chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room's turning, it's been three days now/I had vertigo) and DIZZINESS (getting very dizzy, it's been three days now) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced VERTIGO (Room's turning, it's been three days now/I had vertigo) and DIZZINESS (getting very dizzy, it's been three days now). At the time of the report, VERTIGO (Room's turning, it's  been three days now/I had vertigo) and DIZZINESS (getting very dizzy, it's been three days now) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Follow up contains Significant information: Event added.
Patient has itchy rash, pink/raised/no fever to left lower and upper extremities/torso. Denies shortness of breath at this time.
wife relates pt began sweating, got dizzy & blacked out; went by ambulance to ER; then also had SOB, skin rash, low blood pressure; held for 6-7 hrs; sent home w/rx's of DPH & Pred;
after her second Pfizer covid vaccination, in Sep2021, she developed Bell's Palsy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "after her second Pfizer covid vaccination, in Sep2021, she developed Bell's Palsy.".  Additional information: After her second Pfizer covid vaccination, in Sep2021, she developed Bells Palsy. The reporter seriousness was reported as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient had localized pain at site of vaccine as expected. She had increased pain and some redness on 4/29/12. Patient came by 4/30/12 localized reaction (L) delt 4x8 cm warm to touch. Called patient today 5/1/12, pain & redness improving.
Vaccines given 7/22/09. Child developed erythemic, annular rash day after shots were given, 7/23/09. Mother reports child had low-grade fever. Exact temperature unknown. Child taken to ER on 7/25/09, diagnosed with viral exanthem and told to take benadryl 12.5 mg/5 ml 1/2 tsp every 6 hours as needed. Mother also advised to follow-up on 7/27/09 with child's PCP. Child seen in our clinic on 7/27/09. Rash still present, but better than on 7/25/09. Nurse practitioner advised to continue benadryl and tylenol. Nurse Practitioner felt child had erythema multiforme from immunizations, suspect from DTaP. Mother contacted on 7/31/09 to inquire how child is doing. Mother reports rash was completely gone by 7/29/09. No further rash, fever, or other symptoms.
Child started redness/heat 2 10 pm 6/11/02, no pain, no itch. Mother applied cold cloth @ 10 am when redness with pain, no itching prsent. 17:30 7 cm x 10 cm red papule left deltoid, two "mosquito" bites noted on left margin of papule, were not present 6/11/02. Mother instructed to apply warm, wet cloths 15 every hour. Call clinic when down.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient stated that he is scared of needles. He warned me that he may faint.  Advised him to seat after vaccine. He fainted about 2-3 mins, had a mild seizure but was talking to me. Pharmacy team members called 911. He got back on his feet about 5 minutes later. Then after 45 minutes h went home
Fever on the following day (January 12, 2021) after the second dose that began around 5:00 AM. Symptoms included: fatigue, chills, fever, lack of appetite. The fever was not present on January 13, 2021.
Administered undiluted Pfizer Ped 10mcg/0.2ml shot to patient that was 9 years old. Tried to reach patient, but they are from another country and are using a prepaid phone that was inactivated. Was not able to reach the parents. No local PCP information was provided since this patient is from another country.
I took the vaccine 3:30pm around 7pm - 8pm I started having chest lain and my body started getting numb so i took Benadryl and went to sleep, next day i got up with my body numb and sharp chest pain  on my chest left side. My left arm was red and swollen, the whole arm on the left where i took the vaccine. My tongue started getting swollen so i took Benadryl again. That night i went to sleep than i got up around 1:30am with burning sensation on my left side chest(heart) , i woke up twice with that. Next day i called my doctor than she told me to take 2 Tylenols and 1 Benadryl which i did than fet better all day. Today I didn't took anything in the morning but i felt chest pain on the left side and face was getting swollen than i took Benadryl and Tylenol
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since received his second dose 04/09/21
My Long-COVID symptoms have progressed. My chronic fatigue has worsened, I get migraine headaches that I've never before had in my entire life, I experience word-finding difficulty, inability to concentrate, and brain-fog, I have chronic pain and aches that disrupt my daily life,  I experience post-exertional fatigue to a high degree. I developed Mast Cell Activation Syndrome and Oral Allergy Syndrome which causes me to experience allergic reactions to most foods that manifests symptoms in my skin and GI tract. I started seeing a Naturopath MD over the summer of 2022 and am on a regimen of prescription medications and herbal supplements to try and get the MAST cells under control, but have experienced very little improvement so far.
