chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got his 4 year vaccines 1 week ago. MMR-V was administered in his left thigh. He got KINRIX in his right thigh. He had some redness and swelling develop at the left thigh site on Saturday and Sunday which Mom attributed to the shot but then she noticed that the redness was getting worse on Wednesday. This redness had worsened significantly (doubled in size) when she got home from work on Thursday. The redness is still progressing. It is described as "itchy" and "it tickles" which is what he usually says when it's painful. It does sound like the predominant complaint is of itching, however. He has a history of some mild atopy - has reactive airway symptoms, was recently diagnosed with nummular eczema. He did seem to be fighting of a viral infection on Thursday of last week (the day before his WCC) and had a temp up to 100 but this didn't turn into a full-blown illness. He has also been exposed to his siblings who had flu recently. He has never had a reaction to a vaccine before and has no known allergies. Diagnosed as delayed hypersensitivity reaction.  Given 5-day course of oral orapred.
Intussusception 11/15/11. ROTATEQ given 11/11/11 (3rd dose).
Patient states shortly after receiving the vaccination, she was unable raise her left shoulder and has been in pain. She was seen by her PCP who prescribed her some steroids and Norco to help relieve the pain. She still is unable to raise her left shoulder.
patient received a re frozen dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A / 23C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine). At the time of the report, PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  There were two different lot numbers involved in the incident: 047C21A and 23C21A which were all booster doses. The patient received booster doses that were done from vaccine that was thawed, inadvertently refrozen, and then thawed again before administration.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up appended On 05-Nov-2021: Follow up contains significant information, Suspect batch number was added.
Patient experienced slight swelling and redness in her arms and face. Patient also felt light-headed. These symptoms occurred a few minutes following administration of the vaccine. Patient reported directly to the pharmacy seeking medical attention. The patient was guided to a chair and given a 25mg tablet of diphenhydramine and advised to take small sips of water. Emergency services were called. After 5 mins of sitting and controlling her breathing, the redness in her face and swelling in her arms dissipated. An ambulance arrived on scene and care was transferred to EMS officials for further evaluation. To our knowledge the patient declined to go with the ambulance to the hospital.
30 point elevation of sBP and dBP beginning 3 days after vaccine and persisting at office visit on day 7 post vaccine in my office
Without action, I was sitting in the library at school and moved my shoulder and noticed a pain in my rotator cuff that was extreme and outside of the realm of the normal soreness after a flu shot. When the symptoms did not go away, I went to my doctors on November 20th 2016 to have them look at it. They prescribed a round of steroids and ibuprofen and I immobilized it for a few weeks. When the symptoms did not subside, I went to Physical Therapy in February and after a few sessions I was able to rebuild the muscle in my shoulder so that I could move my arm above my head again. I still experience limited discomfort when using my arm strenuously, but this is now 8 months after the vaccine.
Pt recv vax on unknown date; 1 day later pt exp stiff neck, muscle & bone achiness.
Fever 103 degrees. Severe pain in arm. Swelling. Nausea, vomiting.
A patient got flu when got shot; Initial information was received on 08-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who got flu(influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient wanted to know that the flu could be treated in home or not.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Vacine given in late morning. By 7:00pm started feeling weak, nauseous,muscle aches, bad headache, fever of 100.8 and chills.  I drandk lots of water and went to bed. The next day all the symptoms except the headache and feeling weak were gone, I know these are not life threatening or extreme reactions, but I am concerned that as a senior woman, weighing 108 lbs., that the larger dose recommended by insurance, was too much for someone as small as myself. I think a smaller dose would be better for me. When asked if I had a choice of dosage, the woman said this is what insurance has determined. I want to bring  attention to the fact that a one size fits all may not be safe.
Experiencing muscle aches arms and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Experiencing muscle aches arms and legs".  Additional information: The patient wanted to know if it was safe to take Tylenol or Ibuprofen after the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Head Ache, shivering, joint pain, & nausea.  2:00 AM. Two hours after going to sleep.
Patient began noticing soreness and redness in arm same day of injection, symptoms persisted for next three days until patient reported to pharmacy. Redness has extended down from injection site to lower upper arm (down to elbow). Patient using Biofreeze topically with little to no improvement. Advised patient to follow up with physician if redness and soreness is persisting for additional day, or if symptoms worsen in same time frame.
