chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient experienced pain and stiflness in her arm.; the patient experienced pain and stiflness in her arm/the arm is stiff and difficult to move 2 months later; This spontaneous report has been received from a pharmacist, concerning a 71-year-old female patient. Her historical vaccines included FLU vaccine, PREVNAR 13, and ZOSTAVAX. Information about the patient's medical history, as well as concomitant therapies and allergies were not reported.  On 05-DEC-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dosage form, intramuscularly in the right arm, lot number R034248, expiration date 07-AUG-2020 (concentration, and frequency were not reported) as prophylaxis (reported as to complete the pneumonia series recommendation); the patient was also vaccinated with influenza virus vaccine (reported as FLU vaccine) on the left arm.  On the same day (reported as later on 05-DEC-2019), the patient experienced pain (vaccination site pain) and stiffness (injected limb mobility decreased) in her arm. The pharmacist advised patient to ice and took ibuprofen for the pain. The pain has subsided, but the arm was stiff and difficult to move two months later. The patient was seen in February 2020 by the physician who has ordered physical therapy. At the time of this report, the patient was not recovered from the events.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurred events was not reported.
tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, at the age of 72 years, administered in left arm on 11Mar2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization.  Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 23Mar2021, patient tested positive for COVID-19 infection. Patient was wondering if she should still take the second shot which was scheduled on 01Apr2021. The event was considered as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Roughly 20 hours after the injection, I broke out in internal hives (I have had this reaction to other medications and products before). My skin became blotchy (not itchy nor raised, just red and splotchy) under my breast line, my collar bone area, hair line, and neck. I felt uncomfortably bloated and had hot flashes.
Day after receiving the second dose, I started experiencing a fever, on top of the cough from first dose, with an increase of pain over my body, night sweats, discoloration in my feet. I saw my PCP again, they did an Auto Nuclear Antibody test that was positive and had a high Tighter level. PCP then referred me to a Rheumatologist, where they did more testing of blood work, X- Rays of hands/ feet/ pelvis/ lower back, CT Scans lungs (pulmonary specialist). PCP did a chest x-ray prior to Rheumatologist. I had to see an ENT Dr. do to a growth in my nose, had to get it tested and it is Aplasia (non- cancerous). I also had multiple non-healing ulcers all over my body. A Dermatologist could not determine what they were so they gave me a topical cream for them. Now waiting to see an Ophthalmologist.  I now have a lung physical therapist, occupational therapist for my lungs. Neurologist is going to do a ENG test (next week), podiatrist for my feet. I have also lost a lot of weight and have a Dietician as well.  I am still experiencing all of these symptoms since February. I cannot work or able to practice at all.
Case  previously recorded as MA2009-3334. Initial case report received from a physician via MedCom on 26 OCT 2009. A 2-year-old patient, was vaccinated with 0.5 ml FLUVIRIN (batch no 100813-7P) i.m. on 24 OCT 2009. No adverse event was reported. Reference no. NA09-07008.
Approximately 5 months after my 3rd dose vaccination I contracted COVID-19 and experienced the following symptoms: Sore Throat, Chills, Fatigue, Body Aches, Headache/Migraine. I took Ibuprofen and Dayquil for treatment and it did improve my symptoms except for my Sore Throat. I consulted with a physician and she said I should just keep taking the same over the counter medications that I have been taking and drink a lot of water and rest. As of today 07/14/2022 I am feeling fine and completely back to normal.
Pain at the injection site and headache starting 6 hours after injection ending about 24 hours later. Muscle pain and shivering starting about 12 hours after injection lasting a few hours.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0161) at the age of 54 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: OMEPRAZOLE taken for gastroesophageal reflux disease. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Consumer stated that I had got the first one on 21April2021, Saturday and did not have anything serious just the sore arm that was all and May 8th was the second vaccine. Well it was 17April2021 when they gave the first shot. LOT Number: Reporter stated that the LOT number for the first one is EW0161. I don't know they put down April 17th the date and I gave you wrong date, it is not 24April. 17April was the first shot. About anatomical site of administration, consumer stated on the left arm, both times. About medications consumer stated that no the only one is for acid reflux Omeprazole. About medical conditions, the consumer stated little bit of cholesterol, doctor keeps saying you need to lose weight. I am little bit fat, little bit round. About Laboratory test, consumer stated that not recently, since got the vaccine.  No follow-up attempts are possible. No further information is expected.
