chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First day arm was sore at sight of injection. Early next day, sight of injection was hot, red, and itchy. During the day, sight of injection was swollen, hot, and I felt achy and tired. Fever for the day was 100 degrees F. Early the next day I noticed a blotchy "rash" covering the sight of injection and approximately 2 inches in all directions. Fever was gone; however, sight of injection was painful, hot, blotchy, red, and very itchy. The next day I was fine; however, the arm was sore and stayed sore for a total of 5 days.
Headache and chills that  night; Woke up 26th with a fever, severe body aches; severe headache; chills; weakness and tired. And that lasted for 36 hours. Worse then my COVID symptoms. Evening of 27th, I felt lot better. The 28th, the symptoms were pretty much resolved. Just took Tylenol and Ibuprofen for it. Now I feel fine.
specific symptoms she had been experiencing because of her tick bite had either resolved all together or lessened in severity; This is a spontaneous report from a contactable Nurse reported for herself. A 77-year-old female patient received first dose of bnt162b2 (BNT162B2) on 30Mar2021 (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included patient was bitten by a tick on 06 or 07Jul2019 and was hospitalized because of it on 29Jul2019.  She stated 3 parasites were found in her labs because of the tick bite: Lymes, Babesia, and Ehrlickia. The patient had since been ill and her immune system hadn't been so hot for the last few years and she had been sick because of the tick bite.  "lung" side effects of chest tightness- which felt like her chest had been "wrapped with saran wrap" and what her physicians call it "air hunger". Heat intolerance and sweating. She was in (withheld) for 5 months and then when she went back to (withheld)  in Nov2019 they said that in Babesia world that they call it air hunger, she never felt right with that. When she went in Nov2019 she had a bruise about 2.5 inches wide around the front of her chest and that's how she felt. The Babesia affect her red blood cells, like malaria, and the Ehrlickia only eats plasma. She was in her 30's and she cut her finger. She said to them that she felt like she had the flu and they did a nasal swab and she was positive for influenza A, this occurred in Jul2019. She told them at the urgent care that it was Jul 2019 and you don't usually have the flu in July, and they just said well it is hot and she is old.  Concomitant medications included doxycycline, azithromycin (ZITHROMAX), ceftriaxone (CEFTIN), metronidazole (FLAGYL).  Patient received the first dose of the vaccine on 30Mar2021 and 3 days later, specific symptoms she had been experiencing because of her tick bite had either resolved all together or lessened in severity.  Her "lung" side effects of chest tightness- which felt like her chest had been "wrapped with wrap" were gone.  Her heat intolerance and sweating have lessened in severity. She can't give an exact date for when it stopped she just noticed that it was gone. It was not a drastic elimination but she said then it has taken a while for it go away completely. She was probably the only one who can't wait to get a booster. She confirmed that for both that sometime in Apr2021 her conditions were slowly lessened. Events resulted in physician office visit.  The outcome of events was unknown.  Seriousness: She thought it was medically significant but maybe that was because it only applied to her.  The reporter considered the causality between COVID vaccine and event all of her lung side effects of the tick bite were gone/the heat intolerance and sweating have lessened in severity was Related.
Got COVID; moderna shot on May 13; I want the second shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (moderna shot on May 13; I want the second shot). At the time of the report, COVID-19 (Got COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (moderna shot on May 13; I want the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Company Comment:  This report refers to a case of Product dose omission issue for mRNA-1273 (lot # unknown) with associated unexpected serious adverse event of COVID-19. The event onset occurred after the first vaccination dose, although time to onset was not specified. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  It is not clear the root cause of the product omission issue.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273 (lot # unknown) with associated unexpected serious adverse event of COVID-19. The event onset occurred after the first vaccination dose, although time to onset was not specified. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  It is not clear the root cause of the product omission issue.
