chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg cramps; Toes are open like someone who has arthritis, it is very weird.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 13:00 (Lot number: EN6208) at the age of 60 years 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: MUSCLE SPASMS (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Leg cramps"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "Toes are open like someone who has arthritis, it is very weird.". Therapeutic measures were taken as a result of muscle spasms, feeling abnormal.  Additional information: The patient jumped on her legs and moved it around and drank lots of water. The patient had not received any other vaccines within 4 weeks and had no events prior vaccination. The patient had no additional vaccines administered on same date of COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Significantly and non-typical  heavy and  painful menstrual cycle.   Soaked through 3 tampons and underwear in three hours . Continued to bleed significantly for rest of day. Lightheaded and fatigued. Painful cramps - not typical for my cycle.
profound irritability & lethargy first 6 days sl improvement p/hospitalization for tests but cont to refuse to eat; no fever reported;
I had gone for a scan of my back in May 2022 and there were no complications found. After receiving the Pfizer Bivalent vaccine, I started to experience extreme back pain. I went to see the specialist and they noticed that there wasn't anything wrong around my back, but that I did have cysts located on my pancreas, liver and both kidneys. The only change between May 2022 and November 2022 was the Pfizer Bivalent vaccine. I had more scans completed and they were able to tell that the cysts were not cancerous. I'm very thankful for that, but I was very surprised with what they found. At the present moment, The Endoscopic specialist stated that there was no need for a routine visit to look at the cysts. My pancreas is inflamed, but my PCP does not feel any need to progress with anything at the moment.
Severe Migraine. Migraine pain on top right side of skull, plus severe tiredness behind eyes. No ibuprofen or Tylenol helping with pain, constant pain that will not go away. Migraine so far going on three days.
Had flu shot and the next morning woke up and had blisters around the injection site. It was itchy and red and had some swelling. Called doctor and she started on Benadryl. Also got a fever blister on lower lip.
Dizziness, Myalgia, Fever, NauseaVomiting, fatigue Narrative:
Severe pain at injection site and through upper arm and shoulder. Moderate swelling in upper arm, shoulder, armpit
Pt recvd vax 1987 & devel an unk type of hepatitis which did not require hospitalization; No further details were provided;
(Typical soreness at injection site for several days after injection.) Surprisingly, 10 days later, red and swollen at injection site - this is what I'm reporting.
Pt experienced lightheadedness, feeling faint and a general feeling of un-wellness approximately 5 minutes after receiving vaccine. Had patient sit down and he immediately felt better. Patient then remained sitting for about 30 minutes, and felt fine when he left.
She had a shortness of breath after getting the first dose of the COVID-19 booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 11Aug2022 as dose 3 (booster), single (Lot number: FT7150) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; ARMOUR THYROID; AMLODIPINE; AMOXAPINE; HALOPERIDOL. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 2022, outcome "unknown", described as "She had a shortness of breath after getting the first dose of the COVID-19 booster shot". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: Reporter stated, "The date patient had 11Aug2022. Stated that she don't see any expiration date, on the card it's just Pfizer FT7150 and it was says 11Aug2022. Expiry Date of COVID-19 Vaccine was Unknown. Regarding Lab work reporter stated, "Nag-g 500mg (further it was not clarified, and it was not paraphrased).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-JAN-2008, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUN-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a 48 year old female patient who is also a registered nurse regarding herself. Patient's current condition included kidney disease. On 18-MAR-2013, the patient was vaccinated with a dose of PNEUMOVAX23(lot#,dose not reported), intramuscularly. No concomitant medications were reported. On an unknown date about 2 months ago in January 2013, the 48 year old patient received a pediatric PNEUMOVAX23(lot# ,dose not reported) and did not have a reaction. On 18-MAR-2013, the patient experienced injection site reaction. Her left upper arm was 2.5 inches larger than her right arm. She had edema and redness from her left elbow to her shoulder. Her left upper arm was 2.5 inches larger than her right arm. She has edema and redness from her left elbow to her shoulder. Treatment included ice, BENADRYL and TYLENOL. Patient sought medical attention(called physician). The patient is on the kidney transplant list for a new kidney. The outcome of injection site reaction, her left upper arm is 2.5 inches larger than her right arm, redness from left elbow to her shoulder and edema was reported as not recovered. The relatedness for the events with PNEUMOVAX23 was unknown. Additional information has been requested.
I had a sore arm and was pretty tired after vaccination. I had a slight headache and a fever as well. All of my symptoms lasted a few days. I recently caught COVID-19. I was pretty sick for three or four days. I started Paxlovid and took it for five days. I've had lingering symptoms afterwards. My tongue has a weird film on it. My nasal passage is swollen and inflamed. I also have postnasal drip. I keep testing positive.
