chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No known adverse effects; a patient (who is one of a set of twin children) received a dose of PROQUAD and a dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 14-DEC-2019, the patient (who is one of a set of twin children) was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S013712, expiration date 01-NOV-2020; strength, dose and route were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S004862, expiration date 18-FEB-2021; strength, dose and route were not reported)for prophylaxis(inappropriate schedule of product administration).  No known adverse effects.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA007892:
Patient became very unsteady and unable to walk. Symptoms persisted for 45 minutes in the pharmacy before being transported to ER.
It wasn't an adverse event - I simply caught COVID one week after my Moderna COVID booster.  Also, I ended up having emergency gallbladder surgery a month later, but that wasn't an adverse event caused from the vaccine.
Onset symptoms 10/19/04 PM at HS Arm redness, swelling. 10/20/04 9AM parent notified MD. Tx Ibuprofen PO and Ice. F/U office 10/20/04 3:30PM less swelling but continues red, will continue tx ibuprofen. F/U as needed.
Existing tinnitus grew in volume after Moderna booster.  Even with my hearing aids I?m having trouble understanding conversations due to the increased static sound, specifically in my right ear.
dose administered after vaccine reached beyond use date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after vaccine reached beyond use date (BUD)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after vaccine reached beyond use date (BUD)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after vaccine reached beyond use date (BUD)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that the vaccine was in refrigerator and then administered. Off label stability date of the vaccine was reported as 09-Oct-2021. The reporter did not have any specific details about the patient.  No treatment information was provided by the reporter.
Massive pain left arm, shivering uncolorable for 5 hours, Very tiered. Nausea
Patient complained of her arm hurting, so we applied an ice pack on 1/13/17.  Swelling was significant, but not worrisome. On 1/14/17 at 6pm, we noticed a large raised red patch (rash like) around the injection site.  The patch was about as large as a square post-it note.  there were three small red patches to the left of the large patch  each the size of a quarter.  We drew circles around the patches to see if they grew larger. She didn't have a fever, so we iced the area and had her move her arm regularly.  Within 12 hours, all the red patches were gone and there was only a small lump at the injection site.  This was her 3rd dose of the HPV vaccine.
No adverse effects reported; female patient who is currently 15 years old received 4th dose of HPV series, GARDASIL 9 on 11/2/2019; Information has been received from a medical assistant via a field employee, referring to a 15 years old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included influenza virus vaccine (unspecified).  On 02-MAY-2016, 11-AUG-2016 and 18-JAN-2017, the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, dose 2 and dose 3 (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis.  On 02-NOV-2019, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot#: 1621934, expire date was 29-JAN-2022; strength, dose and route were unknown) (inappropriate schedule of product administration). No adverse effects were reported.
Headache, chills, myalgias, nausea, frontal headache, fatigue within  12 hrs of immunization.
01/04/21: soreness in the injection area (deltoid) 01/05/21: soreness continues in the injection area - specifically if deltoid is contracting to hold the arm out. If arm is supported (by a table for example), deltoid is not reacting. In the morning, everything felt fine but by early afternoon, feelings of fatigue/soreness in other parts of the body has occurred.
I had become dehydrated. June 19th - I had worked out really heavily in the day and I got dizzy that night. I tried to hydrate up. In the morning, I had a galloping heart - an arrhythmia - I went to ER dept. in the mid morning. They did a lot of testing. They gave me a medicine that I didn't tolerate.  They gave me a beta blocker (Metoprolol) - and my heart started galloping all over the place - so they created more of an arrhythmia because I have low blood pressure. I went back two days later - they just sent me home but kept me on it. I communicated with my primary care doctor - and I had to wean have the drug - took two weeks to do that. . He gave me  magnesium/potassium supplement and I've been fine since. Oh and they had given me  Ziopatch - they had given me that at ER on the 20th. They took it off and read the report and it helped show why the doctor why was comfortable taking me off of the blood thinner. I have not had galloping, feeling dizzy times since being off the beta blocker and being on the magnesium/potassium. I still have  minor heart flutters still have but have had that my whole life from time to time. I have stopped:  alcohol, caffeine and chocolate - have stopped those triggers to help lessen things. I have a cardiologist now.
I got the shingles shot twice this year/Suspected vaccination failure; Shingles in my right eye; I have  shingles is awful, in the forehead; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient received 2 doses of Shingles vaccine in the year of reporting. After receiving Shingles vaccine, the patient got shingles in forehead and in right eye. The patient stated that, he/she had this was awful. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
Starting 7 days post second injection I have a rash on my upper trunk and head.  It is a severe macular rash with whiteheads on some of the lesion.  It itches a lot and seems to be getting worse,
Vaccine product experienced temperature excursion. Vaccine was administered before Seqirus was contacted to verify acceptable excursion temperature/time.  No adverse reaction occurred. Seqirus later verified vaccine was still stable at the time of administration.
Patient received 1st dose of Pfizer 1/18/21 and 2nd dose on 3/23/21.  She tested positive for COVID-19 on 4/14/21 through asymptomatic screening.
