US Support.   A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration on an unspecified date (at the age of 15 year old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 of BNT162B2 for COVID-19 immunization and no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced marble sized lump above clavicle and lump right above his collar bone from on the same arm that he had the vaccine. Seriousness of the event was provided as unspecified. NDC and UPC number was unknown. It was reported that the patient (reporter's son) has received his second vaccine of the Pfizer COVID dose on Tuesday and he has since developed a marble sized lump above his clavicle and right above his collar bone from on the same arm that he had the vaccine and reporter was wondering if that was normal and if there was anything that she should do for it. Reporter informed that she is going to call the number and take care of her son first unless Medical information department away to connect her there faster. Outcome of the events were unknown.  Follow-up attempts are possible. Information about batch no/lot no has been requested.
36-year-old right-handed female with no significant past medical history who presents with sudden onset of left-sided weakness and numbness. On 1/1 patient developed fever 102, sore throat, headache, body aches and fainted. She has known exposure to COVID-19 at work. She reports she had a rough night and did not get much sleep but woke up at 8:00 a.m. In her usual state of health. She had coffee and was sitting at her kitchen table doing work online when she started feeling some numbness and tingling on the left side of her face, she thought her blood sugar might be low and got up to have an orange. She noticed she kept dropping room is handling the orange with her left hand prompting her visit to the ED. She is fully vaccinated x3.
Red, painful lump in arm bigger than size of quarter reported by patient described over the phone, did not physically exam arm. Flu shot given one day prior. Not getting better or worse right now.
A knob at the injection site/It's slowly expanding above the injection site.; It's hot; It's hard; Very painful arm after the vaccine; It's little itchy; It's red; It's swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine) and VACCINATION SITE PRURITUS (It's little itchy) in a 51-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.     Concomitant products included UBIDECARENONE (COQ-10) and VITAMIN D NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine), VACCINATION SITE PRURITUS (It's little itchy), VACCINATION SITE ERYTHEMA (It's red) and VACCINATION SITE SWELLING (It's swelled). At the time of the report, VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine), VACCINATION SITE PRURITUS (It's little itchy), VACCINATION SITE ERYTHEMA (It's red) and VACCINATION SITE SWELLING (It's swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Allergy pill.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains Non-Significant Information.
This spontaneous report as received from a nurse refers to a 8 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
One hour post injection - rash/body itching severe nasal congestion - tight throat/cough - took a BENADRYL daily to decrease s/s - still has rash - flu s/s now.
Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3670AA received on 02 August 2010, lot number C3565AB received on 05 October 2010; lot number C3565AB received on 03 December 2010 and lot number C3980AA received on 13 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 March 2012, approximately 6 months after the last dose. On 26 March 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 30 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Donor received shot on 5-14-08 and adverse reaction noted. On 5-16-08 Donor states arm was sore after doing alot of heavy lifting light yard work. On 5-18-08 donor phoned center to report to medical staff, MSA asked donor to comes to center. Donor presents at center with 6"x4" red area with 2x2" hard area at injection site.
Patient reported to having generalized Itchiness in back, and breast with hives after receiving first shot of vaccine.. After 21 days the patient came to the clinic for the second shot, but she still presented symptoms of the adverse reaction. Dr recommended to do not received the second shot. The patient went to the ER to get a second opinion. After having Talked with Dr, he agree with Dr for to not give her the second shot.  Dr.  from emergency department proceed to give her Medrol dose pack, Allegra and Zyrtec to relieve the symptoms.
This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (An 80-year-old grandfather had to be rushed to the hospital after receiving the Moderna COVID-19 booster dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (An 80-year-old grandfather had to be rushed to the hospital after receiving the Moderna COVID-19 booster dose). At the time of the report, UNEVALUABLE EVENT (An 80-year-old grandfather had to be rushed to the hospital after receiving the Moderna COVID-19 booster dose) outcome was unknown. No concomitant medications were provided.No treatment medications were reported.
rt arm, large local rxn (about 12cm marked swelling & induration), fever to 105 for 36 hrs, chills, myalgias;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 04-DEC-2014 the patient was subcutaneously vaccinated with an improperly stored dose of M-M-R II (dose was 0.5 ml, lot#, therapy type and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected, because there was no consent for further contact.
