chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Event outcome was not reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: This follow-up was received on 20-MAY-2021 with updated route of administration and contact details.
One month aver vaccine, I tested positive for COVID. I had a tele-med appt. was given and was told to take cold medicine for my fever. I was also given a chest X-ray, and it came back clear.
Starting Sunday July 29 symptoms included - stomach pain, knot in stomach progressing to sharp waves of pain and muscle tightness and cramping in intestines. There was nausea as the pain increased along with a feeling of needing to have a bowel movement but not able to do so. The pain increased as the week went along. Went to doctor Friday August 3 since pain was moderately severe when the cramps occurred and they were more frequent.
Body aches and fatigue evening of injection Subsequent day developed pain/redness at injection site. Following day temp 99.8 and swelling with increased redness and pain at injection site. Taking tylenol and ibuprofen. Prescribed triamcinolone cream topically initially however area was continuing to enlarge. Placed on doxycycline in case of cellulitis.
After the vaccine, the patient experienced swollen fingers, lips, and feet. The patient also experienced sore joints.
3 episodes of eye rolling and unresponsiveness in 1st 24 hours after vaccine.
covid-19; headache; chills; cough; mucus; all body pain; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all body pain), COUGH (cough), SECRETION DISCHARGE (mucus), COVID-19 (covid-19) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ARTHRALGIA (joint pain). On 09-Apr-2021, the patient experienced PAIN (all body pain) and PYREXIA (fever). On 10-Apr-2021, the patient experienced COUGH (cough), SECRETION DISCHARGE (mucus), HEADACHE (headache) and CHILLS (chills). On 11-Apr-2021, the patient experienced COVID-19 (covid-19). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN (all body pain), COUGH (cough), SECRETION DISCHARGE (mucus), COVID-19 (covid-19), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication reported.
Suspected vaccination failure; I had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had shingles). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:28-FEB-2023 The case  was received from the patient via interactive digital media. The patient had the Shingles vaccine and years later he/she had shingles. The patient believed it was as mild as it was because he/she had had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
My son had allergy reactions, but after when vaccinations was giving. Allergy reactions he had, with is; High fever, 1 time throw up, don't want to eat anything, cry all the time, and after 2/5 days, he had rush.
devel rash on back feet, legs 28JUL93; raised white rash w/red around edges; no c/o fever, sore throat or poor appetite; advised to see MD if sx persists;
The patient did not meet the age requirement per agency.  The patient is 17 years old and not 18.
improperly stored vaccine; This spontaneous report was received from a physician and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003865, expiration date 08-AUG-2020) (strength, route of administration and dose were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 32.5 Fahrenheit degrees (F) for 8 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Started Hallucinating, couldn't grab or hold anything. Hard time walking or standing. All started on the evening of April 9.  Shot was given April 9,at 8:38 am.   Symptoms stopped Sunday April 11 around 4:00 pm.
Four Hours after the initial injection rash appeared and started on my arm. I got the vaccine and waited for a bit, on the way home, I woke up from a nap I was itching on the arm and across my chest and on my back. I contacted my doctor the next morning, he recommend steroids and antibiotic. The medicine I took for a week and I had no more issues once started. I feel well now. I have not gotten any booster since that happened.
swelling in upper + lower lip & swelling in the left eye Ok she left @ 1235 Checked back in c? patient lower lip - minimally swollen  ~830pm
One day after vaccination pt had (L) arm redness and then severe dizziness, confusion, unable to stand, hypertension requiring hospital observation. 4/23/08-records received for DOS 4/15-4/16/08-DC DX: Constellation of nausea and vomiting with vertigo and confusion. Etiologies include viral syndrome, versus vaccination reaction. Presented with 4 day history arm aching and redness, dizziness, fevers and chills vertigo and confusion and trouble functioning. Nauseated.
PENTACEL given in AM today has swelling & redness of right thigh; inconsolable crying for 2 hrs. Seen in office again this P.M. Ibuprofen given, F/U in AM if symptoms persist.
Arm was very sore for 4 days after vaccination.  Have never had a sore arm from vaccinations in the past. At day 4 post vaccination, developed a cough and congestion -- had none previously.  Now on day 9 post vaccination and it is tapering down.
Patient began to describe a cold feeling throughout her lower left extremities and a burning/hot sensation throughout left arm 10 minutes after injection. I assessed the injection was located in correct area of upper arm muscle. I had the patient wait an additional 10 minutes for monitoring.