Numbness in toes, tingling, intial report received from a health care professional on 28/Dec/2005.  An 18 yr old female patient with a medical history of asthma developed numbness and tingling her left and right big toes two days after she had received an injection of Menactra in the left arm.  The symptoms initially occurred in the left big toe, but were present in both the left and right big toes by 25/Dec/2005.  The patient was seen by a physician on 27/Dec/2005 and at that time the symptoms were persisiting.  At the time of this report, she had not recovered from the events. Follow-up information per reporter no treatment was provided for the symptoms.  The progression of the symptoms is unknown.  No diagnostic or lab testing was performed.  The patient did not have any symptoms of a respiratory or gastrointestinal viral infection prior to the onset of the symptoms.  No definitive diagnosis was made.  The symptoms lasted 2-3 weeks and patient recovered.  No further information expected.
Moderna COVID-19 Vaccine EUA Lightheadedness, chills, body aches, injection site pain (left arm). Started immediately after vaccine administration. Body aches, chills , arm soreness lasting through day after vaccine along with headaches.
Incredible fatigue, exhausted, joint pain, muscle aches, head ache off and on,  injection arm pain first three days, brain fog, weakness. Doctors appointment on Monday with covid tests. Both rapid and pcr were negative. Still most of the symptoms are still going on. Still weak, brain fog, joint pain, fatigue and exhaustion. I feel awful and sleep way more than usual.
PT STATES HE NOTICED THE RASH AFTER HE GOT OUT OF THE SHOWER AND WAITED UNTIL TODAY TO NOTIFIED US BECAUSE HE CAME IN FOR THE TB READING, WHICH WAS PLACE 2 DAYS AGO. TB WAS NEGATIVE. HE HAS RASH INNER-OUTTER RIGHT ARM, ALMOST IN THE AXILLA AWAY WHERE THE PNEUMONIA WAS GIVEN. NO OTHER PROBLEMS WITH THE RASH (COUPLE OF BUMPS, BUMPS MEASURE FROM 1.5-2.0CM. HOWEVER, THE INJECTION SITE IS SENSITIVE/TENTERED, PAINFUL, AND HOT WHEN YOU TOUCHED THIS IS THE ON THE LEFT DELTOID.
Patient is 17yrs old and was erroneously given a boost dose.  Boost doses only allowed for 18 and over at the time of vaccination.
malaise; dizziness; "I am not myself"; dull headaches; received 3 dose accidental of Moderna instead of Flu shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIZZINESS (dizziness), FEELING ABNORMAL ("I am not myself"), HEADACHE (dull headaches) and EXTRA DOSE ADMINISTERED (received 3 dose accidental of Moderna instead of Flu shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3 dose accidental of Moderna instead of Flu shot). On an unknown date, the patient experienced MALAISE (malaise), DIZZINESS (dizziness), FEELING ABNORMAL ("I am not myself") and HEADACHE (dull headaches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), DIZZINESS (dizziness), FEELING ABNORMAL ("I am not myself") and HEADACHE (dull headaches) outcome was unknown and EXTRA DOSE ADMINISTERED (received 3 dose accidental of Moderna instead of Flu shot) had resolved.            No concomitant drug details were reported.
After the booster shot I started to develop eczema and never had skin issues prior.  Now I have to use steroid cream daily or it comes back.  On my torso and breasts so far.
Fever, chills, headache, muscle aches throughout body, sore at vaccination site with a short lived rash, fatigue.  It was bad enough to halt daily activities (I canceled a phd interview because of how bad I felt).  This occurred from late 2/4 through morning of 2/6. Taking tylenol seemed to help and I felt immensely better the two or three times my fever broke.
15 x 17cm area of redness, mild swelling, tenderness right deltoid area 4 days after Tdap given in right deltoid. Pt already on Augmentin x 4 days due to injury requiring vaccine. Septra added to Augmentin. OTC Advil.
Within 15 minutes of injection, I experienced itchiness all over my body but it passed very quickly - no hives or rash.  I stayed an extra 15 minutes at vaccine location and felt okay and was able to leave.  The injection site was sore and painful for 36 hours post injection..  I experienced headaches and fatigue 4 hours after the injection that have been intermittent and are still continuing as of this writing.  The night of the injection I had a lot of pain in my muscles and particularly from my lower back down each leg.  I was excessively tired the day after the injection.  Starting three days after the injection I developed a dry cough and slight runny nose and congestion that has continued as of this writing.  I have had NO fevers since the injection.
