chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported. This case belongs to patient no 19 out of 25 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
PATIENT FELT FEVERISH AROUND MID-NIGHT ON THE DAY OF VACCINATION, BUT WENT TO SLEEP.  SHE WOKE UP AROUND 5AM ITCHING, EXPERIENCING RASH FROM GROIN TO ARMPIT, NOW SPREAD UP TO HER NECK, FACE, NOSTRILS, EARS AND SCALP.  HER LIPS ARE SWOLLEN AND EYELIDS AS WELL. NO SWOLLEN TONGUE YET BUT SHE SAID HER THROAT FELT A LITTLE FUNNY.
Information has been received from a 43 years old "MR" her moderator concerning her kids (The patients' age and gender were not provided). It was reported that the reporter was enrolled in a market research program. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date, the patient's kids were vaccinated with a dose of varicella virus vaccine (manufacturer unknown) (lot #, expiration dates and dosages were not informed), (route was reported as injection). Concomitant therapies were not informed. On an unspecified date, the patients got rash after getting varicella vaccine (manufacturer unknown). At the time of the reporting, the outcome of rash was reported as unknown. The causal relationship between rash and varicella virus vaccine (VARIVAX) was not reported. Additional information has been requested.
Vomiting; Dizzy; not feeling well; Hurting/ pain; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP).  A 46 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Aug2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported VOMITING (non-serious) with onset 2021, outcome unknown; DIZZINESS (non-serious) with onset 2021, outcome unknown; MALAISE (non-serious) with onset 2021, outcome unknown; PAIN (non-serious) with onset 2021, outcome unknown. The events vomiting, dizzy, not feeling well, and hurting/ pain were evaluated at the emergency room visit.  The patient took the Pfizer first shot a few weeks back and she kind of got a bad reaction to the left side where she took the vaccine on the left, it was been like very hurting, she was in kind of in pain on that side to past few weeks and the they contacted because she took the vaccine at Facility name so, they contacted to them and they said that they were working on it and they gave reporter this number today to call because patient was been experiencing a lot of pain since, the first dose and she hasn't be able to get the second dose because of that and they went to the ER a few weeks ago, as well because she was vomiting and she was getting very dizzy and they went to the ER. Patient went to the ER because she was not feeling well and she need to be able to do like X-ray on the left side of her body just to make sure everything was fine the lungs and the everything because she was been having a lot of pain and like they just want to make sure her heart and kidney and everything were all fine the way they were supposed to be because she was experiencing a lot of pain. It was been almost like two months now and patient hadn't been able to take the second shot and they were just been little bit concerned because Facility name gave the wrong phone number. They need assistance with the medical bill she got from the ER because they had to go to NAME emergency hospital because she was not feeling well and they send them the bill and she didn't have a health insurance but also she still have a little bit of a lot of pain on the left side so, reporter think it's probably best to take like X-ray to see if everything is fine. Asked was she going to be continued in pain for four to six weeks. This was kind of an emergency she was been waiting for two months now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
ONSET 09/13/2021 WITH SOB, MYALGIA, RHINORRHEA, OLFACTORY/TASTE DISORDER, FATIGUE, COUGH, FEVER 102.6, NAUSEA RESULTING IN ICU HOSPITALIZATION AND DEATH
SEVERE DIZZINESS AND NAUSEA, ALMOST BLACKED OUT, NUMBNESS OF LEFT LEG, OXYGEN WAS DOWN TO 93
A 43-year-old female patient had received an intradermal dose 1 of FLUZONE ID (batch number UT4470BA with expiration date 03/31/2013) in left arm on 08 January 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Concomitant medications were not reported. On 09 January 2013, 1 day after vaccination, the patient experienced redness and swelling 'size of fist' and a big welt. The corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Pain at site of injection the next day. Swollen glands in neck/cervical area and armpit on day 2. By day 3 I was feeling better and by day 4 i did not have any soreness at all.
48 hours after receiving 2nd COVID vaccine, patient felt weak and dizzy, developed hives, vomiting and a 6cm hematoma to L upper arm.  Patient went to the ER.  Patient received prescriptions for Medrol dose pack, famotidine, and an EpiPen. Patient followed up with a provider in her PCP's office on 12/22/21 and was noted to still have a painful lump in her L upper arm and an ultrasound was ordered. Ultrasound revealed that patient had a hematoma.
3-9-21 1PM PT C/O 'LIGHT BURNING IN STOMACH & MILD HEADACHE'  A/O, PINK, W/D, RESP REG WITH EASE.  NO SOB, NO NAUSEA, NO DIAPHORESIS. 1:05PM 'FEELS BETTER NOW'.  NO ACUTE OR OBVIOUS DISTRESS. 1:10PM AMBULATORY TO EXIT- GAIT STEADY. NO DISTRESS NOTED. 3-10-21 9:30AM PT STATES'FEELS BETTER- SYMPTOMS RESOLVED'.
