chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of PEDVAXHIB (lot number L051123 with an expiration date of 13-OCT-2018) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 Celsius (C) for 48 hours. The aforementioned temperature was identified due to a data logger. There were no previous excursions reported. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
The patient had weakness in lower limbs, loss of feeling of balance. The patient has to use a cane to maintain balance. This is new.
pt recv vax 17MAR98 & 17MAR98 immed p/vax pt exp constant pain @ the site of inj, down arm & up to neck;arm felt weak even when opening & closing hand;also had shoulder pain;
Patient was found unresponsive at 6:00am this morning when mom went to wake her for the day. She was limp, breathing normally, and taken immediately to the local Emergency Room when she finally came around after a little while. Further work up/evaluation is currently being done
Pain in injection site; slight nasal congestion; This is a spontaneous report from contactable Nurse (patient) via Pfizer Sales Representative. A 27-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in injection site, and slight nasal congestion on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus. About August 2021 the tinnitus went away. It has returned with my latest flu shot and got worse with the booster from 11/15/21
Swollen, red lesion on left arm. Temperature 100.6. Cellulitis on left arm. Treatment: Keflex and Benadryl.
After the shoot, I realized the pharmacist  injected the shot very low and on the far back of my left arm.  He definitely did not inject in my muscle.  I do think he hit a nerve. Sharp pain in arm.  Pain radiated from shoulder to injection site.  Lasted for a long time so went to a chiropractor from 4/12/2021-4/26/2021.  Had therapy and several sessions of stimulation.  No relief.  Went to Clinic and saw an osteopathic doctor.  She sent me for physical therapy from June 2021-August 6, 2021.  A little relief.  Had several sessions of dry needling.  Since then, living with the pain which has gotten better.  However, it still bothers me at times.  Sharp pain at the injection site.
Left wrist then fingers, then entire left arm tingling that moved to neck/jaw area, then entire right arm/tingled in face; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: ER8731) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history [other medical history: No]. No known allergies. There were no concomitant medications. On 08Apr2021, the patient experienced his left wrist then fingers, then entire left arm tingling that moved to neck/jaw area, then entire right arm/tingled in face (disability) with outcome of recovered. Clinical course details: After the first shot, the patient's left wrist then fingers, then entire left arm tingling, that moved to neck/jaw area, then entire right arm. Lasted for about 2 hours after the shot in full affect. Still tingled in face some around 24 hours later on and off. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. No prolonged hospitalization occurred.
This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to 2 patients of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On an unknown date these two patients were inadvertently administered VAQTA (dose: 0.5 ml, intramuscular, lot#, expiration date were not reported) that had been improperly stored. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
It felt like I was having irritable bowel attack. I was sweating and I was panting and I was very very hot. They laid me down on the floor because it was cool. They gave me an EPI shot and some BENADRYL and I was then able to open my eyes.
patient started feeling light-headed after receiving the shot, she said she was fine at first and went to observation chair to sit. after 5 minutes, she did not feel better and laying down to the ground saying she feeling dizzy. pharmacist on duty came to check her and she said she didnt feel very well. after saying that, she went into seizure for 5-6 seconds. patient did not respond to her mom calling her. when she regained consciousness, she had no recollection of the event. pharmacist on duty, patient's mom and another customer also witnessed the event. 911 was called and arrived on scene. patient felt weak and could not walk so she was taken to ER to further evaluate. No family history of seizure confirmed with the mom.
RASHES, TONGUE/HAND SWOLLEN, DIFFCULTY IN BREATHING  PATIENT REPORTED SHE TOOK BENADRYL AFTER THE SYMPTOMS STARTED.   PATIENT CALLEDTHE PHARMACY ON MONDAY (12/06) AT 9:54 AM TO REPORT THE SYSMPTOMS AND INSISTED PHARMACIST ON DUTY TO WRITE THE SX ON VACCINATION CARD TO AVODI THE 2ND SHOT OF THE SERIES VACCINATION.   PHARMACIST ON DUTY SUGGESTED THAT HE CAN NOT WRITE ON THE VAC CARD BUT REPORT TO THE AUTHORITY ABOUT THE ADVERSE EVENT. PHARMACIST ON DUTY ALSO ASKED PATIENT THAT AFTER SHOWING THOSE SYSMPOTS SHE WENT TO EMERGECY SERVICES OR NOT AND SHE REPORTED SHE DID NOT VISIT ANY ER FACILITY.
