chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 year old body was seen in clinic on 7/20/04 for well. Child check and was given DTaP, IPV. Right arm (deltoid) and he developed swelling with redness: injection site: 4.5x5 inches on 7/21/04 and seen on 7/21/04 and placed on Keflex and Motrin tid prn x 7 days.
couldn't sleep on her side; right arm was warm; had a reaction/not normal; area that looks bruised (right arm); right arm was very solid; right arm was swollen; right arm was red/ looks like a blood vessel is in it; right arm was sore; soreness of the injection site area; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)) and MUSCLE RIGIDITY (right arm was very solid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Dec-2021, the patient experienced INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)), MUSCLE RIGIDITY (right arm was very solid), PERIPHERAL SWELLING (right arm was swollen), ERYTHEMA (right arm was red/ looks like a blood vessel is in it), PAIN IN EXTREMITY (right arm was sore) and VACCINATION SITE PAIN (soreness of the injection site area). The patient was treated with Physical therapy (cold pack) for Feeling hot; Physical therapy (cold pack) for Contusion; Physical therapy (cold pack) for Muscle rigidity; Physical therapy (cold pack) for Peripheral swelling; Physical therapy (cold pack) for Erythema; Physical therapy (cold pack) for Pain in extremity and Physical therapy (cold pack) for Vaccination site pain. At the time of the report, INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)), MUSCLE RIGIDITY (right arm was very solid), PERIPHERAL SWELLING (right arm was swollen), ERYTHEMA (right arm was red/ looks like a blood vessel is in it), PAIN IN EXTREMITY (right arm was sore) and VACCINATION SITE PAIN (soreness of the injection site area) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient reported that she placed a cold pack on her right arm one night and she slept in a chair because she couldn't sleep on her side because of her swollen and sore arm. Patient received her first two Moderna doses prior to the Moderna booster dose.
adverse reaction to the moderna Spikevax; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (adverse reaction to the moderna Spikevax) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (adverse reaction to the moderna Spikevax). At the time of the report, IMMUNISATION REACTION (adverse reaction to the moderna Spikevax) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Four minutes after receiving Pfizer Covid 19 Vaccination (#1 of series), client lost consciousness. Client was diaphoretic, pale. Consciousness returned almost immediately. BP 100/70, Pulse 62, Oxygen Saturation 96%. Client reported feeling nausea as well. Client instructed to place head between legs and take deep breaths. No medication was provided. Ice applied to neck. 5-8 minutes later client was escorted to clinic exam room via wheelchair and placed in supine position. Client observed an additional 30 minutes while symptoms gradually improved. Client ambulated on own to his vehicle after observation period.
Pt states that 1 day after getting Tdap on 9/1/16, she noticed a red, raised, area on her right deltoid that is warm to the touch. Ice pack applied, pt advised to take TYLENOL for pain and to exercise right arm during the day.
Pt received vaccine and sat down in observation and passed out after 3 mins in observation. Pt monitored for an additional 30 minutes then cleared by medical professional to go home with parent.
This spontaneous report as received from a nurse refers to three different patients. In September 2012 the three patients were vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Lot# reported as H011333). In September 2012 the three patients all experienced injection site reaction after being vaccinated with ZOSTAVAX. It was not known if the patients sought for medical attention. Additional information has been requested.
Moderna COVID 19 Vaccine was administered to 33 patients after the beyond use date. Medical Associates Director of Clinical Services and Vaccine Coordinator are working with Agency to reconcile the errors and provide appropriate follow upto affected patients.
L triceps swelling, redness through elbow measurement: L 11.5 R 10.5,  12.5 R 11, L 12.3/4 R 11 3/4. treatment cold compress Keflex 500 mg PO BID x 10 days.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., dose of COVID-19 VACCINE (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No concomitant medications were reported.  Patient received booster dose.  No treatment medications were reported.  The reporter assessed the event as not related to Moderna vaccine, Covid-19 vaccine and Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Syncope:   15 min period of unconsciousness while standing in  shower. Did not realize that she sustained head trauma   2nd episode of loss of consciousness for 10 min Nausea & severe headache. Seen at Urgent Care on 2/15/21. Practitioner performed scans and x rays. Made diagnosis of cerebral concussion. Patient also reported sustaining fracture to incisor which was repaired by a dental practitioner
Patient developed fever with chills and feeling very cold around 6 pm the same day of immunization.  During the evening, she developed a red facial rash (erythema) with four macules on the cheeks and chin.  two additional small eruptions were inside of her mouth.  Felt very tired and lethargic for 48 hours after the immunization.  Note:  She was eligible for her six month follow-up second dose  last October 2018.
