chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flashes after COVID-19 vaccine; Headache after COVID-19 vaccine; Fever after COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Flashes after COVID-19 vaccine), HEADACHE (Headache after COVID-19 vaccine) and PYREXIA (Fever after COVID-19 vaccination) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 27-Feb-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HOT FLUSH (Flashes after COVID-19 vaccine), HEADACHE (Headache after COVID-19 vaccine) and PYREXIA (Fever after COVID-19 vaccination). At the time of the report, HOT FLUSH (Flashes after COVID-19 vaccine), HEADACHE (Headache after COVID-19 vaccine) and PYREXIA (Fever after COVID-19 vaccination) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Good on antibodies.         No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events was not related with Humira. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
No adverse effects reported.; patient was vaccinated with improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a 12 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On 27-NOV-2018, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R002509 with expiration date on 25-JAN-2020, dose, frequency, route of administration were not reported), The vaccine was reconstituted with properly store sterile diluent (dose, frequency, route of administration, lot number and expiration date were not reported).    Administered dose of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14.2 F) for 3 hours and 15 degrees Fahrenheit up to 46 degrees Fahrenheit (30.6 F) for 2 days, 16 hours and 15 minutes. There was a previous temperature excursion for 6 degrees Fahrenheit up to 14 degrees Fahrenheit (11.3 F) for 7 hours and 20 minutes. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1905USA000487: US-009507513-1905USA003150: US-009507513-1905USA003151:
Patient received the TDAP vaccine on 12/15/2020. Patient called 12/21/2020 to the health department and reported that her arm at the injection site is round,  size of a naval orange, red, and really hot. Patient reported these symptoms started 12/17/2020. She also stated she experienced nausea on 12/16/2020 for a couple of hours.
2nd time in Aug2022; 2nd time in Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 83-year-old male patient received bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19", start date: Sep2021, stop date: Sep2021. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "2nd time in Aug2022". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 125/80, notes: blood pressure is in normal bounds, it was 125/80; SARS-CoV-1 test: Negative, notes: Negative now on Covid.  Clinical course: 84 years old great health. Over the last 3-4 years he had Covid 3 times. He has always had the Pfizer vaccine for Covid and has stayed up to date on the vaccines. 10-12 days ago, he had the third round of Covid. In the second round, he was advised to wait some period, either 2 months or 6 months, after ending the Covid to get the booster shot due to his body building an immune response. He is negative now on Covid. He was told he can take the new vaccine now instead of waiting. Why can he take it next week instead of waiting a certain period since his body has built an immunity. There was no information stating there is a certain amount of time that must be observed after infection before a patient can get the vaccine. He got Covid 1st time in Sep2021, 2nd time in Aug2022, 3rd time last week Sep2023. Every 12 months has had Covid. Already consulted his doctor son. The patient original question was about conflicted information now with next round of Covid vaccine will be available as early as next week. His conflict is he could get it next week. That does not sound right.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300966 same patient/drug/AE, different dose number/event onset date;US-PFIZER INC-202300301888 same patient/drug/AE, different dose number/event onset date;
About 30 minutes after vaccine delivery I had a very fast heartbeat and felt warmth and a tingle go down my right hand. I felt woozy and had to pull over. When the police arrived, my pulse, oxygen level, and blood pressure were all normal though my blood pressure was 98, on the high end of normal. It took about 30 minutes for my head to clear and I still feel slightly out of it. The paramedic said my description was consistent with an adrenaline rush. I felt a lesser version of this after the first dose but they said I was probably dehydrated and sent me on my way.
Severe shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced ARTHRALGIA (Severe shoulder pain). At the time of the report, ARTHRALGIA (Severe shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Starting on 11/15/2021, I started getting sick. I got sinus drainage that was going down my throat and it went straight into my lungs. I didn't have a fever, so I don't think it was a sinus infection. I went to the doctor that day and they said that due to me having a post nasal drip that I likely had a sinus infection. They tested me for COVID-19 which was negative. They gave me a prescription for prednisone and Levaquin. Then, as soon as that ran out, they gave me another round, and I took another COVID-19 test which was negative. At this point, I felt I had bronchitis and I was coughing so bad in my chest. I had to get another round of medicine, but before they would give it to me they told me to go to the health department and get another COVID-19 test. This test was negative and they sent another round of prednisone and some other antibiotic. When I called again, they told me they had given me all the medicine I could have. So, they told me to see my allergist. The allergist said that maybe it was a sinus infection but there wasn't much he could do and told me to see an ENT. They put a tube in my ear due to fluid buildup. I could hear slightly better afterwards but I still have the tube in my ear. In March, I started feeling a little better but there wasn't much they could do. I am still left with fatigue and have no energy.
