chrisvoncsefalvay/vaers-outcomes huggingface dataset:
angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Thighs became very itchy overnight 9/14-9/15.  The morning of 9/15 noted that most of thighs were bruised from the itching.  The next few days legs were very sore, tender to touch and also have generalized fatigue.  Took almost 2 weeks for the bruising to resolve.
Vomiting and low grade temp 99.7 (A), vomiting during night of 4/22/02.
Onset of hives 48 hours after injection. Hives persistent through 12/30/2020 at time of visit. Located bilateral axilla and flanks.
Chills and Fever of 100.4 F started on 6/6/21.  Took Ibuprofen 200 mg  2 Tablets every 4 hours until 6/7/21 and help reduce the fever.  On 6/8/21 Patient recovered.
This spontaneous report was received from a nurse regarding an 12 months old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 02-JUN-2018, the patient was inadvertently vaccinated with PROQUAD lot # N024562 and 06-MAR-2019 expiration date for prophylaxis (dose, strength, frequency and route of administration were not reported) instead of M-M-R II for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). No adverse effects were reported. No product quality complain was present.
Doctor was given ZOSTAVAX on 10/12/09 started having rash on face on 10/14/09 seen by dermatologist today- states scraping was done and confirms shingles just started
Extreme constant tinnitus bilateral ears and L>R tympanic membrane intermittent, transient pulsations began 1 month or so after second moderna Lot # 007b21a on 3/26/21. Intermittent Occasional Chest Flutters with tansient lightheadedness, intermittent. Possible PVCs
No side effects reported; HCP calling to report AE for PROQUAD. Improperly stored vaccine was administered. No side effects reported. No other medical information known. HCP permission to contact obtained. See additional AE cases 02477408, 02477532, 02477541, and 02477561. No; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 19-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, lot #W012730, expiration date was validated as: 16-OCT-2023, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) which showed temperature elevated to 6 degree Celsius for 7 hours. There's no previous temperature excursion. No other medical information known (no adverse event).
I am submitting this report not based upon adverse events I experienced after both vaccinations including headache, eye pain, somnolence, dizziness, joint and muscle pain, low-grade fever, loss of appetite. These symptoms resolved two days after first vaccination and four days after second vaccination.  No medical advice was sought and acetaminophen was taken on an as-needed basis.   What I found to be unusual after both vaccinations was profound changes to the color of my urine two days after the vaccinations. I use the PureWick external catheter and urine collection system due to my NMO-related incapacitation. This system facilitates the assessment of urine output and characterisitics. After my first
Rash began a couple of hours after child received immunization rash under right arm, chest and stomach area
increased blood pressure and heart rate - lying down and monitoring - drank water apple juice and crackers.    Resolved over a couple of hours.
12/13/2021 at around 05:30 PM. At around 6:00 Pm I started feeling drying on skin, on nail joint peeling off. The dryness lasted one day when I drank 3 gallons of water. I don't drink or smoke. After 2 days I started feeling the hives. My skin was bumpy I got bumps on my skin and it bleed. My skin came off. It lasted a month after the blood came out it healed itself. When I eat non-veg the hives comes back, especially when I eat chicken it never happened to me before. After my booster I started experiencing hives so much I can't control. I did not go to see a doctor. When the pus came out of my skin it healed itself. I have to avoid eating chicken.
chills; fever; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter asked what he/she could take for chills, fever from Shingrix shot. The follow up would not possible as no contact details were available.
area surrounding vaccine site was red 2-3 inches in diameter in right arm, no induration,no heat present
Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 05 May 2016. This case was linked to 2016SA060451 (same reporter and batch number). This case involves a 26-years-old male patient who was vaccinated with a 0.5 ml intradermal dose of ADACEL (batch number U4939AA, expiration date was not reported) in right forearm instead of TUBERCULIN PPD (PPD/TST) (batch number, expiration date, route and site of administration was not reported) on 21 March 2016. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On 23 March 2016, two days following vaccination, patient had redness around the injection site, one the size of a baseball and the other the size of a softball (erythema). Patient had a hard pea size nodule at the injection site. Patient stated the injection site felt itchy at first and then redness and swelling appeared. Patient had advised to see their primary care physician for evaluation. It was wrong vaccine administered, wrong route of administration and product use issue case. Patient required doctor visit. Lab data was reported as none. Corrective treatment was not reported. On 02 May 2016, patient was recovered from events. List of documents held by sender: none.
Pt states her left arm began to "throb" "within the hour" after receiving the injection. There was nothing noted by nurse at the return visit on 11/7/03 at the injection site (left deltoid) but the lower part of the upper arm, just above the elbow area was cool, reddened, slightly swollen. Pt states this same area had been "bright red" and "very swollen" on 11/5/03 and 11/6/03. F/U call 11/10/03 to pt: pt is better, the swelling is "nearly gone" and "only a little red now".
Nausea, poor appetite; Local site pain / swelling left arm - anthrax right arm vaccine. SXs began after anthrax vax. 3/27/03 of nausea.
forgot to get the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.
large, red, swollen circle appeared 2 days after receiving vaccination. the area throbbed and later in the course started to itch. this cleared up on 10/5/07. the patient took benadryl at bedtime each night until cleared.
