chrisvoncsefalvay/vaers-outcomes huggingface dataset:
New information was received in source details only. Information regarding PREVNAR was received from a physician regarding an unknown number of patients who experienced a higher number of local reactions noted with dose 4 PREVNAR 7 than with first 3 doses. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced higher number of local reactions noted with dose 4 of PREVNAR than with first 3 doses (local reaction). The outcome is unknown. No additional information was available at the time of this report.
I received my vaccine at 10am and by 5 pm I was feeling extremely tired couldn?t keep my eyes open. For the rest of the night I had a fever of around 102 and chills and stomach pain and nausea. These symptoms lasted the entire next day along with extreme fatigue and dizziness that also has lasted up until and ongoing on 04/09/2021 at 8pm fever is on and off at about 101.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles and pain in arm. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. The patient mentioned that he had a sore arm and at the time of receiving 2nd dose of SHINGRIX he had an active case of Shingles. The patient did not want to provide date of birth or physician's contact information or other adverse event information. The patient had denied permission to contact their physician. The patient had provided limited information. For tolerance to next dose, refer case US2018GSK196323.
pt recv vax 15APR98 & c/o soreness & given advil;18APR98 woke up w/bulge to lt deltoid oblong 3 1/2" x 1 1/2" high sore skin;no redness but very sore;went to clinic not infected, probably tissue rxn;20APR98 arm bulge only sl smaller
Fever, chills, sweats, nausea, muscle aches and headache. Happened about 12:30am.  Took some nausea medication and Tylenol.  Was able to get back to sleep after an hour of fighting off vomiting .  Nausea is mostly gone this morning.  Headache and muscle soreness still persist.
NUMBNESS IN TIPS OF FINGERS, FACIAL FLUSHING, HEADACHE AND NECK ACHE X 24 HOURS.
Fever, chills, headache, body aches, dizzy, light headed,  shortness of breath
bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine; About 80% of the dose was administered the other 20% leaked down the patient's arm; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine), UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm) and NO ADVERSE EVENT (no adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine), UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm) and NO ADVERSE EVENT (no adverse event). At the time of the report, DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine), UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (bivalent Covid-19 vaccine that leaked out while Pharmacist was administering a dose of the Moderna bivalent Covid-19 vaccine) and UNDERDOSE (About 80% of the dose was administered the other 20% leaked down the patient's arm).    No concomitant medications were reported.  It was reported as first four Moderna Covid-19 vaccines two primary series and two booster doses were not known. Reporter did not feel that the Moderna Covid-19 vaccine itself contributed to this incident. Reporter not aware of any other adverse reactions.  No treatment medications were reported.
Body aches/soreness, migraine, shortness of breath. Patient felt like he had COVID again for 12hrs (he had COVID previously, and all the symptoms from the vaccine were the same).
This spontaneous report as received from a physician refers to a patient of unknown age (gender not reported). On an unknown date the patient was vaccinated with a shot of ZOSTAVAX (lot #, dose and route not reported). According to the physician, on an unknown date the patient experienced a "skin reaction resembling cellulitis near the injection site" after having received ZOSTAVAX. The patient was treated with an unspecified treatment which was used for treating cellulitis. The patient sought medication attention by seeing the physician. The outcome of the event was unknown. Additional information has been requested.
Pain, swelling, no fever, mildly pruritic, no hand pain/numbness/tingling.
Shortness of breath, headache,  muscle aches, joint aches, nausea
Unable to follow simple commands, slower to respond. Fatigue and confusion. Transferred to hospital with a cerebral hemorrhage
pt devel alopecia @ age 3yr & has cont to exp patches of baldness (fifty cents size);mom has read about cases of hair loss from hep b vax & wants to report this;
This case was reported by a pharmacist via regulatory authority and described the occurrence of viral meningitis in a female patient who received Meningococcal ACWY Vaccine (potential MENVEO) for an unknown indication. On 11th August 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO). On 12th August 2009, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced viral meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), back pain (serious criteria hospitalization) and fever (serious criteria hospitalization). On 16th August 2009, the patient experienced rash (serious criteria hospitalization), nausea (serious criteria hospitalization) and decreased appetite (serious criteria hospitalization). On an unknown date, the outcome of the viral meningitis, headache, back pain, fever, rash, nausea and decreased appetite were recovered/resolved. It was unknown if the reporter considered the viral meningitis, headache, back pain, fever, rash, nausea and decreased appetite to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional information was provided as follows: The age at vaccination was not reported. On 16th August 2009, 5 days after vaccination, the patient experienced rash, nausea and decreased appetite. Correction done on 26 November 2018, following an internal QC. This case downloaded from Regulatory Authority was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Information has been received from a nurse practitioner concerning a 25 year old female patient with drug reactions or allergies to penicillin and "sulfa" who on an unspecified date was vaccinated with a dose of MMR II (Lot # not reported). On an unspecified date the patient had an anaphylactic reaction to MMR II as a child. On unspecified date the patient recovered from anaphylactic reaction. Recently at the age of 25 years old the patient was vaccinated with unknown "whooping cough vaccine". After vaccination the patient developed a rash, nausea and vomiting after vaccination with an unknown whooping cough vaccine (manufacturer unknown). The patient recovered on an unknown date from the rash, nausea and vomiting. It was unknown if the patient sought medical attention. Anaphylactic reaction, rash, nausea and vomiting were considered to be immediately life-threatening by the reporter. No further information is available.
