chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She did not feel good all week; Flu like symptoms; Lightheadedness a lot; Weak / no energy she was down; Injection site sore; Injection site puffy; Arm red about an inch or 2 around the injection site; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down) and VACCINATION SITE PAIN (Injection site sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Muscle pain. Concomitant products included LORAZEPAM, FLUTICASONE, SODIUM PROPIONATE (PROPIONATE), VERAPAMIL, CELECOXIB (ACLEXA), ACETYLSALICYLIC ACID (ASPIRIN 81), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), FISH OIL, CETIRIZINE, MUPIROCIN and NAPROXEN SODIUM (ALEVE).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (Injection site puffy), VACCINATION SITE ERYTHEMA (Arm red about an inch or 2 around the injection site) and HEADACHE (Headaches). On 09-Mar-2021, MALAISE (She did not feel good all week), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Lightheadedness a lot), ASTHENIA (Weak / no energy she was down) and HEADACHE (Headaches) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE SWELLING (Injection site puffy) and VACCINATION SITE ERYTHEMA (Arm red about an inch or 2 around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included naproxen sodium  for headaches.
On 9/28/2022, the very next morning after receiving the vaccine, I was like overnight very ill. my symptoms were coughing and body aches all over. I had nasal congestion, just general flu-like symptoms, very lethargic, very tired. I slept a lot. I was very worn out. There was no chest pain. The respiratory symptoms never got severe. On 9/30/2022, I was not getting better. I called my doctor and he prescribed, over the counter: Mucinex it had acetaminophen and cough suppressant, Delsym, and Advil for body aches. I forced fluids.  Today, 10/10/2022, I still have nasal congestion, I am still coughing up from my chest, my energy level is back, and I am back at work. I was out a total of 4 days from work.
Myalgias with elevated CPK on 12/2/07 after receiving tetanus vaccination 11-23-07.
The patient received the vaccines on 6/25/2019 and called back on 6/28/19 to say that she has diarrhea, and a knot the size of a quarter on her chin, and feels very tired
This spontaneous report was received from a physician refers to 200 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II (lot # M032486, expiration date: 06-JUL-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 9 to 25 degrees Celsius for 5.5 hours. Data logger was not involved. There were no previous excursions reported.
Patient reported feeling nauseous, arm swelling, hot to touch, joint aches, etc about 12 hours after vaccine. The next day she started to feel better but her arm was significantly swollen. She came into the store on Monday 8/17/20 (3 days after vaccine) and her arm was still very swollen, itchy, and hot and moving down her arm past her elbow.
Covid19 breakthrough.  1st vaccine received on 01/12/2021.  80 y/o male with PMHx of HTN, HLD presents to ED with c/o SOB, cough, fever, chills, and malaise that has gotten progressively worse.  Room air sats at home in mid 80's with Tmax reported as 103.2.  CXR/CTA chest negative for infiltrates and pulmonary emboli.  Pt hypoxic eventually requiring 50L heated high flow oxygen.  Pt started on IV ABX, IV steroids and Remdesivir.
cold symptoms; stomach pain; I have pain at the site; fever; nauseous; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold symptoms), ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031912) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Treatment with Paxlovid and used oxygen) on 24-Nov-2022 and COVID-19 (Treatment with Paxlovid and used oxygen) on 11-Jun-2023.    On 25-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 26-Oct-2023, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous). On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms). At the time of the report, NASOPHARYNGITIS (cold symptoms) had not resolved and ABDOMINAL PAIN UPPER (stomach pain), INJECTION SITE PAIN (I have pain at the site), PYREXIA (fever) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, SARS-CoV-2 test: Negative.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747342 (E2B Linked Report). This case was linked to MOD-2023-747350, MOD-2023-747355 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747342:Husband case
L.arm pain that began after receiving the vaccine and has persisted, now >5 weeks from vaccine administration. The pain is located in the L.upper arm but can move around. No redness, rash, heat, swelling, or other symptoms. No fever, chills, or sweats
Fever and fatigue the night of the morning vaccine. Dizziness, fatigue and nausea (including vomiting) the following day.
This is a 83 y.o. right-handed white woman with an acute stroke of the left brainstem. On October 22 she got a COVID booster shot and a flu shot and felt worn our for a few days. On Monday she woke up and had trouble getting out of bed because she felt like she was being pulled to the left. She denies vertigo in the sense of seeing the room spin, but did feel dizzy. She went to a local ED and was sent out thinking she could not walk due to vertigo and was put on Meclizine. She was seen by her PCP who was concerned for a stroke, put her atorvastatin and added clopidogrel to her aspirin and ordered an MRI brain. There was DWI changes with ADC correlate in a small area on the left lateral medulla. She has had 4 PT sessions but still feels unstable on her feet. She states all three of her COVID shots were Moderna.  A CTA of her intracranial and extracranial vasculature ordered by myself (Neurologist) was without stenosis.
