chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to a 42 years old female patient. The patient's concurrent condition included Crohn's disease. There was no known drug allergy (NKDA) of the patient. The patient's concomitant medications included amitriptyline hydrochloride, REMICADE, multivitamin, ascorbic acid, VITAMIN C AND D, ZOFRAN, pantoprazole and mercaptopurine. On 23-JAN-2019, the patient was administered a dose of PNEUMOVAX 23 (lot # R007722 with expiration date 10-MAR-2020; strength and dose detail were not reported) intramuscularly for prophylaxis. On 25-JAN-2019 (reported as a couple days later), the patient developed some pain/weakness in her arm/hand (same limb as injection was administered). It was reported that these symptoms quickly worsened with severe shooting pain down her entire arm into her hand. The patient had significant weakness in the arm with trouble gripping things and her entire arm was swollen. It was reported that the pain was alleviated by ALEVE. It was reported that the symptoms resolved within 3 days. It was reported no redness nor bruising. The outcome of the events was reported as recovered. The causality between PNEUMOVAX 23 and the events was not provided.
Incorrect booster dose given. Patient received 0.5ml of Moderna rather than the 0.25ml booster dose.
Patient passed out in chair about 5 min after shot administered.  BP 70/48, pulse 68, respirations 12, face pale and skin clammy and cool.  Moved back to room via wheelchair and had lie on table for 10-15 minutes. Dr. checked her over, said to have her remain for few more minutes and re-do BP, when WNL can go.  Repeat BP 98/50, no longer sweaty, says feels better.  Had remain in room another 15 min to be sure. Patient released into the care of her mother.
This is a spontaneous report from a contactable consumer or other non-health care professional from a program. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 29Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of vaccine on 29Jun2021 was diagnosed with COVID 19 after wards on an unspecified date in 2021. Patient remains in critical condition in the hospital. He has spent 35 days in the hospital. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on an unspecified date in 2021. The patient was not recovered from the events.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
COLD SWEATS; WEIRD FEELING IN THROAT; LEFT EAR POPPING LIKE GOING UP IN ELEVATION; SINUS CAVITY PRESSURE IN THE  RIGHT EYE; STUFFY NOSE; FEVER 101.3 F; HEADACHE; LITTLE NAUSEOUS; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 165 pounds, and height was 63 centimeters. The patient's concurrent conditions included barrett's esophagus, high blood pressure, premature heart beat, hypothyroidism, sulfa drugs allergy, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of the reporting. the patient had no history of drug abuse or illicit drug usage . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 11:45 for prophylactic vaccination. Concomitant medications included amlodipine, carvedilol, levothyroxine, and losartan.  On 27-MAY-2021, the subject experienced cold sweats. On 27-MAY-2021, the subject experienced weird feeling in throat. On 27-MAY-2021, the subject experienced left ear popping like going up in elevation. On 27-MAY-2021, the subject experienced sinus cavity pressure in the right eye. On 27-MAY-2021, the subject experienced stuffy nose. On 27-MAY-2021, the subject experienced fever 101.3 f. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced little nauseous. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 101.0 F, 97.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, weird feeling in throat, and left ear popping like going up in elevation on 27-MAY-2021, had not recovered from headache, stuffy nose, and fever 101.3 f, and the outcome of sinus cavity pressure in the right eye and little nauseous was not reported. This report was non-serious.
Fever, body ache, joint ache, brain fog, tiredness, and a bubble of fluid in my underarm on the shot arm.
ARM WAS SORE A LITTLE FOR A DAY; HAD A FEW ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry date: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced arm was sore a little for a day. On MAR-2021, the subject experienced had a few aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore a little for a day, and had a few aches on MAR-2021. This report was non-serious.
From the start: Soreness at injection site. Slight headache, fatigue.   Mild fever 100.4 degrees Fahrenheit, Fever did not show up till the morning of the next day.
Patient stated that about 2-3 hours after receiving the shot she started to get a stiff neck. She said the soreness extended all the way down to the back of her arm that she received the shot in behind the shoulder. The patient did not seek treatment from a medical facility; she said she would take her prescription pain medication for the pain. She stated she would go to an urgent care if she got worse. The patient wanted to make sure this was reported as she felt this was a direct correlation to the shot she received earlier.
A temperature of 100.8 (mine usually is 97.9) Body aches Headache
This spontaneous report was received from a male consumer of an unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date, the patient was vaccinated with ZOSTAVAX injection (dosage, route, lot number, expiration date and site of injection were not reported). On an unspecified date, the patient experienced shingles for an unspecified reason. At the time of the report the outcome of shingles was unknown. The relationship between the event and ZOSTAVAX was unknown. A product quality complaint was not involved. Additional information has been requested.
Patient came to pharmacy on 2/21/2018 stating that pain in left arm from FLUAD injection back on 9/12/2017 had not subsided. It hurts to lay on it during sleep and says she has lost some range of motion with it. She has not contacted her doctor with this information. Pharmacist recommended her taking either otc Ibuprofen or Aleve for some relief and use  of an ice pack. Pharmacist will contact her doctor and relay current information.
