chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Injection site swelling; A spontaneous report  was received from a consumer concerning about a 81 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site pain and injection site swelling.  The patient's medical history was not reported.  Concomitant medications were reported as acetylsalicylic acid, metoprolol, isosorbide, losartan and fenofibrate.  On 16 Feb 2021, prior to the onset of the events the patient received their second planned doses of mRNA-1273 (Batch number: unknown) via intramuscular in right upper arm for the prophylaxis of COVID-19 infection.  Later the patient experienced events injection site pain and injection site swelling.  Laboratory details was not mentioned.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event are unknown.  The outcomes of the events injection site pain and injection site swelling remain unknown.
pt recvd vax 16OCT95 & 17OCT95 devel swelling in rt hand & wrist (arm in which recvd inj);pt rxn was tx w/APAP, ice & elevation;
Employee received .2 cc of Pfizer instead of .3 cc inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and PA DOH, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
After 16 hours that the bivalent vaccine was done she developed swollen eyes and lips, cough, and slight difficulties to breath. She was sent to the Emergency room and received medication such as solu-cortef and Benadryl IV. After a few hours observation she was discharged back home. As per the doctor who evaluated her, her lungs were clean on auscultation. The breathing was back to normal and the swollen was going down. On Friday she started with a rash and itchiness all over her body. I asked her to go back again to the ER. She was once again medicated accordingly. She was discharged to go home better, and with a prescription of Prednisone 40mg/daily for 5 days. On Sunday I did a follow up and she was doing fine, no new symptoms.
3 pts recvd Engerix-B & devel rash, hives & diarrhea which persist;
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) 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 UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant product use was not provided by the reporter.  Total of 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 4th of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663010, US-MODERNATX, INC.-MOD-2022-663011, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849: US-MODERNATX, INC.-MOD-2022-662859: US-MODERNATX, INC.-MOD-2022-662860: US-MODERNATX, INC.-MOD-2022-662863: US-MODERNATX, INC.-MOD-2022-662865: US-MODERNATX, INC.-MOD-2022-662866: US-MODERNATX, INC.-MOD-2022-662869: US-MODERNATX, INC.-MOD-2022-662873: US-MODERNATX, INC.-MOD-2022-662876: US-MODERNATX, INC.-MOD-2022-662879: US-MODERNATX, INC.-MOD-2022-662881: US-MODERNATX, INC.-MOD-2022-662958: US-MODERNATX, INC.-MOD-2022-662995: US-MODERNATX, INC.-MOD-2022-663010: US-MODERNATX, INC.-MOD-2022-663011: US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-663016: US-MODERNATX, INC.-MOD-2022-662875:
Developed erythematous papules x 3 on legs 14 days post varicella immunization. Seen 24 hours after onset and noted to have 10 lesions, some crusted on face/scalp/torso/arms/legs.
Very dizzy; Very tired; Lost his appetite; Sleeps al the time; Barely gets to work; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; Feels like the Flu; Developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi.; This is a spontaneous report from a contactable consumer. A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13Apr2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date (at the age of 71-years-old) for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced very dizzy, very tired, lost his appetite, sleeps al the time, barely gets to work, developed a rash on his left arm (same arm where he got the vaccine) that appears like shingles or fungi, feels like the flu. Caller would like to know if this has been reported and if so, how long after the vaccine was this observed. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hearing loss in my left ear along with tinnitus; Hearing loss in my left ear along with tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 16:00 (Batch/Lot Number: EW0158) as 1st dose, single; dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 16:00 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization. Medical history included SARS-CoV-2 pneumonia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not have other vaccines in the last four weeks nor other medications in two weeks. The event the patient had and was still experiencing was hearing loss in his left ear along with tinnitus on 17Apr2021 (also reported as beginning after the 2nd shot) which resulted in doctor or other healthcare professional office/clinic visit. The patient received antibiotics (amoxicillin) as treatment. He was not tested for COVID post vaccination. The outcome of the event was not recovered. The case was reported as non-serious.  Follow-up attempts are needed. Further information is requested.
2 weeks from the day of the vaccination, 04/16/2021, I had heavy ringing in my ears, started feeling vertigo,  nausea,  dizziness and lightheadedness and just started persisting on ever since.  At least 2 weeks after that, I was trying to wait it out, but it persisted on and I made a tele-doc appointment.  The tele-doc prescribed me Prednisone. The tele-doc felt it might go away but set me up with an ENT. A week after that I saw the ENT. The ENT did a hearing test but didn't find anything. I am still having the Nausea and ear ringing, they  are the 2 most persisting symptoms. I feel it's pretty detrimental to my  quantity of life. I just try to keep going and tolerate the symptoms as much as possible.