Swelling; hot to touch; itchy at injection site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in right arm on 12Feb2021 at 10:00 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation at doctor's office/urgent care. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included metoprolol, omeprazole, lovastatin, hydrochlorothiazide, triamterene (TRIAMTERENE/HYDROCHLOROTHIAZIDE) all from unknown dates to unknown dates for unknown indications. The patient previously took keflex [cefalexin], clindamycin, flonase [fluticasone propionate] and experienced drug hypersensitivity. Historical vaccine included dpt vaccine administrated in left arm on 01Feb2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced swelling, hot to touch, itchy at injection site, starting on 21Feb2021 at 10:00, and continuing. The patient did not receive any treatment for the events. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
pt recv vax 21OCT96 & w/in 1hr pt devel erythema from 12-13cm above the site of inj to medial arm, & exp pain & warmth & devel swelling;in addition pt had diff sleeping;tx w/Medrol;
Patient had a subconjunctivial hemorrhage in her left eye that was noticed after receiving the vaccine.  There were not symptoms other than the redness in the left eye.  It was not noticed before receiving the vaccine but was noticed right after.
10/27/12 at 4:00pm swollen lips, puffy fingers, possible swollen tongue.
The day after my shot.  I notice tenderness around my arm pit and left breast area.  Tenderness in neck and some tiredness.  Around day 10, I had swollen left side of my neck where my lymph nodes.  It was keeping up at night.  I went to my doctor on the 16th of November and reported my symptoms.  She told me that swollen lymph nodes are common with COVID-19 vaccines.  It has mostly gone away.  I still can feel that my side lymph nodes of my neck are still a little swollen.  I had earing in my rings in ear for a few days.
Rash on arm/sholder that the immunization was given. Appeared 2 days after immunization was given.
Had face and tongue swelling and tingling plus rashes starting about 15 minutes after. It was not severe but lasted entire day. At night I was shivering with fever of 100.6 - 101.3. I had such severe joint and muscle pain I could not lie down. I was so sleepy but had to get out of bed every 90 minutes or so and walk around because the pain was so bad. I was severely nauseated.
irregular heartbeat; he is not feeling too good; dizziness; eyes are blurry; high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old male patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient's wife stated that he had high blood pressure and she said something was not right her husband was complaining and she gave him aspirin which calmed him down a little bit when he came back from therapy (not specified). Her wife mentioned that for his first dose he felt quite fine but during the second dose, his symptoms started showing after few days. His wife also clarified that he was being taken to hospital specifically for his irregular heartbeat and loud heart sounds. Her wife stated that her husband can feel and hear his heartbeat. Her wife mentioned that she was referring to dizziness when she mentioned incapacitated and also read all that has mentioned. After receiving the second dose of vaccine the patient experienced irregular heartbeat, he was not feeling too good for 5-6 days, dizziness, eyes are blurry, high blood pressure and felt dizzy on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: high, heart rate irregular: irregular. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Day after receiving intradermal flu vaccine, injection site had swelling, redness and warmth to touch. Serosanguinous drainage from site in office today. Patient started on BACTROBAN ointment 2% and BACTRIM DS tablets x5 days.
Wasn?t able to stand up at all... nausea fainting dizziness etc... had to take rescue twice within 5 days... was in the ICCU unit at one point.. diagnosed with orthostatic hypotension
possible late dose/first dose of Shingrix in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: possible late dose/first dose of Shingrix in 2020).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The patient stated that she got the second dose but there was no record of it. This was being reported as a possible late dose. The caller declined to provide more patient information. The reporter did not consent to follow-up. The patient received 2nd dose possibly later than recommended interval, which led to lengthening of vaccination schedule.
unwell feeling; unable to move an inch; it had inflamed every cell in my body; ears, teeth, gums, hair, and especially brain; AS patient. First shot began electric shocks in lower back. Second vaccine after 24 hours gave me blinding siezures in my entire left back muscle. Saw stars blacked out. Laid on wooden floor for 5 hou; Saw stars blacked out; Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient himself). A 67-year-old male consumer received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 22Apr2021 13:30 at single dose for COVID-19 immunisation. First dose of BNT162b2 was administered via an unspecified route of administration in left arm on 02Mar2021 13:30. Relevant medical history included hepatitis C, and ankylosing spondylitis. The patient had allergy to levothyroxine sodium (SYNTHROID). Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Second vaccine after 24 hours gave him blinding seizures in his entire left back muscle. Saw stars blacked out (as reported). Laid on wooden floor for 5 hours unable to move an inch without triggering seizure. 20 hours later he was able to get to bed. Have had overwhelming unwell feeling every single day since. Doctor suggested one Valium twice a day and 2 at bed. Seizures have stopped. The biggest problem is it had inflamed every cell in his body: ears, teeth, gums, hair, and especially brain (as reported). The patient had a concussion 8 years ago and this is triggering swollen brain synapse genius, followed by overwhelming guilt/anxiety/depression/anger (as reported). He got these daily attacks on his entire cellular being (as reported). His wife is freaked out because she had to hear the patient scream at the top of his lungs (even in his sleep if turning wrong) and they don't know how to turn off these full body cellular attacks (as reported). The patient have seen 4 top doctors and they basically have no answers.Onset date for all events was 23Apr2021, unwell feeling, unable to move an inch and inflammation to every cell in his body started at 12:00. All events were life-threatening and emergency room visit was required. Seizure resolved on an unspecified date, while the other events were not resolved. Outcome for inappropriate schedule of vaccine administered and off label use was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, while he was tested for COVID-19 since the vaccination: nasal swab was negative on 10May2021.  Information on lot/ batch number has been requested.
