chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blurry vision / eyes could not focus; second shingrix vaccine yesterday / first Shingrix vaccine in 2018; shivering; fever; flushing of the face; felt both cold and hot; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On 20th August 2020, the patient received the 2nd dose of Shingrix. On 20th August 2020, less than a day after receiving Shingrix, the patient experienced shivering, fever, facial flushing, feeling hot and cold and drug dose administration interval too long. On 21st August 2020, the patient experienced blurred vision. On an unknown date, the outcome of the shivering, fever and feeling hot and cold were recovered/resolved and the outcome of the facial flushing and blurred vision were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shivering, fever, facial flushing, feeling hot and cold and blurred vision to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shivering, fever, flushing of the face and he felt both cold and hot.  When the patient got up in morning his vision was blurry, his eyes could not focus.  At the time of reporting blurry vision has not resolved, face was still flushed, and other symptoms have resolved.  The patient received 2nd dose late, which led to lengthening og vaccination schedule. The reporter consented to follow up.
My charge nurse told me he was tested positive that evening. Started feeling my throat hurting in the morning. Because of being exposed to my charge nurse I had to go get tested. By 9AM body aches, headache, cough, chills.  Fever went down on Thursday 100.8F, hot and cold sweats. I never felt like that before.  I also had some GI issues (diarrhea) and a little bit of shortness of breath, just by walking to the restroom I would be very fatigued and when I checked my oxygen it would drop to 88% just by walking from my bed to the bathroom (Wednesday and Thursday was the worst). I still have fatigue and my throat hurts a little bit, I have congestion again and I started feverish again this Tuesday and lots of cough. Low grade fever (99.9F). My employee health told me to not return due to my symptoms until they subside or go get checked. Coughing and sneezing restarted yesterday. I had returned to work on Monday but then by Tuesday symptoms started reappearing.
Patient complained of left hand numbness around 15 minutes after receiving injection. Patient is alert, responsive, only other complaint is palpitations. Denies ShOB, chest pain, throat tightness. Both the numbness and palpitations are not new, have been happening intermittently and is being  evaluated for these symptoms. HRRR no murmurs, CTAB no wheeze, MMM, BP 142/98 with pulse of 64. Numbness mostly resolved after a few minutes. Extended observation time by 15 minutes past original time. No further issues.
Patient received 2nd COVID vaccine on 2/19/22 at 1173. she stated that about 6 hours after receiving shot, a lump appeared at the site of injection on her left deltoid and reports it hurting even with the slightest touch, but not red; site is tender. She stated that when she woke up this morning, her left arm is very tender to the touch and her left breast is now swollen. Patient reported being involved in car accident on 2/11/22 and impact was on your left side. She also said that she did not have any reaction to the first Pfizer dose (was not trisucrose formulation like 2nd dose). I let patient know that her body can be having a hyper immune response due to the recent car crash and the Pfizer dose increased that response. I suggested patient goes to the emergency dept to make sure that this reaction does not develop into something worse.
2-3 days p/vax pt began having seizures & was taken to hosp seen & released but treated for ear infection;
Patient became dizzy while receiving vaccination. He fainted/passed out briefly and the paramedics were called. When they arrived patient was awake and conscious and said he didn't need further help, that this reaction was "normal" for him.
Immediate paralysis of left arm. +2-12 hours, left eye socket numbness +6 hours - persisting today, loss of left hand small finger control +12-48 hours, violent chills/shaking, body aches
Received vaccination at about 245pm. A rash occurred on both sides of face. Possible "hives" by 815pm that evening. Stayed for about 2-3 hours & disappeared. No other occurrences.