The child fainted about 2 minutes after the vaccination. She fell and hit her head. Her father who is a doctor attended to her.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (dose and route of administration were not reported); lot # M031568 with expiry date 24-DEC-2017 and lot # M031945 with expiry date 27-DEC-2017. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013636.
Presented with N/V x4 days; Incidental finding of +Covid; no change from chronic cough or chronic SOB/ dx with Covid PNA; treated with steroids/Vit C/Vit D/Zinc and low O2; discharged to previous Rehab
Mother states that on the day after receiving vaccine child had jerking of arms on and off throughout the day and ate less. Was not both arms at the same time and was noted to be different than Normal limits more resp.
HARD TO WALK; STIFF KNEES; SUSPECTED GUILLAIN BARRE SYNDROME; TINGLING IN KNEES; INFLAMMATION IN KNEES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgeries, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced inflammation in knees. On an unspecified date, the patient experienced hard to walk, stiff knees, suspected guillain barre syndrome, and tingling in knees. Treatment medications (dates unspecified) included: tramadol hydrochloride, and diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in knees, hard to walk, tingling in knees, stiff knees, and suspected guillain barre syndrome. This report was non-serious.
Before I left the hospital parking lot I could taste the   drug in my moth.  By the time I got home I had the dry heaves.  I was also alternating hot and cold.   This went from about 7 pm to 8 AM the next day.  That  day I had a head ache which I normally do not have.
cellulitis left thigh.  Put on Bactrim susp 8ml BID x 10 days
This spontaneous report as received from a physician refers to one of two patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-JAN-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # K006960, expiry date 19-FEB-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse experiences were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
I am post menopausal.  My last period was in December 2019. After my first vaccine on 4/1/21 I started my period on 4/13/21. It lasted 4-5 days and was light. I had my second vaccine on 4/23/21 and had another heavier period starting on 5/4 and still having it today.
My mom (the patient) has a complete no recollection of what happened yesterday.  She could not remember even having the vaccine nor what she did that day.  I showed her the vaccine record and the photos we took.  As I spoke to her, she kept on repeating and asking me the same questions she had asked 15 minutes ago.  My dad and I saw her took her blood pressure medicine around 7:30 a.m. while we were in her room.  I was afraid she will not remember her taking the medication so I removed her medicines from her cabinet.  Sure enough, at 8:30 a.m she was looking for her medications and told me that she need to take it since she had not taken one this morning.  :(  My mom's memory has always been sharp and we had never had this issues before.
Pt  came in to get her last dose of Pneumonia. Pt claims she has redness and swelling on her arm after getting Pnumovax 23 vaccine. I felt for the correct muscle administered the shot. Pt has no adverse reaction when after wards. It was only after 6-7 hours later did she complain of, redness, soreness and said her arm was swollen. MD called in abx for her and when she came the next day, I couldn't see any swelling but just redness near the injection site (which was in the deltoid muscle) Pt states she thinks I injected her at shoulder blade, even though there was no redness there.  Pt is fine now, taking abx just has soreness. Not redness except by injection side and surrounding areas.
Information has been received from a pharmacist concerning a 70 year old male who in December 2007, was vaccinated with ZOSTAVAX (Oka/Merck).  In December 2007, after being vaccinated, the patient experienced hearing loss.  The patient's hearing loss persisted.  Upon internal review, the patient's hearing loss was considered to be an other important medical event.  The patient sought medical attention by seeing the physician.  Additional information has been requested.
The patient reported that the day of the vaccine she had body aches and chills. Within 3 days he developed an increasingly severe headache that caused extreme nausea, vomiting and loss of appetite.  Patient has now recovered but is concerned about her second immunization.
Sore arm, headaches, painful and swollen lymph node on left side under left ear -- still swollen and painful after 3 months since the first injection.
pinpricky; blister on finger; itchiness on her hands and feet; swelling of left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pinpricky), BLISTER INFECTED (blister on finger), PRURITUS (itchiness on her hands and feet) and VACCINATION SITE SWELLING (swelling of left arm at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 PARAESTHESIA (pinpricky), BLISTER INFECTED (blister on finger), PRURITUS (itchiness on her hands and feet) and VACCINATION SITE SWELLING (swelling of left arm at injection site). At the time of the report, PARAESTHESIA (pinpricky), BLISTER INFECTED (blister on finger), PRURITUS (itchiness on her hands and feet) and VACCINATION SITE SWELLING (swelling of left arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. Treatment included cortisone cream.   This case was linked.