pt exp redness, pain, & heat & site;seen 22OCT95 @ health center dx cellulitis secondary to vax;
Pt recv vax on 11/5/98; on 11/6/98 pt exp raised, red, itchy welts over body x 1 mon
first seizure experienced 6/19/21, second 8/04/21, third 9/14/21, fourth 1/29/22, fifth 3/25/22.  Never had any type of seizure disorder ever, no history of seizure disorder in family
I took the vaccine too/Suspected Vaccination Failure; It is the worse pain I ever had/who gets it; Worse pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I took the vaccine too/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: It is the worse pain I ever had) and pain (Verbatim: Worse pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-MAR-2023 The case was received from the patient via interactive digital media. The patient had some of the worse pain he/she ever had. The patient took the Shingles vaccine too and prayers for any one who gets it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Woke up from being asleep and whole body was having spasms and twitching. They were not painful but lasted about a half hour and we?re uncontrollable. One side of my body would have a shiver go down and then my muscles would contract and I would need to pull all my limbs on that side close to my body and then the same thing would happen to the other side. The only way I could describe it at the time was I thought I was having a seizure though I have never actually had one before. In the morning I was relatively sore all over my body but no other symptoms after that.
This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for himself. A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced measles, seizures and headache all on an unspecified date with outcome of unknown.
Headache; Chills; Feeling fatigued; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021 14:30, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. In December 2021, 15 hrs 30 min after receiving Shingrix, the patient experienced headache, chills and fatigue. On an unknown date, the outcome of the headache, chills and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. Reporter could not provide the lot or expiration date of the vaccine administered. On the day of reporting (this morning around 6am), the patient woke up with a headache, chills, and felt fatigued. Reporter gave consent for safety to contact her but did not provide any information to contact her health care professional. The reporter consented to follow up.
pt reports a rash (raised, pinpoint) devel 12APR94 on face, arms, around neck, chest, below knees; had itching; states rash faded the next day; no treatment;
Headache; Tiredness; Chills; 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 82 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 82 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Tiredness"; CHILLS (non-serious) with onset 31Mar2021, outcome "unknown", described as "Chills". Additional information: The patient had headache, tiredness and chills after receiving the first dose of the vaccine today 31Mar2021. Caller asked if he can proceed with his 2nd dose on 21Apr2021 even though he experienced the mentioned side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This site is scheduling second doses during the 4 day grace period.  They are NOT adhering to the 21 day interval as noted on your site and under the FAQs.  I received my first dose on April 2, 2021 and second dose on April 21, 2021.  I have talked to 2 additional people who went to this megasite and these 2 additional people have also confirmed their second doses were during the 4 day grace period.  This is not how they should be scheduling doses, especially for an entire megasite!  My patient ID on my vaccine card and I live in NJ.  I called the Dept of Health as well and they provided incorrect information to me.  Please help. Thanks
Arm sore and hot; these symptoms continued until day 3 Started feeling sick about 12 hours after dose; fever, chills, muscle aches, headaches, general flu symptoms .   Lasted for 48 hours.
Pt vaccinated with Typhoid/Influenza 2 days later developed rash on arms &trunk fine red rash & blotchy. No welts, hives or SOB. Had slight headache. Did not seek medical help. Resolved 1-2 days after treatment.
HALF DOSE LEAKED/PARTIAL DOSE; HALF DOSE LEAKED/OOZED OUT FROM ARM; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAR-2021, the patient's half dose just leaked/partial dose and it oozed out from arm. She would like to know if it was okay to re-administer the whole dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the half dose leaked/partial dose and half dose leaked/oozed out from arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210336532-covid-19 vaccine ad26.cov2.s -Half dose leaked/Partial dose . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Narrative: COVID infection following COVID vaccine series 07/22 Janseen, dose #1 11/21 COVID swab, result: detected 11/23 pt cc: cough, fatigue, rhinorrhea, fatigue exposure: unknown 12/01 clinically resolved
Nine days after vaccination, injection site became inflamed. Site was red, swollen, itchy, and hot and firm to the touch. Area of redness is approximately 2.5 inches in diameter. No treatment was sought.
Patient was seen for follow up visit. MMR and VARIVAX were ordered by provider. MMRV combo was drawn up and given. Patient is to young for (discovered on/report 6/2/17 Agency reported) MMRV.