Patient received Moderna first dose on 3/22/2021. She called on 3/24/2021 to report that the night of 3/22/2021 she woke with chill, nausea and body aches. She states that on 3/23/2021 her body was sore with continued nausea. She states she was "unable to move L arm at all".  States she is some better on 3/24/2021 and is able to pick L arm up. She denies loss of feeling to arm but states that it really hurt, was red and "rashy". Instructed to call her primary care provider or come to clinic. Called patient back later on 3/24/2021-reports she is feeling some better-has not spoken with her MD. Called patient on 3/25/2021, states she still feels "pretty rough" but arm is better and she can pick it up over her head. Swelling and redness going away. Feels better overall but still sick and complains of nausea. Primary care provider has not called her back, offered services at our clinic.
Rash, chills, nausea, fatigue. Called TM health, made a primary care appt, was given prednisone for rash.
Skin crawling on back.  Thumbs on right & left hands numb.  Neck stiff on R&L in back.  Ears throbbing - like an engine.  Coughing, low grade fever, burning pain left buttock.  03/13/2008 MR received from PCP. Pt seen 11/9/07 "doing well". Next seen 1/29/08 with c/o tingling sensation and numbness both thumbs since YF vax on Jan 18,2008.  Next seen 2/8/08 with c/o sore throat and neck pain. DX: yellow fever side effect.  Sent for neuro consult. 4/2/08 Neuro consult received for DOS 2/1/2008 with Impression: Recent onset bilateral thumb paresthesia off and on and now slowly improving is either related to diabetic sensory neuropathy or carpal tunnel syndrome.  The possibility of an allergic reaction to the yellow fever vaccine is unlikely because of the focal paresthesia.  EMG/NCS showed bilateral carpal tunnel syndrome as well as sensory peripheral neuropathy.
Pfizer-BioNTech COVID-19 Vaccine EUA:  About 2-3 hours after injection, I have started to experience some adverse affects. The injection arm has become very sore, I am now very tired and my body temp seems to be up and down. I keep getting hot and cold flashes. I am also feeling sick to my stomach.
On 9-26-2016, patient got 2 shots, PNEUMOVAX 23 and FLUZONE HD. Patient got "ice cold" night of shot. Swelling was noted in arm where she received pneumonia shot. She could not move her arm that night to brush teeth. On Friday 9:30, swelling has started to subside.
vax area 6-7mm bright red, hot, swollen  w/less red area 6mm wide w/white circle around;entire area hard & swollen x 7-9 days w/center turning purple & discoloration still notable 8DEC97;painful area along femoral vein;enlarged node lt groi
Patient tested positive for Covid 19 on 03/27/2021, no symptoms noted, preprocedure
changes in menstrual cycle, abnormal bleeding, severe menstrual cramping, worsening migraines
Scheduled for her second dose today at 12 O'clock but she is not feeling well and unable to receive it; sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced scheduled for her second dose today at 12 o'clock but she is not feeling well and unable to receive it and sick on an unspecified date. Patient stated she had an appointment for 12:10 and she is calling to cancel it because she is sick and wants to reschedule it. Patient then inquired if she can be scheduled a new appointment and asks what hour on Saturday. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The shot was painful and I immediately felt my left arm get very warm from injection site down to my fingertips. My fingertips were also tingly and numb. About 5 minutes after my right arm starting feeling warm and fingertips numb and tingly as well. I also felt weakness in my right hand and dropped a bottle of water. About 40 minutes later my right arm/hand started to feel better. About 1 hour later left arm is still sore, but tingly feeling is better.
Two days after receiving vaccines, patient presented to the office with right upper extremity redness. Patient was sent to the emergency department at Hospital. Patient was diagnosed with cellulitis and received antibiotics. Patient was admitted to the hospital on 09/20/2018 and discharged on 09/24/2018.
