chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient appeared extremely tired in post vax area and was having trouble walking. Parents stated he has extremely anxiety and took an unknown anti-anxiety medication approximately one hour prior to vaccination. Parents stated he usually takes the medication at bedtime, Pulse ox 99% pule 81. Patient placed in trendelenburg position, able to answer questions, observed for an additional 10 minutes. Color improved, patient stated he was able to walk on his own. Parents advised to contact medical provider to review heavy sedation caused by medication.
pt lt upper arm is red & warm;affected area is 2cm x 2cm & tender;advised to apply ice, use Ibuprofen & given claritin;
Within moments of vaccine administration, patient reported not feeling well, dizzy, wanted to lie down after lying down, feet elevated, she reported her throat feeling tight, face flushed, around mouth feeling numb, heart feeling fast. HR ED, BP 140/80 911 called, pt transported to Emerg Dept (went to hosp)
Rash starting in center of chest and under breasts, spread to stomach, and spanned across sides of torso onto back. Spread mildly onto shoulder/neck. Pain/soreness at injection site, started a few hours after injection, and subsided a few days after injection.
vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022; receiving doses after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Beyond Use Date was reported as 02-Feb-2022. It was reported that the vial was initially stored in the refrigerator on 03-Jan-2022. The vials had not underwent temperature excursion.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (date, lot number, dose and frequency unknown). No other suspect therapy or concomitant medication was reported. On an unknown date the patient experienced a broken blood vessel in left eye causing redness and pain. A patient of the pharmacist reported that the unspecified eye specialist stated that she is the second person that the eye specialist has seen who developed a broken blood vessel in the eye after receiving ZOSTAVAX. The outcome of broken blood vessel in left eye causing redness and pain was reported as unknown. The reporters relatedness and itching and redness covering approximately 2 inches at the injection site and broken blood vessel in left eye causing redness and pain to ZOSTAVAX is unknown. Same reporter link: 1309JUSA005073. Additional information has been requested.
01/08/22 presents to ED for "fall". PMHx of "end-stage renal disease" "cirrhosis, T2DM, ITP, ESRD on HD"
Patient claims vaccine was give too low in arm.  Adverse event = redness and swelling of elbow and area around elbow of right arm.  Warm to touch.
Vaccinated with Pfizer vaccine 1/9/2021 and 12/19/2020.  On 3/17/2021 developed chills, cough, nasal congestion.  +PCR for COVID
fever, head cold, ache in knees, elbows, loss of energy & feeling like crap in general;
Patient came to the office to receive her second dose of Hepatitis A vaccine and MENACTRA vaccine.  She was given the Hep A in the Left arm and did ok, then when the CMA was giving the shot in the right arm, the patient stated that her left arm feels weird. She immediately laid back on the table, CMA asked if she was ok and pt stated NO and immediately started to have a seizure. She straightened her arms straight out and her eyes rolled to the back of her head and started to seize. This happened for about 1-2 minutes and she started to come around. An ambulance was called and they arrived in less than 10 minutes. The APRN in the office checked the patients BP at 90/62, pulse 56, 95% O2 and FSBS 91. The ambulance arrived and immediately took her to the emergency room.
pt devel severe swelling, redness, heat & hardening of skin @ inj site on rt thigh;temp @ this time 99.3 R;site very painful to touch;ice pace applied & mom instructed on care of site;APAP q 4hr
half of the residents have had a bad reaction to the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (half of the residents have had a bad reaction to the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (half of the residents have had a bad reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (half of the residents have had a bad reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Information has been received from a nurse practitioner concerning a 57 year old female patient with hypertension and environmental concerns who on 03-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Concomitant therapy included lisinopril (manufacturer unknown), HCTZ/triamterene and VALTREX. Nurse practitioner reported that a patient who received ZOSTAVAX (Merck) developed a large, red, indurated and painful injection site reaction. Nurse practitioner stated that on 06-JAN-2011, the patient reported that her arm was very painful and a 6-8 cm area of hot induration surrounding the injection site, which was approximately midway down the patient's arm below the deltoid muscle. Nurse practitioner reported that the patient was in so much pain that she was unable to move her arm. Since the site was so "angry", the nurse practitioner prescribed a MEDROL dose pack and ZYRTEC (daily for 10 days), as well as an antibiotic, KEFLEX (500mg BID for 5 days) since, according to the nurse practitioner's judgement, it looked as if it might develop into a cellulitis. Nurse practitioner said that there was no evidence of a rash. There were no laboratory diagnostics studies performed. Nurse practitioner also reported that on 10-JAN-2011, the patient had fully recovered. Follow-up information was received from the nurse practitioner concerning the female patient with allergy to CELEBREX, wasp stings and no illness at time of vaccination. The nurse practitioner stated that on 03-JAN-2011 after receiving ZOSTAVAX, the patient developed an approximately 6 cm, red, hot, indurated area at injection site, inferior to deltoid muscle on right arm. The patient was treated with KEFLEX, ZYRTEC and MEDROL dose pack. The events resolved on 3 days and the patient recovered on 06-JAN-2011. The patient did not seek medical attention. Additional information is not expected.