03-21-03 pt. c/o chest pain on 3rd day after vaccination. She consulted with ER Doctor and had an EKG (Abnormal results)and follow up with an angiogram with negative results. 03-25-2003 she states she is no longer having any complaints.
Fatigue, nausea, low grade fever, headache, arm pain from injection site up my arm into my neck, lite headed.  Lasted about 10 hours. Stayed home, rested, hydrated, took one Tylenol.
5 minutes after receiving vaccine , patient experienced sweating and dizziness, gave patient water and had patient keep head upright, patient was fine after 5 more minutes.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 05-JUN-2017,  the patient was vaccinated with an expired dose of M-M-R II lot # L020189 with expiration date of 03-JUN-2017(strength, dose, frequency, route of administration, were not provided) for prophylaxis. No adverse effects reported. No further details were available. Additional information has been requested.
A blister popped up near the site; patient received booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 11:15 (Lot number: FE3592) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "chronic pain disorder" (unspecified if ongoing). Family history included: "odd reactions to about everything" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot No-EN6207, Route: Injected into left arm), administration date: 16Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Lot No-ER8729, Route: Injected into left arm), administration date: 06Apr2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Nov2021 11:15, outcome "unknown", described as "patient received booster dose"; VACCINATION SITE VESICLES (non-serious) with onset 09Nov2021, outcome "not recovered", described as "A blister popped up near the site".  Additional information: A blister popped up near the site (on same arm, left arm, same side as administration), but not sure if it was exactly where injection was given. It was rather nasty. It was only about less than the width of her pinky finger, very small. Hasn't gotten any bigger. Blister was on the left arm. Started to get smaller. She had been really careful not to burst it. She woke up and had scratched in herself in her sleep and it hurt like heck enough to wake her up. Part of the blister burst and was drying out. She had chronic pain disease prior to vaccination and a couple other things, but nothing that would cause the blister. NDC number and expiry date were reported as unknown. No investigation assessment was reported. She worked as a research assistant with behavioural pharmacology. Knows that some of the rare side effects that happen don't necessarily get listed if they fall under a certain percentage point. She is the kind of person that gets the rare side effects. Additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, relevant tests were reported as none. The adverse events did not require visit to emergency room or physician office. Vaccine wise pretty normal. Outside of that, family has odd reactions to about everything, but not vaccines.   Follow-up attempts are completed. No further information is expected.
Patient had red streak under armpit about 3 inches long and pain under arm and at injection site. BENADRYL 25 mg every 4-6 hours and ibuprofen.
no additional AE; Nurse reports that an expired dose of ROTATEQ was administered; This spontaneous report was received from a licensed practical nurse, referring to a 9-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally, lot # 1705097, expiration date 20-APR-2022 (dose was not reported) for prophylaxis (Expired product administered). There was no additional adverse event reported (No adverse event).
sluggish; felt tired; left arm started feeling stiff; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to alcohol (fermentation in champagne, wine). Concomitant medication included unspecified medication for daily birth control. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient's left arm started feeling stiff around midnight of the day of vaccination. On 31Mar2021 (reported as next day), the patient felt tired and sluggish especially in the afternoon. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events left arm started feeling stiff, sluggish and felt tired. The clinical outcome of the event left arm started feeling stiff was resolved on an unknown date in Mar2021 while that of felt tired and sluggish was resolved on 31Mar2021.   No follow-up attempts are needed. No further information is expected.
patient missed the second dose of IMOVAX RABIES with no reported adverse event; Initial information was received on 08-Feb-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA047970(CLUSTER).  This case involves a 10 years old and unknown gender patient who missed the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES].with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect RABIES (HDC) VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for dog bite (Immunisation).  On an unknown date the patient developed a non-serious patient missed the second dose of imovax rabies with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that "Caller states 2 patients received their first dose of IMOVAX 2 weeks ago after being bite by a dog. Their first dose was administered the day of the bite. Caller states they missed their second dose and are coming in today. Caller is asking does he need to restart the series or resume where they left off. This situation is reported to PV due to 2 patients missing their second dose of IMOVAX RABIES in the post exposure series and deviating from the recommended administration schedule".  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  At time of reporting, the outcome was Unknown for the event patient missed the second dose of imovax rabies with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Information has been received from a physician concerning a patient who was vaccinated with Rotateq. Subsequently, the patient experienced diarrhea for a couple of days after the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Bad red rash on injection arm; Swelling on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Bad red rash on injection arm) and VACCINATION SITE SWELLING (Swelling on injection arm) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SINUS MEDICATION) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Bad red rash on injection arm) and VACCINATION SITE SWELLING (Swelling on injection arm). At the time of the report, RASH ERYTHEMATOUS (Bad red rash on injection arm) and VACCINATION SITE SWELLING (Swelling on injection arm) outcome was unknown.            Treatment details was not provided. Action taken was not applicable as the patient received both the doses of vaccine.
