chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 25-Oct-2017 and additional information received on the same date. This case involves 65-year-old female patient who was vaccinated with FLUZONE HIGH-DOSE once (batch number: UI892AB, expiry date: 06-JUN-2018), intramuscularly in left deltoid (dose and dose in series was not reported) on 23-Oct-2017 in the evening. Patient's medical history and concomitant medications were not reported. On 24-Oct-2017, one day following the vaccination, patient noticed slight pink area. On 25-Oct-2017, two days post vaccination, the area from where she received the injection and below it was red. Patient noticed erythema extending down arm almost to elbow; redness was traveling down her arm. There was pain upon palpation and patient indicated that when she touches there area, there was some pain. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown at the time of reporting. List of documents held by sender: none.
High fever x2 days. Extreme redness at injection site, spreading to entire upper arm. Swelling for several days, with pitting for 36 hours. Lethargy, loss of appetite. Day five showed some improvement but still red and moving but resolved in some areas.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (dose reported as 0.5 ml, intramuscularly, lot # unknown). On 13-SEP-2013 the patient was vaccinated with the second dose of GARDASIL (dose reported as 0.5 ml, intramuscularly, lot # unknown). No adverse effect was reported. Additional information has been requested.
Breathing issues; Death; A spontaneous report was received from a consumer concerning a 78 years old, female patient who experienced breathing issues/dyspnoea.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   The patient experienced breathing difficulty on 12 Mar 2021. The patient died on 12 Mar 2021.  Treatment information was not provided.   Action taken with the drug in response to the events is not applicable.  The patient died on 12 Mar 2021. The cause of death was not reported. The reporter wanted to conduct a autopsy to find out if the death was caused by the vaccine.; Reporter's Comments: This is a case of death in a 78-year-old female subject with unknown medical history, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Pain at injection site followed by Angina, Heart palpitation, Tightness in chest, lowered pulsox, dizziness. Followed by admission to emergency room with diagnosis of ABNORMAL ECG, lowered pulsox, Atelectisis (Chest Xray) Followed by referral to Cardiologist Symptoms are persistent Undergoing further treatments and further tests scheduled as of the date of this report.
This spontaneous report as received from a 66 year old male patient with high blood pressure, antidepressant, hypothyroidism, diabetes type 2, glaucoma and no known drug reaction/allergies or pertinent medical history. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX as a vaccine. Concomitant therapies included losartan (manufacturer unspecified), levothyroxine sodium, metformin, unspecified eye drops for glaucoma and bupropion hydrochloride. On 19-JUN-2013, the patient experienced very dark stool and reddish urine after having taken ZOSTAVAX. The patient did not seek medical attention. No treatment was given. No lab diagnostic tests were performed. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.
very bad case of shingles 7 months after; This is a spontaneous report from a contactable nurse. This 40-year-old female nurse (patient) re-ported for herself that:  A 40-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration, administered in right arm (reported as right arm) on 01Jan2021 14:00 (at the age of 40-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type Vaccine: Hospital. Patient relevant medical history included multiple sclerosis, gluten allergy and dairy allergy from an unknown date and unknown if ongoing. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Ek5730) via an unspecified route of administration, administered in right arm on 12Dec2020 14:00 (at the age of 40-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was not tested for covid-19. The patient did not receive any other vaccine in four weeks and the patient did not receive any other medications in two weeks. On 22Aug2021, patient developed very bad case of shingles 7 months after. Patient reported that patient was reading more and more online that patients with auto immune diseases may develop shingles afterwards. So patient reported her case as a possible link and would like to share the possibility. Patient received creams and pills as treatment. Outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
When I woke up to use the bathroom I was ataxic and had nystagmus. A while later I became nauseous. I took a baby aspirin because I was afraid I was having a stroke. This lasted about 5 hours. Then I developed a head ache just behind my nose. The headache subsided in the mid afternoon, but I was wiped out and slept most of the day. Today (the next morning) I feel fine, just a little tired.