"A nurse reported that a 9 month old female inadvertently received 2 doses of Acel-Imune on 6/10/99. The infant also received Hib-Titter and IPV vaccines. This report was received on the date of immunizations; no adverse experience had occurred at that time."
whole left side just itches.; I was sitting at my desk and all of a sudden the whole left side of my face started tingling badly and burning.; I was sitting at my desk and all of a sudden the whole left side of my face started tingling badly and burning.; Then from there my ear kind of went numb and thenI got light headed and dizzy; Then from there my ear kind of went numb and thenI got light headed and dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 16Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included shingles (had about 5 months prior to). Concomitant medication was not reported. On 16Feb2021 (after about 5 hours of vaccination), patient was sitting at desk and all of a sudden the whole left side of face started tingling badly and burning. Then from there ear kind of went numb and then got lightheaded and dizzy. On 19Feb2021, patient had whole left side just itches. So, patient went and got on the bed for a little bit. Then the next day was ok, not a 100% but fine now. Patient almost went to the emergency room. Patient wanted to know whether the vaccine was triggering the virus in people that have had shingles. Patient face start tingling and burning badly, ears got numb right on the side where had shingles. While patient was sitting and talking, whole left side just itches, like the start of shingles but it was all the way down left side. It was on my left fingertip too. Like shingles. Just like left side, that's the side where got shot in and that was the side had the shingles on. So that was patient concerned because shingles was a virus and wonders if there was something in the vaccine. It was not as severe today as the day that when got the vaccine. Patient was concerned about taking the second dose. If had a harder time with the second dose, would be scared to death and if do not get the second shot because of this, at least have some in. So, if patient gets COVID, would not have it as bad. The outcome for event whole left side just itches was unknown and for all events was recovering.   Follow-up attempts completed. No further information expected.
pain in his heart; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (pain in his heart) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac arrest in 2009, Open heart surgery in 2009 and Mitral valve replacement in 2009.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (pain in his heart) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, ANGINA PECTORIS (pain in his heart) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sick; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, fever and chills. On an unknown date, the outcome of the sickness, fever and chills were recovered/resolved.   It was unknown if the reporter considered the sickness, fever and chills to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient was sick, had fever and chills.  The side effects lasted for about a day or so. The reporter didn't want to provide any additional details.
62y.o. male who presented with progressive edema and dyspnea. He does have chronic LE edema and has his legs wrapped on a weekly basis -- he has known venous insufficiency. He was just seen in the office on 8.12 and his creat was worse.  This was thought to be due to his diuresis which was slowed to bumex 2mg BID  metolazone 2.5mg MWF Aldactone 50 He was also advised to hold his ARB. Once he slowed these medications, his swelling and breathing worsened. Patient is stable for discharge with outpatient follow-up.
Within a week of receiving shingles vaccination I experienced outbreak of genital herpes that did subside for 10 weeks, despite use of valacyclovir as directed. After outbreak subsided within 3 weeks had new outbreak which again took more than 2 months to clear up. Continuous and weeks long outbreaks continued for 2 years and then began to lessen in frequency and intensity and duration. Because of the location of the herpes blister I was in quite severe discomfort for months at a time. I have never seen this as a reported side effect, but it should be made known to persons considering the vaccine.
t103.6 1 hr p/receiving vax; APAP given w/dec in temp in 15 mins;
WE ADMINISTERED A SECOND DOSE FROM A VACCINE WHICH PASSED IT BEST USED TIME.  VACCINE WAS ADMINISTERED AT 8:25AM AND BEST USED TIME WAS AT 1:35AM 8-21-21
24 hours post vaccine (VZV) mom reported entire body was red. 48 hours post vaccine fever of 102 and cough. 72 hours post vaccine-itching red rash-progressed to blisters with poor appetite, restless sleep, lethargy, cough, congestion and yellow nasal drainage continue at 5 days post vaccine. Talked with mom 1/31/2007 rash improving, continues with cough, nasal drainage. Has MD appointment 2/1/07. rit cough.
