chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CRAMPING SENSATION; BAD LEFT LEG PAIN; HEADACHE DAILY; LEFT LEG MUSCLE PULLED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg muscle pulled. On 10-APR-2021, the subject experienced headache daily. On 21-APR-2021, the subject experienced cramping sensation. On 21-APR-2021, the subject experienced bad left leg pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad left leg pain, headache daily, and cramping sensation, and the outcome of left leg muscle pulled was not reported. This report was non-serious.
5 days after injection I noticed a hive on my stomach.  The hives spread to additional areas of body over the next 24 hours including the face, scalp, neck, arms, back, and additional hives on chest.  This morning the majority are focused on my head and face area.  I've double checked everything and haven't eaten or been in contact with anything out of the ordinary.    Also want to point out I had Covid in October 2020.  Also, I had a very sore arms for 2 days after shot along with exhaustion the 2nd day and a fever/chills (103 degrees) on my second night after injection.
pt recv vax 28AUG96 & 29AUG96 exp one nickel-size hive on forehead;no tx was given;sx cleared by 30AUG96;
Within the first 10 minutes, I felt a burning sensation run up the left side of my head.  I felt dizzy as if I were going to faint but I tried to relax and felt a little better.  I left after 15 min and then I felt very dizzy again same reaction except I could feel burning sensation throughout my entire body down to my toes.  I asked my husband to turn around and go back to facility. They took my blood pressure, which was high 176/9?  I thought I was dehydrated, so I kept drinking water.   Then I relaxed a little and the symptoms relaxed a bit.  They took my blood pressure again and it went down to 146/?  I was feeling okay and we were heading home and then I got another episode like I wanted to faint.  We headed to hospital and they ran tests.  Tests were fine.  They gave me an IV with liquids, I felt better after leaving.  I was fine for 2 day but then on the third day I broke out in rashes on my legs.  It's been a week and feeling a bit better each day dizziness is fading but not entirely gone.
Severe Kidney pain; slight fever; Sore arm at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Severe Kidney pain), HEADACHE (Headache), PYREXIA (slight fever) and VACCINATION SITE PAIN (Sore arm at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST, ATORVASTATIN, MELOXICAM, DULOXETINE, CYCLOBENZAPRINE, LORAZEPAM, OMEPRAZOLE, ARIPIPRAZOLE and GABAPENTIN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache). On 30-Apr-2021, the patient experienced RENAL PAIN (Severe Kidney pain), PYREXIA (slight fever) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, RENAL PAIN (Severe Kidney pain), HEADACHE (Headache), PYREXIA (slight fever) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications reported.
50 Mg Benadryl  Pt presented to monitoring area  c/o throat tingling, tightness. waS given benadryl 50 mg PO; obServed vitals Stable throught. Denied Shortness of Breath. normal cardiac exam; CTA (B) Admits to to Penicillin allergy. otherwise Stable through out symptoms subSided post benadryl
We were walking with a group of 10 people. We came back Monday, I had to be tested on Sunday by the authorities with a negative result before we could fly. I felt like I had a dry throat, a stuffed head and my ears did not pop, my head was absolutely full. We flew all day Monday and we got home Tuesday. I thought we that flying all day and maybe this was a result. I had more jet lag than typically, sluggish, a dry throat, stuffed head. It was a long flight, so I thought I would give it a day. I took a COVID-19 test yesterday and that came back positive. I had a virtual visit with my doctor today and he prescribe Paxlovid. Since returning in the last day I have heard from other travelers that have also tested positive. - 4 of the 10 people have tested positive.
Began shaking  and face tingling 6 minutes after shot, started to feel slightly better.  10 minutes after shot, neck became red, red welts appeared on bilateral upper arms.  took 25mg of po benadryl at my desk.  25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless,  limbs  went numb, rushed to ER via wheelchair.  Treated in er for anaphylaxis.  Arms and legs felt covered in  "icy hot," tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor.   ER gave steroids, benadryl, pepcid, 2L ivf.   ativan given later in evening for nervousness.