After shot felt increasingly nauseous and dizzy and tired. I went to the bathroom and threw up.  Upon return to the observation area, I lost consciousness, fainted, and woke up on the floor.  My blood pressure was low but within normal range and my blood sugar was normal.  I was not nervous about receiving the shot or possible symptoms and do not have a history of fainting not relating to medication side effects (meds I am no longer on) and over exertion ( ie. likely not psychosomatic).  Fainting on a hard surface led to a serious concussion with effects (brain fog, fatuige, headache, and dizziness primarily) continue to persist.   I saw doctors at an urgent care and them the ER where they performed a pregnancy test (negative), blood sugar test (normal). EKG (normal), and a concussion screening that led to a CT scan (normal).  I left with no explanation as to why I felt sick and fainted after the vaccine and was only told later by my psychiatrist to report.   The only clear side effect was pain in the arm of the injection site.  Other possible vaccine symptoms overlap with concussion symptoms.
Dtap/IPV given (R) thigh; 5/3/13 pt presented with 5" x 3" erythema on (R) thigh, minimal induration, non-tender, gait WNL (R) thigh circumference 12"; (L) thigh 11" circumference trmts cool compress/ibuprofen.
I received the COVID-19 vaccine at 9:30 am from vaccination clinic. I had just recovered from COVID-19 about two and a half weeks prior. I had no immediate reaction. I worked the entire day with no adverse effects other than a sore arm, which I expected. Later in the day at about 7:45 pm I went for a 6 mile run and got home at approximately 8:49 pm. Within half an hour of getting home, I quickly became feverish. The fever continued to rise until I was extremely hot, and hotter than I can ever remember as an adult or child. I did not have access to a thermometer so I cannot reliably report what the temperature was but I am estimating 103. It felt like every part of my body, including my legs, was hot to the touch. By 1 am I had serious chills and was shivering under winter blankets despite an outdoor temperature of 70-80. In addition, I had an extremely elevated heart rate and chest pain. I also had generalized muscle aches all over my body.  I did not sleep at all that night. The fever began to slowly dissipate early in the morning but the elevated heart rate continued for approximately 24 hours. The discomfort resulting from my elevated heart rate was substantial and alarming enough that I sought advice from my primary care physician after a nurse at my Occupational Health clinic suggested potentially getting an ECG. Ultimately, by Thursday morning, the symptoms had decreased and I declined any follow up. However, this was the single worst reaction I've ever had to any vaccine and the single worst fever I've ever experienced as an adult or in my memory as a child. Although I am aware that people who have already had COVID-19 tend to have worse reactions to the first COVID vaccine, I am filing this report primarily because of my concern that exercise may trigger an especially severe reaction.
I became very fatigue and had body aches. I also had a high fever. I was sick for about two days.  After the first dose I had a miscarriage.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart flutter, ticking. Reporter was a little bit upset and that was really her question. Patient reported cardiac symptoms after the first COVID-19 vaccine and was seen at the emergency room as directed by primary care physician. She received an EKG, blood work since has gone for a stress test as evaluated by her primary care physician and everything's coming back negative. Heart flutter symptom was more intense throughout day less and less now, so it feels like a flutter and throughout the day. She has also read information from the CDC about myocarditis and pericarditis and wanted to make sure everything she is experiencing was reported. Patient has already reported it a couple of times, the agent do not tell that in MI as they don' list any cardiac side effects of adverse events so she was more curious about the questionnaire that was sent out. It was stated that she was just frustrated, why do she waste her time. The patient underwent lab tests and procedures which included blood test resulted as negative, stress test resulted as negative, EKG resulted as negative on an unspecified date. The outcome of event was recovering. Information about lot/batch number has been requested.
pt recv vax 11DEC96 & 28DEC96 devel an red rash on trunk, face & neck;
fever 101.4 and muscle aches and elevated heart rate all responded to acetaminophen
This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways from a contactable consumer (patient). A patient of an unspecified age, gender and ethnicity received PREVNAR 13 (lot number and expiration date not reported) at single dose and ACT HIB (lot number and expiration date not reported; Sanofi Pasteur) at unknown dose, both via unspecified routes of administration on 22Jun2017 for immunization. Patient medical history included allergy to egg. Concomitant medications were not reported. It was reported that the patient received the two vaccines on 22Jun2017 (reported as yesterday from the time of the report) and went into an allergic reaction on unspecified date. The patient stated "I need to know if these vaccines have egg in them. No one could find where they did or did contain egg, Egg is my major allergy but I have another one no one can pinpoint." Outcome of the event was unknown.
