chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 62-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 22Nov2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm and on 01May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic fatigue syndrome" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: migraines. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  Clinical information: Adverse event Had positive test results for 9 days. Days 5-8 was feeling better. Day 9 redeveloped bad headache that she had on days 1-2. Day 10 first negative test but headache bad and legs achy or just not feeling well. Felt lousy day 11-12. Awoke day 13 yesterday (from initial day she felt symptoms and initial positive test) feeling like she did on day 1. Bad headache, sinus drainage which was causing sore throat, nasal passage burning and nose running. Felt wiped out all over again. Did home test and tested positive after negative a few days ago. Today headache improved. Just mild off and on, sneezing and runny nose and just feel lousy in general. Adverse event country: Adverse event start date: 09Jun2022 Ae resulted in. No Known allergies. Other medical history of chronic fatigue syndrome, migraines. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment: Yes. Did you/the patient previously receive a COVID-19 Vaccine: Yes. Patient considered event as non serious.  No follow-up attempts are possible. No further information is expected.
Patient inadvertently received more than recommended dose.  Prescribed 0.5ml, was given 1.5-2ml.  Patient remained asymptomatic.  Monitored in office for 45minutes following immunization.  Repeat BP prior to departure from office was 118/78
Patient developed flu like symptoms, chills, fever, headache, shortness of breath the morning following his vaccination. Called EMS due to shortness of breath and was taken by ambulance to Hospital. He was observed overnight and had a nuclear stress test the next morning which he reports as normal and was discharged home. He has felt well since that time. Patient states doctor said he did not think the symptoms he had were related to receiving the Covid-19 bosster.
Red itchy bumps on left arm. New patches of eczema on left arm and stomach.
Head and ear pain on left side began on 3/6/2021. I took Tylenol and OTC ear drops but pain continued to get worse. 3/10- pain worsened, ear itched, hyperacusis began. 3/11- 8am Finally made an appointment in clinic due to the worsening ear pain and was prescribed ciprofloxacin/dexmethasone drops and told to contact clinic in 24 hours if symptoms didn?t improve.  3/11- 8pm noticed weakness on left side of face (inability to close eye tightly), went to bed. 3/12-6:30am weakness on left side progressed- eye wouldn?t blink/close, asymmetric smile...called clinic and was asked to come in. My primary saw me and sent me to the ER. They looked in my ear and Diagnosed me with Ramsay Hunt Syndrome (shingles outbreak in ear/ impacting facial nerves causing acute paralysis) on 3/12/2021 after initial symptoms began on 3/6/2021.  I was put on 1000mg of valacyclovir 3x day and 60mg prednisone for 1 week each. Moderately-Severe Paralysis remains as of 3/24/2021.
Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19 disease. The patient had no allergies to medications, food and other products.   The patient had no medical history related to mentioned adverse events and did not have any acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccination.     On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 20-Apr-2022, the patient received the first booster dose of the vaccine.  No treatment information was provided.
Tremors; shortness of breath; Fever; Chills; profuse sweating. Headaches.
I received the vaccine at 12:30 on Wednesday (3-31-21) and  I had chills and began running  a temperature of 102.2-102.4 which continued until Sunday, 4/4/21 at noon.  I also had a migraine headache causing  nausea and was  unable to eat until the morning of 4/4/21. I slept for the most part of two days and on the third day I was less sleepy but, still had all the other symptoms I mentioned as well  as I ached in all my joints.  As of  (4/22/21)  I am still unable to lay on my left side due to my  left arm hurting when I do.
Pain at injection site. Achy body. **Severe pain in my left hip and down my left leg. Unable to walk without severe limp and pain.**
The night after the booster was administered I experienced pain in my left armpit and could feel that the lymph nodes were swollen. The pain increased throughout the next couple of days and persisted throughout the week. I took ibuprofen or ADVIL to help with the pain and had trouble sleeping. I was also experiencing the expected symptoms of fever, body aches, and fatigue. After a week, the symptoms had lessened and I did a work out for the first time since receiving the vaccine. I experienced burning in my chest, arm, and neck and stopped exercising at that point. I rested for a week and attempted to exercise again and experienced the same thing. I had an annual physical later in the spring and mentioned this to my doctor but since I was no longer experiencing this issue, they didn't offer any advice or treatment for the issue. I'm concerned about taking another vaccine because each time I receive one, the symptoms get worse and I have concerns also about the effects it may have on fertility.