PULSATING BEHIND LEFT EAR INCREASES AND DECREASES; LEFT ARM PAIN; LEFT EYE PAIN BEHIND EYE; BLOOD SHOT TO LEFT EYE; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight was 96 kilograms, and height was 73 inches. The patient's past medical history included heart attack, and concurrent conditions included social drinking of alcohol, and cigarette smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for prophylaxis for heart attack, hydrochlorothiazide for prophylaxis for heart attack, and ramipril for prophylaxis for heart attack. On 07-APR-2021, the subject experienced left eye pain behind eye. On 07-APR-2021, the subject experienced blood shot to left eye. On 07-APR-2021, the subject experienced left arm pain. On 09-APR-2021, the subject experienced pulsating behind left ear increases and decreases. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye pain behind eye, and left arm pain on 09-APR-2021, was recovering from blood shot to left eye, and had not recovered from pulsating behind left ear increases and decreases. This report was non-serious.
No adverse reaction. Doing inventory count today and realized count was off. Child was given extra dose of IPV.  Spoke with parent and she not had any adverse reactions.
Information has been received from a physician concerning a female who on 21-FEB-2009 was vaccinated with first 0.5mL dose of GARDASIL. There was no concomitant medication. On 22-FEB-2009 the patient experienced heart racing, rash at injection site and pelvic pain. At the time of the report the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Patient described rapid heart beat within 24 hrs. of vaccine. Pt. seen at urgent care. EKG normal Pt. referred to cardiology
Red circle rash on Left Deltoid, sore to the touch, hard, itchy, but not painful when it is not touched
I have had pain in my Right arm since the flu vaccine was given.  It hurts to lift and move my arm with basic movements.  It is painful to brush my teeth, brush my hair,  and getting dressed.   I notified Pharmacy today as I was trying to give it time to resolve on its own.  Pharmacy suggested to call my primary care physician.
low grade fever, 99.7, chills, very tired, injection site extremely itchy, large area turned red
REDNESS AND ITCHING AT INJECTION SITE OF ZOSTAVAX. NODULE AT INJECTION SITE OF ZOSTAVAX. HEADACHE AND DIZZINESS WITH NO FEVER.
p/vax pt devel sx of or similar to Bell's Palsy-numbness in eyes, lips, tongue;
Began with stiff neck with pain.  Became severe within 2 hours.  Constant pain at top of spine, occicipital bone, right sided more affected.  Unable to turn head or move it due to pain and stiffness. Used ice with limited improvement but no medication. Symptoms included difficulty/stiffness with jaw movement.  Continued constant pain, but limited improved by morning of 2/26. Gradual improvement throughout the day. Took ketoprofen at 4:40 PM on 2/26/14 with significant improvement. Today some limited stiffness but pain not significant.  Symptoms continue worse on right side.
On Tues 8-7-12, reaction began later that day. High fever (102.8), chills, pain in arm at injection site, swelling, tenderness, hot to touch, redness. Wound up in E.R. on 8-9-12 - Admitted to hospital. Treated for both infection & inflammation. Cellulitis. Fasciitis.
severe diarrhea; gas; bloating pain in standing up and walking in intestinal tract; bloating pain in standing up and walking in intestinal tract; This is a spontaneous report from a contactable consumer(patient). A 62-years-old non-pregnant female patient received BNT162B2(Solution for injection, Lot Number: en6203), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:45 as single dose and previously took BNT162B2(Lot Number: el3247), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 11:15 as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication in two weeks included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.  Patient did not had Covid prior vaccination and had no known allergies. No other vaccine in four weeks of vaccination. On 05Mar2021 17:00, the patient experienced severe diarrhea, gas, bloating pain in standing up and walking in intestinal tract. No treatment for adverse events and not tested Covid post vaccination. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Headache, Nausea Vomiting, night sweats, right deltoid edema Narrative:
Complained of pain injection site and radiating up the left shoulder, neck, and occipital.
