chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; weakness; Cough; felt mild symptoms/Symptoms worsened; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), VACCINATION COMPLICATION (felt mild symptoms/Symptoms worsened), ASTHENIA (weakness) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient is reported to be diabetes.).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION COMPLICATION (felt mild symptoms/Symptoms worsened). On 25-Apr-2021, the patient experienced COUGH (Cough). 25-Apr-2021, the patient experienced ASTHENIA (weakness). On 27-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, COUGH (Cough), VACCINATION COMPLICATION (felt mild symptoms/Symptoms worsened), ASTHENIA (weakness) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: high (High) Blood pressure was 203/50..         Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-Significant follow up updated on 29-Jun-2021 and email address updated for reporter/caregiver
Her father is scared either way; Her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's daughter). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 28Jun2021 (at 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included had multiple health conditions and concomitant medications were not reported. Reporter calling about her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use. Caller stated that her parents got their 1st dose of vaccine on 28Jun2021, however, they were informed on 02Jul2021 that the vaccines were expired (start date 28Jun2021). According to them, the vials was supposed to expired in Aug2021, but the vial has been stored in the fridge for 38 days and you're not supposed to use it after 31 days. The vaccine shot that was in the refrigerator for 38 days was still given to reporter's parents. The patient (her father) was the very concern and had multiple health conditions and was afraid of allergic reactions. The patient wanted to make sure that if he doesn't get revaccinated, he was still protected. The patient was scared either way on unspecified date. Reporter wanted to know if they should be revaccinated or to resume the vaccination series as scheduled or was it safe to use the 38 days; and let's say they want to get revaccinated and decided to go for the full MODERNA series instead of Pfizer because they fear getting Pfizer again since they already got one shot, what was the data Pfizer have on people getting one shot of something and change to a different COVID Vaccine.  Information on lot /batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021865048 same reporter/drug/AE, different patient
On 1/3/01 the pt experienced a rash that started at the injection site on arms and legs and worked down legs and arms. The rash was fine that turned red. Cheeks were red and there was a rash on the stomach. 1/4/01 the pt was holding joints like they were hurting. The pt was also cranky and had diarrhea. Saw an MD who said it was an allergic reaction to the vaccine.
The needle separated from the syringe; Patient was not administered the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (The needle separated from the syringe) and UNDERDOSE (Patient was not administered the full dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced DEVICE CONNECTION ISSUE (The needle separated from the syringe) and UNDERDOSE (Patient was not administered the full dose). On 23-Jul-2021, DEVICE CONNECTION ISSUE (The needle separated from the syringe) and UNDERDOSE (Patient was not administered the full dose) had resolved.        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.   Concomitant drug was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: non significant follow up added
Covid; Covid; This is a spontaneous report from a contactable Other Healthcare Professional (HCP).  A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was scheduled for her second dose of vaccine tomorrow (08Jan2021) but she was diagnosed with Covid on 07Jan2021.  Outcome was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Urticaria up & down arm and (L) side of face. No SOB/wheezing. Tx with topical ice (+) CLARITIN 10mg symptoms improved in 30 minutes.
Burning and itchy, redness on both palms of my hands.  Hot flashes for 1 month during the night. Hot flashes gone but the burning and itchiness on both hands are worse still since March symptoms.
7 year old child recevied fluzone HD QIV/no AE; Overdose; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00793015).  This case is linked to case 2021SA328195(CLUSTER).  This case involves a 7-year-old (unknown gender) patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On 25-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ747AA and expiry date not reported) via an intramuscular route at a the left thigh for prophylactic vaccination.  It was an actual medication error case due to overdose and inappropriate age at vaccine administration (latency: same day).  It was reported "Nurse manager reports that two of their patients; a 9 year-old child and a 7 year-old child, received a FLUZONE HIGH-DOSE QUADRIVALENT. She is seeking information to provide to the children's mother."  At the time of reporting, no adverse event was reported.  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 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.