Swelling on her left arm; Redness on her left arm; Lymph node on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on her left arm), ERYTHEMA (Redness on her left arm) and LYMPHADENOPATHY (Lymph node on her left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling on her left arm), ERYTHEMA (Redness on her left arm) and LYMPHADENOPATHY (Lymph node on her left arm). At the time of the report, PERIPHERAL SWELLING (Swelling on her left arm), ERYTHEMA (Redness on her left arm) and LYMPHADENOPATHY (Lymph node on her left arm) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received and the following was updated: patient's age and date of birth; dose #1 details.
Throat hurts; blood pressure increased; general body ache; back pain; diarrhoea; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), DIARRHOEA (diarrhoea), PAIN IN EXTREMITY (pain in arm), OROPHARYNGEAL PAIN (Throat hurts) and BLOOD PRESSURE INCREASED (blood pressure increased) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (high blood pressure) and Hyperglycemia. Concomitant products included ATENOLOL for Hypertension, CLONAZEPAM for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced BACK PAIN (back pain), DIARRHOEA (diarrhoea) and PAIN IN EXTREMITY (pain in arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat hurts), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN (general body ache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain), DIARRHOEA (diarrhoea), PAIN IN EXTREMITY (pain in arm), OROPHARYNGEAL PAIN (Throat hurts), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN (general body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
- Beginning approximately four to six hours after the shot, I experienced soreness in my upper arm. The soreness continued through the next day, and was worse in the morning and got worse as the day went on. I took one aleve and it helped. The soreness began to go away the next day.  - On day 8 after receiving the first dose of the Moderna vaccine, I noticed during my evening shower that the skin on my arm surrounding the injection site was firm, quite warm to the touch, and bright red. At this time it is not painful or itchy. I do not recall seeing it yesterday, so I believe it started at some point today.
No additional AE reported; Medical assistant calling for TE evaluation states one dose of PROQUAD was administered to one patient on 11/3/2022.    ?    Names of vaccines involved (including lot/exp) PROQUAD  W010064  9/20/2023        ?    Temperature -10°C up to 8°C (-2.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 03-NOV-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W010064, expiration date: 20-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of -10 degree Celsius up to 8 C (-2.7C) for 4 hours (product storage error), there was stated that no previous temperature excursion occurred. No additional adverse event were reported.
"Felt nerve pain after. Pain into neck, supraspinatus muscle, down lateral arm, into thumb and first two fingers of right hand; across back below scapula felt muscle weakness and shoulder instability of right shoulder and scapula. Burning nerve pain also along scapula on spinal side." Pain description check boxes include: ache, burning, numbness, pins/needles, stabbing.
Patient experienced dizziness and pallor after HPV vaccine.  Patient sat down with head down, apple juice was provided, and patient monitored for additional 15 minutes, after which patient's dizziness and pallor improved and patient left the clinic with mom.
3 days post vaccine diffuse/ severe urticaria not explained by another cause. This required oral steroid, antihistamine (Zyrtec/Benedryl/ Pepcid),  She had facial swelling along with these hives.
Mixed Pfizer Vaccine for first dose and for the second dose Moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed Pfizer Vaccine for first dose and for the second dose Moderna) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed Pfizer Vaccine for first dose and for the second dose Moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed Pfizer Vaccine for first dose and for the second dose Moderna) outcome was unknown. Not Provided      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.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 10-SEP-2018 the patient was vaccinated with Oka/Merck VARIVAX lot # N034556 for prophylaxis. Concomitant therapies included sterile diluent. On 10-SEP-2018, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event.
Shingrix 2nd shot. Started with muscle pain followed by restless night, up set stomach, weakness and 101 +temp. I slept on and off the following day and had no appetite. temp went down by evening (6 or 7 PM) Felt better next day, but still weak. Pain where shot was administered continued for 5 more days. Shot was given in left arm. I have never had any kind of reaction like this before. When my symptoms started my husband suspected the vaccine and found all my complaints matched the possible reaction symptoms.
This patient wanted a primary dose of Pfizer COVID vaccine and was accidentally given a dose of COVID Pfizer Bivalent Vaccine,.   Patient experienced no adverse reactions and Pfizer was notified of error.  They have provided instructions to continue to monitor and how to get patient back on schedule to get properly immunized.  Case No. Private.
