chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHAKING; CHILLS; HEADACHE; NAUSEA; 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) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On an unspecified date, the subject experienced shaking, chills, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, chills, headache, and nausea. This report was non-serious.
Diarrhea, severe since 10am day following booster shot and continuous. Explosive despite peptobismal. No fever or other concerns. Some pain at injection site normal.
Information has been received from a 35 year old Hispanic female licensed practical nurse with an allergy to procaine hydrochloride (NOVOCAIN) who on 31Jul2001 was vaccinated SC in the right arm with a second dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that titers determined in January 2003 and February 2003 were negative. The reporter indicated that there was no adverse event. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Day 1: pain at injection sight, mild headache, resolved with ibuprofen. Day 2:  menstruation occurred 2 weeks early, moderate bleeding, moderate uterine cramping, muscle pain, severe fatigue. Day 3-5: menstruation continues, moderate bleeding severe fatigue, extreme thirst.
Patient reported full body hives starting day after immunization. Patient self treated with OTC diphenhydramine. Symptoms started within 7 hours after immunization.
Child began with fever, child went to ER was tested for influenza, influenza test negative. Child fever caused a febrile seizure, child was monitored and released home. No admission. Child also began with diarrhea.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a patient of an unknown demographics who was vaccinated with a dose of FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. On an unknown date, the patient developed a non-serious rash on their L deltoid and back (rash) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also a case of actual medication error due to wrong vaccine was administered. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This is a spontaneous report from a contactable consumer (husband) reported for a female patient (wife).  A female patient of unspecified age and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number and expiration date: Not reported), via an unspecified route of administration on an as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date it was reported that the patient experienced Dementia. The caller stated that since the patient received her second vaccine shot, she seemed to be so weak and she cannot stand up on her own feet. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
He was found unresponsive, cold and with rigor mortis  present after family requested welfare check. He had not been seen for 36 hours.
I had a stroke in the cerebellum part of my brain after my 4th dose. I didn't have good balance at all. I have a history of spinal problems and I had several test's ran and by the time they found out that I had a stroke I had significantly improved. I didn't have speech problems, or the droopy face. I just had trouble walking and I was having to hold onto something to be able to walk. I wasn't dizzy at all, and I didn't have vertigo.
10/23 member started with warm hands and itching all over approx 1 Hr after Flu vaccine, took BENADRYL. Then about 10  AM 10/24 tongue swells
On October 3rd 2019 I had the first Shingles shot.  I had no immediate reaction, not even flu-like symptoms and was otherwise in good health, mentally and physically.  However, on October 6, 2019 I had an extreme sudden onset of full body tremors.  My arms and legs were flailing uncontrollably, I had contractions in my torso, my head was bobbing up and down, and I had difficulty walking and talking.  The extreme symptoms eased within 3 days however the full body tremors and difficulty walking and talking continued into mid-November.  The episodes varied in length and intensity.   I had a whole series of tests, blood, heart, lungs, neurological, and a brain MRI.  No condition which would explain the symptoms or the sudden onset was found.   The symptoms continued to ease and become less frequent in December 2019 and I began to be able to resume normal activities.  In January 2020 I was seen by a Neurological specialist in their Movement Disorder Clinic.   I was diagnosed with a Functional Movement Disorder and was set up to receive Neuro-Physical Therapy.  However, there is an extreme backlog and I can't be seen until the last week of April 2020.  As before, the symptoms continued to become less frequent and shorter in duration through January 2020 and into February 2020.  I had the second Shingles shot on February 20, 2020 and the severe, long lasting full body tremors returned on February 22, 2020.  The episodes are lasting 3 to 4 days again and I am unable to leave the house.  It is now March 7, 2020 and the tremors continue as they did after the first Shingles shot.   I believe something in the Shingles vaccine has caused this condition and while it is not life threatening it certainly is debilitating.  Hopefully this post will help to define the issue and expand the warnings for a severe reaction such as mine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium
pt devel a fever of about 103 approx 5hr p/vax;mom states pt screamed for about 2hr;
No adverse event; Adult patient received expired first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine).    No concomitant medication was reported.    Date of expiration was reported as 01-APR-2023. Date the vial was initially stored in the refrigerator on 29-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-718681 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718681:(MASTER)
Redness & swelling devel w/in a couple of hrs p/vax; Motrin & APAP prescribed;
Cold sores; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the COVID Vaccine on 06Jan2021, the first shot and the patient now had broken out with cold sores and the patient has had cold sores before in mouth. Normally, the patient would just take some Acyclovir and Valacyclovir (Intent: Treatment) that had prescribed by doctor but now the patient was concerned about taking it (Acyclovir and Valacyclovir) and it doing something to the vaccine and making it not as efficacious. The patient wondered if that is true. Outcome of the event was unknown.  Information on Lot/Batch has been requested.
expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The date of refrigeration of the dose was 07-May-2021.
Child vaccinated with H1N1 vaccine at school by nurse on 11/11/09.  Mother reported to school nurse on 11/16/09 that child was nauseated on 11/12/09 then stayed home from school on 11/13/09 with hives, aches, and fever.  Red raised blotchy areas under both arms were noted by school nurse on 11/16/09.  School nurse states that child was taken to private doctor and the doctor did not say whether he thought the reaction was to the shot or not.  Child was started on prednisone, Benadryl, and Tylenol.  Mother states that the child would return to school on 11/17/09.