Very painful lump in fat tissue starting next morning. Red spot starting that evening, gradually growing for 4 days. Hot, hard lump and redness still present after 5 days. No irritation/ pain in muscle at all this time. Lump and pain localized in fat tissue only.
1) c/o 1/2" area red, hard, swollen, tender x 3-4 weeks 2) c/o aggravation of asthma sxs within 1-2 days of vacc.  3) c/o sxs sinusitis 4) c/o increase C-reaction protein 2 days after vaccine given.
Patient received Moderna (80777-0273-10) Booster, patient received half of the adult dose.
At night her foot and legs got swollen. In the morning, her hands and face were swollen too.; At night her foot and legs got swollen. In the morning, her hands and face were swollen too.; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced at night her foot and legs got swollen in the morning, her hands and face were swollen too on an unspecified date. Clinical course was reported as she already reported AE to previous agent. She received their 1st dose of the Pfizer covid vaccine yesterday. At night her foot and legs got swollen. In the morning, her hands and face were swollen too. The clinical outcome of the event unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Right Arm Pain, Right swollen lymph nodes , right shoulder and neck swelling and pain for first week. From day of vaccination (7/23) to Currently (8/25)  my entire body is still extremely swollen from head to toe and my hormones are out of wack and my menstrual cramps have been excruciating.  Before shot, all of my hormonal symptoms were under control. I do not know how to get rid of the swelling and pain and fear that I have permanently made my condition (endometriosis) worse.
Insomina; Painful swollen hot red itch arm; Headache; Joint and muscle pain; Brian fog; Polydipsia.
Fever; Chills; Headache; Little energy; Dose number 3; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 16:45 (Lot number: FL3197) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955), administration date: 04Apr2021, when the patient was 17 years old, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955), administration date: 27Mar2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 16:45, outcome "unknown", described as "Dose number 3"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Fever"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Headache"; ASTHENIA (non-serious) with onset 17Dec2021, outcome "recovered" (Dec2021), described as "Little energy". Therapeutic measures were taken as a result of pyrexia, chills, headache, asthenia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Therapeutic measures taken as a result of reported events included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Approximately 4 months after my 3rd dose vaccination I contracted COVID-19 and experienced the following symptoms: (Tightness of chest) Unusual pressure on my left side (Heart to rib cage) and I contacted my Doctor because I wanted them to do an X-Ray and see what's happening but they advised me to do a COVID-19 test first before they see me and the result was positive. I did not take anything for treatment and just let my symptom run its course. Overall it was 7 days until I have fully recovered from my chest pain.
5 minutes after vaccination, could not swallow trachea bothersome,  could not drink water, trouble breathing, not feeling normal, no saliva, Patient stated anxiety, pt then turned blue in the face. EpiPen injected then, blood pressure increased, heart rate increased,  then taken to ER. Allergic reactions, glands swollen, face red and body, pt still experiencing trouble to breath, weak, throat pain.   ER treatment anti inflammatory, Benadryl and EpiPen, and fluids. Pt was discharge hours later with prescriptions. Next day rash all over body, severe heat in body, Thursday PCP visit Friday red all over, very weak, face swollen trouble breathing; 2nd ER visit, attending Dr -- allergic reaction to vaccine and treated with anti inflammatory, medications and flushing and referred to Allergist Specialist, discharged with prescriptions. Still fatigued, swollen glands, trachea, hard time breathing still.
5/14/21: 1432 hours- Pfizer dose 1 administered. At 1445 hours patient stated that she had a scratchy feeling in her throat and tightness in her maxillary sinus, pt pointed to sides of nose below eyes. Her voice was clear, RR 17 bpm, O2 97%, HR 93 bpm.  1447 hrs- Informed nurse of adverse reaction 1449 hrs- pts voice was clear, pt drank water without difficulty swallowing  1450 hrs- RN's arrived at the tent 1452 hrs: Patient is clearing her throat and states her throat is still scratchy 1453 hrs- Benadryl 50 mg administered orally per standing orders. 1455 hrs- Pt is talking to talking, her voice is clear and is sipping water. Pt RR is 17 bpm, O2 at 98% on room air, paulse is 89 bpm. Pt voice is clear 1510 hrs: Pt states sinuses are clear and still has mild scratchiness is throat.  1515 hrs; pt denies difficulty breathing, her voice is clear, is she sipping on water.  1518 hrs; Rn paged ems  1520 hrs: vital signs 133/87, HR 75 bpm, RR 17 bpm, O2 97%  1521 hrs: paramedics in tent monitering patient 1525 hrs: paramedics left after speaking to patient 1530 hrs: Pt states she is feeling better and the scratchiness in her throat is less. RN spoke with pt and informed her that she should not take another Pfizer vaccine due to the reaction she had.  1535 hrs- Pt states she is feeling better and is ready to leave. Instructed pt and spouse to call 911 or seek emergency medical help for any breathing difficulty or worsening of symptoms. Patients and spouse state they understood instructions
This spontaneous report as received from a health worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in March 2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose number, site and route of administration were not reported). There was no adverse effects reported. It was stated that the vaccine underwent a temperature excursion of 31 Fahrenheit for an unspecified time frame. In reference to previous excursion the reporting nurse stated that excursions showed minimum reached 31 Fahrenheit on several days starting March 2016 into April 2016. This is one of several report received from the same reporter. Additional information has been requested.