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 20-OCT-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), dose, route and anatomical location not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 1104 hours with highest recorded temperature of 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse events were reported. This is one of several cases received from the same reporter. Additional information has been requested.
On 1/25 awoke with loss of peripheral vision in the right eye.  This has persisted despite high dose IV steroids.
pain right below rib cage in the middle; very uncomfortable; nausea; pain in side; dry heaves; Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection), PAIN (pain in side), RETCHING (dry heaves), ABDOMINAL PAIN UPPER (pain right below rib cage in the middle) and NAUSEA (nausea) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZVA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TERAZOSIN and FINASTERIDE for Enlarged prostate, AMOXICILLIN for Urinary tract infection, LISINOPRIL for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CYSTITIS (Bladder infection). On 06-Feb-2021, the patient experienced PAIN (pain in side), RETCHING (dry heaves) and NAUSEA (nausea). On 09-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (pain right below rib cage in the middle) and DISCOMFORT (very uncomfortable). The patient was treated with ACETAMINOPHEN;CODEINE ongoing since an unknown date at a dose of one pill 350mg APAP/30 mg. At the time of the report, CYSTITIS (Bladder infection), PAIN (pain in side), RETCHING (dry heaves), ABDOMINAL PAIN UPPER (pain right below rib cage in the middle), NAUSEA (nausea) and DISCOMFORT (very uncomfortable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: A follow up was received on 24-JUN-2021, with no new information
Starting a few days after second injection, entire torso as well as upper thighs and upper arms were cover in petechiae. These lasted a couple of weeks. Nerve pain, similar to what one describes as fibromyalgia started around the same time and has continued intermittently since then, made more severe if I am feeling ill. Intermittent swelling of the hands and feet, accompanied by cold appendages and numbness has also occurred off and on since injection. Headaches are a near constant, beginning with injection and continuing since then. All these events were reported through the CDC form which was texted to me ever so often. This latest report, however, pertains mainly to the neurological event which occurred in mid-September of 2021. What occurred: It was an ordinary day and I was feeling fine, my husband and I were in the park. The following was reported to me by my husband: While setting up our picnic blanket, I suddenly became confused and combative. I seemingly did not understand what was being said to me. I wondered off, he thought to go the bathroom, but I did not return for 90 to 120 minutes. When he tried calling me, I did not answer my phone or texts. After 90-120 minutes, some strangers had come upon me and noticed I looked confused. They tried to assist me but I did not understand them, and seemed to not know how to use my phone. When my husband called again, they took my phone from me, spoke with him, and arranged a rendezvous. I was told I looked frightened and very confused. My husband did not know what was happening, but determined he should take me home. During the time I was missing, I know for certain I did not fall down or sit down, or lose physical consciousness at all, because I was wearing pristinely white clothing in this muddy environment, and I had no evidence of touching the ground on me. On the way to the car, he described that I appeared back to normal, except that I fell as we were in the street. I landed hard on my face, primarily the mouth and chin, and remember the feeling of my teeth, which cut through my lip and chipped off, hitting the asphalt. It is not yet known if the fall was a coincidence or related to the neurological event, but it jolted me back to cognition. I have no memory of this incident between starting to set up the picnic blanket and when my face hit the ground, which seemingly jolted me back to reality. Still confused about what had happened, and not yet having been told the story above, I tended to my wounds at home. Once I was told what had happened, and the facility opened, I went to urgent care. The doctor there did not provide any treatment other than superficial. I sought care at a primary care doctor who recommended I see a neurologist. I was on the waiting list to get in for several months. In the mean time, I had surgery to repair my lip and remove the debris within it. I am now under the care of Dr. and she is pursuing answers.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2020, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported.
Below happened 5 minutes after receiving the shot at 5:00pm  Soreness /pain in throat Blurred vision  Ligt headed  5:30pm-6:30 pm Tiredness  Felt Down/ lethargic /mood was off   8:00 pm and onwards noticing the following  Increased heart rate 130 (using a monitor) Sore throat or discomfort in throat.
I received my second dose of Moderna?s Covid shot at 11:00am.  By approximately 11:00pm (or so) both my daughter and I who had the second doseh same lot, felt like we were dying.  The worst I have ever felt in my 48 years. 103° fever, such severe chills a heating pad and two VERY thick blankets didn?t help, every muscle hurt like I?d been hit by a car, my skin was so painful pajamas hurt, my hair hurt, my neck hurt, I had an excruciating headache (which is saying a lot as I?ve lived with chronic daily intractable migraine for 30 years and am sadly accustomed to severe pain) .  I took two of my Oxycodone I have for my migraines and they didn?t even touch the pain I was in.  Today, two days later, I have a 100° fever, sore throat, sore body but considerably less sore than that initial 12-14 hours of extreme pain, continued headache, still quite lethargic, injection site is extremely painful and skin all around is still very sore to touch.  Red and itchy and upper arm is swollen.    Knowing now how I/we (again, my almost 19yo had the exact same horrific symptoms) felt after the second dose, I would be very hard pressed to ever get this vaccination or any type of booster ever again.  It was that bad and I know the importance of this vaccine.