Body aches and pains back neck shoulder ribs x3 days. Narco not helping, today ibuprofen, Tylenol, codeine.
I received the Jansen 1808978 vaccine on 03/25/2021 at pharmacy , on the following day 03/26/2021 at 8:30 pm I became disoriented / dizzy along with severe tinnitus and for the first 30 minutes I lost hearing in my right ear but it?s been over two weeks and the ringing is still going on .
Pt. states vaccine just above elbow. At approximately 9pm became red and inflammed, hot to touch with swelling. Also c/o itching. Over the next few days the redness increased. She had an appointment with Dr. on 10/17/19 and gave pt. antibiotic for infection of L arm. F/u with Dr. on 10/18/2019. Pt was advised to come here to the Clinic for reporting of outcome.  S/s have resolved.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACYCLOVIR [VALACICLOVIR] on 29-Mar-2021 for Shingles, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I had severe pain in my shoulder. Pain was not in the muscle of my arm but in my shoulder joint. I could not move my arm without pain throughout my shoulder up to my neck and down to fingers.  I took Tylenol (3 tablets every 5-6 hours) to alleviate pain. Tylenol helped minimally. Severe pain that made it impossible to do daily activities lasted 24 hours. Pain was tolerable with continued Tylenol for another 24 hours.  Pain still present today 4/16,  but no Tylenol in 18 hours.
TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a pharmacist on 10-Jan-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX2019-091 (PVX201901-000029; female) and PVX2019-092 (PVX201901-000030, male) were created and cross-linked in the database.  This case report describes an adult male consumer who "took Vivotif with food". The consumer was receiving Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took the three doses of Vivotif with food. The doses were taken on 03-Jan-2019, 05-Jan-2019, and 07-Jan-2019, respectively.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000029:
Expired vaccine stored in the refrigerator; No adverse event; A patient got an expired dose this week; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week), PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week), PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A patient got an expired dose this week) and PRODUCT STORAGE ERROR (Expired vaccine stored in the refrigerator).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dose administered after manufacturer date of expiry. The vial was initially stored in the refrigerator on 10-Apr-2023. The vial did not undergone any temperature excursions. No side effects reported by patient.  No treatment medications was reported.
On datasheet the vx I was given read as expired; This case was reported by a consumer and described the occurrence of expired vaccine used in a patient who received Flu unspecified (Flu vaccine) (batch number FZ453, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter reported that the patient just received Flu vaccine of NDC 58160-890-41 from lab. The reporter stated that the expiration date on the datasheet was given and read as expired. The provider stated that it was an error from their part, and they were missed to write the expiration date. Additional supportive information: The patient received a Flu vaccine which was already expired, which led to expired vaccine used. Follow-up would not possible as no contact details were available.
This spontaneous prospective pregnancy report as received from a physician refers to approximately 25 years old female patient. The physician reported that the patient who was 6 weeks pregnant with last menstrual period of approximately 30-DEC-2013 and estimated date of delivery of approximately 06-OCT-2014 received the first dose of GARDASIL (dosage and lot# unspecified) on 10-FEB-2014. Trimester of exposure was first trimester. Initial exposure to GARDASIL was at 6 weeks. The pregnancy outcome was pending. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 61 year old female patient. Information about patient's medical history was not provided. On 02-APR-2015 also reported as "today", the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose: 0.5 ml, frequency, route of administration and indication were not specified) (lot # K001504, expiration date: 28-MAR-2015). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected, as no consent was give to follow up.