Patient began having tremors late evening of 9/13/04. On 9/15 she was seen by PMD with low grade fever and tremors. On 9/16 she had periods of apnea with unresponsiveness and seizure like activity and was taken to ER and admitted. The only rash noted was on the buttocks. On 9/17 she was transferred. On 9/20 she continued to experience seizure like activity with periods of apnea. Discharge summary received on 10/05/2004 pt experienced GERD. Follow up 01/18/05: Patient has recovered from adverse event.
Redness, swelling at injection site. (4-5 days). TX-apply ice, seen by PCP, Abx given. No fever or itching noted.
has an itchy rash on her legs; has lots of red dots on the bottom part of her legs that's really itchy; is going crazy; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date  at a single dose for COVID-19 immunization.  The patient's medical history included kind of itchy before the first Pfizer COVID vaccine. Concomitant medications were not reported. On an unspecified date, the patient experienced an itchy rash on her legs. The patient received the Pfizer COVID  vaccine and was not sure if this issue was related with it, but had lots of red dots on the bottom part of her legs The patient reported she was going crazy and that it was really itchy. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Babesiosis aggravated from trivial to emergency requiring 4 day hospitalization.  Substantial depletion of red blood cells (anemia, platelets and white cells.
Very bad reaction; terrible chills that lasted 30 minutes,Her teeth were clanking; Flu-like symptoms that lasted for 72 hours; Lost taste; Lost smell; Her cough was back; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Very bad reaction), CHILLS (terrible chills that lasted 30 minutes,Her teeth were clanking), INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted for 72 hours), AGEUSIA (Lost taste) and ANOSMIA (Lost smell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (Very bad reaction), CHILLS (terrible chills that lasted 30 minutes,Her teeth were clanking), INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted for 72 hours), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Her cough was back) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ADVERSE REACTION (Very bad reaction), CHILLS (terrible chills that lasted 30 minutes,Her teeth were clanking), INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted for 72 hours), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Her cough was back) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Rash at the site of the injection, spread across and down the upper arm. Rash warm to the touch. Arm was achy, sore, and occasional tingly feeling was present.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.   On 17-Nov-2021, the vaccine was placed in refrigerator and no temperature excursion reported.  No treatment medication were provided.
About a week after the vaccine I noticed 1 patch of hair loss which procceded to 2 or 3.  I visited my Dermatologist who injected steroids into each spot but within the next week more and more patches would fall out.  A bedtime oil was prescribed for me to use and I am still experiencing the issue to date which has caused me to have to chop off all my hair yesterday.  I have a 4week F/U appt with the dermatologist to see if any changes has occured
The patient is a female almost 2 months of age now, who was admitted after developing fever up to 103.0 (several dats after receiving 2 months shots (Hib #1, PCV-7 #1, IPV #1, DTAP #1). The child has also had some mild upper respiratory symptoms with rhinitis and mild non productive cough. The initial physical examination was unremarkable for concerning findings. Overall appearance of the child was non toxic and initial blood work evaluation revealed a white count of 10.2 with predominance of lymphocytes. Blood and urine cultures ordered, which are negative to date. Chest x-ray also unremarkable. Clinically, the child's temperature curve was downward trending and had been afebrile for 24 hours at the time of discharge. Antibiotics were not administered. the child was given only Tylenol and Motrin. Follow up: At next well child check or call sooner if rectal temperature greater than 100.4 (extreme inconsolability, vomiting, rash, or any other concern sign or symptom.
soreness; headache; bilateral hamstring muscle pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose no. 1), administration date: 05Jan2021, for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "soreness"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "bilateral hamstring muscle pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She receives IVIG treatment every 30-32 days. She did a blood test to detect antibodies against COVID infection on 26Feb2021 and the results was negative. Antibodies in some persons can be detected within the first week of illness onset. In SARS-CoV-2 infections, IgM and IgG antibodies can arise nearly simultaneously in serum within 2 to 3 weeks after illness onset. Thus, detection of IgM without IgG is uncommon. How long IgM and IgG antibodies remain detectable following infection is not known. It is also important to note that some persons do not develop detectable IgG or IgM antibodies following infection. Thus, the absence of detectable IgM or IgG antibodies does not necessarily rule out that they could have previously been infected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild
6/13 Sunday she was tired and achey, T 100. 6/14 Monday, she said her stomach hurt and headache at the end of the day. 6/14 during the night she woke up her Mom and said her chest hurt. She has mild exercise induced asthma. She said her chest felt tight, and it hurt to breathe. She went back to sleep in Mom's bed.  She got up very early 6/15. She took a shower, and it helped. She does look like she has laboured breathing, she does seem uncomfortable or unhappy. No fever today, not checked, but does not feel warm. She does have an inhaler, she did use it, but didn't help. She did eat and drink 6/15. She ate cold cantaloupe, and it helped her feel better. Is not complaining of burning. She has not done anything strenuous at camp yesterday. She does not have a history of seasonal allergies. Not in distress. No runny nose, she has had a little cough, when she breathes deeply. No rash on her body. She did feel nauseated 6/15. No diarrhea.  Evaluated at PCP's office .  Chest pain/difficulty breathing resolved on 6/16
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-JUL-2014, the patient inadvertently received a dose of GARDASIL (dose and route were not reported) instead of (manufacturer unknown) "IPV/polio vaccine". No adverse effect reported. Additional information has been requested.
