chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Wolff-Parkinson-White syndrome (Heart condition called WPS) and Anxiety (Patient takes Valium for anxiety to help him sleep.). Concomitant products included DIAZEPAM (VALIUM) for Anxiety.    On 07-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged). At the time of the report, COVID-19 (Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that 1st booster she did not remember the dates. For the 1st booster and with bivalent booster he experienced no symptoms. On 30-Jan-2023 patient got COVID-19 with severe symptoms and this disease was prolonged. Case previously reported in case number AE-00017459, C-INT-0003300 No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714780 (E2B Linked Report). This case was linked to MOD-2023-715098 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2023: Live Significant follow-up received includes medical history and concomitant medication added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714780:Wife's case
Pt. complains of sharp pains that would last for seconds on the top right side of her head that radiates down the side of her head.
Woke up with 3 canker sores in mouth 2 days after receiving vaccine. Have not seen this symptom reported anywhere else.
Significant red rash lower than vaccine site seen Friday morning , warm to the touch.  This was more of a big red blob on the arm.  On the right truck there was a scattered hive like rash.  Both sites had extreme itchiness, controlled by benedryl.
The patient has not had any adverse reaction to the Moderna Dose. The patient was given the dose in error. Patient had already received the Pfizer vaccine series. Dose 1 was administered on 2/1/2021 and Dose 2 was administered on 2/22/2021. Patient physician was notified of error. Patient is being monitored for 72 hours for vitals and signs and symptoms of any adverse reactions. Attending physician did not order any Medical test.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER2613), in right arm and on 08Apr2021 as dose 2, single (Lot number: ER8729), in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM type 2" (unspecified if ongoing), notes: Other medical history: DM type 2; "HTN" (unspecified if ongoing), notes: Other medical history:HTN; "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: TRULICITY; METFORMIN; METOPROLOL; VALSARTAN; EXTRA STRENGTH TYLENOL PM; TUMS EXTRA STRENGTH; IMODIUM. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro; Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor; Minocyclene, reaction(s): "Known allergies: Minocyclene", notes: Known allergies: Minocyclene; Advil, reaction(s): "Known allergies: Advil", notes: Known allergies: Advil; Aleve, reaction(s): "Known allergies: Aleve", notes: Known allergies: Aleve; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient was treated with  Paxlovid from 17Aug2022 to 22Aug2022 for the treatment Covid- 19.The patient received Multivitamins.  No follow-up attempts are possible. No further information is expected.
Flu like symptoms 24 hours after shot. Fever, chills, sick to stomach, uncontrollable shaking!
seizure (status epilepticus) 9 days p/MMR concurrent w/BOM & fever; on no meds @ time of sz; angioedema of oral pharyngeal-laryngeal membrane w/acute anoxia & status epilespticus; 6NOV92 low frequency hearing loss;
Development of chills, diaphoresis, headache, stomach cramps, nausea, diarrhea, fever.
Disorientation, severe dizziness, upset stomach, pale, decreased temperature and blood pressure. Pharmacist on duty called 911, patient declined hospital.
Rash developed on face (both cheeks ranging from jaw to ear in a sweeping motion), right ear (very swollen, weeping, very itchy and then painful), right hand along knuckles, and later on right torso ranging from hip to braline. At my doctor's recommendation, I have been using oral benadryl at night and zyrtec during the day plus topical hydrocortisone and benadryl cream.