Left leg swollen, red and hot where imz were given. Tx Augmentin or Cefzil depending on insurance coverage and Benadryl 1/2 tsp Motrin 1 tsp every 6 hours. F/U if fever or rapid expansion of erythema.
Its been over a year since the first vaccine; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date a year ago prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patients did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The Health care professional reported that patients had received 1st dose of Shingrix more than a year ago. The health care professional inquired that if they can restart the Shingrix series. No further details were provided. The reporter consented to follow up.
Within 2 minutes after receiving the Gardasil vaccine (subsequent to receiving Varivax) patient had a near syncopal episode while sitting in the chair.  Patient face totally lost color and she reported feeling numb in her lips and shaky in her extremities. Patient needed to be aroused. Pt was placed in the supine position and BP was 78/32 and pulse 45. It took 5-10 minutes to recover before patients color returned and repeat BP was 108/62 pulse 60.
Since increase in Pristiq having pain in left gluteal muscle; This is a spontaneous report from a Pfizer sponsored program COVAX US SUPPORT via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; desvenlafaxine succinate monohydrate (PRISTIQ), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient previously took venlafaxine hydrochloride (EFFEXOR). Patient was taking EFFEXOR but was switched to PRISTIQ. HCP also increased dose. Since increase in desvenlafaxine succinate monohydrate having pain in left gluteal muscle. Received 1st dose of vaccine and after vaccine left gluteal muscle was hurting. The action taken in response to the event for desvenlafaxine succinate monohydrate was unknown. Outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested.
My arm is still red about 4 inches down from the injection site; Arm  a little itchy; This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were unknown.   It was unknown if the reporter considered the erythema of extremities and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient stated that the arm about 4 inches down from the injection site was red and little achy but patient was concerned that till the time of reporting the arm was red.
it gave me the flu; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional.  This case involves adult patient with an unknown demography details for whom it was reported that it gave the flu (influenza), while being received vaccine influenza vaccine.  This case is linked to case 2020SA314745 (same reporter).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.    On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient had flu (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071621:
Erythema measuring 7.5x5cm.  underlying induration measuring 6cm at widest point.
Place below injection site red/hot/swollen, then progressed to whole arm and then torso. Pt experienced difficulty swallowing and then was seen in ER.
Patient received the first dose of Moderna Covid-19 vaccine on 2/11. Approximately 30 minutes afterwards, she developed "numbness " over the right half of her face.  She did not develop facial drooping or slurred speech. Symptoms lasted approx. 12 hrs and resolved w/o intervention
pt recv vax 1995 & in DEC96 pt exp herpes zoster on inner aspect of the lt upper & lt lower arm & chest;
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.32.  Concomitant products were not provided.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 03 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash were unknown. It was unknown if the reporter considered the injection site pain, itchy rash, headache, fatigue, muscle pain, erythematous rash and raised rash to be related to SHINGRIX. Additional details reported as follows: The patient experienced local injection site soreness. The caller reported that 2 days after the injection the patient developed red raised itchy rash in spots all over back, up to base of neck around shoulders and down the front trunk. The caller stated that patient used TYLENOL for pain and BENADRYL for itchy rash.
Sever e pain in my sinuses and in my head. Congestion in my sinuses. Vomiting from 11:00 p.m. to 6:00 a.m. my body was wrenching from nothing to throw up. Chills. No fever all of the mucus was clear. I've used hot compresses for my sinuses and cold compresses nothing helped. I took Mucinex DM and two Aleve about 6:00 a.m. and started to have some relief from the pain in my head.
During 4 month visit parents described infant as screaming and crying for a long time hours after the second set of shots. Was very inconsolable.
headache, pain behind left eye, nausea, Dizziness, fever, chills, migrane, back rash and rash on palms.
Fever, chills, headache, beginning around midnight (10 h post-vaccination). Muscle soreness, joint pain, following a few hrs later (4 am), developed hyperasthesia in late afternoon (3 pm) following day. Fever & chills ceased approx. 10-11 am following morning (20 h post-vaccination), headache treated with aspirin (10 mg, as needed)until evening, muscle soreness, joint pain gradually subsided by 9 pm, hyperasthesia subsided after that all symptoms passed by am of 2/14/19.
17MAR93 10AM noticed rash by rt ear; 103 R then 1/2 hrs later had hives an groin, neck, arms, mouth, ears, head face back of knees;
pt recv vax;devel pain&tenderness under the arm,w/ lymphadenopathy,swelling&erythema at inject site;tx w/ meds for possible cellulitis
Central Serous Chorioretinopathy was diagnosed in left eye after vaccination. Blurred vision began approximately one week post vaccination of second dose.
light headed, dry-parched feeling-(w/in 24hr /p) red large swollen area-hurt to touch on rt arm;
One week after my first dose of the Moderna COVID 19 vaccine (administered 12/24) I developed a large, itchy rash/hives at the injection site. The hives began 12/30 and are still present.