I broke out in a horrible itchy rash with welts all over my trunk.  I call the pharmacist who administered the vaccine. She told me to take benedryl and said i may need a steroid shot. The next day, 9/26/2019, when I woke it at was far worse. I phoned my dr and made an appt.  He gave me a steroid shot and had me start taking  24 hour xyzoz antihistime.  It did clear up a lot but im coming up on the dosage time and Im getting red and itchy again.
Arm swelling, redness, warm to touch and itching. Patient advised to apply cold compress and antihistamine for itching. Denies fever.
Expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Reporter stated that there was a confusion between expiration date printed in the carton and expiration date when the code was scanned. The vaccine was placed in refrigerator on 29-Oct-2021. The vaccine did not go any temperature excursion and patient did not experience adverse event.  No treatment information was provided.
Patient was given the Moderna Bivalent Booster dose from a vial that was 23 hours post-puncture left at room temperature; no reported adverse side effects reported by patient
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 48-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known drug allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included taking PAXLOVID from 30Sep2023 to 05Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache.  All over body aches Chills Neck pain  Injection site pain
Five minutes after receiving vaccine I experienced a tightness in my throat.  I did not have any difficulty breathing and did not mention this reaction to the vaccine administrator.  The feeling lasted the remainder of the day.
Patient have 2nd Moderna vaccine administered at 2:02 pm . At 2:30 pm patient reported an itchy skin, vague tingling and mild throat closing. Patient was accessed by P.Bergen PA and Benadryl 25mg was administered per his order. Patient was sent to ED via ambulance.
rt arm swollen,red,hard and hot to touch. ?cellulitis started on septra
Chills 102.5 fever 120-149 heart rate Dizziness Incontinence  Headache Nausea Joint and muscle pain
Site: Bruising at Injection Site-Mild, Additional Details: Sufficient bruising 3-4 inches from injection site, 4-5 inches in diameter
High fever (103.3) on 2/21/2021 that lasted for 6 hours and stopped with ibuprofen.  Left arm soreness persisted for 3 days and stiffness in the left shoulder became more prevalent.  During the last 3 months, range of motion in the left shoulder has decreased, general weakness in the left arm noted and now there is severe pain in the left shoulder when moved in certain positions.  Large decrease in range of motion.  Can no longer reach across my chest with severe pinching on the top of the left shoulder joint.  Can no longer swing a golf club without severe pain and swing limitations due to range of motion decrease.  I saw my primary care physician last week and he has referred me to an orthopedic doctor.  My appointment is for Monday, June 7th in Stephenville, Texas.
Pfizer 1/15/21 and 2/15/21. Positive on 1/6/22
Fever and chills for 18 hours - treated with tylenol or ibuprofen. Full recovery after 18 hours.
At 11:30 pm the patient, my mother, experienced extreme rapid heart beat, pain in her chest and neck, and  nausea. She stated it was intense and severe but can't say how long it lasted.  She was about to call 911 when her symptoms subsided.  She fell asleep and didn't tell anyone until the next day.  She has felt ok since then but we will be following up with a doctor next week.
After 7-10 days, slight rash started, then progressed to cover entire body by 15 days.  Still apparent.  Fever lasted only about 1 day - started on 11th day.
Runny nose, sore throat, congestion, lost voice, fatigue; symptoms began March 15, 2022 and lasted approximately three weeks after taking prescription antibiotics.
Inflammation and tenderness of dermal filler which was placed in Dec2019.; Inflammation and tenderness of dermal filler which was placed in Dec2019.; first dose 20Dec2020/second dose 06Jan2021; This is a spontaneous report from a contactable physician (patient) reported that a 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) on 20Dec2020 11:45 then received the second dose on 06Jan2021 14:30, via an unspecified route of administration on the right arm at single dose for COVID-19 immunization. Medical history included allergic rhinitis, depression and gastrooesophageal reflux disease (GERD); all from unknown dates. On Dec2019, patient was placed with dermal filler. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN) and omeprazole. On 08Jan2021 07:00, the patient experienced inflammation and tenderness of dermal filler which was placed in Dec2019. No therapeutic measures were taken as a result of the reported events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Several pts did not convert p/ series of 3 hep B vax on 0,1,6 months schedule rather than 0,1,2,6 month schedule recommended for hemodialysis pts.
Pt received first dose Moderna 4/1/2021 then first dose Pfizer 6/9/2021. Pt stated that she talked to someone on the phone that said it was okay for her to restart a series of Pfizer since it had been over 2 months since her dose of Moderna. No known adverse reaction occurred with either vaccine. Patient was notified via voicemail on 6/10/2021 that she should not come for her second dose of Pfizer to follow current CDC recommendations on administration of two different mRNA vaccines.
First overnight after vaccination. No fever. Nightmares and vivid dreams all night long. Generalized myalgia and arthralgia (even my fingers and toes). I have had dengue (?break bone?) fever twice ?. It felt almost as bad. It?s like looking at your extremity wishing to move it, but it hurts so much that you just give up! Sounds dramatic but it is the best way I can describe it.  Got better as I incorporated into the day. Some residual fatigue for 1-2 days. All resolved.