As soon as I go the shot I didnt have any severe symptoms, but as I drove (20 min) to reach my home. After reaching my home even after few hours also I didnt have any symptoms. But before I went to sleep (around 12:30 am ), i started to have mild pain near the vaccination sight. Even during my sleep i felt okay, but as soon as I woke up (around 09:00 am) i felt mild symptoms on pain, as I started attending to my regular activties right after 10:00 am, i started to feel severe chills, fever,  body pains, lazyness, moderate headache and severe pain at vaccination site. Again I had some food and slept due to severe body pains and even through the sleep also I had severe body pains, fever, nausea and lazyness. As I woke up after my evening nap of 3 hours, i woke up at 6:00 pm and felt chills, body pains., fever and nausea.
PATIENT STATED THEY EXPERIENCED SWELLING AT INJECTION SITE THE SIZE OF GRAPEFRUIT AND HAD FEVER AROUND INJECTION SITE LASTING 2 TO 3 DAYS. PATIENT ALSO DEVELOPED BLISTERS AROUND INJECTION SITE.
Inappropriate age at vaccine administration; Shingles rash; Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2S7, expiry date 15th November 2021) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced shingles and vesicular rash. On 16th September 2019, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles, vesicular rash and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The pharmacist reported that patient received first dose of Shingrix and had now been diagnosed with shingles rash.
Diarrhea/uncontrollable loose stools; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 6th August 2019 04:30, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 23 hrs after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that male patient received the first dose of Shingrix and 23 hrs after receiving Shingrix, the patient experienced diarrhea. The reporter stated that, the patient has not attempted to alleviate the symptoms with any treatment at the time of reporting. The reporter consented to follow up. The reporter granted permission for follow up
PATIENT REPORTS RASH COVERING MAJORITY OF BOTH CHEEKS, WITH THE LEFT CHEEK MORE AFFECTED THAN THE RIGHT. RASH IS RED, BLOTCHY, AND WARM TO THE TOUCH. SKIN APPEARS "SHINY." NO FEVER, PAIN, OR ITCHINESS.
After administering the vaccine, we realized it had been approximately 17 hours since the vaccine was punctured.  Moderna is good for 12 hours after being punctured.
Tenderness at injection, then 5 days later, redness and itching, the redness spreading down the upper arm and turning a purple/red shade.  a topical ointment applied to stop the itching.  the redness remains.
Pt started feeling foggy headed and light headed. Complained of stomach pressure that would go away when she put pressure on the area. Pressure on chest went away around 1:35. Spoke to pt at 4 pm. She is now feeling fine. pt has had history of anxiety in the past and thinks part of reaction may be due to anxiety. She also mentioned that she didn't sleep much last night due to stress of getting the vaccine today.
Right after the second dose I experienced an arthritis flare up and my arm was in a lot of pain. On 12/1/2021 I began to experience Tachycardia around 10:20PM. I then went to the ER and was diagnosed with Tachycardia where they then were able shock the heart back to a sinus rhythm. With medication prescribed Amiodarone, I have not experienced any symptoms.
Patient arrived for her second dose of Pfizer Covid19 vaccine but was mistakenly given a dose of the Moderna Covid19 vaccine.
Pain, Swelling, Bruising, Heat and Redness at and around injection site. Have had for 48 hours post injection.
This case was reported by a other health professional and described the occurrence of expired vaccine used in a female patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unkown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date.
client given Hepatitis A #1 vaccine in afternoon of 9/26/08 within one hour of getting vaccine client noticed redness swelling and tenderness at injection site and tongue became tingly mom gave client benadryl tongue symptom resolved puffiness of arm lasted aprox. 5 days tenderness of arm lasted aprox. 2 days
STROKE; This spontaneous report received from a consumer (husband of patient) concerned a 64 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user and non smoker and other pre-existing medical conditions included no known allergies, no medical history and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, administered in last week of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021 at 7.00 am, daughter of patient found that the patient was on the floor and staring at ceiling. The patient was taken to the Emergency Room (ER). The physician of emergency room said that patient had a stroke. On the same day patient was transferred to the hospital where computed tomography (CT Scan) was done and a stroke was confirmed (patient would see the back physician in OCT-2021) did not have any specific information or the test results. The patient was completely healthy with no medical condition. The patient was under the care of physician. The date of admission and discharge from hospital were not reported. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210835603- covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt got immunizations on 27 Aug 13 R leg - Hib and PCV-13 L leg MMRV and DTap-IPV. FOC called 28Aug13 stated pt complaining of pain in R leg, warm to touch, will not put pressure on leg. Father stated symptoms started about an hour after they got home. Pt was seen by PCM and was instructed to take ibuprofen every 6-8 hours for approx 24 hours. As well as instruction to walk on leg.