Developed chronic immune thrombocytopenia (ITP).  I do not know how immediately after COVID vaccination I developed ITP, but for a period of two weeks or more, I noticed bruises on my body, which is what led me to go for bloodwork on July 5, 2021, which is what in turn led to the ITP condition being discovered.   I assume that I may have had the condition for some time before discovering it, since the bruises only appeared when I carried out an especially physically demanding cleaning/organization project.  By July 5, my platelets were at 13,000.
1. Extremely severe migraine attacks - Jan 2003 - Throbbing pain - lasted two days - migraines every week or two after first severe attack - got shot of Toradol to ease pain and started using Relpax to control future attacks.  2. Severe migraine attack on the following dates with duration - numerous dates and every month since Jan 2003 at least twice a month lasting 4 to 12 hours - Still suffer attacks at present. 3. Severe Obstructive Sleep Apnea - First diagnosed as mild on 23 Apr 2003 but was not satisfied becasue I was always sleepy in the daytime and sweat profusly at night - retested on 4 Aug 2005 - diagnosed with severe Obstructive Sleep Apnea and was prescribed a CPAP with a setting of 14 daily to sleep. Continues to present date.  4. Chronic fatigue and aching joints and muscles - Started in Jun 2003 and worsened over the years to present - consulted with doctors in Jun 2003 for retirement physical and with PCM after retirement on numerous dates and was prescibed Tramadol or Hydrocodone for relief. Visited neurologist in March 2007 and diagnosed with Fibromyalgia. Doctor stated I have had it for some time but other doctors do not believe in it or would not diagnose it. Under doctors care for medication for restless leg syndrome and therapy to help cope with chronic pain and suffering.  03/27/2007 Brief MR received from neurologist for visit of 03/16/2006 where pt. reports better sleep with wrist splints without paresthesias of the hands.  Restless leg syndrome improved.  Still having leg pain.  Assessment:  Carpal Tunnel Syndrome. Restless Leg Syndrome.  Lumbar radiculopathy.  04/04/2007 MR received for multiple OVs from 5/2004 to 9/2006.  Problem lists include hypertension, hyperlipidemia, migraine headaches, fatigue, leg and back pain, atypical chest pain.  Prescribed CPAP in 4/2005     DX:  Sleep Apnea.  Carpal Tunnel Syndrome.  Daytime fatigue and tiredness 2' to sleep apnea.  Morbid Obesity. DJD.  GERD. Lumbago. Peripheral Neuropathy.
Local mild redness/tenderness, warmth, on the R site of arm.  Fever.
Trochanteric bursitis bilateral severe day 7,8,9. Right sided chest pain day 7,8,9,10 Headache and nausea daily for  1 week  Not responsive to Tylenol or ibuprofen. Spontaneous resolution
Approx. 5x5cm avoid, erythematous, warm, indurated plaque at site of varicella vaccine (administered 2 days ago). No vesicles, no other lesions noted. Treatment: cold compresses pm.
Approximately 10 days following the vaccine, I began to feel mild weakness in my right hand and wrist.  The vaccine had been administered in my right arm.  Over the next two to three weeks I have noticed some additional weakness in both my right and left arms and also my neck muscles.  It is currently mild in nature, but a few days ago I had a little difficulty lifting myself out of bed.  I also notice the weakness after driving in the car for a while when my arms are in a somewhat horizontal position holding the steering wheel.  The weakness in my neck muscles is particularly noticeable in the evening and has caused some fatigue.    I have not noticed any significant weakness in the lower body nor have I experienced any additional symptoms.  Notably, I was scheduled to receive the second dose of the Pfizer  COVID19 vaccine on February 5, 2021, but have delayed it and rescheduled it to February 11, 2021
About 5 days , I ended up with an abscess tooth and now I need a root canal . Not sure if it is connected but I have never had any trouble with my teeth .
Woke up scratching my neck.  It felt hot and itching.  When I checked it was red with welts.  Later I got a headache and nausea.  I took fexafenadine twice that day, called the allergist that I go to on the 9/15.  I was told not to come in for allergy shots for that week and to continue to take fexafenadine for the rest of the week.  If it got worse come in to see a Doctor.  I took two fexafenadine on 9/15 and dropped down to one one 9/16.