She is feeling like she really has COVID; She is feeling like she really has COVID; Not feeling well; I'm not feeling good; I feel like anything that makes me feel this bad cannot be good for me; Experiencing side effects, her arm is swelling up to the elbow; not feeling well about the whole arm; Experiencing side effects, her arm is swelling up to the elbow; not feeling well about the whole arm; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. After having the first dose of Pfizer COVID-19 Vaccine the patient she was not feeling well, she was experiencing side effects, her arm was swelling up to the elbow, her whole arm was (incomplete sentence), she was not feeling well about the whole arm. She was experiencing like she was feeling like she really has COVID, that's what she felt.  She asked if she allergic to something, and if she can still going to receive the second dose. She not feeling good, don't feel like doing this and just not getting it. She feel like anything that makes her feel this bad cannot be good for her. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "eosinophilic esophagitis" (unspecified if ongoing); "elevated BP" (unspecified if ongoing); "dermatitis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FLUTICASONE PROPIONATE; CETRIZINE; MONTELUKAST SODIUM; SPIRONOLACTONE; PSEUDOEPHEDRINE HYDROCHLORIDE, start date: 13Jun2022, stop date: 21Jun2022; GUAIFENESIN, start date: 15Jun2022, stop date: 23Jun2022. Past drug history included: Biaxin, reaction(s): "Allergy: Biaxin", notes: digestive issues; Doxycycline, reaction(s): "Allergy: doxycycline", notes: digestive issues. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022 at 01:30, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: Finished Paxlovid on evening of 20Jun2022. Began home testing on 20Jun2022 and continued to test positive; (24Jun2022) Negative, notes: Finished Paxlovid on evening of 20Jun2022. Began home testing on 20Jun2022 and continued to test positive (results grew progressively more faint) until 24Jun2022, when I had a negative result; (25Jun2022) Positive, notes: On the following day (25Jun2022), I again tested positive (very faint); (30Jun2022) Positive, notes: have continued to test positive through yesterday (30Jun2022). Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Evaluated 1/24/03 by pediatrician, due to edema and erythematous rash L deltoid area which began approx. 3 hrs after getting DTaP, MMR & IPV. Reaction size half dollar.
exp severe stomach cramps went up into back & around to chest & had difficulty breathing had 3 episodes a/given Compazine;
Muscle pain and cramp like symptoms mostly in legs over night for 6 days, fatigue, loss of weight and appetite
On the third day after the vaccination numbness and tingling occurred in my right side of the body - arm and leg, eventually lower back as well (the shot was done on the right arm). Trouble sleeping occurred (waking up during the night and not being able to go back to sleep). No sleeping issues in the past prior to the vaccination.
Dizziness, extreme fatigue, brain fog, intermittent nausea lasting for a total of 1 month.  Livedo reticularis on backs of both upper arms, worsened tinnitus lasting through the time of this report.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-APR-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Synacope, pt briefly got light headed and slightly nauseated, almost fainted. Had history of fainting when receiving vaccination. Fully recovered w/o complaints within 15 minutes of onset.
Was really tired after the first vaccine; This is a spontaneous report received from a contactable consumer (patient). A 53-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left deltoid single dose for COVID-19 immunization on 29Mar2021, 11:30am, at 53-year old. Medical history included: bipolar disorder, breast cancer, slightly high blood pressure. Concomitant medications included: ongoing letrozole 2.5mg tablet once daily from 2017; ongoing omeprazole 20mg once daily for constant heartburn; ongoing propranolol (PROPANOLOL) 20mg twice daily from 2016; ongoing clonazepam 0.5mg twice a day for anxiety from 2016; ongoing venlafaxine hydrochloride (EFFEXOR) 75mg for bipolar disorder. The patient previously received flu shot (vaccines, unspecified) a couple of years ago. The patient was really tired after the first vaccine. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a six month old male patient who on 05-NOV-2009 was vaccinated with a dose of ROTATEQ, a dose of PREVNAR and a dose of PENTACEL. On 05-NOV-2009, six hours after vaccination, the patient had multiple seizures. The seizures came in clusters. The patient was admitted to hospital from 05-NOV-2009 to 10-NOV-2009. The patient was still on medication and his mental development saw to be delayed. Physician suspended giving vaccines until patient was off his medications. At the time of report the patient's status was unknown. Additional information has been received from the physician who indicated that the patient had infantile spasm on the evening of 05-NOV-2009. The patient was taken to the emergency room. The physician stated that the patient was seen in her office (date not reported) and the patient was sent to the medical center. The patient was referred to a pediatric neurologist. The physician stated that the patient had mental development delay. The physician stated that she did not know the cause of the patient's mental development delay. Additional information has been requested.
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms.  We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
Pt developed fever 103F post vaccine. Pt reports fever, nausea, vomiting. Dx  with gastroenteritis. 1/28 noted increased redness and swelling. Localized reaction to DPT or Hepatitis B VS cellulitis, child limping, reddened ecchymotic area surrounding injection site. Warmth.
Left sided focal seizure 13 hours after recieving vaccine. Presented to ER with temp of 103.  Total time of seizure was 30 minutes. Pt hospitalized for 3 days. 3/30/07 Received medical records from hospital which reveal patient experienced a left sided focal seizure consisting of focal twitching of left arm & leg w/unresponsiveness. 13 hrs s/p vax w/fever of 103.  Seizure lasted approx 30 min & abated w/ER tx.  Transferred from outlying ER to higher level of care.  Admitted 3/13/07-3/16/07.  Admit exam revealed lethargy & slight gen muscle hypotonia. No further fever or seizure activity & muscle tone improved but remained slightly hypotonic at d/c to home w/follow up arranged w/PCP & ped neuro. FINAL DX: Left sided focal seizure associated w/fever occurring s/p 6 mo immunization series.