chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008v21a and 013m20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash) outcome was unknown.            Concomitant medications include Cholesterol medication and Hypertensive medications.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received and contains No New Information.
Around injection site develped a hard lump, about 2" in diameter.  The site was very hot and had redness and swelling that covered the entire top 1/2 of her thigh, probably about 5-6" in diameter.
Moderna COVID-19 Vaccine EUA - after receiving the second dose of the moderna covid-19 vaccine, pt developed a red and warm to the touch face while being observed in the waiting area.  Also, while being observed and these symptoms were noticed, pt fainted in the waiting area.  She regained consciousness seconds later and we continued to monitor her for an additional 30 minutes.  No other adverse events were noted, she declined additional assistance.
I felt sick for about 4 weeks after getting the injection. I hadn't been sleeping well and was run down at the time of the shot. I wondered if having Hashimoto's thyroiditis made me vulnerable to adverse reaction.
complaint so  dizziness, palpitations and chest pressure  approximately 15-20 mins after vaccine administration.
Hot to the touch (little bit of a temperature) at both injection sites; First shot missed the muscle; Tight at both injection sites; Red at both injection sites; Puffy at both injection sites; Sore at injection site; Sleepless night for a week; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleepless night for a week), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle) and VACCINATION SITE INDURATION (Tight at both injection sites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On an unknown date, the patient experienced INSOMNIA (Sleepless night for a week), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle), VACCINATION SITE INDURATION (Tight at both injection sites), VACCINATION SITE ERYTHEMA (Red at both injection sites), VACCINATION SITE SWELLING (Puffy at both injection sites) and VACCINATION SITE PAIN (Sore at injection site). On 09-Mar-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, INSOMNIA (Sleepless night for a week), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle), VACCINATION SITE INDURATION (Tight at both injection sites), VACCINATION SITE ERYTHEMA (Red at both injection sites), VACCINATION SITE SWELLING (Puffy at both injection sites) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-259384 (Patient Link).
Very sore shoulders bilaterally.  Deep, splinting type of pain.  Very rapid onset.  Range of motion is normal if done very slowly, but pain during some motions is extreme. Also, sore hips and muscle tightness in biceps, gluts & hamstrings.
About 12 hours after the vaccination, became lightheaded when I layed down and sat up or any change in position. Felt slightly nauseated with the dizziness, lasted for 12 hours and then resolved.
In 1999, at 12 months of age, the patient was vaccinated with a dose of varicella virus vaccine live. On 08/28/2000 it was reported that the patient is breaking out with chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a certified medical assistant (CMA) concerning a 21 year old female with no pertinent medical history or drug reactions or allergies who in February 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 658563/1063U). There was no concomitant medication. In approximately March 2008, "about 1 month after the first dose", the patient was not feeling well. The CMA thought she was referring to flu-like symptoms. Subsequently, on an unspecified date the patient recovered from not feeling well and flu-like symptoms. The patient did not seek medical attention. Additional information has been requested.
After 2nd Vaccine on 3/6/21, she became ill on 3/8/21, fever and chills was in bed all day on 3/9/21 with the same symptoms.  Woke up on 3/9/21 with shingles, Her PCP was treating her with Famciclovir and Gabapentin for pain.  She no longer had the fever or chills but still didn't feel well.  On 3/17/21 she was admitted at Medical Center which she was treated for a blood clot in her lung and for pericardial effusion. She was put on blood thinners which then caused a bleed in her hip bone.  She had a surgery to put a filter in to stop more blood clots and to drain the fluid from her heart.  She died on 3/27/21 around 3:30pm.
w/in 15min of vax parent brought child back into clinic c/o arm itching, swelling & red @ site of inj;mom didn't take child to MD;
PATIENT after a week from being administer the tdap and shingrix vaccines , in the same arm, patient experienced difficulty moving left arm.    If  patient extends arm too far, she experiences pain.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-MAR-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine was administered at a private doctor's office/hospital. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-MAR-2017, he was treated by a physician for a blistering vesicular outbreak, which was then diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient reported localized redness, swelling, and warmth at the area. No other symptoms were noted.  Redness and swelling has decreased since 06/23/2019, but partially remains. Warmth has resolved.
Received the vaccine while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 03-Jun-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant) had resolved.            Treatment information was not reported.
This spontaneous report received from a nurse refers to a patient with unknown demographics. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (dose, route and frequency: unknown) (lot # L030870, expiry date: 11-JUN-2018). The temperature excursion details for vaccine were as follows: temperature 30.1 degrees Fahrenheit (F), time frame: 6 hours, 36 minutes. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report received on 24 January 2013 from the Investigator participating in the post-marketing observational study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4182AA received on 22 May 2012, lot number C4270AA received on 26 July 2012 and lot number C4275AA received on 26 September 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 30 December 2012, approximately three months after the last dose. On 31 December 2012, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 31 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 31 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I had issues with leg that. wen t for 1 week with issue and finally when to the doctor after thinking it was a blood clot. The doctor confirmed the blood clot. It started on the lower portion of the right leg. It began looking like a bad bruise but then got bigger. There was a considerable amount of pain in the area.  It started around the ankle and continued upwards on the leg. The doctor prescribed Eliquis 2*per day.
Chest pain for 6 days, chest pain started 5 minutes after the injection,   heart palpitations 2 days starting the next day after the injection, headaches 2 Days in a row the day after the injection.  The chest pain did not progress.