Swollen, warm, red rash on upper arm. Pain in arm and arm feels heavy.  Pain and heaviness started on 6/16/21 and rash appeared on 6/17/21. Also experiencing chills and possible low fever on 6/17/21.
7/9/20 Fever the day after vaccine (101.2 F) and extreme fatigue.  7/10/20  No fever, less latigue.  Inflammation, redness, itching of arm. 7/11/20  increased inflammation and severe itching. went to urgent care, diagnosed with cellulitis. prescribed cephalexin,  advised to use benadryl cream and zyrtec tablets. 7/12/20  and 7/13/20  inflammation improving, still some fatigue
He received covid 19 shots on 3/24/2021, 04/07/2021, 04/21/2021, 01/14/2022. and possible another dose under a different name, pfizer shot on 05/05/2021
Pt recv vax on 10/27/98; on 10/28/98 pt exp numb LA
Legs broke out into a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Legs broke out into a rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 10-Mar-2021, the patient experienced RASH (Legs broke out into a rash). At the time of the report, RASH (Legs broke out into a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided
2 days after immunization, pt developed 10 x 9 cm patch of induration/ warmth/ redness over right anterior thigh
10pm chills and felt hot, 1am on 5/8/21 threw up 3 times, 5/8/21 body aches especially in my legs, 5/9/21 dizziness and nausea
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for Covid-19 from 21May2022 to 25May2022. The patient received some herbal medicine in 2 weeks product from 20May2022 to 21May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills day after vaccine. Subsided after drinking cup of tea and going to bed. Itchy rash left lower arm and hand day after vaccine. Right arm and hand, right and left upper thighs, left buttock,  left mid-back and abdomen. No treatment yet.
Shot given yesterday. Mother called clinic this AM to report that child is in bed sick with nausea (no vomiting) and headache. Mother reports that child had similar reaction after 2nd Hep-B.
I got sudden sob, had trouble swallowing my water was driving on way back to work. Got pulled over. Heart was racing. Got hot starting shaking. Sob. Hands feet and face started to get numb. And almost passed out.
Hives on hand,on legs,on torso,on buttocks; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on hand,on legs,on torso,on buttocks) and PRURITUS (itchiness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (Hives on hand,on legs,on torso,on buttocks) and PRURITUS (itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from 28-Jan-2021 for Hives, at a dose of 2 Tab as required. At the time of the report, URTICARIA (Hives on hand,on legs,on torso,on buttocks) and PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Patient received Hepatitis B vaccine in right arm and varicella booster in left arm.  Both arms became numb and left leg became numb.  She feels as though the left side of her face is numb and it is hard to make facial expressions.   On physical exam, there is no asymmetry or slurring of words.  Right and left deltoids are tender with no redness or swelling.  All vitals are within normal limits.
Felt faint.  Hypotension noted.    17:38  BP: 79/40.  P: 80.   No respiratory distress noted.  Deep breathing  exercises.  Denies nausea and vomiting.  Cool damp cloths applied to back of neck.   17:52  BP:  96/58.  O2 Sat: 97%.   Able to eat snack and drank 500ml of water.   18:00 BP: 110/72.   Denies dizziness, n/v.  Stated she felt "back to normal."   Discharged ambulatory to private vehicle by nurse.
Gave patient their flu vaccine - patient started to bleed so I set down the vaccine before engaging the safety device. Wiped off blood and put bandaid on the patient. When I picked up the shot to engage the safety device I accidently stabbed myself in the left 1st finger.