This is an ex-24 week gestation extremely low birth weight male, on ventilator support for subglottic stenosis. One hour after vaccines and Tylenol he became hypoxic requiring very high pressures then nitric oxide inhalation. Ten hours later he became hypotensive. Sixty hours later he was almost back to baseline.
Client was vaccinated for Covid with Pfizer vaccines on 4//20 and 5/11/2021.  Covid symptoms started around 8/17: extreme fatigue, loss of appetite, sore throat.  Hospitalized on 8/24 and on admission tested positive for Covid.  Reported as a breakthrough Covid case in a fully vaccinated person.
No additional AE reported; Patient was administered improperly stored PROQUAD Incorrect product storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion with 5.612 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion.    This morning on 28-MAR-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U029320, expiration date 19-MAR-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Treatment of COVID-19; Treatment of 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 51-year-old male patient received BNT162b2 (BNT162B2), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247247 Same patient, different drug, different event;
First swollen knot, red, painful, itchy injection site.   On 03/06/2013 noticed a rash higher on my shoulder.  By next day rash look like shingles.  There is no information to tell me if this IS shingles and what steps I should take to protect myself and others.   Merck should cover the rash reaction in their information. Is this rash shingles?   I still have the shingles rash, my doctor has prescribed a steroid and Valacyclovir but will the Valacyclovir negate the vaccine for which I have paid over $200?
pt recv vax 6MAR98 & 11MAR98 pt dx w/chickenpox during a visit to ER;
Pt received 1st Moderna immunization on left deltoid on Sunday 4/25/21 around 3:00 pm. Patient reported symptoms of arm pain at site of injection (left arm) starting around midnight 4/26/21.  Symptoms became more noticeable next day around 5am 4/26/21. Patient reported arm pain/tenderness/soreness at injection site, as well as pain radiating down toward lower arm. Patient also reported signs of axillary pain and tenderness in the underarm area and near left breast.
Elevated A1C level; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jul-2021. The most recent information was received on 21-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GLYCOSYLATED HAEMOGLOBIN INCREASED (Elevated A1C level) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (Elevated A1C level). At the time of the report, GLYCOSYLATED HAEMOGLOBIN INCREASED (Elevated A1C level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Glycosylated haemoglobin: 8.2 (High) 8.2 and 9.4 (High) 9.4.         Concomitant medications were not provided. Treatment information was not reported. It was reported that for the last 7 years, the patient had maintained an A1C average from 6.5 to 6.9. The patient asked if there was a problem with high A1C reported after having the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up information received on 22SEP2021and updated narrative.
swelling to left side of neck, difficulty breathing, patient states felt as if "whole body was swollen but was not visible to others in household", patient called her physician's office, Dr. and was told by staff that it was a normal reaction to vaccine patient took ibuprofen 400mg at 10am, Tylenol 500mg at 12pm
1st dose 18-oct-2019 and then the 2nd one 12-apr-2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18October 2019, 0.5 ml intramuscularly).   On 12th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The pharmacist stating that she had a patient get her first Shingrix vaccine and received 2nd dose late.  The pharmacist did not have any additional details about the vaccine in terms of lot or expiration. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose late which led to lengthening of vaccination schedule.
This is a spontaneous report from a contactable nurse who reported from physician's office via a Pfizer Sale Representative. This contactable nurse reported similar events for 3 different patients. This is one of 3 reports. An elderly female patient (over 65 years old) received PREVNAR 13 (lot number J67647) on unknown date, at single dose. Medical history and concomitant medications were not provided. One week later the patient called back and said that she had severe itching and little bumps at the injection site since unknown date and nurse also reported that there was not redness and no swelling. Events outcome was unknown at the time of report.
Patient is a staff member from a long-term care facility.  Patient self-reported COVID positive status to pharmacy on 6/17/21.  Patient starting experiencing symptoms on 6/15/21 and tested positive with CVS test on 6/17/21.  Reported symptoms include cough, fever, body aches and fatigue.  Patient is quarantining at home for 10 days and has not seen a doctor. Per patient, her daughter attended a church camp from 6/7/21-6/11/21 and tested positive once returning home.