Tingling and lump  to Left arm, numbness to jaw and mouth for 30 minutes
I got tinnitus the evening that I was dosed; I got tinnitus that evening and I still have it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FH8020, Expiration Date: Apr2022) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown). Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol. Concomitant medication(s) included: LISINOPRIL/HCTZ taken for hypertension; ATORVASTATIN taken for blood cholesterol increased. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), administration date: 16Apr2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 02Dec2021, outcome "not recovered", described as "I got tinnitus the evening that I was dosed; I got tinnitus that evening and I still have it". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Additional information: Got flu shot (Unspecified flu shot) within 4 weeks of getting COVID 19 Vaccine., No, got it at so patient don't have that information. Suspected side effects from the COVID vaccine. Patient was informed about the role of Pfizer Drug Safety. Patient stated, Tinnitus, I got tinnitus the evening that I was dosed last Thursday, so week ago Thursday. It was my booster dose, 'would' be my third, and patient got tinnitus that evening and still have it. Patient stated yes, this is my booster so my previous shot was in April. Patient don't have them handy actually.  know my second one was16Apr, yeah for second, yeah 16Apr2021. Patient got it at (withheld), so don't have that information. Do you want all my medication because I am also taking, I have hypercholesterolemia, so high cholesterol. It's atorvastatin. No follow-up attempts are possible. No further information is expected.
After this patient & her sister received their vaccine, they were waiting when her sister fainted and started shaking so this patient got really anxious and threw up on the waiting room floor.  We had her take a seat and called the paramedics.  the mom gave both girls ibuprofen immediately after the vaccine while waiting.  The paramedics attributed this to nerves and not a true allergic reaction.
Within 5 minutes of receiving vaccines mom states she noticed child had developed hives on body primarily of face and upper trunk area. Immediately returned to office where child was given  6.25 mg  of Children's Diphenhydramine 12.5mg/5mL. Improvement in rash noted within 5 minutes of administration. No swelling of face or mucus membranes, vomiting, or dyspnea noted at any point. Child kept in office for greater than 30 minutes for evaluation for anaphylactic reaction.
I woke morning of the 8th with shortness of breath and just recently had a lung transplant. My oxygen levels were 98-100% but the morning of the 8th, my oxygen levels was 92-95%. I sent the message to my transplant nurse practitioner and she set up an appointment for me at the end of the month. It was continuously getting worse so a family member drove me to the hospital. They did blood test, chest x-ray, and CT scan. Saw something brewing in my right lung. I was suppose to have a bronchoscopy done on the 26th. Doctor saw how hard it was for me to breathe and I was admitted into the ER. Had a double lung transplant on August 4th.
This spontaneous report as received from a other health professional refers to a female patient of unknown age with immunisation. The patient was vaccinated with, 1 DF ZOSTAVAX on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included fenofibrate, PROTONIX, simvastatin, JANUMET, glimepiride, vitamins (unspecified), iron (unspecified), COMBIPATCH and vitamin D (unspecified). On an unknown date the patient experienced fever and redness at the injection site. Treatment given was TYLENOL (ibuprofen). The outcome of fever and redness at the injection site was reported as recovered/resolved, date unspecified. The relatedness for fever and redness at the injection site is unknown for ZOSTAVAX. No further information was provided.
No adverse effect reported; one dose of improperly stored PROQUAD (S002926 7/28/2020) was administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies was not reported. Concomitant therapies included sterile diluent, which was stored properly.  On 01-JUL-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(lot # S002926,  expiration date: 28-JUL-2020, therapy type: rHA, strength and frequency were unknown) subcutaneously for prophylaxis (Incorrect product storage). No adverse effects were reported.   The stored temperature was -14 to -10 degree Celsius (-12.98 degree Celsius). The time frame was 4 hours and 30 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger.
pt recv flu vax ID instead of an mantoux ID;pt devel fever, achiness, chills, nausea, & diarrhea;pt was recalled to facility & recv Mantoux inj in another site;
Literally, one of the worst headaches I?ve ever had.  Definitely a 9 on the 10 scale, and I almost went to Urgent Care, but couldn?t drive.  The  medication reduced it to around a 7-8, where it is staying.  Came on in the early morning, 2:30 am, and I still have it at 11:20 am.  This is very unusual for me, and I know my headaches.  This is the first time I took a Moderna shot, all my others have been Pfizer, which gave me only a mild (3-4) headache that lasted about 12 hrs.  I know headaches are common side effects, but this one seems more brutal than I?ve heard from other Moderna patients.  If the headache isn?t gone this evening, I will drive to Urgent Care, but I?m counting on the Fiorinal and the Tylenol 4 to keep it bearable.  I really had no other symptoms.