Administered on 03/10/2023. The BUD for this vial was 02/18/2023.
Bad congestion and runny nose starting 48 hours after booster, continuing to present (about 94 hrs).  Mild diarrhea (not too loose but frequent). No fever registered (1 degree below normal), but sweaty and shaky. Tired. Clear mucus, one change to yellow last night but then right back to clear. Sneezing was first noticed symptom, that started about 42 or so hours after booster. Noticed shot was given very high on arm (much higher than original doses) and left swollen pimple type protrusion (did not happen with original doses), which is also odd. Quite chaotic at the pharmacy that day. Could be a cold or covid (test pending),  but concerned and wanted to report.
This spontaneous report was received from a nurse refers to unspecified number of patient of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions was reported. On an unspecified dates, the patients were vaccinated with improperly stored doses with GARDASIL 9 from lot # N001533 with expiry: 16-OCT-2019,  for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 9 degree Celsius to 25 degree Celsius for 34 minutes. The temperature excursion was detected by digital data logger. The vaccine had no previous temperature excursion. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1707USA007839.
both of her eyes blew up after a few days; looked like conjunctivitis; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (both of her eyes blew up after a few days) and CONJUNCTIVITIS (looked like conjunctivitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (both of her eyes blew up after a few days) and CONJUNCTIVITIS (looked like conjunctivitis). At the time of the report, OCULAR DISCOMFORT (both of her eyes blew up after a few days) and CONJUNCTIVITIS (looked like conjunctivitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.  Upon internal review on 21-May-2021, the age was corrected to unknown.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/26/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with the patient's grandmother on 5-9 and they will not have the patient get revaccinated.
ADMITTED 1-31-22, TESTED + FOR COVID 2-2-22.   PASSED AWAY ON 2-24-22   ADMITTED WITH CONFUSION.  HAD PROBLEMS WITH MENTAL STATUS DURING HOSPITAL STAY.  GIVEN REMDESIVIR AND ALSO DECADRON.  HAD SPECIALTY CONSULTS.  HAD POOR ORAL INTAKE.  HAD FEEDING TUBE.  GIVEN TX FOR BACTERIAL PNEUMONIA.  HAD SET BACK WITH MENTAL STATUS, WORSENING RENAL FX N AND WAS EVENTUALLY PLACED ON COMFORT MEASURES.
Information has been received on 08/09/2001 from a consumer concerning his 8 year old son with no significant past medical history and no known allergies who two years ago in approximately August 1999 was vaccinated with varicella vaccine. There was no concomitant medication. On 08/09/2001, it was reported that the pt developed a "severe case of shingles" after his cousin exposed him to chicken pox about a week ago. The pt sought unspecified medical attention. Additional info has been reqeusted.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 15-OCT-2012 11:37, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Painful injection site, body aches and slight headache began 3.5 hours after 2nd dose and an hour following these side effects, I had cramping in fingers and toes. The next morning I woke up with body and muscle aches, fever of 101 degrees, splitting headache, cramping throughout body, sore and swollen injection site, body sweats, swollen lymph node in left arm pit and back/rib pain. This lasted 3 days and I sweat profusely on and off the entire time. By day 4 post injection, fever was gone but felt exhausted after short amount of time after walking.  Five days post 2nd dose, I started experiencing shortness of breath while climbing stairs and walking short distances. I had pain in my lungs when breathing.  Two weeks post 2nd dose, I started to have less shortness of breath, could walk farther distances, but any incline made it harder to breath. Three weeks post 2nd dose, I am back to exercising moderately, which I hadn't been able to do since 1st dose. Climbing stairs can still be difficult. Spotting has been happening since a few days post 2nd dose and still continues.