Very swollen lymph nodes in right armpit and right breast. Extremely tender. Pain level 6/10.
headache; cold chills; Fever; Had aches; This is a spontaneous report from a contactable consumer(patient). A 72-year-old female received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number; EN6198 and Expiration date was not reported), via an unknown route of administration in right arm on 24Feb2021 at 16:00(at the age of 72-year-old), as 1st dose, single for COVID-19 immunization. The patient medical history including any illness at time of vaccination were none. The vaccine was not administered at military facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was not provided. Prior vaccinations within 4 weeks were none. The concomitant medications were not reported. Patient received the first dose of the Pfizer Covid 19 vaccine last wednesday on 24Feb2021. She felt fine after vaccination. On 28Feb2021, she started having fever (of 99.8, which her normal is 97.4), fever broke at 11pm last night and no other fever. The fever broke, she discovered she had a fever and then about 7 hours later it broke, she had taken some Tylenol. She had cold chills and had a real bad headache that lasted for about 24 hours and today she does not have a fever, her fever broke. She said it started, about all day long she had a headache and they have had some crazy weather so she thought it may have been the barometric pressure and then she started having the cold chills in afternoon and the temperature, usually she did not run a fever, so she was a little concerned, she said she hopes she didn't have COVID but she still had her taste and smell and she checked her temperature and she has no fever today. The chills are somewhat resolved but she was still chilly even with the heat on and extra clothes she was cold. She said the chills are ongoing but improved. She no longer has the headache today. She confirmed fever chills and headaches was everything she experienced following the vaccine. She doesn't feel really good either and she was wondering if it is normal that many days after the vaccination to have side effects. The events did not require visit to emergency room and physician office. She complained a product complaint.The outcome of the event had aches was unknown and for the event chills was recovering, whereas headache and fever was recovered.  No follow-up attempts are possible. No further information is expected.
Fever, achiness, very sore arm, lasted 48 hrs. Naproxen provides temporary relief.
Covid vaccine was given to 6 patients including this patient using a vial that had been in the refrigerator for 32. This is two days past the manufacturer recommended storage of 30 days. Nurses in the clinic did not realize this until a day after administration.  We did contact the manufacturer for guidance.
client screened,nocontraindications,vaccines given,client stood up,moved to stand behind parents who took turns getting flu shots, client momentarily lost consciousness,slid to carpeted floor,immediately opened eyes,skin sweaty, BP 116/58,P60,R20,PERRLA,had not eaten all day.no tx. parents declined medical tx.No injuries.
Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Right thigh hot to touch, red, swollen. Knot and bluish ring around injection site.
slight swelling and tenderness of LO arm. Soreness and aching L shoulder Narrative:
tired and really weak; tired and really weak; She was glad she did not have an appetite; really cold/the chills are like she is sitting on ice; Loss of taste; nauseated; she vomited nothing come out except yellow stuff she was spitting up from her stomach.; Chills; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) (at the age of 72-year-old) as single dose for COVID-19 immunisation.  Medical history included problem with her blood pressure and active TB (tuberculosis), both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient reported loss of taste began on Sunday (on 18Apr2021), when woke up Sunday she was nauseated, she didn't have anything to eat so, when she vomited, nothing come out except yellow stuff she was spitting up from her stomach. She clarified the loss of taste, nausea and vomiting began on Sunday 18Apr2021 and that were all ongoing. She said that chills started the day of the shot (on 15Apr2021). She felt tired and really weak and she was really cold. She said the chills were like she was sitting on ice, she confirmed they are ongoing. She was glad she did not have an appetite. The patient outcome of the events was not recovered (she said all of that was persisting just about the same).  No follow-up attempts are needed. No further information is expected.
Within 30 minutes of administration, pt developed localized swelling, erythema, ecchymosis and pain at administration site.   (Vaccine was given SQ/IM due to her diagnisis of ITP.)
1)Tingling sensation in legs, more noticeable with movement 2) menstruation cycle full flow slowing , cycle normal 3-5 days, slowing after 2 Days
Roughly 15 minutes post injection, body felt hot, I broke out in a massive sweat, heart rate went way up and I almost passed out and had to lay on the floor of the target pharmacy while EMTs were in the way. I was held for about an hour or more for observation until heart rate was controlled. Once home, heart rate continued to jump up even while sleeping.
She also stated that she had 20 chills in one hour; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She also stated that she had 20 chills in one hour) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 028H21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (She also stated that she had 20 chills in one hour). At the time of the report, CHILLS (She also stated that she had 20 chills in one hour) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-416093 (Patient Link).