Pt. c/o swollen, red, painful left deltoid.  Area feels warm to touch and hard area around injection site.  Pt. unable to lift left arm above head.  Shot given at 5:00 pm and c/o reaction starting at 8:00 pm.  Saw physician next day and got Cephalexin 500 mg tid x5 days, Claritin 10 mg daily x1 day.
Low-grade fever, but aches, chills, and weakness making it feel higher, starting a few hours after vaccine. Not helped much by Tylenol or Advil. Insomnia the night following vaccine.
1hour after injection severe headache, took 500mg naproxen headache left, slept, got ready for work arrived work5:15am in 4/29/2021 worked 4 hours let management know couldn?t continue  went home freezing fingers felt like icicle?s took hot shower slept fever started 4/30/2021 low grade 99.1 fever stopped 4/30/2021 late afternoon. Still as of 5/1/2021 weak
This case was reported by a healthcare professional and described the occurrence of intermittent fever in a 51-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 12 August 2011 at 12:00 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 15 August 2011, 3 days after vaccination with BOOSTRIX, the subject experienced intermittent fever, right arm pain and right arm tingling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 15-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA) who was a medical science liaison with GlaxoSmithKline. The age at vaccination not reported. The reporter heard these events at a dinner meeting last night, no specific dates were known. The patient received the dose of BEXSERO in unknown arm and experienced pain in the arm after receiving BEXSERO. This case was linked with US2018054841, reported by the same reporter.
Pt developed active case of shingles. Rash on whole back, under arms, chest - burning tingling pain in these areas - sore to touch.
Red swollen arm; Red swollen arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Red swollen arm), VACCINATION SITE ERYTHEMA (Red swollen arm) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (Red swollen arm), VACCINATION SITE ERYTHEMA (Red swollen arm) and PYREXIA (Fever). At the time of the report, VACCINATION SITE SWELLING (Red swollen arm), VACCINATION SITE ERYTHEMA (Red swollen arm) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-375565 (Patient Link).
Upon waking 2 days after receiving vaccine, I suffered from excruciating headache that was incapacitating.  It did not resolve with aspirin, which prompted me to check my blood pressure.  My BP was extremely elevated at 145/85.  I then took 1 dose of common "water pill" 25 mg hydrochlorothiazide.  This did not bring down BP or resolve headache, 2 hours later I took 20 mg of Valsartan.  This also did not resolve headache or lower BP, so I took another 20 mg of Valsartan, followed by another 25 mg of water pill.  My BP stabilized later that evening and headache resolved by 8 p.m.  This same event occurred 2 more times, the last day being 4/10/21.  On that date I was completely incapacitated by excruciating headache.  I took 40 mg of Valsartan but headache did not resolve until late that evening.
p/vax pt w/rash all over abd;took DPH by mouth for sx;rash completely gone;no rxn from first immun;
warmth and suspected fever, mild delirium followed by pruritic rash on face, arms and legs
Dose was given from a open vial 9 day out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given from a open vial 9 day out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given from a open vial 9 day out). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose was given from a open vial 9 day out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
patient reported pain on right arm toward  posterior side of deltoid muscle, he claimes he has  had it ever since he recieved his shingrix shot, & the  pain radiates to elbow. pain at rest is 3-4 but  up exertion pain increases to a 9-10. pain wakes  him up at night. Taking ibuprofen for relief.
Information has been received from a nurse concerning a 9 week old female patient. There was no concomitant therapy, relevant medical history or drug reactions/allergies. On 11-AUG-2017, the patient was administered first dose in vaccination series of ROTATEQ (lot # M012495, expiration date 09-OCT-2017; dose and frequency were unknown) orally for prevention of rotavirus. On 11-AUG-2017, the patient spit up the dose a few minutes later. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event was recovered. The causality between the event and ROTATEQ was not provided.