Muscle aches after 2nd dose; Headache after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and FATIGUE (Fatigue after 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and FATIGUE (Fatigue after 2nd dose). On 29-Mar-2021, MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and FATIGUE (Fatigue after 2nd dose) had resolved.            Patient was not under any regular or concomitant medication, and stated that patient had no allergies history. Treatment medications were not reported.   This case was linked to MOD-2022-468797 (Patient Link).
Extremely heavy period with extremely painful cramps and passing clots. Unable to stand straight and to work.
03/12/2021 - On march 19th I woke up really dizzy and my word were slurred. I took my dogs for a walk while in the midst of the walk I fell on the ground. 03/22/2021-03/29/2021 - my feet were burning  03/30/2021- 04/07/2021 my pee was burning and 04/08/2021 - received the second dose. I have chilis, fever and felt restless. 04/09/2021- I was very sick I was trying to get my fever down. My fever strike up to a 102 and 7:30pm  04/10/2021 - I woke up okay  04/11/2021 - I started having Diarrhea   04/24/2021-05/01/2021- I had heavy bleeding
This spontaneous report as received from a physician refers to a male patient of unknown age. On 13-NOV-2012, the patient was vaccinated with a single 0.65 mL subcutaneous injection of ZOSTAVAX (lot # not provided) and experienced on the same day a tightening of the throat and difficulty breathing. Unspecified treatment was given to the patient. The patient seek medical attention. The outcome of the events was unknown. The relatedness of the events with ZOSTAVAX was not provided. Additional information is not expected.
REACTION; SEVER PAIN; This spontaneous report received from a consumer via a company representative  concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received booster of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced reaction after the booster and severe pain (Dose number in series 2). As per the reporter, "Johnson and Johnson it was not just Johnson and Johnson my friend had her reaction after the booster getting some better after all the sever pain etc". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from reaction, and sever pain. This report was non-serious.
Body aches; Super hot; Cold chills; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced cold chills, body aches, super hot, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of cold chills, body aches, super hot, headache and fatigue was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
may have been sweating in the night but she has no fever.; experienced hoarseness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (experienced hoarseness) and HYPERHIDROSIS (may have been sweating in the night but she has no fever.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPHONIA (experienced hoarseness). On 01-Mar-2021, the patient experienced HYPERHIDROSIS (may have been sweating in the night but she has no fever.). At the time of the report, DYSPHONIA (experienced hoarseness) and HYPERHIDROSIS (may have been sweating in the night but she has no fever.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
A nurse reported that a female, approx. 26-27 years of age, received an injection of Pnu-Imune 23 (date not specified). Within hours, post vax, she developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move her arm. She experienced nausea and vomiting and developed a fever of 101F. The symptoms resolved within a few days. No further information was available at the date of the report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23, lot 469401. (See HQ9560211APR2001, HQ1777307JUN2001 and HQ1777407JUN2001).
Circulation problems; Dehydration; Light-headed and dizziness; Nauseous; Dry mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CIRCULATORY COLLAPSE (Circulation problems) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psychiatric disorder NOS since an unknown date. Concomitant products included LITHIUM and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCULATORY COLLAPSE (Circulation problems) (seriousness criterion medically significant), DEHYDRATION (Dehydration), DIZZINESS (Light-headed and dizziness), NAUSEA (Nauseous) and DRY MOUTH (Dry mouth). At the time of the report, CIRCULATORY COLLAPSE (Circulation problems), DEHYDRATION (Dehydration), DIZZINESS (Light-headed and dizziness), NAUSEA (Nauseous) and DRY MOUTH (Dry mouth) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment:  Very limited information regarding these events have been provided at this time. No further information is expected.
Dizziness; Hot flashes; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness) and HOT FLUSH (Hot flashes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and HOT FLUSH (Hot flashes). At the time of the report, DIZZINESS (Dizziness) and HOT FLUSH (Hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter no treatment information provided by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-095268, US-MODERNATX, INC.-MOD-2021-094933 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095268: US-MODERNATX, INC.-MOD-2021-094933:
I had the vaccine on January 5 and I was fine the whole day.  For the next two days my arm was sore from my elbow to my shoulder.  the third day my whole upper right side was crippled were as my shoulder neck and arm was almost paralyzed and I couldn't really move without severe pain.  A few hours later, my legs felt like noodles like I would fall over; I ended up leaving work early that day incase I couldn't get home.  The next morning I went to work.  the pain moved to my left side, same areas and creeped around my left rib cage.  This has been going on since.  I had off January 11 and 12 for my weekend.  I haven't been back to work since January 13.  I have had severe pain in my left neck, shoulder, rib cage, elbow, and now my left wrist and at times, my left hand feels numb.  Also, the within the last 24-48 hours my breasts have been tender.  I've been lethargic since yesterday and now my vision is blurry.  My nurse keeps telling me to rotate between ibuprofen and tylenol, it's not helping at all, I am extremely uncomfortable and in pain.  In fact, when I take the ibuprofen, it causes more pain.  I've been trying to reach the on call doctor for pain medication and no one is calling me back.   The only relief I have is when i hold my arm above my head.  I am groggy and I am feeling emotional.   I've missed a week of work and I'm nervous about getting my second vaccine, but I will get it. Oh, and I'm not sleeping well.