2nd dose headache prior to leaving vaccine site,  dizzy that after noon,   still headache took Tylenol did sleep fair, next day,  spaced out, also had periods of sweating,  around 7pm I felt exhausted, then started aching , did this throughout the night  and continued thought today , took my Blood pressure  pressure was normal but indicated I was  having a-fib, I just feel out of sorts and  haven't contacted  my physician because of the expectation of side effects,  After taking my BP I realized the reason for my sweating was  due to A-FIB ,caused by vaccine
Subsequent to receiving vax, the pt developed flu like symptoms. No further information was available at the date of this report. Manufacturer's Comment: The reporter indicated that 31 employees experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.73.  Concomitant medication of the patient was not reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 03-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Received second dose on 9/24. 9/25 I developed fever, extreme chills, nausea, and lightheadedness for 8 hours. 9/26 I started to feel pain in my labia. When I looked in the mirror, it looked like small dots of blood. I thought  it could be a UTI. 9/27 Evening, the pain had become much worse; my labia was swollen, extreme pain when urinating and wiping myself, no discharge or smell, pain when sitting and itchiness. The spots were now yellow/white raised bumps. 9/28 I had an emergency OB appointment. Provider took sample to test. Area was very sensitive to the touch. She said it didn?t fit the symptoms of a bacterial infection, and it also didn?t fit other traditional viruses. She performed a papsmear as a precaution. She prescribed an antiviral and lidocaine topical ointment to try to help. She wasn?t sure what it was. I had to stay home from work for 2 weeks because I was unable to sit or walk without pain. I had to wash my genitals in the shower after each bathroom use because of the extreme pain urinating and wiping. Washing with water, ibuprofen, and the lidocaine cream helped soothe the pain periodically.   I found articles online with pictures that looked identical to my condition. ?Acute non-sexually reactive Genital Ulcers related to Covid-19? or ?Lipschitz Ulcers?. I informed my provider of my discovery.  I did not know I was pregnant at the time until 10/12/21. Est. due date June 14 2022.
Reported 1 week after vaccination via phone call to health department,  pain at time of injection in arm that progressively worsened over the week and radiates into neck and "around heart".  Treatment and outcome unknown at present as client was advised to seek immediate medical attention due to presence of symptoms.
I had total hip replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 02Apr2021 (Lot number: ER8730) at the age of 73 years as dose 2, single and intramuscular, administered in arm, administration date 12Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 28Sep2021, outcome "unknown", described as "I had total hip replacement".  Clinical course: I called Pfizer because I had some headache after 3rd booster shot. No problems with the first 2 shots. With the 3rd shot. I had a headache an hour or so later. It eased, but had a headache most of the next day. The headaches continued on off for about 3 weeks. They other perstiant information was, I had total hip replacement 28Sep2021. So when I got the booster. It had been 5 and half weeks from that surgery.   No follow-up attempts are possible. No further information is expected.
Metal like taste and smell 2 days  after 2nd injection. Has lessened in 10 days but still comes and goes
Chills ;shaking uncontrollably);  weakness, dizziness, and pain in arm at point of injection
Rt. arm swelling with red line from Rt. shoulder to Rt. fingertips on Fri. day after shot and went to ER on Sat. Rx. with Doxycycline and Prednisone x one week.
