chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office nurse concerning a patient who was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Subsequently the patient experienced injection site tenderness, injection site redness and also fluid collection which progressed down arm. The patient received antibiotic treatment. Subsequently, the patient recovered from injection site tenderness, injection site redness and fluid collection which progressed down arm. Injection site tenderness, injection site redness and fluid collection which progressed down arm were considered other important medical events (OMIC). Additional information has been requested.
Received expired 2nd booster dose beyond 12 hours post puncture; First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose beyond 12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022 at 2:55 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022 at 2:55 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose beyond 12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose beyond 12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster of Moderna COVID-19 vaccine was administered on 01-NOV-2021 and second booster was administered on 12-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. On 06-Apr-2022, the vial was initially stored in the refrigerator. Number of doses/vials included 1 vial (10 dose each). On 11-Apr-2022 around noon, the vial was first punctured. The vial was stored at room temperature post puncture. The vial had not undergone temperature excursions. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was around 26 hours. Treatment information was unknown.
MULTIPLE visits to clinic and ED for breathing issues Most recent visit--diagnosis of  eosinophilic asthma, persistant asthma, SOB, asthma exacerbation
SWELLING, REDNESS, WARM TO TOUCH ON RIGHT ARM, AREA MEASURING 5" WIDE X 6.5" LONG. DEVELOPED 6-7 HRS AFTER INJECTION.
Extreme malaise. Muscle aches. Chills Arm soreness and redness around injection site of about three inches in diameter.
THE VACCINE  WAS MIXED AT 11:30AM YESTERDAY AND IT WAS GIVEN AT 1:30PM TODAY
This case involves a patient (unknown age and gender) whose both arms were little bit sore and they hurt worse if press on them (pain in extremity), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient's both arms were a little bit sore and they hurt worse if press on them (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Got flu shot and booster. Both arms a little bit sore. They hurt worse if i press on them (Haha)." It was unknown if the patient experienced any additional symptoms/events. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information on the batch number for this case.
I contracted COVID-19 on 07/01/2022 with symptoms of congestion, sore throat, low grade fever, and body aches. I was prescribed Prednisone, and Benzonatate on 07/05/2022. I was ill for 5 to 6 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
Pt presented a week later with complaining about rash on his body. It looked like mosquito bite on his legs and back of trunk, and pt was having itchiness, but no pain or any discharge.
Dizziness, feels shaky, hoarseness, headache, muscle twitching within 2 hours of injection. Patient had T-100.4 prior to injection and recent closed head injury approximately 19 hours prior.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and the expiration date were not reported). There was no concomitant medication provided. On an unknown date after receiving ZOSTAVAX, the patient developed an unspecified rash on an unspecified location of their body. The pharmacist was interested in Varicella Zoster Virus Identification Program(VZV) Analysis by PCR (Polymerase Chain Reaction) and wanted to send viral isolates. The outcome of rash was unknown at the time of reporting. Relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
about 20 hours after shot, woke up feeling achy, sore.  24 hours after shot, started running fever (101.5).  felt sick to stomach, headache, achy and had chills.  slept for 6 hours.  about 36 hours after shot, finally felt ok, but woke up the next day with a rash all over upper torso.  I am now four days past my vaccination and my entire upper torso itches.  will continue with benedryl hoping this ends soon.
Raised itchy red rash over left deltoid and left antecubital fossa, a few similar lesions on anterior chest, stomach and right hip.  Lesions persisted for one week with some residual papular lesions 18 days later.  No systemic symptoms reported for Pfizer-BioNTech COVID Vaccine EUA.
Narrative: COVID infection following COVID vaccine series 01/21, Pfizer, dose #1 02/11, Pfizer, dose #2 08/03 pt cc: chills, fatigue, headache, myalgias, rhinorrhea
On the same day of vaccination on the night I started to have, chills, I had a migraine, fevers, & my arm was sore from the vaccine. This symptoms lasted for about 72hrs. I had to call the nurse line 4 hrs after I started feeling sick.
Patient came to our store for her first Covid-19 vaccine appointment on 4/25/21 at 3:05pm.  After she got her first dose vaccine, Pharmacist went over all the potential side effects, app and told her to wait in the waiting area for 15 minutes for adverse reaction observation.  Within 3 to 5 minutes, patient came to the pharmacy counter complaint that her toungue feel heavy, hard to talk and her throat feeling swollen.  She was able to breath but worried.  She had no sign of rash or itching.  Patient was fully alert and awared.  She said she had the same issue when she had nuts when she was younger and did not happened again since then .  On Patient's Var form she did not indicate that she has any history of allergic reaction.  Pharmacist gave her Epinephrine 0.3mg injection to her thigh and within 5 to 10 seconds she felt release from throat swollen and toungue heavy.  Pharmacist took her BP 117/74 and Pulse 85 (within normal range) and told patient that we are going to call paramedic to check on her and she agreed.   Pharmacist told shift lead who was happened right next to the vaccine room to call emergency number.  Paramedic arrived, took her vitals and said that she needs to go to the hospital for observation.  She refused at first but then agreed when the paramedic told her she need to stay in the pharmacy for 1 hour for observation if she does not want to go to the hospital for observation.  Patient is able to walk out with the paramedic to the hospital.