By 2:30 I began to feel sick to my stomach.  I was asked if I want to go to the ER or go home.  I went home. 5 hours later the intra-muscular pain started in the left arm.
This report of rash is being submitted in an expedited time frame as requested by the FDA. Follow up information received from the physician provided recovery status (patient recovered). Information regarding Flumist nasal solution was received from a physician regarding a 9 year old male patient who experienced a runny nose and a rash described as red bumps like mosquito bites. The patient received a dose on 12/12/03. The patient had no medical history. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 0.5mL (IN). Patient was not taking concomitant therapy. On 12/13/03, 1 day post immunization, the child developed a runny nose and a rash described as red bumps like mosquito bites on his back. The bumps did not itch. The rash spread from his back to his chest within a day. On 12/14/03, the runny nose resolved spontaneously. The physician reported that the child had recovered. (OMIC)
Throbbing sharp chest pain near heart at wake up, 18 hours after first dose of Pfizer vaccine, duration 2 minutes, severity 8/10  Is it possible this was the induction and dispersal of the vaccine by my heart?  Has anyone else experienced chest pain 18 hours after their Pfizer vaccine?  Thanks!
Administration Error:  This is a 12 year old patient that had come to our physician clinic for a flu vaccine dose.  Instead of receiving the expected flu vaccine, a Pfizer Pediatric Covid-19 vaccine (for 5-11 years; orange top) was administered instead.  This patient had already completed his primary Covid-19 vaccine series with the Adult/Adolescent Pfizer vaccine (12+; purple top).  Dose #1 was on 8/30/21 (lot#FD8448) and Dose #2 was on 9/20/21 (lot#30135BA).  No adverse effects reported after dose 1 or 2.  Patient/parents notified of error. Patient was observed for 15 minutes following the 3rd dose with no reports of adverse effects.  Gaps in the established workflows and safety double checks were identified are are being corrected in this clinic.
Red blotchy patch of skin around injection site, first noticed on 3/20/21 and is still present as of today 3/24/21.
Patient received dose before grace period window. First dose was received on 7/24/21. No reaction at time of vaccination or during observation period.
Noticed within days lost eye contact, lost all speech, withdrew socially, initiated self stimulating behaviors, sleep disturbed.
This spontaneous report as received from a physician via a field employee refers to a 69 year old male patient with no pertinent medical history or drug reactions/allergies. On 04-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J006242, expiration date 03-AUG-2014, intramuscularly (dose not reported). Concomitant therapies included pravastatin, celecoxib, VENTOLIN, SPIRIVA (also reported as "SPRIVA"), aluminum hydroxide, magnesium hydroxide, simethicone (reported as "VAROMIL"), ranitidine, TEGRETOL, sertraline hydrochloride, FLOMAX and vitamin D (unspecified). On an unknown date in December 2013, the patient developed vomiting, dizziness, fever and chills after receiving PNEUMOVAX 23. The patient sought unspecified medical attention via office visit. ZOFRAN was given for adverse event. No lab diagnostics studies were performed. The outcome of the events was unknown. Additional information has been requested.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 9 month old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  On an unspecified date in July 2004, the patient received the second dose of Infanrix in the leg.  The day after the vaccine was received on an unspecified date in July 2004, the patient experienced an injection site reaction characterized as redness and inflammation.  The patient was seen at a physician's office.  The outcome of the events is unknown.  The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Severe itching all over body; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching all over body) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided). Concomitant products included EMERGEN C, CENTRUM FOR WOMEN and PROBIOTICS NOS for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Severe itching all over body). On 29-Jan-2021, PRURITUS (Severe itching all over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: 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. Further information has been requested.
Arm became painful and swollen that evening.  Swelling to greater than 4 inches around site, red and warm to touch.
dizziness; hot flashes (like crazy); normal nausea; felt tired for a long time; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HOT FLUSH (hot flashes (like crazy)), NAUSEA (normal nausea) and FATIGUE (felt tired for a long time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (dizziness), HOT FLUSH (hot flashes (like crazy)), NAUSEA (normal nausea) and FATIGUE (felt tired for a long time). At the time of the report, DIZZINESS (dizziness), HOT FLUSH (hot flashes (like crazy)), NAUSEA (normal nausea) and FATIGUE (felt tired for a long time) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HOT FLUSH (hot flashes (like crazy)), NAUSEA (normal nausea) and FATIGUE (felt tired for a long time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (dizziness), HOT FLUSH (hot flashes (like crazy)), NAUSEA (normal nausea) and FATIGUE (felt tired for a long time). At the time of the report, DIZZINESS (dizziness), HOT FLUSH (hot flashes (like crazy)), NAUSEA (normal nausea) and FATIGUE (felt tired for a long time) outcome was unknown. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 3:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 3:11 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was Concomitant medications were not reported by the reporter.  Patient received booster dose. Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported by the reporter.
