chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The shot seemed very high in my shoulder.  I have had pain in my left shoulder since the shot.  It started on the day of the shot and continues through today.   It was more intense at the time of the shot, but it still is painful.   It is difficult for me to sleep on my left side and it hurts when I lift my left are in certain ways.
First shot was accompanied by severe, but expected, pain 3 days in left arm.  Menstural cycle began 5 days early and was so severe thought to be  burst cyst or appendocitis.  10 days after the second shot, severe crushing and shooting pain in the left arm.  Numbness, coldness, and loss of sensation in the left foot.  Pins and needles and coldness in the hands made worse by being outside.   Pain in the arms was so severe would wake from sleep.  Shooting electrical pain from the base of the skull through the spine into the arms and legs.  Subsequently, loss of sensation in the hands and feed.  Tremors and profound core weakness.   Multiple flareups of the pain, usually in conjunction with the menstrual cycle that resulted in two visits to the ER in May and then in early July.  Patient contacted doctors about potential of Guillen Barre due to timing shortly after the vaccine, but was told that "10 days is too long afterwards to be related".    ER gave an urgent neurological referral to the Northwestern Memorial Neurology department, but the neurology department refused to honor it and patient had to wait almost 3 months to see a doctor.  A primary care physician, physiatrist, and four neurologists,  plus 2 ER visits were consulted during the period.  All initially dismissed the systems as stress and treated with various forms of pain medication or antidepressants until the Small Fiber Neuropathy was revealed from the August test.  Neurologists said they have never seen anything like this before, particularly in a healthy 35 year old woman.  Sensation has not returned to hand, feet, or face.  Tremors continue and worsen periodically, particularly in relation to menstrual cycle.
Back is hurting, but that is happening since the baby was born.; Got chills/is still having chills and stuff; Headache; Got a sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Got a sore arm), BACK PAIN (Back is hurting, but that is happening since the baby was born.), CHILLS (Got chills/is still having chills and stuff) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (COVID positive test or diagnosis in dec-2021) in December 2021.    On 10-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jun-2022, the patient experienced PAIN IN EXTREMITY (Got a sore arm). On 13-Jun-2022, the patient experienced CHILLS (Got chills/is still having chills and stuff) and HEADACHE (Headache). On an unknown date, the patient experienced BACK PAIN (Back is hurting, but that is happening since the baby was born.). At the time of the report, PAIN IN EXTREMITY (Got a sore arm) and BACK PAIN (Back is hurting, but that is happening since the baby was born.) outcome was unknown and CHILLS (Got chills/is still having chills and stuff) and HEADACHE (Headache) had not resolved.            No concomitant information were reported by the reporter.  Patient received second dose of the Moderna covid19 vaccine on the 10-Jun-2022, and on the 11-Jun-2022 they got a sore arm and on the 13-Jun-2022 they got chills, headache and was still having chills and stuff. Also their back was hurting, but that was happening since the baby was born.  Patient did not have any allergies (medications, food and other products). It was reported as patient no medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient could not provided information about their first dose also reporter reported that symptoms was just starting but AE did not required patient to seek medical care (office visit, Urgent care, ER, hospitalized) and patient did not experienced a similar event in the past.  No treatment information were reported by the reporter.   Reporter did not allow further contact
headache, chills, bone and joint pain, loss of appetite, dizziness, drowsiness, lightheadedness, general exhuastion.  chills lasted 24 hours.  headache on right side of head come and go.  still present 3 days later.  exhuastion and lightheadedness still present on day 4
pain at injection site; Fatigue for two days following administration, pain at injection site for two days; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-SEP-2023, the patient received the 1st dose of Shingrix. On 01-SEP-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site) and fatigue (Verbatim: Fatigue for two days following administration, pain at injection site for two days). On 03-SEP-2023, the outcome of the injection site pain and fatigue were resolved (duration 2 days).   The reporter considered the injection site pain and fatigue to be related to Shingrix.     The company considered the injection site pain and fatigue to be related to Shingrix.   Additional Information: GSK receipt date:05-NOV-2023 The reporter reported that seriousness for fatigue for two days after administration, pain at injection site for two days was non serious. The reporter consented to follow up.
Broke out in a full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke out in a full body rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D1A and 027B21H) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Broke out in a full body rash). At the time of the report, RASH (Broke out in a full body rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications included antihistamine and a nasal spray. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received: No new information.
Patient given high dose flu instead of regular dose flu in error. patient's mother is monitoring patient for increased intensity of local reaction.