Patient had acute onset of wheezing approx 18 hrs after vaccines. Was diagnosed with pneumonia by CXR overnight (approx 4 hr) hospitalization for O2, antibiotic and bronchodilators.
Lightheaded, loose stools, fever 101.5/chills, cough-productive clear phlegm, sinuses started getting congested, decreased urinary stream/burning/headache, nausea/emesis x1.
Awoke 5/26 with pain at site, site was red, warm, hard lump. Pain with ROM.
I'm on day 3 of a blistering migraine headache. Usually over-the-counter remedies are not working.
Noted bruising on the left deltoid measuring 20 mm. by 20 mm. Skin warm to touch w/ redness covering entire deltoid area.
Horrific nosebleed; Blood pressure reading was 70/46 mmHg; Fatigue for a couple days, she was tired; Pain in the arm; A spontaneous report was received from a consumer concerning 75-years-old, female patient who experienced horrific nosebleed (epistaxis), fatigue for a couple days, she was tired (fatigue), pain in the arm (pain in extremity), and  blood pressure reading was 70/46 mmHg (hypotension).  The patient's medical history included nosebleeds, high blood pressure, and diabetes type-2. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, metformin, atorvastatin calcium, iron, and ascorbic acid.  The patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly for prophylaxis of COVID-19 infection on 20 Feb 2021, at 1:40 PM.  On 21 Feb 2021, approximately at 9:00 morning, the patient was awakened by the feeling of something in her throat which she described as a horrific nosebleed. She stated that she was unable to stop the bleeding and went to an urgent care facility and was then transported to the hospital. On the same day, the patient reported that she was admitted, and her blood pressure reading was 70/46 mmHg. On 23 Feb 2021, she was released after two days of stay. The patient reported that the hospital did not provide an explanation for the cause of the nosebleed. The patient reported felt pain in her arm and felt fatigued for a couple of days after receiving her first dose of the vaccine. She stated that she felt that because she was tired and because she lost a large amount of blood due to her nosebleed, that was why she required hospitalization. The patient did not take blood thinners. The patient was feeling better now. On 20 Mar 2021, the patient was scheduled to have her second dose of the Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events, horrific nosebleed (epistaxis), fatigue for a couple days, she was tired (fatigue), pain in the arm (pain in extremity), and blood pressure reading was 70/46 mmHg (hypotension), were considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
I had severe arm pain body aches headaches dizziness mevk pain unable to focus hard to breathe
Patient suffered fist size welts which were red and hot on his arms and legs.  He had pain in the arms and legs.  Hives occurred under his arms, on his back, legs, and arms.  Severe itching occurred with this for 5 days.  He was treated with Prednisone and Ranitidine.  He has NO history of egg allergies.
Patient was accidentally given a inadequate dose and or empty syringe based off professional judgement and extra product being left over.  Pharmacist repeating dose with patient being on board.
Whole body is aching; Arm is swollen; Can't lift arm; Restless; Didn't sleep after 2nd dose; Terrible headache; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless) and SLEEP DEFICIT (Didn't sleep after 2nd dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless), SLEEP DEFICIT (Didn't sleep after 2nd dose), HEADACHE (Terrible headache) and PYREXIA (Feverish). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless), SLEEP DEFICIT (Didn't sleep after 2nd dose), HEADACHE (Terrible headache) and PYREXIA (Feverish) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Redness at injection site, knot in arm, pain, Pt. c/o not  being able to move his arm.  Rash around injection site
New onset headache Seen by onsite EMT Vitals: BP 140/82 O2:98% Pulse:86 Resp: 14 Pt.discharged home with husband at 11:30 AM.  Recorded by, RN
Staff member called to report an elevation in blood pressure (168/96) and pulse (103) with fever of 103.6F. Symptoms lasting into next day-was seen by his PCP with no additional follow-up needed.