10 days of almost constant muscle twitching below the injection site at the elbow area/ top of forearm. This uncontrollable muscle movement is almost constant. I have strong pain and fatigue if I use my arm.  Additionally, the injection site bled and remains bruised after 10 days.
pt recv vax 6AUG97 & 11AUG97 pt devel a swollen gland node on rt anterior side;evening of 13AUG97 pt devel hives & went to ER;
Pt received Pfizer x2 vaccine in April 2021. Pt became COVID + on 9/8/2021. Needed 2L O2. Admitted to the hospital on 9/8/2021 and receiving remdesivir and dexamethasone.
Facial paralysis was noticed on 2.2.2022.  At routine well visit check at pediatric office the facial paralysis had become pronounced and a diagnosis of Bell's Palsy was made by physician.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 16-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures were of 32 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
7 days post vax the pt developed a rash of about 6 spots that became blisters at about 10 days. The pt was not eating well, was vomiting had diarrhea lasting 3 days then coughing lasting about 2 days. On 1/11 the pt experienced a fever of 102.5 to 105.6 and was taken to the MD. On 1/12/01 had a seizure, was staring and wouldn't respond which lasted 2 minutes and went to the ER and was admitted to the hospital.
Narrative:  In June 2021, patient was admitted to Hospital for PE and CHF exacerbation and was discharged later in June 2021. Patient had extensive B/L PE, no right strain as seen on CT 5/26. Appears stable. However, his sister (POA) has refused the second dose and the booster. Per hospital chart notes, "Patient's sister stated that Patient had a reaction to 1st vaccine resulting in a blood clot and he is not cognitively intact to understand the risk of receiving another COVID-19 Vaccine"
This case was reported by a consumer via out of hour services and described the occurrence of headache in a male patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. In October 2017, 9 days after receiving FLUARIX QUADRIVALENT, the patient experienced headache and influenza. On an unknown date, the outcome of the headache and influenza were unknown. It was unknown if the reporter considered the headache and influenza to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient had headache and symptoms progressed from there. The patient felt like she had flu.
Information has been received from a nurse practitioner concerning a 65 year old female who on 01-FEB-2011 was vaccinated with PNEUMOVAX 23. On 01-FEB-2011 once the patient received PNEUMOVAX 23 she experienced a tingling in her arm, flushing and itching in her neck and face, increased blood pressure and palpitations. The patient was given "unknown medication" for treatment of adverse events, and she did not seek medical attention. The patient present status was unknown. Additional information has been requested.
Patient reports heaviness in throat and dry mouth post vaccination, but denied shortness of breath and no trouble swallowing. Patient also denies signs of hives or itching, but does report mild "shivers." Patient states that they have not eaten today and has minimal water intake. Patient desired to walk to observation. Benadryl 50mg was given and patient was observed for an additional 15 minutes. Patient walked out with spouse.
Vaccine dose was administered from the vial punctured for > 12 hours; Flu like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Long term) and Hyperlipidaemia (Long term). Concomitant products included SIMVASTATIN for Hyperlipidaemia, AMLODIPINE, CARVEDILOL and OLMESARTAN for Hypertension.   On 09-Jun-2021 at 8:31 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 09-Jun-2021 at 8:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021 at 8:31 AM, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved. On 11-Jun-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu like symptoms) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours).    Concomitant include Ivtz taken at a dose of 25.   Patient was given Moderna vaccine forty-six hours after the vial was punctured. As per the manufacturer patient was encouraged to be re-vaccinated due to lack of effacious. Patient declined to be re-vaccinated due to the flu like symptoms that were resolved forty-eight hours after receiving the vaccine. Patient felt vaccine was effective.  No treatment details  were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received contains updated information on patient demographics, medical history, concomitants, route of suspect drug, event added.
More than 48 hours after receiving the first dose my lymph nodes near my left clavicle swelled up and became very sore. That same night, more than 64 hours after receiving the first shot, I had a intense fever for three hours and was able to break the fever.  I did have COVID-19 back in July 2020 with 2 confirmed positive tests.
Mom reports infant developed fever night of immunization that lasted for 4 days. Also reports mild irritability and diarrhea. Child developed mild rash on back and abdomen on day 4. Mom treated symptomatically.
This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-JUN-2017, the patient who was intended to receive ZOSTAVAX, was inadvertently vaccinated with one dose of VARIVAX subcutaneously, lot # M042857, expiration date 21-OCT-2018 (dose was not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.