Joint pain/In pain; Doesn't feel well; Hands and feet swollen; Alopecia/ Lost just about all of her hair/Baldness/about to shave her head; Rash/have a rash on the face all of the time; Nightmare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vegan" (unspecified if ongoing), notes: a healthy, exercising, vegan, organic person and now patient doesn't leave her house. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization, reaction(s): "Alopecia/ Lost just about all of her hair/Baldness/about to shave her head", "Joint pain/In pain", "Doesn't feel well", "Nightmare", "Hands and feet swollen", "Rash/ Rash on the face all of the time". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain/In pain"; MALAISE (non-serious), outcome "unknown", described as "Doesn't feel well"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Hands and feet swollen"; ALOPECIA (non-serious), outcome "unknown", described as "Alopecia/ Lost just about all of her hair/Baldness/about to shave her head"; RASH (non-serious), outcome "unknown", described as "Rash/have a rash on the face all of the time"; NIGHTMARE (non-serious), outcome "unknown". Additional information: Patient can't work because she was in pain, bald, and had a rash on the face all of the time. She said she went from a thriving, spry person to a not leaving the house person. She didn't want this to happen to anyone else.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079801 Same patient/vaccine, different dose and event;
Within 2 minutes of getting the vaccinations, the patient said he was not feeling well repeatedly.  He was sitting down in the pharmacy waiting area when the next thing you know he passed out completely and fainted, with his head slumped down into his chest. Myself and a customer who happened to be there lifted him out of the chair and laid him on the ground, and elevated his legs.  He did hit his head slightly when we laid him on the carpet, but there was no lasting bump or contusion. Within about two minutes, he came back to full conciousness and was feeling much better, and by that time EMS had arrived.
The pt received the Lyme vaccine through Yale study 1994-1998 with a history of Lyme arthritis in 1992. Since receiving the vax she has had progressive worsening of the arthritis in her knees with symptoms unresponsive to both PO and IV antibiotics. The reporter feels there is a correlation with this progressive arthritis and the Lyme vaccine.
Pt had a medical history of diabetes and presented with shortness of breath.  He also has cough, fevers, weakness and muscle aches.  Pt deteriorated quickly and passed on 1/17/2022.
headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Swollen and red; Injection site was itchy and Red; Injection site was itchy and Red; Injected arm was a little Sore; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injected arm was a little sore/vaccination site pain, arm at the injection site was itchy/accination site pruritus and red/vaccination site erythema, injection site was swollen/ vaccination site swelling and red/vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 029L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, first day the patient experienced injected arm was a little Sore. On 30 Jan 2021 Saturday, the patient experienced arm at the injection site was itchy and red. On 31 Jan 2021 Sunday morning, the patient experienced injection site was not itching. On 31 Jan 2021 Sunday afternoon, the patient experienced injection site was itching, swollen and red. On 01 Feb 2021, the patient experienced injection site looks a lighter red, but the light red area was big 3.5x2 inch.  Treatment details included diphenhydramine topical  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, injected arm was a little sore was resolved on 24 Jan 2021. The outcome of events, arm at the injection site was itchy and red, injection site was swollen and red, light red area was big 3.5x2 inch was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 63-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 08-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804085 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
-Terrible headache (close to migraine-level pain) starting shortly after receiving the vaccine, lasted ~ 1 week -Fever of 101.1 started ~24 hours after receiving the vaccine, lasted ~12 hours (fever started around 5 pm, was gone when I got up the next morning)
she has pain in her arm; it's swollen; pain in her neck; red and hard; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. This contactable consumer reported for herself that a female patient of an unspecified age received 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 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced, she has pain in her arm, it was swollen, red and hard and had pain in her neck. No treatment was received for events. She wants to know if this was normal. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Have a lot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Have a lot of joint pain) in a female patient of an unknown age 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 ARTHRALGIA (Have a lot of joint pain). At the time of the report, ARTHRALGIA (Have a lot of joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment information was not provided
more than 30 min after vaccine I felt light headed, weak, nauseous, and tingles in my legs and hands and jaw
Pt recvd 1st dose of vax 8MAR91; @ 8-9PM that same day, an area on arm about 4cm around inject site was very itchy, red & slightly swollen;
Pt received her 1st dose of the Pfizer vaccine in the right arm at approximately 2:45 PM on May 29 at pharmacy. Pt was recommended to sit for 15 minutes in the waiting area after vaccination for observation, but she and mom opted to go shopping in the store. At approximately 3:37 PM, pt and mom came back to the pharmacy to tell me (the pharmacist) that she had hives and showed me red bumps on her left arm. I had the pt sit while mom went to go buy Benadryl. After 5 minutes, I checked on the pt. She had taken one dose of Benadryl and stated that she was dizzy and feeling itchy all over. After chatting with mom for 5-10 minutes, the pt stated that she felt like her symptoms were not worsening and were stabilizing. The pt then said she wanted to rest at home. I recommended she sit for a little longer, but mom stated she would keep a close eye on the pt and had an epipen at home. They then left the pharmacy. I followed up with mom on May 30th at approximately 4:00 PM to see how the pt was doing, and she stated that they were at the ER because the symptoms were not getting any better, and the pt "felt like she was having an asthma attack." Pt's mom states that the pt is doing much better after receiving IV meds.
Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and enter my nasal cavity.  At which time it seemed to dry up what ever nasal mucus I had.  Almost immediately I felt dizzy  and light headed.  Then came the  my heart beating faster.  My breathing quickened cold sweats began with the palms of my hands.  This continued for about 3-4 minutes.  When my heart/ blood pressure seemed to go back to normal, I sat for an additional 15 minutes.   I had 3 more incidents that day of dizzy and lightheadness throughout the day but not to the extent of the initial, almost passing out, spell. For 12 hours after injection,  other than the typical reported symptoms of  sore arm, fatigue which I did experience,  i felt like I was in a haze, similar to when you have a fever for 11 hours.  And oddly, almost immediately the haze and fatigue lifted.  No other adverse reactions after that.
Itching, headache, red blotches on skin, raised heart rate, swelling throat
UTICARIA BY HISTORY 2 HOURS AFTER VACCINES.  DIPHENHYDRAMINE PRN AT TIME OF EXAM NO RASH WAS NOTED.
I took the first dose of Moderna Covid vaccine on 1/14/21. A week later I developed an itchy, red and raised rash around the area of injection. The size is approximately 9cm by 6cm. I put hydrocortisone ointment on it. On 1/22 evening I woke up in the middle of the night with significantly pruritis at 4 different areas of the body including the arm. I had to take diphenhydramine to help with the itchiness and to fall back asleep.
My noises of tinnitus is a  high squeal, louder in my right ear and yet pretty loud in my left ear.  I was hoping it was going to fade but I am now 21 days later without reduction of the issue.
Pt received Moderna COVID vaccine on 3/29/21. Pt became positive with COVID on 4/6. Pt was hospitalized for COVID on 4/14/21.
After 2 days post vaccine I woke up to go to work and as soon as my feet hit the floor I had excruciating pain in my feet. After 2 weeks of no improvement, I saw a foot doctor and the x-rays that were taken did not show any arthritis in feet. For about 8 months I had this pain and there is still residual pain in the left foot currently. Every now and then the pain does go away however the tenderness in my foot is still painful. I work part time and lost out on some extra work due to this symptom.
Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs) and Drug allergy (Vitamin E topical). Concomitant products included FLUOXETINE from 09-Sep-2000 to an unknown date for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 4:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs). At the time of the report, SOMNOLENCE (Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs) had not resolved.            No treatment information was provided.  Patient was experienced lethargy and body aches for 2 days after one of the shots.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant Follow-up received - Patient demographics, reporter details, suspect product, concomitant product details, vaccination facility details and narrative updated. On 04-Aug-2021: Non-Significant Follow up
BOTH DOSES - SHOT 1 ON  1/27/21 / SHOT 2 ON 2/25/21 -ALLERGIC REACTION- COMPLETE BODY WAS ITCHING, SLIGHT BREAK OUT (NO HIVES);CONTROLLLED  WITH BENEDRYL -  SHOT 2 INCLUDED ADDITIONAL FLU TYPE SYMPTOMS - EXTREME BODY ACHES, HEAD ACHE
Fever, Dizziness, Nausea, Leg cramps so severe he still has trouble walking.
1st dose on 2020 and is late for the 2nd.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22nd January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
No additional AE reported; 36 year old patient was administered Proquad, but should have been administered MMR II; 36 year old patient was administered Proquad, but should have been administered MMR II; This spontaneous report was received from a nurse and refers to a 36-year-old patient of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.   On 14-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), 0.5ml, lot # T025223, expiration date 19-JAN-2022 (route of administration was not provided) for prophylaxis, but the patient should have been vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No additional adverse event reported.
Patient had redness at the site of injection, itchiness, and mild pain. Patient was counseled to try Benadryl for the the site reaction and acetaminophen for the pain.