Potentially got the dose from a vial punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided
Tingly numbness rear L sole, heal, & rear arch. Spread 1/2 rear calf, then to include entire L palm, forearm while present in leg. 1 wk later numbness receded. Present only in L foot. Ruled out GBS.
Patient developed injection site reaction of redness, warmth, pain and inflammation around injection site, day 1 following injection. Area was marked. Day 2, redness extended beyond markings. Day 3 redness extended minimally beyond new markings. Level of warmth, pain and inflammation has remained the same at this time.
pt recvd vax & devel inj site rxn characterized as red, raised, painful & warm area around the site, the day p/flu vax;this is one of three patients from this site who exp the above reaction coincident w/the use of lot number 4958068
I received 2nd dose of Moderna COVID-19 vaccination on 8/13/21.  A few hours after I felt fatigued. The fatigue did not go away in "1 to 3 days" as widely reported. 17 days aftert the second dose I am still experiencing chronic fatigue and brain fog that has kept be homebound . I have not been able to work or have had to decline participating in job interviews. Before the injection I was very fit and active: lifting weights, jogging and cycling. Now I feel fatigued after light walking or basic household chores.   The vaccine caused a powerful immune system "flare" and debilitating neuroinflammation. I have been following the advice fo online doctors and taking antihistimates, Vitamin C, Quercetin and NAC to help.
Pt received Vvax #1 on 7/24/06 Dx with chicken pox on 8-6-07 at Dr. office 1st pox noted by parent on 8/4/07 Received Rx Acyclovir 200/5 4ml po QID x 5 days
Burning throat 5 minutes after injection.  Day after injection- sore throat, fever, body aches, nausea, vomiting, extreme thirst, arm burning, arm swollen, arm temperature hot, ear pain left side, neck pain left side, muscle cramps
Patient came into vaccination site on 1/03/21 for COVID-19 Pfizer second dose. Patient received first dose on 12/13/21. Patient reported to the RN that 10 hours after her first dose she experienced dizziness, nausea, vomiting, and diarrhea for 7 hours and SOB for approximately 30 minutes. Patient did not go to ED or see PCP. Patients mother gave her paracetamol. Patient stated that within 7 hours her symptoms had subsided. The RN submitted a medical consult via text message to vaccine operations Leads, requesting to proceed with the COVID vaccine Pfizer second dose. Per regulatory authority guidance, approval to proceed with COVID vaccine Pfizer second dose was obtained from medical consult team, vaccine operations Lead registered nurse, via doctor approval. Patient received COVID vaccine Pfizer second dose LOT#: FL3198 at 1632. Patient was educated on adverse reactions of COVID vaccine and when to seek EMS. Patient and patients mother verbalized understanding. Patient left vaccination site with her mom at 1647 unassisted and with a steady gait.
7/28/2020:  right deltoid rabies vaccine administration according to records; patient reports was given on left; 7/14/2020: right deltoid rabies vaccine administration; 7/7/2020; left deltoid rabies vaccine administration. Left axillary and breast pain, swelling, and tenderness beginning 24 hours after vaccination. Ultrasound 8/10/2020 showed abscess. Drained. Culture grew Pasteurella multocida
Vaccine administered on 8/19/2019. Shingles diagnosis 9/6/2019
I had the normal sore and stiff arm.  I also felt jittery, like my blood sugars were off.  This calmed down when I ate.  It seemed like what I normally did--such as one cup of coffee a day and supplements--had exaggerated effects.  Ibuprofen twice a day seemed to take care of the aches at the beginning.  I ran a low grade fever for several days.  About 4-5 days after, I started with some zit-like bumps near my breast and neck.  The next day I noticed a light, pin-prick rash near my belly button.  The next day, it had spread to my torso and a little to my back.  On Saturday, the 20 I had a full-body rash: torso, legs, arms, and neck.  I went to the clinic and she gave me a steroid shot and told me to take Benadryl.  That evening my throat felt a little swollen and funny.  On Sunday, Feb 21, the rash was more pronounced.  But the achiness was more manageable.