Patient returned to the pharmacy on 10/7/2018 to report an adverse reaction to his vaccination received 9/23/2018. He reported short term joint discomfort lasting 24-48 hours. He also reported a dark purple bruise at the injection site that has persisted. The presence of the bruise was confirmed on 10/7/18. It is on his left upper deltoid and slightly larger than the size of a quarter, circular in shape. The patient reported there has been little to no change in the size or color of the bruise since it appeared. He states no other signs (pain, warm to the touch, swelling, redness, etc) are present.
The next day after my vaccination,  a little less than 12 hrs, I started having severe neck pain . I didn't wake up with the neck pain or do strenuous activity I was just at work typing at my desk. It got so bad I couldn't look up or down, it then turned into a headache. It got so bad the next day I went to urgent care. The Dr. said that the muscle was knotted at the base of my neck and gave me a muscle relaxer and 800mg ibuprofen. I the next day the headache had gone away and the pain was a little better. I couldn't take muscle relaxer 3 times a day because I'm a mom so I went to a massage spa and that helped a little. Today I just feel like I have a migraine and the pain is gone, It was just really odd the way it came on.
Had SHINGRIX vaccine yesterday and experienced chills, fever, muscle aches, nausea, headache, shivering and general malaise starting 6 hrs after the injection. Symptoms got worse and I took 800mg of Ibuprophen and slept. Still not 100% this morning.
This spontaneous report as received from a pharmacist refers to a patients unknown age and gender. On unknown date, the patients were vaccinated with ZOSTAVAX (dose, duration and indication were not reported). On an unknown date, the patients developed an injection site reaction. The outcome of the patients developed injection site was unknown. This is one of several reports from the same source. Additional information has been requested.
rash on the opposite side arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed a rash on the opposite side arm after receiving the COVID vaccine first dose on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
With the first shot, she had a little sore arm and that was it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "With the first shot, she had a little sore arm and that was it.".  Additional information: The NDC number and expiry dates were not provided and Lot number was not provided as the patient was unwilling to complete the report. There were no other products or investigation assessment provided. The patient was advised to follow up with primary care physician or local healthcare provider for treatment recommendations and medical advice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe COVID-19 infection with ARDS.  Requiring mechanical ventilation, paralysis and flolan nebulization.
Swollen right arm, erythema, patient stated feels warm (she had me touch her arm & I did not note any fever/heat). States it was painful especially the first night and reported day 3 at which time it was tolerable.
soreness at the injection site; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 01Dec2021 09:45 (Lot number: FF8841) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: environmental (dust, mold,mildew, etc)" (unspecified if ongoing); "known allergies: food" (unspecified if ongoing); "known allergies: pets" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA; NASACORT; VITAMIN D [COLECALCIFEROL]; FISH OIL. Past drug history included: Robitussin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM, Route of Administration: Intramuscular), administration date: 19Feb2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 10Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 09:45, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 17:00, outcome "recovered" (02Dec2021), described as "soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Soreness had resolved by the next morning. Additional concomitant product included multi-vitamin.  Follow-Up (06Dec2021): Follow-up attempts are completed. No further information is expected.
Body jerking, conscious, oriented time/place. Eyes became glazed, body limp. Called 911. Symptoms lasted 45 minutes. Mother left with student and went to family MD.
Rash on sides of chest, cracks in between both legs, rash on back of legs, rash appeared 2 days after immunizations given. Tx: Atarax, Orapred, Hydrocortisone cream.
got the shot and, didn't prevent getting shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot and it did not prevent him/her from getting shingles. However, the doctor said it would had been a lot worse if he/she had not received the shot.  The patient felt it was bad enough. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
WITHIN 2 MIN OF VAX BECAME DIZZY, RAPID PULSE, FLUSHING, SHALLOW AND RAPID BREATHING, NAUSEA, HEADACHE, AND ARM FELT FALLING OFF.SYMPTS ABATED ON WAY TO ER, BUT 1 HR LATER, RESUMED. BENADRYL ADVISED AND SYMPTOMS ABATED. PT TOOK 2 NUPRIN.
Information has been received from a physician concerning a 15-month-old female who in the end of January 2007 or the beginning of February, was vaccinated with ProQuad. The patient experienced rash within 1 week of vaccination. Unspecified medical attention was sought. No laboratory or diagnostic testing was performed. The outcome was reported as recovered. There was no product quality complaint involved. No additional information to report. Additional information has been requested.