dehydration; anemia; neutropenia; thrombocytopenia; abnormal liver enzymes; increased blood sugar level; dysgeusia; developed severe throbbing headache; fever (102-103 F); chills; This is a spontaneous report from a contactable physician (patient). A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6193), intramuscular, administered in Arm Left on 25Mar2021 08:30 as single dose for COVID-19 immunization in a hospital. Medical history included supraventricular tachycardia and NSTEMI (Non-ST Elevation Myocardial Infarction) both from an unknown date. No known allergies. No COVID-19 prior to vaccination. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD) and asa (ASA) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL9266) on 04Mar2021 in the left arm for COVID-19 immunization and experienced severe throbbing headache, fever and chills. On 25Mar2021 22:30, 14 hours after the second dose, the patient developed severe throbbing headache, fever, and chills lasting for 72 hours. On 08Apr2021, the patient was hospitalized for 1 day for dehydration, anemia, neutropenia, thrombocytopenia, abnormal liver enzymes, increased blood sugar level, dysgeusia. The patient again developed severe throbbing headache, fever (102-103 F), and chills. The patient underwent lab tests and procedures which included blood glucose: increased on 08Apr2021, body temperature: 102-103 fahrenheit on 08Apr2021, hepatic enzyme: abnormal on 08Apr2021, panel of lab tests: normal on 28Feb2021. The patient was tested for COVID-19 via nasal swab taken post vaccination with a negative result on an unspecified date. The patient was treated with IV fluids. The events required healthcare professional office/clinic and emergency room visit. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Breakthrough case admission after 2 vaccines Pfizer 3/17/21 Lot# ER2613;  Pfizer 4/7/21 Lot# Ew0158
SORE THROAT WITH EAR PAIN, FEVERISH & CHILLS ON&OFF, EYES HURT, DIZZY, TIRED, CONGESTION, HAY FEVER SNEEZING, HEADACHES, SHORTNESS OF BREATH, CHEST PAINS, BODY ACHES...LASTED OVER A WEEK...STAYED IN BED ON DAY 3 & 4(SUNDAY...PLANNED ON ER VISIT ON MONDAY, IF COULD NOT GET OUT OF BED), TIRENESS, SORE THROAT, & SNEEZING LINGERED TO DAY 10-11 OF DAY OF FLUMIST.
A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 15-year-old female. No relevant medical history was reported for his patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
pt recvd vax 19JUN95 & pt became pregnant-LMP 19JUL95;@ 28 wk gestation, tp was treated w/terbutaline for pre-term labor;MAR96 pt was restricted to bedrest;pt delivered a nl infant @ 37wk gestation;
delayed cutaneous hypersensitivity being  treated with benedryl, ibuprofen, clobetasol cream
5/17 Crushing Headache, Fever, Sore Jaw and Neck, Swollen Glands 5/20 Joint Pain, 6/05 Jaw and neck get worse. 6/07 Lower Legs and Arms become numb. Legs become weak and shaky.
17MAR98 mom noticed bruising on pt hand;18MAR98 noticed red blood spots or rash on stomach;pt taken to MD dx as poss ITP;
pt recv vax & devel fever to 104 (w/APAP) & 1 1/2hr screaming p/vax;also swelling & redness @ inj site;reporter states feel event possibly r/t DTP will no longer give pertussis;
Patient developed a "goose egg" at the injection site 9 days after vaccination. Patient stated injection site was swollen, red, and warm to the touch.  Patient reported these symptoms on 04/20/21 and was instructed to seek medical attention.
The day after vaccine 8/29 I experienced fever, muscle aches, chills, headache. Headache grew in severity and intensity in days to come. Symptoms subsided on 9/1.  On Monday 9/6 fever, muscle pains, chills, headache returned, by Tuesday 9/7 there was light sensitivity along with severe headaches. Thursday 9/9 went to emergency room with fever, severe headache, light sensitivity, nausea, and vomiting.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a hospital for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a 57 year old female with no pertinent medical history and no known drug reactions/allergies who on 06-JUL-2007 at 10:45 AM was vaccinated IM with a first dose of Zostavax (Oka/Merck) (Lot#652965/0622F). Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and estrogens conjugated (PREMARIN). On 25-AUG-2007 the patient developed shingles. The outbreak was on her abdomen, side and back. She had pain, burning, and lesions in the area. The patient sought unspecified medical attention. As of 30-AUG-2007, the patient's shingles persisted. Follow up information from the nurse indicated that the patient was seen on 30-AUG-2007 complaining of a rash for 5 days. The doctor observed 1 pustule or lesion on the front of the abdomen. No other lesions were seen. The patient also complained of increased stress. The physician prescribed alprazolam (XANAX), valacyclovir (VALTREX) and cephalexin (KEFLEX). The patient was instructed to follow up if the symptoms persisted. The diagnosis was infected lesion vs. shingles. The prescribed made covered both. On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.