Tight sensation in her throat, tongue felt tingling.  Temp increased to 99, blood pressure increased to 179/99
Father alerted this RN to patient development of extreme fatigue after approximately 13 minutes post administration. This RN administered  Zyrtec 10mg solution p.o. and manual blood pressure via right arm was 132/90, HR=81-88, O2= 98% via pulse oximeter and respiratory rate=12. Patient became more difficult to arouse, transported via wheelchair to room with reclining chair and epinephrine on site. Father report patient with NKDA, and no known history of adverse reactions to past vaccines or injection. No known medical history, other than medication for attention deficit per father.  Code called by non-clinical staff member. This RN re-assessed patient and patient reported new onset of sharp chest pain to center of chest- no abnormal heart sounds auscultated at that time. Emergency response team arrived concurrently, and Pediatric MD began assessment of patient at 14:03pm. Patient began to complain of swelling to throat and new difficulty breathing. This RN administered 0.3cc Epinephrine, at 14:04pm per protocol and Pediatric MD aware. Immediate response in patient noted. Patient alert and oriented to person and place. Patient stable and transported by pediatric emergency nurse via wheelchair to the Pediatric Emergency Department for further evaluation and monitoring after administration of Epinephrine. Patient accompanied by father.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-JUN-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 23-APR-2015, the patient was treated by a physician for the onset of a rash, which was diagnosed as shingles. The patient was prescribed valacyclovir, lidocaine, and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was considered to be not recovered. Additional information has been requested.
I received a DT shot at the hospital after a cut in my arm was stitched up. Around or about 2 to 3 weeks after I began to have pain in the right elbow which then spread to the left elbow and then one shoulder then the other. I saw my primary physician on about 8/24/05 who prescribed naproxen for inflamation. this has had no effect on the arms and the pain has progressed further into the thumbs now. It is painful to move any of these joints now and I have been referred to a orthopedic for appointment on 11/30/05. From study of FDA sites and others this seems similar to only Brachial neuritis. If any help of advice can be given please advise this has become very painful and debilitating.
Arm itchy on day of shot, full body itchy next day, no hives, week after shot injection site raised circle shape and very itchy, lasted about four days.
Diabetes, allergen induced asthma. I also get recurrent shingles after some vaccinations. This also happens after taking prednisone. Or having severe stress. I was down to one case every 18 months, after the Moderno vaccine, I am now getting monthly breakouts. The first time it  happened was when i had the H1N1 one vaccine back in 2009. After that, I was getting shingles monthly, then quarterly, then yearly, then down to about once every 18 months. Now I?m back to monthly following the Moderna vaccine.  But I will take shingles over Covid any day.
Medical assistant administered dose of pfizer monovalent for ages 6 months - 4 years of age incorrectly instead of pfizer bivalent for ages 5 - 11
Covid Vaccine administered. Patient monitored for 30 minutes d/t reaction. Within minutes of receiving the injection, patient started to itch on his arms and it spread to legs. No visible rash. Minutes later patient complained of stomach pain and vomited and felt generally unwell. Patient then reported facial "tightness" and tingling. Reported no issues with breathing or airway. Called ER 2 at this point and he was assessed by the ER team.
3 lt sided focal sz from 3PM to 12MN;Annual follow up states the pt has recovered.
Same day I had face tingling that lasted a few days  , a few days later I had severe headaches and nosebleeds ,both  temples are sensitive to touch ,  they are still going on currently but not as severe and no nosebleeds . Went to the ER with chest pain and back pain a few weeks after the shot as well .  Nothing showed up to worry the ER but I?m still having chest pain , back pain, headaches and my calves are tingling / popping 24/7.
Got the flu three times; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) from the via social media  and transmitted to Sanofi on 19-Nov-2020.  This case involves patient with an unknown age who got the flu three times (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, patient got the doses of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number unknown via an unknown route in an unknown administration site for prophylactic vaccination) three times in patients life and the patient got the flu three times (influenza).   Patient reported that it was a coincidence that patient had experienced event influenza in the same years. Patient saying the event might not had occurred due to the NFLUENZA VACCINE because it was a month or two months later each time after receiving the INFLUENZA VACCINE.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for influenza.  There will be no information regarding the batch number for the case.
Couldn't move or lift the arm; Might have some swelling; Severe pain in the arm; A spontaneous report was received from a consumer concerning a 69 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in extremity, injected limb mobility decreased and swelling.  The patient's medical history was not provided. No Concomitant medications were reported .  On 18 Feb 2021,thursday, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. After receiving the vaccine she developed extreme severe pain in her vaccinated arm from joint to elbow and she was not able to move or lift her arm. Also patient experienced swelling. All the events lasted for three days.The patient used lidocaine patch for the events.  The treatment for the events was reported as lidocaine patch.  Action taken with mRNA-1273 in response to the events was unknown.  All the events were reported as resolved and the event couldn't move or lift arm was reported as resolving.