I woke up on June 27, 2022 and felt like I had a fever, I had a raspy voice, sore throat, headache, cough. My wife took my temperature for me and we used a home COVID-19 test that came back immediately. I could not get in to see him but was able to have a phone visit on June 28, 2022. He prescribed PAXLOVID that I was able to start that day along with TESSALON PERLES for the cough. He advised me to rest. I am now feeling better. My sense of taste and smell are coming back, still have slight congestion and cough.
Event occurred after 2nd Dose. On 12/14/2021, Patient was sent by her infectious disease doctor to be admitted to the hospital to receive IV antibiotics due to a recent wound culture that showed multidrug-resistant Pseudomonas.  Patient is unable to come to the doctor's office or her infusion clinic because the patient is Covid positive.  Her symptoms for Covid are a mild cough and no respiratory distress.   Patient on tylenol, multivitamin. Outcome: Inpatient
No Adverse Event; Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021) and NO ADVERSE EVENT (No Adverse Event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EW0182, EW0172, FL3198 and 054A22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high, COPD, Heart failure and Coronary artery disease.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021).    It is unknown if patient was under any concomitant or regular medications No treatment information was provided.   This case was linked to MOD-2023-712562 (Patient Link).   Reporter did not allow further contact
Syncopal event several hours after vaccination followed by right sided weakness, sensory loss and aphasia later found to have a left M1 occlusion requiring tPA but no thrombectomy after patients symptoms completely resolved with tPA. At this point we think the likely etiology of the event was paroxysmal atrial flutter.
Patient awoke  morning after the vaccine with  symptoms consistent with Bell's Palsy on right side of face: drooping mouth, drooping eyebrow, eye unable to close, no wrinkles on forehead.
On 1/17/2021 patient woke and began her day as usual, was found down by family member 1 hour later conscious but unable to speak and unable to move her R side.  She was admitted to the hospital - Initial NIHSS was 26 and CT imaging showed no acute hemorrhage but mild hypodensity of greater than 1/3 of the MCA territory (TPA not recommended).  CTA did show distal L M1/M2 occulsion and she was transferred to larger facility for thrombectomy.  Unfortunately the patient had persistent severe neurological deficits after thrombectomy.  Was discharged home on hospice care and expired on 1/23/21.
10:40 am: Patient presents with palpitation and tremors. Vital signs: BP 166/95, HR 95, O2sat: 98% 10:50 am: Vital signs: BP 163/96, HR 90, O2sat: 96% 11:00 am: Vital signs: BP 165/98, HR 82, O2sat 98%
p/vax pt exp chills, muscle pain, general malaise,T102r, & shakiness;pt began shaking violently;pt recv APAP & sx subsided;sx resolved p/taking Ibuprofen;
About 7 hours or so after I was vaccinated I began to feel a pulsing type of headache, but i was tired so I fell asleep. About 3 hours later (around 6am) I woke up with the worst headache I've ever felt. On a  pain scale of 0 to 10 it was a solid 10. It was a splitting headache, a pulsing and crippling pain, it was also sensitive to light. Every time I moved or changed the direction in which I was looking the pain would surge through my head and paralyzed me. I took 1000 MG of acetaminophen and then half an hour later I took 800 MG of ibuprofen. The headache calmed down a for a while, but 8 hours later I was already feeling just as bad as when I felt the headache the worst, so I took another dose of acetaminophen and ibuprofen. The entire day went on like that, along with body aches, some nausea and fatigue. Throughout the next four days,  all of those symptoms gradually diminished. On the third day after vaccination, the injection site felt very sore; my whole arm would hurt every time I moved it.
Red rash on arm for 3 days, getting more extensive each day. Rash not at injection site,but on same arm but much below the injection site. Left arm hard and  extremely tender, inflamed lymph node under left arm.  Went to doctor yesterday to get the rash checked out.   Rash not getting any bigger today.
Passed out 10-15 minutes after shot. 1 week after shot started vomiting after eating, and having heartburn issues not previously seen. My doctor has diagnosed this as GERD. This has continued months later, including a loss of 28 lbs (Not previously obese).
Myalgias. Pleuritic chest pain. ST elevation. Low-normal LVEF 50-55% on echo.
Large, red induration at site of injection on right thigh. Size is 10-12 cm.
Arm where shot was given got swollen, red, hot to the touch and bumpy. It hurt all the way to the bone. No feve, but swollen lymph nodes in the neck.
Information has been received from a RN concerning an adult female pt who was vaccinated SC with a first and second 0.5mL dose of varicella virus vaccine live. It was reported that the pt had a negative antibody titer. Unspecified medical attention was sought and no prescription drug was required. No product quality complaint was involved. Additional information has been requested.