Visited adult foster care home to give immunization. Administered around 8 AM and had him sitting for 5 mins. After no reported issues he moved to living room and was standing with another resident. Around 8:40 AM the other resident reported that the patient was "passed out." Immediately 2 caregivers and myself checked on the patient. He was barely coherent, swallow breaths, and laying to his left. We used a blood pressure monitor to try to get his blood pressure and called 911. We couldn't get blood pressure so we moved him off the bench onto the floor. I took his blood pressure at 8:41 AM using a wrist monitor and it was 95/53 with 67 pulse. He vomited on himself and was incoherent at this point. He turned pale and was started to talk. 911 arrived and gave him IV fluids and checked his blood pressure and EKG. Still hypotensive they took him to the hospital.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. On 03-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J004332, expiry date: 26-SEP-2014, dose, units, route of administration, anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
On 10/1/19 patient was diagnosed with shingles across face, mouth and nose.
Patient presents to clinic with mother approx. 40 minutes after onset of symptoms, mom reports patient was "a little fussy" the night before (3/20/19), mom gave TYLENOL prior to bed. Mom also states she gave two bites of mashed banana for the first time. Rash initially started on right side of anterior chest spreading to posterior and anterior trunk as well as some areas of bilateral lower extremities. Area of injections do not look inflamed. BENADRYL prescribed as needed for itching or irritation of rash. Prednisolone prescribed for allergic reaction and rash. Treatment discussed with patient's PCP, Dr., who is in agreement with course of treatment. Patient is to follow up with PCP early in the next week. Follow up contact initiated on 3/22/2019 by clinic nurse, with no contact made due to call being unable to be completed due to restrictions being placed on patient's mother phone. Contact attempted again on 3/25/2019 and 3/26/2019 with no contact being made due to restrictions placed on mothers phone. Patient has follow up appointment scheduled on 3/26/2019 with PCP, Dr.
pt recv vax 26FEB97 & w/in 1hr of vax pt devel itchy, blotchy skin, tongue & lip swelling & h/a;pt taken to ER tx w/med;
Swollen injection site, low grade fever, redness, increased swelling and blisters.
This death was reported to us and we do  not have a date of covid test.   He had old records from that reported he had had covid in the past.  I do not have the dates.  I have no records of his covid illness.  He passed at his residence .
Shot received at 5pm on the 27th of April. Same night full headache began. Some Point in the middle of the night into the day 28APR21 flu like symptoms began. Severe muscle ache and fatigue. Still with headache. Feels like a truck hit me.
I started vaginal bleeding like I had started my period again. I had already had my period for the month of March.  It lasted for a week just like a normal period.
Swelling arm; Red; Hot; Pain; Muscle ache; Headache; Nausea; Exhausted; Tremors in hands; Tremors in head; Diarrhea; Dizziness; Pain in both lower lung lobes; Shooting pain on torse/shooting pains left leg; Intense burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Intense burning). On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg). On 04-Mar-2021, the patient experienced TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot) and PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PAIN (Intense burning) had resolved. At the time of the report, PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot), PAIN (Pain), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
My elbow is bigger than the golf ball on my left arm; That vaccine is poisonous; Sometimes it runs a temperature over 100 degrees over one spot, the rest of my body is cool; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient experienced that patient's elbow is bigger than the golf ball on left arm. Patient thinks that vaccine is poison. Sometimes patient runs a temperature over 100 degrees over one spot, the rest of the body is cool. Patient thinks that the vaccine is poisonous. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.