Shortly after receiving 2 vaccines in (L) arm - he walked out of room on his own & suddenly collapsed on to the wall in the hallway. I rushed to assist when I heard the bang on the wall & found him sitting in an awkward position - unaware of his surroundings. I laid him down on the floor & elevated his lower extremities. He slowly recuperated & became oriented to place/person/time. He stated he felt better & understood that he fainted & stated that it happen to him when he gets blood drawn. The nurse & I lifted him when he felt he could walk, sat on a chair & kept monitoring him for another 10-15 minutes. We took his blood pressure, which was slightly elevated (135/65) & gave instructions to him & his mother for him to rest, drink fluids, eat & not drive today. They were understanding of the instructions and proceeded to leave the office. I called the house @ 4:15PM to ask for a F-U report, got An Answering machine & LMTCB. 10/30/20 10:30 AM ADDENDUM: I reached out to Mom again & she returned call informing that Patient was back to normal - yesterday.
Vertigo especially when laying down; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:00, the patient experienced vertigo especially when lying down. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo especially when lying down was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hep A, MCV4 were both administered with different needles on left deltoid. Pt was talking to me, 2 min later pt tried to get up, and fell, hit his head, called out for help. After pt woke up, had him lay down, breathe. Sat him down on chair, gave him Sprite to drink, took VP, resp. had him walk around.
Headache, Myalgia, Fever, CHILLS, CONGESTION,  Narrative:
This spontaneous report as received from a 61 years old female patient with no drug allergy refers to herself. The patient's medical history included chicken pox. The patient had developed chicken pox twice in her life, once as a baby and once after 30 years of teaching. The patient was vaccinated with ZOSTAVAX (lot# unknown) and influenza virus vaccine (unspecified) in a different arm on 29-SEP-2012 or 30-SEP-2012. On 21-OCT-2012 the patient developed "pustules" around the left back portion of her neck. She stated that her neck felt warm at the time. She applied BENADRYL gel to the area and the warmth went away, and at this point the area looked better than it did initially to where the pustules are disappearing. The BENADRYL stopped the itching for the treatment information. There was no lab reported and the patient did not sought medical attention. The outcome of was reported as recovering. Additional information has been requested.
VACCINE WAS ADMINISTERED TO A 16 YEARS OLD BY ACCIDENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine was administered to a 16 years old by accident, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine was administered to a 16 years old by accident was not reported. This report was non-serious.
Approximately 4-5 hours after receiving the vaccine, I broke out in hives large about 5 in in diameter and raised. These were on my stomach. I had red patches on my chest area. I was on my way to pharmacy (dr would have been closed) and when he saw it, he told me to take liquid Benadryl. I called Dr.'s office on Friday May 1 (morning after) he told me to take 50 miligrams of Benadryl. I broke out again about 8:30 pm on 5/1 on my legs, thighs, and arms also left ear was blocked up. The original shot was given on April 30, 2009 at about 10:35 AM. The last out break was on Friday.
HR 158 to 132; bp 148/70; o2 sat 99-100%; monitored 15 minutes additional; bp 122/70 8 minutes later hr 120; patient states she feels better and wanted to go home;
Red bump at site of injection; Sense of smell has improved; Sense of taste has improved; Slightly swollen at site of injection; fever of 99.6; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved), VACCINATION SITE SWELLING (Slightly swollen at site of injection) and PYREXIA (fever of 99.6) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis and Pansinusitis (chronic pansinusitis).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved), VACCINATION SITE SWELLING (Slightly swollen at site of injection) and PYREXIA (fever of 99.6). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved) and VACCINATION SITE SWELLING (Slightly swollen at site of injection) outcome was unknown and PYREXIA (fever of 99.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 99.6 (Inconclusive) Fever of 99.6.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Patient demographics, Relevant medical history, Dose details were updated.
Thrashing, screaming, unconsolable. Child states he saw "crawly" things on wall. Mom stated he seemed awake. -Has never done this before.
Started feeling weak, tired, sore throat, and headache in the morning after getting his second dose.  Then he threw up.  He laid down and started getting a fever in the afternoon, reaching 103.0 at one point.  We started giving him Tylenol which reduced the fever, but it kept fluctuating the rest of the day.  He had chills, and his left armpit hurt.  He took over five naps that day, and more the next day with headaches continuing, but no more fever.  After the first two full days, his only remaining symptom was the pain in his left armpit.  It subside four days later.
Pt fainted/syncope s/p vaccination. No head injury. Experience nausea. symptoms self-resolved and pt discharged home in stable condition with family.  BP 93/56 HR 76 RR 16, unlabored  SpO2 99% RA