This spontaneous report as received from a Doctor of pharmacy refers to a 83 years old female patient. The patient was vaccinated with ZOSTAVAX on 03-AUG-2012. Pharmacist reporting that the patient, received a dose of ZOSTAVAX (lot # 0619AA) on 03-AUG-2012, that expired on 26-JUL-2012. At the time of the report the patient had not demonstrated or reported any adverse effects. Additional information has been requested.
A few minutes after immunization patient presented with sweating, flushed, felt like they are having a panic attack, patient felt shaky, felt liking seeing stars, trouble breathing . Patient was helped to immunization room and observed for a few more minutes. Symptoms resolved and patient was released to go home.
Approximately 5 minutes after receiving injection, patient reported feeling mildly short of air. 1410-BP 132/89 HR 104 SpO2 99% 1420-BP 130/86 HR 85 SpO2 99% - reports that symptoms have resolved. Denies need for further intervention. Education provided to seek medical attention for further sx Pt was ambulatory and left the clinic.
On 3 April 2021, on the ninth day after receiving my first Moderna injection, I started to experience pain, redness, tenderness, and slight swelling with elevated skin temperature at the site of the injection in my left upper arm.  The feeling of warmth and tenderness has persisted throughout the day and into the evening while swelling is moderate.
initially eval in ER for jaw pain, fever dx w/clinical case mumps;pt exp t104, weakness, h/a, & diff breathing (x4 wk off work); still exp some residual weakness, jaw muscle spasms;
Headache, Myalgia, Arthralgia, injection site pain, chills, lightheaded Narrative:  Employee reports injection site pain/discomfort, chills, headache (5-6 out of 10 on pain scale), joint pain, body aches, fatigue. Also reported "feeling a bit loopy, not dizzy, lightheaded." Reports use of ibuprofen 800mg with some relief.
crying inconsolably for extended periods of time, extreme crankiness - yelling, screaming, sobbing, whining
I received the Pfizer  vaccine in my left arm on April 21st 2021.  at 8:00 am.  i was fine until about 9pm that evening when the left side shoulder and neck start to hurt.  I also notice that my armpit on left side was swelling up.   I figure it would be something that would go away by morning. Woke up on April 22 with a baseball sizes lump under my arm, pain and stiffness in my shoulder, neck and chest. I'm greatly concern since i had  none of these symptoms prior to vaccine.   today is april 23rd and my lump has gotten bigger.
Initial report received from nurse on 20/Sep/2005. A 22 month old male child immediately developed hives at the injection site, and an hour later had generalized hives after receiving the intramuscular injection of Fluzone (Preservative Free), lot number U1743JA in the left thigh on 17/Sep/2005. The patient received the flu vaccine last year with no adverse event. The generalized hives lasted for three days. The patient also had signs and symptoms of a cold with congestion, and "acted like their throat was sore." There was no wheezing or respiratory distress. As per reported the signs and symptoms of the sore throat were still persisting at the time of this report. Follow up information received 01/Dec/2005. The vaccination was administered on 17/Sep 2005 at 11:00. There was no illness at the time of vaccination. At the time of this report, the patient had recovered.
Tingling in hands/random tingle in my arm/elbow area; Numb fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hands/random tingle in my arm/elbow area) and HYPOAESTHESIA (Numb fingers) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     No medical history was reported by reporter.    On 12-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PARAESTHESIA (Tingling in hands/random tingle in my arm/elbow area) and HYPOAESTHESIA (Numb fingers). At the time of the report, PARAESTHESIA (Tingling in hands/random tingle in my arm/elbow area) and HYPOAESTHESIA (Numb fingers) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood test: unknown (normal) blood work tests to rule out Lymes Disease and other potiential issues and she found nothing unexpected. On 13-May-2021, Spinal X-ray: negative (Negative) X-rays of spine and neck, all showed negative. On 13-May-2021, X-ray: negative (Negative) X-rays of spine and neck, all showed negative.         Concomitant medication reported : Men's Daily vitamin-once daily by mouth and indication for use is Health. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Significant follow up: Patient demographic details, vaccine facility center details, , concomitant details,new event were added.