This spontaneous report as received from a 64 year old female patient referring to herself. The patient's pertinent medical history included asthma and no drug reactions or allergies. On an unknown date in February 2018, a little over three weeks ago, the patient was vaccinated with ZOSTAVAX (dosing details, lot # and expiry date unknown) underneath the left arm for prophylaxis. Concomitant therapies included VENTOLIN, QVAR and venlafaxine ER. On an unknown date in 2018, the patient began experiencing fever, chills, and terrible headaches that lasted for approximately three and a half days. The patient sought medical attention by calling the pharmacist. It was reported that her husband saw on television something about a class action law suit filed in relation to ZOSTAVAX. It was reported that the patient experienced the symptoms after she received the vaccine. No treatment was provided for the events. The outcome of pyrexia, headache and chills was reported as recovered. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1803USA004165.
Rash on neck. Itchy.  Warm to touch.  Took diphenydramine without relief.  Rash spreading on face/trunk.  Given solu-medrol in office and hydroxyzine at home.  only received dose #1.
Shingles; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 (reported as 3 weeks ago) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced shingles in between doses and second dose was scheduled tomorrow (as reported). The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
From initial information received on 29Mar05 from a health care professional regarding an adverse event occurring, it was reported that a 44 yr old male pt received a dose of Typhim Vi, lot number X0521-2 administered in the right deltoid on 24Mar05. The route of admin was not reported. One day later, on 25Mar05, the pt developed shingles in the area of L1 and L2 as well as on his left groin and left buttock. The shingles were described as being very painful. The pt was treated with Valtrex, oral Benadryl, aspirin and hydrocortisone cream. At the time of this report, the pt had not recovered from these events. The pt had previously received a dose of Twinrix, lot number AHABA015AA, administered IM in the left deltoid on 03Mar05. He received a dose of Ipol, lot W0704-2, admin IM in the left deltoid on 11Mar05 and c/o fatigue the following day. The pt also had a dose of Diphtheria and tetanus toxoids, lot number TD109, admin in the left deltoid on 15Mar05. The pt's previous adverse event of fatigue is captured in case 200500637. Follow-up information received on September 2, 2005. The patient received Diphtheria and Tetanus Toxoids intramuscularly in the left deltoid. The patient developed rash consistent with Herpes Zoster. Hew was seen on March 28, 2005 and treated with Valtrex. He recovered fully on April 4, 2005.
The pt got chickenpox after having had Varivax on 2/1/99.
4 inch red area that itched for 2 days.  MD gave patient Benadryl and it has resolved.
I began losing the hair on my head in small patches and it has very rapidly progressed. I have lost more than half of my hair. It is possible that the booster triggered my alopecia, causing a flare up. This is the most substantial hair loss I have ever experienced.  I am being treated with topical medication, steroid injections, oral steroids and have not yet had any progress. Next steps are to include additional treatments and changing my medication.
Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
Patient called and reported he was admitted to the hospital from having a stroke from the vaccine. Was told to call the pharmacy to report his stroke from the Pfizer Bivalent vaccine.
On 9/22/2015, a red bump rash appeared on patient's sides of his torso, with several bumps on his legs, and face. This rash continued for 5 days. On 9/24/2015, patient had an event where his eyes were focused completely to the left and was completely unresponsive for 7 seconds. He was seen that afternoon by Dr. and it was determined that patient suffered an Absence Seizure. Beginning on 9/27/2015 and lasting until 9/30/2015, patient has been suffering from high fevers fluctuating from 102.5 and is continuing to have fever.
Patient states 1 Hour after flu vaccine. She was not feeling well. She hurt redness and swelling at the left upper arm. She started Benadryl 11/20. Presented 11/21/2005 no symptoms of cellulitis.
Pt reports many allergies. Was advised not to get the shot unless done in the ED. Pt spoke to another Nurse with out my knowledge and got the shot.After ten minutes pt began itching all over, Red raised rash began appearing over her body, lips felt tingly. Given Benadryl 50 mgs chewable tabs at approx 10:20am.  Emergency services Called and pt went to the ER and was advised that she cannot get a 2nd dose of COVID because it's contraindicated due to severe allergic reaction. Pt went to ED but was not admitted. States Received IV fluids and some medicine that  made her sleepy of unknown name. Was sleepy for 3 days after that and all signs and symptoms resolved.  Wants to get 2nd dose even though we said  not to. Will get in ED.
Non-febrile, Sore Throat, Chills, mucous & post nasal drip.  Sore throat began 11/20/21 and is gone this morning 11/22/21.  Remaining symptoms continue.  Rested in bed at home all day after emergent visit yesterday, 11/21/21.
No adverse reaction. Patient received 0.5 ml dose. Recommended dose for patient this age for AFLURIA QUAD is 0.25 ml.
Bloating in my Colon and constipated, I had no appetite for 9 days, I had a inflamed and swollen colon and tenderness on my lower left abdomen, feeling like I had a bowel movement but I couldn't.