Feet and legs felt like she was walking in a muddy land; Difficult to move because lower legs felt like it was 30 or 40 pounds each; It was warmer than the rest of my arm; It was itching; Arms started to swell; It was reddish pink; A spontaneous report, was received from a consumer (patient), an 85 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced feet and legs felt like she was walking in a muddy land (peripheral neuropathy), difficult to move because lower legs felt like it was 30 or 40 pounds each (bradykinesia), it was warmer than the rest of my arm (vaccination site warmth), it was itching (vaccination site pruritus), arms started to swell (vaccination site swelling), and it was reddish pink (vaccination site erythema).  The patient's medical history was not provided. Concomitant medications were not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A), intramuscularly in the left arm for the prophylaxis of COVID-19 infection.   On 21 Jan 2021, right away after the vaccine was administered, the patient had nothing. After taking a nap, that day while the patient wanted to get up, but feet and legs felt like she was walking in a muddy land and shoes would pick up mud and become heavier. It was difficult to move because her lower legs felt like it was 30 or 40 pounds each, which went away. About a week later, the patient felt nothing. On 27 Jan 2021, the patient's arm started to swell, just at the area, as big as a kiwi. It was warmer than the rest of her arm, reddish pink and was itching, but did not want to scratch her arm. That lasted about two days. The patient had no fever, and no chills. No treatment details were provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, feet and legs felt like she was walking in a muddy land, difficult to move because lower legs felt like it was 30 or 40 pounds each was recovered on an unknown date in Jan 2021, that of event it was itching was recovered on 27 Jan 2021, and that of events it was warmer than the rest of my arm, arms started to swell, and it was reddish pink were recovered on 29 Jan 2021.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event and excluding any other etiology,  a causal relationship with the events cannot be excluded. Vaccination site pruritus, Vaccination site swelling, and Vaccination site erythema are consistent with the vaccine profile.
patient was upset receiving vaccines and  was  unable to be held still  medical assistant giving the vaccine was only able to get 0.2 ml administered , mom declined to have the rest administered as patient was very upset after receiving multiple vaccines, mom chose to come back another time for re-administration of the vaccine. Called stated, can re-administer the full dose again in 4 weeks.  no adverse reactions took place , no injury  this is just occurrence reporting
Pt. states no prob with vaccine administration; mild soreness initially then about 12/4 he had eruption of abscess left ring finger, now sim. on rt thumb. (None prior). Followed by onset of tingling/heaviness in both arms ltr at night-disturbed sleep->then also noticed during day starting about 12/15. No weakness or pain, mainly forearms and hands without illness or injury. No prior sim occs. Seen at PCP office 12/17/09.
pt awakened 130AM 21FEB w/ t104.4 ax,moaning;t dec to 102.5 w/APAP;also had discomfort @ inj site;
my mother received the booster shot and approximately 24 hours later passed away from a massive heart attack. she had no known or pre diagnosed heart conditions that we are aware of.
No additional AE or PQC reported.; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 21-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #W025273, expiration date: 10-AUG-2024, administered for prophylaxis (strength and route of administration were not provided) that was after a temperature excursion (product storage error). The vaccine was exposed to 34.7 degrees Fahrenheit for 13 hours 15 minutes 0 seconds. There was no previous excursion. No additional adverse event was reported (no adverse event).
Very flushed, face is red like had alcohol; Very sore today, body aching; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Very flushed, face is red like had alcohol) and MYALGIA (Very sore today, body aching) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-May-2021, the patient experienced FLUSHING (Very flushed, face is red like had alcohol) and MYALGIA (Very sore today, body aching). At the time of the report, FLUSHING (Very flushed, face is red like had alcohol) and MYALGIA (Very sore today, body aching) outcome was unknown.            Treatment medication was not provided Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received on 21-jun-2021 contains no significant information.
p/vax pt exp confusion;nerves were frayed;lost 5 pounds;felt overwhelmed; tx: anxiety pills & lymerix d/c;confusion lasted few days & nervousness gone, but pt still does not feel rt;can feel blood rushing through his system;