My left arm and leg suddenly felt like they were not there. I tried to move my leff arm but couldn?t. So i tried harder. At that time my entire body stArted pulsing  like one jokt per second. ThE entire incident was about 20  or 30 seconds.  When it stopped i took extra kepora and it has not recurred.
patient reports itching on face and face feels warm.  Benadryl given.  Symptoms resolved.
Initial report received from a non healthcare professional who is also the patient on 03 December 2012. A 41-year-old female patient, who has history of seasonal allergies and exercise induced asthma, had no illness at the time of vaccination and no concomitant medications, had received a dose of FLUZONE vaccine (batch number-UH759AB, dose number not reported) intramuscularly in left deltoid on 27 November 2012. On 28 November 2012, the patient had Pink eye in the morning. On an unspecified date, patient was treated with "Cipro" eye drops. The laboratory investigations were none. The symptoms had resolved pretty much but the final outcome was unknown. As per the physician of the patient, the event was not related to vaccine. Follow-up information received from healthcare professional on 12 April 2013: The patient was visited physician on 02 December 2012. On unspecified date, after 3 days of antibiotic "Cipro" eye drops, the patient's eyes were improved. No signs of infection. The patient had occupational health initial injury evaluation done on 30 November 2012 which showed possible bilateral conjunctivitis provisional work related. Documents held by sender: Employee health sheet and occupational health initial injury evaluation report.
Per patient, one hour after vaccination patient experienced tingling lips, itching/hives on the body, and irritated/swollen throat. They went to urgent care for evaluation.
sever body aches; severe under arm pain; Chills; severe injection site pain; This is a spontaneous report from a contactable nurse (patient).  A 44-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EJ1686) in the hospital, via an unspecified route of administration on 19Jan2021 at 08:30 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history nor any concomitant medications. The patient did not have any allergies.  The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine and did not receive other medications within two weeks prior to the COVID vaccine. The patient received the first dose (lot number unknown) of BNT162B2 on 28Dec2020 (age at vaccination: 43 years) on the right arm for COVID-19 immunization. The patient experienced sever body aches, severe under arm pain, chills and severe injection site pain on 20Jan2021 at 02:00 AM. The patient did not receive any treatment for the events. The outcome of the events was recovered. The patient has not been tested for COVID-19 post vaccination.
Patient was given the fourth dose of prevnar too early. Pt had received 3 doses but received 4th one 2 months too early and will have to receive another dose in 6 months.
Caught Covid/ the husband got a mild case but the wife had a fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever). At the time of the report, COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did not get 4th dose but had 3rd dose on Oct2021.  No concomitant medications were reported. No treatment medications were reported.
Information has been received from a nurse concerning a female patient who was vaccinated IM with 0.5 ml third dose of GARDASIL. Subsequently the patient had been "in bed for 5 days with chills and diarrhea". There were no AE with the fist and second dose of vaccination. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pain and muscle pain/aches. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 2 employees experienced adverse events including muscle pain and aches after receiving FLUARIX. See case ID A0899571A for details of the other report.
Within 1/2 of immunization, patient returned to the doctors office to report injection site was itchy. Site was seen by Dr. Site was also red, slight swollen and warm. Within 24 hrs itching was gone. Site is slight swollen and pink per patient.
Her chest and diaper area were covered in Petechiae and bruises.  Her socks had bruised her ankles so I took her to pediatrician on 6/7/2010 who ran a CBC which showed her platelets at 6,000.
This spontaneous report as received from a pharmacist, via company representative, refers to a male patient of unknown age. About a year ago, in 2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced shingles of an unspecified eye. Pharmacist reported that "recently", on an unknown date, patient went into the pharmacy to have an unspecified antiviral prescription filled due to the shingles of an unspecified eye. The outcome of shingles of an unspecified eye was not reported. The relationship between ZOSTAVAX and the event was not reported. Patient was seen by an unspecified physician on an unspecified date. Additional information has been requested.
Patient called because having some discomfort at site of injection & some swelling during conversation realized she may have received IM instead of SQ (at 45 degrees pinched but upper arm instead of back).
Severe chills/chattering Sore muscles Next morning: extreme dizziness/nausea/headache Took aspirin morning after vaccine Most symptoms subsided afternoon 2APR except headache  still present late after noon.
Information has been received from a physician concerning a female pediatric patient who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Oka/Merck), and subsequently developed a rash. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint. No further information is expected. This is one of several reports from the same source.