Intense dizziness,  hard to walk straight ,  very troubling. Only been a couple days but have read a forum on last which others reporting lasting for weeks. I am very concerned,  I would not like to live like this permanently
Received Pfizer vaccine 2/2/21 and 2/23/21.  Symptom onset 7/4/2021 with cough, runny nose, muscle aches, sore throat, fever and headache.  Tested positive for Covid-19 on 7/7/2021
This is a spontaneous report from a Pfizer-sponsored program from 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 03Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included Lupus. The patient's concomitant medications were not reported.  Patient got her first dose of the vaccine last 03Mar2021. She experienced chills, fever and body pain on the second day after the first dose of the vaccine. Now, she feels weak and has no energy. She wanted to know if this was normal. She has a pre-existing condition which was lupus. She was worried that she might get a worse reaction after the second dose. Her second dose was scheduled on 24Mar2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 1/2/2016 she began fussing/crying and not acting herself. She was not walking normal and as the day progressed it became worse. By the end of that night she would not stand or walk much, she was staring into space at times and not responding normally to our interactions with her. By 1/3/16 she had to be taken to ER and was admitted to PICU with potential GBS diagnosis or ADEM per the ER admitting doc.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly dose of VAQTA (lot # R006210 exp date 22-APR-2019) (dose and route not reported). There was a data logger issue. The temperature of excursion was 47 °F to 77 °F (47.3 °F) for a time frame of 5 minutes. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1809USA009046: US-009507513-1809USA009096: US-009507513-1809USA009097: US-009507513-1809USA009098:
Am an anesthesiologist. Approx 3-5 min after uneventful injection, my suddenly heart rate started to climb above 100, felt dizzy and had rigors. Emts came to assist took vitals; slightly elevated BP but normal sats. About 5 min after that my lips, eyes, nose, tongue and throat felt a little swollen. They then placed right AC PIV and gave 50 mg of IV Benadryl. I didn?t want Epi at that time bc my bp was good and going to hospital. They agreed. Once at hospital they have decadron  10mg IV push. I spent about 4 hrs in ED  where I had 2-3 sudden episodes of tachycardia as high as 140s.
Patient was indavertently given dose of Moderna COVID-19 vaccine rather than Pfizer COVID-19 vaccine. Patient's father aware and no adverse reactions noted at this time.
On 07/30/2022 I had sneezing; body ache; and chest congestion; fatigue; and tiredness. 07/31/2022 along with the rest of the symptoms plus fever of 99.5. I called on Sunday with a doctor but the prescription was called in on Monday. They prescribed me with PAXLOVID for 5 days. I took over the counter NYQUIL to help me with sleep I took it for 5 days.
Just couple hours after the shot, I was throwing up and had really bad stomach pain. I haven't been able to go No#2 and can't keep any food or liquid down. Constant throwing up and feel very weak.
Patient broke out in noticeable hives on his forehead, behind his left ear and on his left arm around 4pm on 12/9/17. There were no other symptoms other than the hives. We reached out to the nurse advice line to inquire whether we should give him BENADRYL or take him in for evaluation. They told us to give BENADRYL and re-evaluate in 30 minutes. The hives were still present, but there were no other symptoms other than a mild fever. We gave him a second dose of BENADRYL around 10pm and he went to bed. He woke around 8am the next morning and the hives resolved. No other symptoms have been noted other than some soreness at the injection site.
A report has been received from a Health Professional concerning a 6 month old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that patient received FLUMIST BOOSTER 17 DAYS APART which started on 17-Sep-2012. The outcome of the event of FLUMIST BOOSTER DOSES 17 DAYS APART is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by MedImmune on 19-Oct-2012 Physician: No new information to add. Corrected report. New reporter were added. Corrected report 06-Dec-3012. The coding of FLUMIST booster doses 17 days apart was changed from drug administration error to inappropriate schedule of vaccine administered.
This spontaneous report was received from a female patient of unknown age who was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On approximately 05-OCT-2017, (also reported as "05 October" and "Thursday"), the patient was vaccinated with expired dose of ZOSTAVAX lot # M003487 with an expiration date 21-APR-2017, 1 injection for prophylaxis (route of administration and anatomical location were not reported).
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. This is one of the many reports form the same source. Additional information has been requested.
Resident received the 3rd COVID -19 Pfizer vaccine on 10/20/2021. The next day, resident reported feeling hot and cold, generalized body aches, decreased body strength, and localized pain on injection site. Pt denies SOB/coughing/sore throat. Pt was noted to have elevated BPs  (160-228/42-86) on 10/22 . (Baseline BP 150s/60s)
Nausea Vomiting redness/soreness at site; chills; fatigue; body aches Narrative:  Employee experienced redness and soreness at injection site. On 4/20 at 24.5hrs after vaccine, employee began experiencing chills with nausea, fatigue, and body aches. Symptoms subsided about 12 noon on 4/21.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dyspepsia, Pre-diabetes and Obesity.    On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Dec-2020, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related.    No concomitant medication information was provided.  No treatment medication were provided.  Patient had no adverse reaction