Sore arm; Received the entire vial of the undiluted Pfizer COVID vaccine; Received the entire vial of the undiluted Pfizer COVID vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for two patients. This is the second of the two reports. An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0168, Expiration Date: Aug2021; 84-year age at time of vaccination) via intramuscular route administered in the right deltoid on 12May2021 at 09:38 (at the age of 84-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included diabetes mellitus from 14Sep2017 and ongoing, dialysis and end stage renal disease from 18Sep2017 and ongoing, and cardiac disorder from 22Jul2017 and ongoing; ESRD from 18-SEP-2017 ongoing; Heart Disease from 22-JUL-2017 ongoing. The patient's family history and concomitant medications included none. The patient previously received first dose of BNT162B2 (Lot ER8736, Expiration Jul2021) administered intramuscularly in right deltoid on 21Apr2021 at 9:29 for COVID-19 immunisation. No other history of prior vaccinations. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and sent home. They were instructed for any signs and symptoms to report to ER immediately. Neither patient was experiencing any symptoms at the time. Upon follow-up on 02Jun2021, it was reported patient had sore arm on 12May2021 17:30; Reported seriousness criteria non serious, not received Treatment. The outcome of the event sore arm was recovered on unspecified date in May2021, and the outcome of other events was unknown.  Follow up (02Jun2021): This follow up-spontaneous report received from a contactable other HCP in response to HCP letter (sent) via follow-up letter which included that: New AE details (sore arm); Relevant Medical History (ESRD, heart disease, diabetes).  Follow-up attempts were closed and completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021537945 same reporter/product/event, different patient.
After 5-6min after injection pt c/o nausea then face turned red eyes rolled back lost consciouness and became pale, flaccid, and clammy. Ambulance was called and pt was taken to the ER.
SHORTNESS OF BREATH, LOST HIS BREATH AND UNABLE TO TAKE DEEP BREATHS; This spontaneous report received from a patient concerned an 82 year old male. The patient's height, and weight were not reported. The patient's past medical history included: loss of muscle control, and concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced shortness of breath, lost his breath and unable to take deep breaths. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, lost his breath and unable to take deep breaths on 07-APR-2021. This report was non-serious.
I got the first shot and felt I'll the next day; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got the first shot and felt ill the next day.  The patient had recently got the second dose and was questioning if the side effects were better or worse with 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002780:Same reporter,same suspect,same patient,different dose(second dose) , invalid case
Within an hour I started getting a headache and felt nauseous. Very tired. Approximately 8hours later I had a 103 temperature and was vomiting most of the night and suffered the chills which made me shiver uncontrollably.  I was feeling terrible the whole next day but the vomiting had stopped.  The headache and fatigue  along with more than usual muscle aches. The next day the headache stopped but the fatigue and muscle aches slowly diminished.  Today I am back to about 80 percent of being normal still am a little fatigued.
VERY TIRED; HEADACHE (ABOVE THE EYE); LIGHTHEADEDNESS/DIZZINESS; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the subject experienced lightheadedness/dizziness. On 17-JUL-2021, the subject experienced very tired. On 17-JUL-2021, the subject experienced headache (above the eye). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheadedness/dizziness, very tired, and headache (above the eye). This report was non-serious.
Nausea/vomiting, severe body aches (I could hardly get out of bed), debilitating headache that was not helped by any over the counter pain relievers.  Exhaustion and dizziness. Symptoms started at 3 am the day after vaccination so approx 18 hours after. The headache, nausea, and dizziness lasted until 7pm that same day so 16 hours. The body aches and exhaustion lasted 3 days total.
Client originally given the 1st dose of Moderna on 05/07/2021, by previous healthcare worker, but client not in the age range for the Moderna vaccine. Per Dr. client was to receive the 2nd dose of Moderna, per off label use. Client denied any adverse reactions, denied difficulty breathing, denied itching, and reported just pain at injection site. Mom also present and denied all adverse reactions.
HAD ISSUES  FROM COVID SHOT; This spontaneous report received from a patient concerned a 76 year old female of unspecified race and ethnicity The patient's weight was 60.5 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. 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 administered 1 total for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Epoprostenol sodium. On an unspecified date, the patient experienced had issues from Covid shot, and was hospitalized on 25-OCT-2021. It was reported that the patient was still hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had issues from Covid shot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20211100399-Covid-19 vaccine ad26.cov2.s - had issues from Covid shot. This event(s) is considered un-assessable. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient basically passes out temporarily after immunizations.  He knows it is going to happen and he says it is like a nap.  He had a little shaky hand, seizure like, and his head tipped down and seconds later he was talking and fine.  Said they gave him water last time it happened, so I got him some water and he felt fine.