Left deltoid, injection site was painful, red, swollen, hard and hot to the touch for about 20 hours the following day, which completely resolved within 24 hours. A week later, this morning the injection site started itching, developed into a red raised, hardened bump, like it was a week ago. It's itchy, red, swollen, hot to the touch, not painful, close to a quarter in size. No other adverse reactions at this time.
Felt dizzy for the first week ( lightheaded ) , chills without a fever . One week later SEVERE pain in my middle back radiating through to the front and around the side ( unable to be touched ) .. Feels like shingles pain...no rash
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient's relevant medical history, concomitant medication and past drug history were unknown. The patient was vaccinated with (Oka/Merck) VARIVAX (lot # L002214 and expiration date on 21-JAN-2017) which was given either on 30-JUN-2015 or 01-JUL-2015. The patient was administered the (Oka/Merck) VARIVAX after it had a temperature excursion (incorrect product storage). It was unknown if there was any relevant laboratory data. At the time of this report on 02-JUL-2015, the outcome of incorrect product storage was unknown. It was also unknown if the patient would ever get the (Oka/Merck) VARIVAX again. This is one of several reports received from the same reporter.  Additional information has been requested.
Patient called to pharmacy stating on 10/7/17 that he was experiencing bruising and pain in arm at site of injection. Iced w/cold pack.
After 1st shot, no real effects except a sore arm.  After 2nd shot, flu like symptoms (chills, fever, body aches) starting on day 2 thru days 3. Lingering effects for about a week after. Unknown at the time, but as soon as the flulike symptoms resolved on day 3, I then had a sciatic nerve issue which required a doctors visit. Pain made daily routine difficult and sleep very difficult to achieve.  Med prescribed at that time included a steroid pack and therapy, followed up by an MRI. Steroids did begin dissipating the sciatic inflammation within a couple days and within 5 days was mostly normal, no pain by the end of 7 days or so.  After the 3rd shot (the booster shot) (sorry I do not have the lot number information with me at this time), severe headache and flu like symptoms started within a couple hours. Flulike symptoms dissipated within a day or 2 which was then followed again by sciatic nerve pain. I received another steroid pack from my spine/back doctor. That steroid pack did not resolve the issue which got progressively worse. On Dec 24 I visited an ER clinic where they prescribed another steroid pack and also Oxycodone for the pain. Second consecutive steroid pack does appear to be working as the sciatic inflammation is receding. Pain is dissipating and after the 3rd or 4th day I have not had to take the oxycodone for pain relief.
On Dec 22, I had my Pfizer vaccine. I only had some injection site sore/pain until 5 days later when I started to have papular rash and vesicles in the areas around the injection site. The involved area got extensive from shoulder to thumb from day 6 to day 12. The rash is only limited to the arm receiving the vaccine injection. Then I have low fever and weakness for two days. I just started to feel better this morning (post injection day 14).  I attached photos of my arm to show the rash. Confirmed by dermatologist as VZV positive on 1/5/2021. They did a biopsy and viral testing.
red arm; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red arm), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever). At the time of the report, ERYTHEMA (red arm), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication information was provided.  No treatment information was provided.   This case was linked to MOD-2021-238268 (Patient Link).
Blood pressure was up to 160/110 a few days after my first shot, down to normal after several days then up on the night after second dose, not as high but up to 135/92
This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received SHINGRIX (batch number 27KF5, expiry date 10th June 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles after receiving SHINGRIX vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for infection, time to onset for event and laboratory confirmation for varicella zoster virus infection were not provided.
After vaccine administration patient developed a red pinpoint rash on the face and scalp. He also had a 3/4 in. diameter red circle around the inj. site. Children's BENADRYL 1 tsp was administered by mouth which improved redness and decreased the number of spots on his face (Inj. site on the (R) leg).
Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) 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 (No reported medical information).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Information has been received from a medical assistant concerning a patient who on 19-APR-2011 was might or might not intramuscularly vaccinated with a dose of PNEUMOVAX 23 (dose and lot# not reported). The patient's arm was pierced with a needle but it was unsure if PNEUMOVAX 23 was drawn into the syring prior to attempting the intramuscular injection. No adverse symptoms reported. Additional information has been requested.
osteoarthritis; muscle pains in his shoulders; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis) and MYALGIA (muscle pains in his shoulders) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (muscle pains in his shoulders). On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis). At the time of the report, OSTEOARTHRITIS (osteoarthritis) and MYALGIA (muscle pains in his shoulders) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Event outcome information updated.
Patient stated she is still having soreness in her arm and shoulder. She was concerned the vaccine was administered too high.
Client states she began to experience numbness and tingling in left arm, leg, and foot on 07/14/2002. She was evaluated 07/15/2002- blood work done-all WNL. Relates she also had severe headaches with some blurred vision. CT scan of head- WNL on 07/26/2002. Is now experiencing stiffness of neck with h/a. to see PMD 8/13/2002. Conts. to c/o severe h/a.