pt recv vax 7OCT98 2PM & 3Pm noticed 50 cent piece size swollen, hard white area @ inj site;called hlth dept 430PM was instructed to apply warm compress;area of swelling progressed to redness & hot, spreading from elbow to under axilla;ER
9am vaccine-Novartis (lot #102139P1) administered. 10:15 am ED reports hot face and neck with itching-scratching area. Administered Benadryl 50mg po- No SOB, oriented, steady ambulation. 10:25 am ED "nauseous", itching continues, legs and arms "hot"- no rash observed to extremities-face and neck red from continuous scratching. 10:35 am arms and legs itching, No resp difficulty. Additional Benadryl 50mg po given. Is dizzy. NO SOB. 10:45 ER notified of plan to transport. Dr ordered & administered epinephrine 0.3mg IM due to distance to hosp and transport by family. New c/o SOB. 10:50 am transport to hospital by grandfather.
Received vaccine on Saturday morning.  Started aches and fever on Sunday morning. It is now Tuesday, May 18 at 10:05 am and I'm still experiencing a low grade fever and hot to the touch left arm. Aches have subsided. Just thought I should report a four day fever and breaking out in a sweat that continues.
Symptoms onset 1 day after vaccination.  Symptoms include: nausea, lethargy, sore throat that has not resolved since onset on 4/22.
extreme fatigue, lightheadedness, nausea, headache, large red raised area at sight of injection.  Started on Keflex d/t growing redness and warmth at injection at site.  Symptoms lasting over 3 days
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempts to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Small 8 mm firm round mass at injection site with 2 cm area of redness.
Received tetanus shot in right deltoid 10/4/04. On 10/6/04 she noticed a "pulsating" mass in her necknear clavicle. 10/8/04 noticed second mass. Seen 10/11 by doctor. Noted to  superficial nodes slightly larger than BBs. No adenopathy of neck.
This case was reported by a consumer via call center representative and described the occurrence of ear noises in a adult patient who received SHINGRIX. On 18th April 2018, the patient received the 1st dose of SHINGRIX. On 23rd April 2018, 5 days after receiving SHINGRIX, the patient experienced ear noises. On an unknown date, the outcome of the ear noises was unknown. It was unknown if the reporter considered the ear noises to be related to SHINGRIX. Additional details were provided as follows; On Monday, the patient had a sudden onset of a high pitched squeaking in ears. It lasted 3 or 4 hours and subsided. On Tuesday, when the patient woke up it was back and did not subside until 4 or 5 PM. On the day of reporting, (Wednesday), the patient felt fine and the patient's blood pressure was unchanged. The patient went for a hearing test on the day of reporting and hearing had little or no changes since last exam 2 years. It was asked if the patient had a change or addition to the medications the patient took and the SHINGRIX was the only medicine. The patient had researched the side effects and did not find any reports of tinnitus and was curious to see if others had reported anything like this. The patient had an appointment with medical doctor on Thursday, 3rd May 2018. That was the first available appointment. The patient was thankful for the opportunity to contact.
Swelling on opposite side from injection site (bicep and lower arm had edema, erythema-but nothing around injection site, no pain or redness just on opposite side of arm and lower arm near elbow also swollen).
High high high fever. exceeded 105 while i was sleeping. I've been taking advil and Tylenol to try to get it under control. I'm also eating ice cream and using an ice pack.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding the concurrent condition or medical history was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M000442 with expiration date 31-MAR-2018, lot # M034894 with expiration date 11-NOV-2018, lot # M035487 with expiration date 23-FEB-2019, lot # N002914 with expiration date 04-NOV-2019, lot # reported as N006321 with expiration date 08-NOV-2019) (dose and route unknown) for prophylaxis. No adverse events were reported. The vaccines were stored under 0-1 degrees Celsius for 3 hours and 43 minutes and 9-25 degrees Celsius for 3 hours and 4 minutes.   Data logger was involved. This is one of several report received from the same reporter. Sender's Comments: US-009507513-1707USA010873: US-009507513-1707USA010872.
Several hrs /p DTP , had fever, over 104 F at home, 103.8 in ER. Mildly irritable, lethargic, fed very poorly. Rxn lasted for 1 day then resolved