Large, red circle around injection site; Arm felt tender; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm felt tender) and VACCINATION SITE ERYTHEMA (Large, red circle around injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm felt tender). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large, red circle around injection site). At the time of the report, VACCINATION SITE PAIN (Arm felt tender) and VACCINATION SITE ERYTHEMA (Large, red circle around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient developed Shingles after the first dose of Shingrix. The reporter consented to follow up.
This case was reported by a healthcare professional (medical assistant) via a sales representative and described the occurrence of injection site induration in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). In 2014 the subject received a dose of INFANRIX (unknown details). In 2014, within weeks of vaccination with INFANRIX, the subject experienced injection site induration (described as "knots at injection site") and injection site redness. The reporter noted that "the timeframe was is the past 2 weeks." The reporter stated that after the subject received INFANRIX, the subject "developed huge red knots at the injection site." No other events were reported. It was unknown if the immunization series was discontinued. At the time of reporting the outcome of the events was unknown. The healthcare professional considered the events were probably related to vaccination with INFANRIX. The medical assistant reported 4 other cases with INFANRIX. See A1060686A, A1060690A and A1060692A for details on the other cases. Follow-up information was received on 10 March 2014 via healthcare professional who reported the 4-year-old female subject started to experience the events on 02 January 2014. The subject had no relevant medical history. The events were not attributed to medical history/ concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via medicinal product. No action was taken with INFANRIX, the series was not discontinued or delayed. The reporting healthcare professional did not consider the events to be serious. The events resolved on an unspecified date.
Hives. First all across chin. VERY red w/ white"ish" hive spots. Small spots on rest of body. They soon went away and new "spots" appeared. After Benadryl everything went away then came back wore after 6 hours.
little tachycardic; I felt anxious about what I was feeling; she felt her lip and cheek tingling; felt kind of itchy but under her skinitchy sensations all over her body that come and go; felt a quick weird sensation under scapula; tingling sensation going down the side of her back that she got the vaccine on/all of her left side was tingling/woke up to a weird tingling all over her body/tingling on her hands; This is a spontaneous report from a contactable other health professional. An adult (18-64 years) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248) via an unspecified route of administration, in the left arm, on 18Jan2021 07:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma. Patient had BNT162B2 on 28Dec2020 in the left arm for COVID-19 immunization (first dose with lot number: EL1284). Concomitant medication included ibuprofen, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and norethisterone (NORA-BE).  On 18Jan2021 08:00, about 15 min after vaccination, the patient felt a quick weird sensation under scapula and a tingling sensation going down the side of her back that she got the vaccine on. Maybe 30 min after vaccine (18Jan2021, 08:15), she felt her lip and cheek tingling. An hour after (08:45), all of her left side was tingling and felt kind of itchy but under her skin. She had just finished working night shift and fell asleep. She slept 9 hours and woke up to a weird tingling all over her body. She was a little tachycardic because she felt anxious about what she was all feeling (19Jan2021). Once she had calm herself down, her heart rate was back to her baseline. She had no difficulty breathing, no rashes, and otherwise felt fine. She had dinner and was awake for few hours before sleeping another 8 hours. It was now about 33 hours after and she still have random tingling/itchy sensations all over her body that come and go and tingling on her hands that has never stopped.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Edema, redness and warmth to left forearm 4 days after administering DTaP left deltoid region. Referred to PCP.