Heat In face; Swollen face; "Slits" for eyes; Rash on arms, face, neck and sides; Hives on arms, face, neck and sides; Missed second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose), URTICARIA (Hives on arms, face, neck and sides), FEELING HOT (Heat In face), SWELLING FACE (Swollen face) and EYE DISORDER ("Slits" for eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical reported history provided by the reporter.   Concomitant products included GLIPIZIDE, METFORMIN, VERAPAMIL and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) 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 10-Mar-2021, the patient experienced URTICARIA (Hives on arms, face, neck and sides) and RASH (Rash on arms, face, neck and sides). In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On 17-Mar-2021, the patient experienced FEELING HOT (Heat In face), SWELLING FACE (Swollen face) and EYE DISORDER ("Slits" for eyes). In March 2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose), URTICARIA (Hives on arms, face, neck and sides), FEELING HOT (Heat In face), SWELLING FACE (Swollen face), EYE DISORDER ("Slits" for eyes) and RASH (Rash on arms, face, neck and sides) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information included, oral prednisone and diphenhydramine was provided.  Patients Chronic or long-standing health condition included diabetes but no recent change in status of chronic condition was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY 2021 contains Patient address updated, Patient demographic details and Anatomical location was updated
4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog.  Most symptoms have resolved but fever and brain fog persist as of day 6. Sleeping 14+ hours per day, unable to work due to symptoms.
Chills, fever, nausea, tiredness, light-headed,stomach pains, diarrhea
Fever: 100.9; body ache, headache; drowsiness; sweating
After 2nd covid shot on Feb 26th, starting  March 1st,  watery Stools 1 to 3 sometimes 4 a day(once 5 times)  stools were 5 to 7 on Bristol stool chart !  most were with nausea and urgency!  lasted  for two months before slowing.   Self treated with Imodium ad, pepto bismol.   PCP  tested for Covid, flu A and B, and C-diff.(all three negative)   referred to  have colonoscopy.  was clear.  tested for  wheat allergy, negative,  but diagnosed with microscopic colitis  from colonoscopy's test on 5/11.  but since that day symptoms have subsided.    with maybe one or two episodes of watery stools.     I kept a journal each day of covid contacts (for contact tracing just in case) and also kept notes of when and what kind of bowel movement I had!
Pain  , tenderness and small palpable bumps on left axilla & pain  and tenderness on lateral side of left breast.
Injection about 1:20 pm.  By 7 pm, developed body aches, then chills, headache, upper jaw ache.  Fever 100.2F overnight.  Minor stomach queasiness.  Treated with acetominophen which gave some but not total relief.   11 am day after injection still experiencing backache and headache, mild queasiness.  Injection site mildly sore.
Left upper arm started to get warm, red, and tender just below injection site. Pt given KEFLEX and BENADRYL.
sick with symptoms; sinus infection; bad cold; sinus congestion; mild cough; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold) and SINUS CONGESTION (sinus congestion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy NOS.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022 at 7:00 PM, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 26-May-2022, the patient experienced ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold), SINUS CONGESTION (sinus congestion) and COUGH (mild cough). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ILLNESS (sick with symptoms), SINUSITIS (sinus infection), NASOPHARYNGITIS (bad cold), SINUS CONGESTION (sinus congestion) and COUGH (mild cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: neagtive (Negative) Tested negative for Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Reportedly, Patient Last course of treatment completed on May 18, 2022. He Developed minor sore throat on May 24, 2022. By May 26, 2022, he was definitely sick with symptoms mimicking a bad cold or sinus infection. Sore throat, sinus congestion, and mild cough and reports No fever.  Treatment details was not reported by the reporter.  Pfizer have permission to contact them and also have permission to contact the patient's healthcare provider about this report .  The device date was reported as 28-May-2022
5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the welts/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (5 from Moderna that had similar reaction hives the welts/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the welts/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Case contains information of 5 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the welts. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710286:Master case (1 of 5 patient)