pt recv vax 12JUN95 & rxn began 13JUN95 felt like a bruise, hardened, red given DPH for itching size 2" x reddened;
Information has been received from a physician concerning an 8 year old(also reported as 10 year old) female who on an unspecified date was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. The patient did not develop any symptoms. According to the reporter, the incident was due to human error and not product confusion. No further information was available. There was no product quality complaint involved. Follow up information has been received from the vaccine clinic nursing supervisor who said the patient received the wrong vaccine due to human error. She noted that " the clinic was very busy and one of the nurses took the ZOSTAVAX out for the administrating nurse on the private side and left it on the counter. The nurse who administered the ZOSTAVAX to the 10 year old picked it up thinking it was the VARIVAX. and administered it without double checking. The nursing supervisors stated that it was a trickle down effect of one person trying to help out and then in the rush of the moment, the administering nurse did not do the required double checks. The reason the event was even noticed was because there was only one vial left of VARIVAX and when the nurse who was to administer the ZOSTAVAX went to pick it up there was none left. The patient's mother was contacted and reported that the patient was doing just fine, and had no problems or reactions. No further information is expected.
I was told to reach out to you about the possibility that the HPV9 vaccine may have made my daughters Lyme disease active. She was diagnosed with Lyme disease after getting the vaccine.
Extreme sweating/diaphoresis during the night, extreme muscle pain all over my body, general malaise
intense ringing in the ears; headache; 1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of TINNITUS (intense ringing in the ears), HEADACHE (headache) and INCORRECT DOSE ADMINISTERED (1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphocytic colitis. Concomitant products included EZETIMIBE (ZETIA), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, GARLIC [ALLIUM SATIVUM], VITAMIN C [ASCORBIC ACID], MONASCUS PURPUREUS (RED YEAST RICE), SIMVASTATIN (ZOCOR), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ZONISAMIDE, MELOXICAM, FOLIC ACID, ASPIRIN [ACETYLSALICYLIC ACID], MELATONIN, PYRIDOXINE HYDROCHLORIDE (MELATONIN [MELATONIN;PYRIDOXINE HYDROCHLORIDE]), FISH OIL, UBIDECARENONE (COQ10 [UBIDECARENONE]), MAGNESIUM, BUDESONIDE, CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]) and PROBIOTICS [UMBRELLA TERM] for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced TINNITUS (intense ringing in the ears), HEADACHE (headache) and INCORRECT DOSE ADMINISTERED (1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021). On 18-Aug-2021, INCORRECT DOSE ADMINISTERED (1st dose on 09Feb2021,2nd dose on 09Mar2021,3rd dose on 18Aug2021) had resolved. At the time of the report, TINNITUS (intense ringing in the ears) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Blood pressure measurement: high mmHg (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details were reported. Patient did not experience any adverse events after 1st and 2nd dose. Patient experienced adverse events after 3rd dose, which was authorized by his HCP due to his conditions/medications. Patient has a condition called lymphatic colitis, and the medication for it makes him immunocompromised.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified date, in a range from 01-APR-2015 through 30-APR-2015, the patients were vaccinated with improperly stored doses of VAQTA (Lot# K005958, expiration date: 09-FEB-2017) (Strength, dose and route were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Fine red raised rash over face, head & back; pruritis; DPH given; sx lasting 1 wk; posterior & anterior lymph node swelling;
Prior to CVD vaccine menstrual cycles were normal.  Post vaccine she had severe cramping, severe nausea and vomiting.  This has happened every month after getting her vaccine.
Patient was to receive 6 vaccinations on her visit, of which Gardasil was one. She received the Gardasil, a Hep B, and a Hep A in her left arm. As soon as the nurse gave the third injection, patient slumped over as if she had fainted. There had been no indication that she was about to faint. When I went to support her head, her eyes were wide open, pupils dilated. She was non responsive. Her feet and hands contorted, her tongue turned white, she started to foam at the mouth and she stopped breathing. The seizure lasted > 2 minutes. This is a very healthy athlete with no seizure history. While being transported to the hospital, she experienced 2 more syncopal episodes without seizure, but accompanied by dizziness, nausea, and sweating. All tests (urine, blood) run at the ER were normal. After 6 hours she was released and has experienced no further incidents.
During observation after vaccine, member c/o itchy throat and cough. Benadryl given while in office.