PATIENT FELT LIGHT HEADED AND DIZZY AFTER VACCINATION DURING 15 MINUTE WAIT PERIOD. MOTHER SAID HER EYES ROLLED BACK AND SHE FELL AND MAY HAVE HIT HER HEAD BECAUSE HER HEAD WAS HURTING WHEN SHE CAME TO MOMENTS LATER.  SHE FELT FINE EXCEPT FOR A LITTLE HOT AFTER THE EVENT. THEY WAITED FOR ANOTHER 20 MINUTES BEFORE MAKING SURE SHE WAS OKAY AND LEFT WITH NO TREATMENT
My head felt like It was under water, had sinus issues, headache and vaccine sight issues days after getting the vaccine, warm, red and pain at injection site
Red raised whelps at site of injection - > 2 inches below on left arm, came up 3 after vaccine is sore, no itching, not bitten anything and don't need anything as of now (no need to go to MD).
Pt experienced a fever of 105 for 3-4 days. Onset of fever began at 36 hours post vax with other symptoms.
Upon left arm injection, I felt severe pain.  I believe the facility hit the bone and went too low on my arm.  I have had a bruise since at the injection site.  However, below the injection site i have had a large red patch.  Approximately 2 inches by 3 inches.  It grew to that size within a day of injection.  The pain still was so bad I went to the doctor. She looked at it and said they most likely hit lower on the arm than the muscle. But also I had an adverse reaction to the shot.  I documented photos as well.  There is no site to download them for you.  I also went to Pharmacy to tell them as well.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a company representative. The reporter is the patient.  An 85 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient reported they are an 85 years old female with some underline problems and they tested positive for COVID-19, their doctor tried to order Taxlozid (as reported) for her. The patient was fully vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fainted while getting down from Exam table.  Child fell and hit forehead on counter-top.  He required sutures in Emergency Dept.
aching, h/a, n,v, fever, chills since 3NOV92; 20NOV feeling 100% better;
at first my left eye started getting itchy and my eye lid started to get red and swell.   over the next couple of days it kept getting worse.  Then it spread to my right eye.  I was given Erythromycin ophthalmic ointment and started taking benadryl, zyrtec and eye drops but nothing helped.  There was a severe burning and itching sensation in both eyes, non-stop.  the skin around my eyes has turned dry and itchy as well.   The itching spread to my ears, forehead and other parts of my body.   Eventually I was given a Medrol pack, this has helped alot but I can feel the itchy and burning trying to come back.  I am on the 5th day of the methylprednisolone, the itching is minimal now but my eyes still burn from time to time.  the burning feels like I just cut an onion .  In addition to this, I was having stomach issues for the first week, I was having diarrhea and random lower body parts were itchy.    When i put hot water on the itchy areas, it felt very good, but it did not relive the pain/itching.
I feel weak; side effects of booster shot; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (I feel weak) and VACCINATION COMPLICATION (side effects of booster shot) 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 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced ASTHENIA (I feel weak) and VACCINATION COMPLICATION (side effects of booster shot). At the time of the report, ASTHENIA (I feel weak) and VACCINATION COMPLICATION (side effects of booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR  36 HOURS
Pt. rec'd. (PNVX-23) on 3/26/18 and called next day with redness spreading over R upper arm. He was seen on 3/28/18. Evidence of redness swelling extending from upper arm to elbow = Dx cellulitis after PNEUMOVAX 23 injection.
Patient with swelling, warmth and itching erythema and pain right thigh at site of DTaP and IPV given on 4/19/06. Care sought on 4/21/06 patient with low grade temp Benadryl 12.5 mg given. 4/24 v'd with mom and son much improved.
diagnosed with COVID in May.  Early part of May symptoms develop with headache, cough, wheezing, shortness of breath, muscle aches, tired.  The wheezing and coughing got better the shortness of breath improved however the headache remained.  She continues to have a headache 7/10.  Generalized headache.  The headache is been present since mother's Day.
arm hurting; arm red; sick; weird feeling- arm; arm itching; arm warm, hot; (hard pocket) that is leaking out maybe pus- arm; hard pocket- arm; arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting) and ERYTHEMA (arm red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PROGESTERONE;ESTROGENS for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm) and PERIPHERAL SWELLING (arm swollen). On 28-Apr-2021, the patient experienced FEELING HOT (arm warm, hot). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), ERYTHEMA (arm red), MALAISE (sick), FEELING ABNORMAL (weird feeling- arm) and PRURITUS (arm itching). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PURULENT DISCHARGE ((hard pocket) that is leaking out maybe pus- arm), INDURATION (hard pocket- arm), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), ERYTHEMA (arm red), FEELING HOT (arm warm, hot), MALAISE (sick), FEELING ABNORMAL (weird feeling- arm) and PRURITUS (arm itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional adverse events. On 07-Jul-2021: Outcome recovered.
Information has been received from a certified medical assistant concerning a patient who on 08-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), IM. On 08-AUG-2008, the patient received late the second dose of GARDASIL vaccine (yeast). The patient is not experiencing any known symptoms. Additional information is not expected.