Pt was given the HPV vaccine outside of the schedule recommendations. Pt has shown no adverse effects from receiving this vaccine.
high blood pressure; arm a little sore; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (arm a little sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Warts (since approximately 5 years ago she had 18 warts in her 2 thumbs). Concurrent medical conditions included Blood pressure high (Started since she was 30 years old; high blood pressure for a couple of days after 1st and 2nd dose), Acid reflux (esophageal), Diabetes (started 3 years ago, there were no recent changes in status such as improvement or worsening), Allergy to antibiotic and Asthma (since she was 50 years old; there were no recent changes in status such as improvement or worsening). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), LISINOPRIL for Blood pressure high, METFORMIN for Diabetes, INSULIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (arm a little sore). On 05-Mar-2021, HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (arm a little sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that, after the vaccines were given, patient just had her arm a little sore and had high blood pressure for a couple of days, but it went back to normal.  It was reported that patient ever had not COVID + tested or diagnosed. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-629209 (E2B Linked Report). This case was linked to MOD-2022-629204 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-629209:
Pt vaccinated with DTP developed lethargy over 24 hrs, uncontrollable crying in excess of 3 hrs, high pitched screaming.
11:15 AM PT ARRIVED IN OBSERVATION STABLE. HE FELT DIZZY. SAT IN CAR FOR 15 MIN. PT REMAINS DIZZY. PT INSTRUCTED TO DRIVE TO TENT. DENIES SOB AND CHEST PAIN. 11:30 AM BP 155/101 HR 103 SPO2 98% 11:50 AM PT STATES HE IS FEELING BETTER. DENIES DIZZINESS @ THIS TIME. PT DENIES SOB AND CHEST PAIN AT TIME OF D/C. 11:57AM BP 153/85  HR 106 O2 96%
Patient is experiencing numbness from tip of thumb to forefinger of left hand (vaccine was administered to left arm).
Pt had T p/reaching home in 1/2 hr. Sz /p receiving DTP & was taken to ER. Emesis x 1. Seizure by mothers description as shaking all over the body for a few min then she became limp. D/C from hosp after two days.
Information has been received from a 73 year old female with stage three renal disease, and no history of drug reactions or allergies who on 08-FEB-2008 was vaccinated subcutaneously with "a single dose" of ZOSTAVAX.  Concomitant therapy included "calcitrol", amlodipine besylate (NORVASC), furosemide, "nephrocaps" and esomeprazole magnesium (NEXIUM).  On 10-FEB-2008 the patient developed redness, itching and soreness at the injection site.  The patient stated she "has not developed a rash or any lesions at the injection site".  The patient had not contacted her physician, and there had not been any treatment initiated at the time of reporting.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient had not yet recovered.  Additional information has been requested.
started 2PM high pitch cry APAP given; area of site very red, swollen, hard; ice cold compress; crying cont till about 4PM; then only when leg was touched;
Eating dinner, then sudden onset seizure with head turning to left, eyes fixed, drooling, became stiff and twitching noted. Lethargic afterward and vomited once. Temperature 99.4-101. Taken by EMS to hospital. Became more alert after 30 minutes- vomited again.
Patient called the afternoon of 8/16/19 and reported that she is noticing hive all around her neck area.  She stated she received the vaccine 8/14/19 with no reactions between 8/14-midday8/16 besides arm soreness and some mild fatigue.  She took 1 tablet of Benadryl on her own and was counseled on taking 2 tablets of Benadryl.  She was counseled accordingly and checked for any signs of a severe allergic reaction  (e.g, throat swelling, tongue tingling, trouble breathing) but she reported none. Patient stated she does have very sensitive skin and does sometimes breakout in hives but is unsure what the hives could be attributed to this time besides the vaccine.  She was advised to reach out to her physician to check if she should receive a 2nd dose of Shingrix under her PCP's guidance.  She reports no injection site reaction nor hives nor swelling.
Pt had HPV, Hep A, & Verasella.  Symptoms were dizzyness, nausea, hot flash, blurry eyes & tingling ears, pt layed down for 15 min w/ ice pack.