Prescribed 2-mL dose, received 1-mL dose/requested to receive Hepatitis B vaccine (Engerix B) double adult dose, however the patient received a single adult dose.; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HBV (Engerix B adult) (batch number 25K3M, expiry date 2nd June 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The pharmacist reported that the patient was preparing for hemodialysis and was requested to receive Hepatitis B vaccine (Engerix B) double adult dose, however the patient received a single adult dose. The vaccine administration facility was the same as primary reporter.  The case was under escalation to determine if patients should receive 1ml or 2ml dose of Engerix B adult before hemodialysis. The reporter did not consented to follow-up. Additional supportive information: The patient received a single adult dose, which led to underdose.
I got lethargic. I tried to take a nap but I felt like I was freezing and couldn't get warm. A few hours later, I got up from a nap and had a fever of 103.2. The next day my knees and hip were killing me. It felt like my hips and knees were being ripped apart. I had pain in my knee and hip joints. I had a little bit of a headache. On Monday my fever went down. On Tuesday my symptoms went away and I felt back to normal. About a month later I had the headache, fever, joint pain, and a rash. The doctors said it could of been a tick born illness but test was negative. My white blood cell count and iron was low.
Tdap given first in Right Arm, followed immediately by flu vaccine given in LA.  Immediately upon receiving flu vaccine, patient asked, should I be feeling dizzy?  I said no and had him lay down with feet up.  He then became unresponsive, with fixed pupils, and tonic seizure primarily of left side of body, which lasted <30 seconds.  I had medical assistant call 911.   Following seizure, patient took a few more seconds to a minute before becoming responsive, although pale and diaphoretic.  He was then oriented to time, place, date, person. PEARL.   He denied shortness of breath, swelling of throat, itching or rash.  BP 122/74, pulse 60 and regular. O2 sat 97%.   Ambulance arrived in 5-10 mn.  BP at that time 107/63 pulse 60 regular.  O2 sats remained in 96%-97% range.   Patient started to feel more stable, said he was feeling better and was asked to sit up, he again began to be lightheaded, had him lay down again, repeat BP at that was 78/42, pulse 60, occasionally irregular.  Decision made to transport patient to ER.  Patient and wife confirm no history of seizures, no known history of prior vaccine reactions, and no hx of neurological disorders.  Denies illness or recent illness other than minor cold sx.   BP at time left clinic was 90/51, pulse 60, O2 sat 97%, taken by ambulance.  Follow up phone call with patient and ER on 11/12/13.  Patient was not admitted.  In ER was neurologically intact. Diagnosis given in ER was vasovagal syncope, and patient discharged home.  On 11/12/13 patient reports he has been feeling fine since, and returned to normal activities.
This case was reported by a consumer via call center representative and described the occurrence of pruritus aggravated in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pruritus (1st dose received on 13th April 2018, for tolerance see case US2018171057). Concurrent medical conditions included itchy skin and hypersensation skin (started in April after 1st dose vaccination). In June 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than 4 months after receiving SHINGRIX, the patient experienced pruritus aggravated, skin ulcer, hypersensation skin and condition aggravated. The patient was treated with Cortisone Topical Cream and Over The Counter Medication (Unknown). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pruritus aggravated was not recovered/not resolved and the outcome of the skin ulcer, hypersensation skin and condition aggravated were unknown. It was unknown if the reporter considered the pruritus aggravated, skin ulcer, hypersensation skin and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient experienced terrible itchy skin and sores in her ears, arms and on her neck. The itching was incessant and she had tried cortisone creams, OTC products and the only relief she could get was with scolding hot water which provided her temporary relief. The patient reported a sensitivity to her skin after the vaccination, which included her chest was still itching from April where the electrocardiogram monitor electrodes were placed. The back of her shoulders are itching as well. The itching is worse on the reporting date than it was in April. The contact details of the physician was provided.
Fever of 101.0, chills, body aches. Symptoms all started about 24 hours post-second dose and resolved within about 24 hours.