dizzy; has had a headache and it is getting worse; she is so sick; she can not lift her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HEADACHE (non-serious), outcome "unknown", described as "has had a headache and it is getting worse"; ILLNESS (non-serious), outcome "unknown", described as "she is so sick"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "she can not lift her head". Additional information: The age of the patient was reported as 68 with unknown unit. Reporter wanted to know how long this will last and what to do to feel better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; 9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Nov-2022, 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 14-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that the vaccine was delivered to the hospital on 20-Sep-2022. The vaccine was administered to 5 patients on 14-Nov-2022, 2 patients on 15-Nov-2022 and 2 patients on 22-Dec-2022. Treatment medications were not provided. This case was reported for patient 1 of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-725026, US-MODERNATX, INC.-MOD-2023-725032, US-MODERNATX, INC.-MOD-2023-725033, US-MODERNATX, INC.-MOD-2023-725034, US-MODERNATX, INC.-MOD-2023-725035, US-MODERNATX, INC.-MOD-2023-725036, US-MODERNATX, INC.-MOD-2023-725037, US-MODERNATX, INC.-MOD-2023-725038 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725026:(Patient 02 out of 09) US-MODERNATX, INC.-MOD-2023-725032:(Patient 03 out of 09) US-MODERNATX, INC.-MOD-2023-725033:(Patient 04 out of 09) US-MODERNATX, INC.-MOD-2023-725036:(Patient 07 out of 09) US-MODERNATX, INC.-MOD-2023-725037:(Patient 08 out of 09) US-MODERNATX, INC.-MOD-2023-725034:(Patient 05 out of 09) US-MODERNATX, INC.-MOD-2023-725035:(Patient 06 out of 09) US-MODERNATX, INC.-MOD-2023-725038:(Patient 09 out of 09)
Information has been received from a health professional concerning a patient in sixth grade who was vaccinated with a dose of Varivax. On 18-APR-2006 the patient experienced chickenpox. Additional information has been requested.
Slight Headache and arm soreness right after vaccine but then I started feeling bad - aches, body aches and pain and increased reflux and started having diarrhea. I was feeling sick eating. It went off and on and off and on for awhile. Then exhaustion and it's hard to move. Joint pain and muscle cramping. I thought maybe I had Celiac Disease. I had skin rashes and I started having almost like moles that would pop up and be filled with blood and they itched like crazy. Lack of sleep but still bone tired exhaustion. Nausea is constant, I can get the heaves but I don't vomit. I made an appt with a gastroenterologist. I went in to get tested. I was told I was nuts about it being food allergies. He said I was obsessed with food. I have increased anxiety now and I have never been an anxious person. People were starting to say I needed to talk to someone for anxiety. I am feeling increased worse as days go by. I have some increased yellowing of skin and some yellowing in my eyes. I am losing weight because I can't even eat. I have pain and swelling in my mid-section. I can't sleep, can't lay on stomach (from car wreck) or either side or on my back. I get a low-grade fever and then chills. My ankles are swelling. I have chest pain, it's terrible. A couple of times, I have almost gone to ER because it feels like a heart attack. I know that it's in my esophagus, and it hurts right in the middle of my chest, it hurts when I swallow. It's like a pressure. It's hard and it's a tremendous buildup of pressure in my esophagus. Knuckles are swelling. Joint pain. I have pale stools, like a tan yellow. Goes between diarrhea to not really constipation. Lately it has been more toward normal. It's getting real hard to function.
A report was received from a health care professional on 10/24/2003 concerning a 31 month old female vaccinee who was inadvertently administered Fluvirin vaccine on 10/21/2003. No adverse effects were associated with this inadvertent administration. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/12/2003: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction. No follow up pending, all information received.
Patient was supposed to receive the Moderna BIVALENT vaccine. The incorrect vaccine was drawn up and patient received the Moderna MONOVALENT vaccine.
After my Moderna vaccine, I had enlarged lymph nodes at the base of my neck, right side. I went to see my PCP who ordered an u/s of my neck. My PCP referred me to see a surgeon due to my enlarged lymph nodes.  Now I have lymph nodes on my left side of my neck as well.
Patient received her 2nd dose of Moderna from a refrigerated vial which had expired by 11 days.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: getting a positive test again after testing negative; Negative, notes: getting a positive test again after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Adverse event: Rebound infection- symptoms returned 5 days after treatment and getting a positive test again after testing negative. Adverse events started on 28Jul2022 and no treatment received for AE. Patient received Paxlovid from 19Jul2022 to 23Jul2022 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen, painful neck gland(s) left side of neck.  Low grade if any fever but feeling feverish and indisposed, tired, fatigued. NOT my energized self.
Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Upper torso and extremity rash, itching severe 2 days post-injection.  Lasted approximately 12-14 hours. Resolved with Bendadryl 25mg dose x2
11/24 evening: Soreness in arm where vaccine was injected, pain was gone on 11/27 11/25 evening: fever (101.7), malaise, chills, strong headache (symptoms similar to a flu); symptoms are still ongoing at time of reporting (11/27)
ON 4/25/08 PT COMPLAINED OF CHEST DISCOMFORT AND DIFFICULTY BREATHING.  SUBSIDED AFTER 1 HR THEN APROXM 2 WKS LATER DEVELOPED 10(3CM) PURPLE LESIONS ON THIGHS.