Pt tested positive for COVID with surgical pre-screening, surgical procedure was performed as scheduled.  Pt was asymptomatic.
pt recv vax 2OCT96 1130AM 21OCT96 10PM noticed itching on arm where flu vax given  red hard-lump (small) & hives around inj site;deltoid bruised;
Headache began 5 hours after vaccination, still ongoing 26 hours later. Vomiting began 24 hours after vaccination and lasted for 7+hours.
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (orally, exact dose, lot # and expiration date were not reported). The administered doses experienced a temperature excursion of 34.7 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. The stored vaccines were back in proper temperature range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from an LPN concerning a 56 year old white male who on 10/11/99 was vaccinated with a 1st dose of neumococcal vaccine 23 polyvalent, IM in the right arm. The same day as vaccination, the pt experienced arm redness, soreness and swelling over the entire upper arm. The pt was also febrile. The pt was seen by a physician. The pt was treated with cold packs for 20 minutes. The pt was also treated with Rofecoxib, Diphanhydramine HC1, and cephalexin monohydrate. Subsequently, the pt recovered.
shingles; itchy hives on the stomach; soreness at the injection site; redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), URTICARIA (itchy hives on the stomach) and HERPES ZOSTER (shingles) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 15-Jan-2021, the patient experienced URTICARIA (itchy hives on the stomach).   On 22-Jan-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), URTICARIA (itchy hives on the stomach) and HERPES ZOSTER (shingles) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include antiviral medication. Concomitant product use was not provided by the reporter.
The evening that I got the shot I had a low-grade fever and severe headaches. The next day I had a really painful mass in my groin on the left side. The headaches are still present at base of my Occipital Lobe. There is a lump there that is the size of a marble. I went to the ER four days after the shot, and they gave me antibiotic. after locating a mass in my groin.  The doctor thinks it might be a lymph node 1X3 centimeter lump. I have an Ultrasound scheduled for this week.  Both Lumps are still present. Tylenol normally works on the headaches. I have been to the ER, PCP and a gynecologist.
abdominal pain; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix .5 ml. On 5th May 2019, 5 days after receiving Shingrix, the patient experienced abdominal pain and diarrhea. On an unknown date, the outcome of the abdominal pain and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the abdominal pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left arm. The pain was described as dull cramps low in the patient's stomach. The reporter gave consent to follow up.
Blurring in one eye; This case was reported by a consumer via interactive digital media and described the occurrence of blurred vision in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, 1 day after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received the first dose of Shingrix 4 days ago and experienced blurring in one eye starting the day after vaccination.  The patient saw nothing on side about that being a possible side effects. The patient asked if the patient could get any more information.
Presented to the hospital with complaints of altered mental status and shortness of breath. COVID-19+ w/pna; tx w/remdesivir, abx, Vit C, steroids, O2, IGG, zinc, O2; did not improve w/ tx; DNR status confirmed w/comfort care & pt expired.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of an unknown demographics who received an expired dose of vaccine PENTACEL (lot number, expiry date, route and site of administration were not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. PENTACEL was administered to a patient and the dose expired the day prior. It was not reported if patient had any adverse event or not. 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 and Module VI of the 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. Documents held by sender: none.
Liam seemed fine after the shots - until morning. On the way to school he made strange jerking motions. I was then called 3 hrs later & told that he slept all morning, could not sit up, talk or walk. We went to the ER & they confirmed it was a seizure.
Patient called the next day and reported injection site soreness and flu-like symptoms. She went home for the remainder of the day to rest. As the day progressed the experienced worsening of the Sx and reported a fever as high as 102. She continued with ibuprofen and rest. Sx started to subside around 3 PM on 03/29/2019 and she was afebrile as of 6 PM on 03/29/2019. Still is reporting feeling of malaise, but has returned to work.
At today's visit, she is feeling poorly after receiving the first dose of the Pfizer COVID-19 vaccine two days ago on 3/30/21. She initially had fatigue and mylagias but subsequently developed non-productive cough, shortness of breath, rhinorrhea, and sore throat. She does not have any known exposures but lives with a roommate and has been out in public in the past two weeks. She thinks she has a low-grade fever but has not checked her temperature yet.