Tingling and numbness in hands and feet 12/13/10 extreme nausea, right arm & neck tight & cramped hands turned purple. Called 911 12/14/10 - ambulance crew gave him oxygen. Seemed to improve after oxygen. Pt chose not to go to hospital. Pain all over. Spoke with wife 12/15/10 - feeling better but feeling run down.
Itching; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PRURITUS (non-serious), outcome "unknown", described as "Itching".  Additional information: The report relate to study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
upper arm injection site aching; very very tired; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (very very tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 25A21A and Q2AA21A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (Myalgia Rheumatica) since December 2019, Giant cell arteritis since 06-Jan-2021 and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) and SPIRONOLACTONE for Blood pressure high, OLMESARTAN MEDOXOMIL (BENICAR) for Polymyalgia rheumatica.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, 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 VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (very very tired). At the time of the report, VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (very very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient first started with dose of 60 mg of steroid. Then on 06-Jan-2021 she was suspected to have Giant cell arteritis, the dose was decreased to 50 mg. On 26-Jan-2021 she was at 10 mg of steroid. On Feb2021 further decreased to 20 mg of steroid. On 26Feb2021, the day of first dose of vaccine the patient was taking 14 mg of steroid (lowered by patient under physician's supervision).
2nd night: overall tingling sensation, splitting headache. 3rd day: 20 plus red spots on calves, large swollen lymph glands, especially in left armpit (some swelling to this day). Hot swollen injection site, severe stomach ache and nausea. 4th day: hot swollen right eyelid. (See attached letter) Most symptoms subsided but still some swelling in lymph glands. I am enclosing a report and letter to my primary care physician that I completed on July 3 2017, but apparently overlooked mailing to you at the time. My physician has a record of this, however, with follow up phone conversations that transpired at that time. The nurse stated that it appears that I had a case of shingles. On Friday, September 29, 2017 I experienced soreness in the groin area of my left leg, which I attributed to having taken a 2-mile walk and thought perhaps a seam had rubbed. On Saturday night, September 30, 2017, however, the pain was significantly worse, so I had a look and was shocked to see the classic symptoms of shingles. Approximately a 4 or 5-inch hot, red circle with a well-blistering, festering, raised circle in the middle that was at least the size of a 50 cent piece. The next morning it had turned to light yellow blisters that had merged and by evening, the whole area was mustard-yellow blisters. I applied NEOSPORIN and covered the area with a large BAND-AID. The symptoms subsided each day and today I have a crusted scab. I had a previously-scheduled appointment with my primary care physician on Wednesday, October 4, at which time she confirmed that this is, indeed shingles. So I am left with the conclusion that I've now experienced two rounds of shingles subsequent to the vaccination. It's difficult for me not to also conclude that the vaccination contributed to this development, given the timing.
Feeling of heat in mouth,  numbness in mouth, swelling in throat (not severe), difficulty swallowing (not severe), tongue swelling,  Day 3 post injection: hives on upper left arm just above elbow,  Day 4: headache (severe), numbness/tingling in jaw, neck and face, swelling of lower legs.
Leg muscle pain moving to upper lower stomach and shoulders Sunday very fatigued. Wednesday more muscle pain very fatigued Thursday low grade temperature 99 to 99.4.
This spontaneous report was received from an administrator regarding two patients of unknown age and gender. The patients' medical history, concurrent conditions, or concomitant therapies were not reported. On 10-SEP-2017 and 13-SEP-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB intramuscularly (lot number reported as "N011851", expiration date: 19-DEC-2019) for prophylaxis. According to the reporter, the doses were exposed to temperatures between 9 degrees Celsius (C) to 25 C for 10 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse effects were reported. Lot number N011851 is an invalid lot number for LIQUID PEDVAXHIB.
Itchy, warm to touch and swelling at injection spot. Area seems to be getting larger over 24hrs.
4 hours after immunization had stomach ache, low grade fever.  10:30 PM had high fever, delusional, jerky motions for 2 hours.  Swollen glands and could not hear out of left ear.  Achy muscles, sore throat and not eating.