Cough- but the type of cough is not uncommon for me due to allergies  Puffy eyes/face started around 2:30-3pm Tight throat, felt restricted started around 3:30pm Took Benadryl at 4:30pm Went to Urgent Care at 5:30pm  Took Prednisone at urgent care Got a prescription to continue prednisone for the next two days & an epi pen to have at home in case it was needed
Information has been received from a nurse practitioner concerning a female patient (age not reported) who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient fainted post vaccination. Subsequently, the patient recovered from the syncope. The nurse reported that the patient was not disoriented, was very aware and her blood pressure (actual BP not reported) was within normal limits. The patient was offered a sugar drink (soda) after the event and recovered from the event. The nurse practitioner noted that the patient had eaten before coming in for the vaccination. Additional information has been requested.
Initial report received from a health care professional on 28 Jun 2010: This patient was vaccinated with MENVEO (batch no: 100005 (box)), (dose: 0.5 ml) intramuscularly on 28 Jun 2010. The patient was administered lyophilized component of the vaccine with sterile water instead of liquid conjugate component of the vaccine. The patient had no adverse events. No further information was reported. Follow-up report received from a health care professional on 07 Jul 2010: Batch number of vaccine was reported as 029011 (previously reported as 100005). This patient had a medical history of vesicoureteral reflux and was concomitantly using LOTRIMIN ULTRA topically for keratosis pilaris since 02 Feb 2010. The reporter stated that the patient didn't experience any adverse event after administration of lyophilized component of the vaccine with sterile water instead of liquid conjugate component of the vaccine. The patient will be revaccinated with MENVEO in 2 months.
Developed urticarial rash about 2 hrs after receiving Hepatitis A vaccination. Resolved overnight
pt recv vax & 1-2 days later devel a hugh area of redness & swelling @ the inj site;
This spontaneous report as received from an unspecified non health professional via a company representative refers to a patient of unknown age and gender. It was reported that the patient received 4 doses of GARDASIL (route, dose and lot # not reported) (date unspecified). Additional information has been requested.
What appeared to be a boil developed 6 days after the shot at the MMR site. No fever. It was treated with BACTRIM & ICHTHAMMOL & warm compresses & drained pus and then healed.
This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. No adverse reactions were reported. On an unknown dates, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M025194, expiration date 01-MAR-2019 for prophylaxis (strength, dose, route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005953: US-009507513-1701USA005954: US-009507513-1701USA005955: US-009507513-1701USA005956.
Red itchy lumpy area below injection site 4/1-4/3, no treatment, resolved spontaneously. On 4/7, I woke up with a sensation of swelling and tingling  in my upper lip, but it was not visible.  Woke up 4/8 and the swelling in my upper lip was visible, the upper and lower lip began feeling severely chapped throughout the day, and I developed fever blisters on the top and lower lip.  Reporting on this second day, 4/8, so I don't know how long it will take for them to resolve.  I take Benadryl nightly for seasonal allergies, not specifically for these symptoms that appear to be vaccination reactions.
The first day, I had nausea and a huge headache. I think they shot me too high - pain when I moved my arm for about a week - around rotator cuff. About a week later, I had stomach aches all week and diarrhea for a week - nothing changed in my diet so don't know what caused it. When the bump developed on the 23rd -  mass developed on upper right forehead - goose egg developed. I had not bumped my head .I used some ice that night. When I woke up the next day, mass was much bigger - pushed on eye and eye brow. Pre-septal Cellulitis - diagnosis - entire forehead swelled up almost to the point that right up was  completely closed up. Put on antibiotics. It didn't go down the first few days - I'm allergic to many antibiotics (had to switch it three times). They cut the infection out - there was a bunch of bacteria that got squeezed out. I had to have the infection cut out three times - because the swelling wouldn't really go down.  I did a course of antibiotics for 10 days - Augmentin - 500 mg. I still have a slight bump there - probably scar tissue.
The pt developed itchy (hives) rash on face and spreading to knees and arms following day after the flu shot was given on 11/14/2002.