H1N1 vaccine. Flu-like symptoms developed with 48 hours to include; dizziness, headache, nausea, weakness, fatigue. Symptoms were self limiting and did not result in f/u care. Report also submitted to VAERS.
Case number PHEH2016US026470, is an initial spontaneous report received from a pharmacist on 10 Oct 2016. This report refers to a 44 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618701) at a dose of 0.5 ml on 10 Oct 2016. The pharmacist stated that, 2 patients received FLUVIRIN that reached 76F for 13 hours. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
Information has been received from a pharmacist concerning a currently 67 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown date, the patient was administered ZOSTAVAX 19400 PFU lot # M036297, expiration date 14-NOV-2017, (dosage was not provided), administered per subcutaneous route, for prophylaxis. Concomitant therapies were not informed. The pharmacist reported a temperature excursion of 21F and a time frame of 18 hours and 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA014091: US-009507513-1611USA014123: US-009507513-1611USA014124: US-009507513-1611USA014125: US-009507513-1611USA014126: US-009507513-1611USA014128.
IN THE FOLLOWING ORDER APPROX. 3 HRS. AFTER RECEIVING VACCINE: Aching, SHORTNESS OF BREATH, WHEEZING, HIGH FEVER, headache, nausea.  Symptoms lasted for approx. 14 hours, intense for first 8 hours then gradually subsiding.
Stomach problems; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems) and LETHARGY (Lethargy) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems) and LETHARGY (Lethargy). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems) and LETHARGY (Lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
The evening, post vax, pt reported to ER with vomiting, hemocult (+) diarrhea and dehydration. Pt received 4 bolus of NS, bicarb and admitted for workup (blood and urine cultures-neg). Placed on ?.
16 y.o. scheduled into Moderna vaccine clinic and was given vaccine.  Vaccinator did not recognize by DOB that patient was 16. (Age not specified on form).  EUA for Moderna COVID vaccine is for persons age 18 and older. Patient did not have any reaction to 1st dose of Moderna vaccine.  She returned to clinic on 2/22/21 for 2nd dose and it was recognized that she was 16.  COVID Pharmacist consulted who in turn consulted with CDC/State officials. Per clinical considerations for the Moderna vaccine, 2nd dose of Moderna vaccine can be given to those 16-17y as off label use.  Mother and patient informed of EUA age cutoff for Moderna vaccine and re: clinical considerations/off label use.  Both gave verbal consent to patient having 2nd Moderna vaccine. 2nd dose given. No allergic reaction immediately following vaccine.
A week and a half after my booster shot, Moderna, I started breaking out into hives and it hasn't resolved. Booster received Dec 1
A 72 y.o. male who presents to the ED on 7/24/2021 with SOB.  He reports that he developed  shortness of breath, fatigue,  and cough 10 days ago.  He reports a history of COVID-19 vaccination with Pfizer in February 2021.  Patient was treated with dexamethasone, remdesivir, zinc, vitamin D and C.  Patient was improving slowly but still needed more than 4 L oxygen with ambulation.  He left AMA on 7/27/2021.  Later that same evening, he returned to the hospital as he was still short of breath.  He required heated high flow for his hypoxia, steroids and remdesivir were resumed.  He received tocilizumab on 7/31/2021, but still ended up on the ventilator from 7/31/2021 until 8/6/2021.  He was discharged to a Rehab facility on 8/18/2021, and discharged to home on 9/1/2021.   He presented to outpatient testing at pharmacy which proved to be positive.  Given his worsening symptoms he presented to the emergency room and was found to be hypoxic requiring supplemental oxygen.
Burning and numbness and tingling in entire right arm. It is bad enough to wake me.uo throughout the night. No issue previously on this side of the body.
Patient become diaphoretic, nauseous, and pale. There was no SOB reported. Patient's anxiety recovered--given juice and a snack and reported feeling better. BP 110/77, 94% SP02, Pulse 85. Patient went home in stable condition