The morning following the shot my arm was pretty sore.  By the end of the day my head was slight hurting (not enough to take anything). On day two that morning I noticed I was getting very sweaty then noticed my heart rate seemed to be increasing. Started to monitor it and noticed it was fluctuating between 108 and 72 (resting) which is slight elevated (resting). Also started getting tired and not very hungry.
One-sided rash and muscle aches (neck side) about 3 days after vaccination. Had injection-site redness that subsided. Other adverse events are non-injection site events. Still achy, but rash improving. No typical allergic rxn presentation.
The patient received her 1st dose on 2/16, she developed redness, hardness, and swelling to the injection site for the next 3 days. This extended about 2 inches around the injection site, and resolved after the 3rd day. On 3/2/21 she went for a walk and developed shoulder tightness, arm pain, swelling, redness, a "lump" that was very hard to the touch, and itching at the injection site again. She continues to be symptomatic with all of these symptoms, but it is started to improve after 3 days.
On 5/11/02, swelling was noted to right deltoid. On 5/12/02, had increased swelling and new erythema and pain. On 5/13/02, had increased erythema and continued swelling. Treated for presumed cellulitis with Keflex.
stye in left eye. then a week later, major swelling in right eye. both new occurrences with no history before vaccine
Pfizer 3/24/21 and 4/14/21. Positive on 1/22/22
Sore arm,; Weak body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 20-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 09:00 (Lot number: Ew0175) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Aug2021 19:00, outcome "recovering", described as "Sore arm,"; ASTHENIA (non-serious) with onset 26Aug2021 19:00, outcome "recovering", described as "Weak body". Therapeutic measures were not taken as a result of pain in extremity, asthenia.  Additional information: patient has not received any other vaccine with in four weeks. Other medications in two weeks were yes. Prior to vaccine patient was not tested with covid-19 and not been tested since the vaccination. patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant via a field representative refers to a 13 year old female patient with no drug reactions or allergies, the medical assistant's daughter. On 19-SEP-2012, 14-NOV-2012 and 21-MAR-2013, the patient was vaccinated with the three doses of GARDASIL because patient's mother wanted her to have it, respectively. It was reported that the patient experienced stomach cramps and diarrhea within 24 hours of receiving each GARDASIL dose. The patient did not seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. The representative reported that the adverse events experienced lasted 24 hours. The outcome of diarrhea and stomach cramps was reported as recovered. Additional information has been requested.
Due to my IBS, I follow a strict diet.  I have not changed or added any new food to my diet.  Days after receiving the vaccine, I started to experience stomach issues such as indigestion, bloating, sensitivity to certain foods that I was used to eating.  I am no longer able to eat dairy.  If I do I get diarrhea.  I've had diarrhea for over 20 days.  My stomach is always bloated and with lots of gas.
PT WAS NOT FEELING GOOD AND TURN PALE .THEN START TO FEEL BETTER IN TEN MINUTES
has allergies; This is a spontaneous report from a Pfizer sponsored program Support a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not report-ed), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as dose 2, single, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated that she received the 1st dose of covid 19 vaccine last 19Mar and received the 2nd dose last 09Apr. However, has allergies and some adverse events as of the moment. The outcome of the event unknown. No follow-up attempts are needed. information about lot/batch number can not be obtained.
p/vax, sometime after, pt's development regressed/stagnated; lost eye contact, appeared deaf, went into own world, lost speech;dx w/autism; Per follow-up dated 10/2/00, the pt is still autistic in the mild-moderate range. Language developmental milestones are still severely impaired, as well as, scattered areas of development. Pt is still in his own world most of the time and has tested positive for brain-autoantibodies of myelin shealth.
Left eye was red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 13:00 (Lot number: FF2588) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: OCULAR HYPERAEMIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Left eye was red".  Additional information: He stated about one week after he had the shot he had red eye on left eye. Left eye was red, in the afternoon, like 2 or 3 clock. The vaccine was administered in left shoulder. No other additional vaccines were administered on same date of the Pfizer suspect. The adverse events did not require emergency room or physician office. There was no prior vaccinations (within 4 weeks).  Follow-up attempts are completed. No further information is expected.
Reported local redness and pruritis. Encouraged to use ice at site and BENADRYL po.
MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: OU3A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at the injection site. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced chest pain. On 20-APR-2021, Laboratory data included: EKG (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 23-APR-2021, chest pain on 22-APR-2021, and pain at the injection site. This report was non-serious.
Swelling, 3 in area of redness with increased warmth, itching, mildly tender - occurred just below site injection.
-Vaccinated  1/28/2021 @10:00am -Experienced burning/itching with slight redness on left deltoid, left side of neck, behind the left ear and down the left shoulder blade @12:00-9:00pm on 1/29/2021 - Woke up on 1/30/2021 with erythematous, pruitic, and non-raised rash on stomach, chest, sides and back. Progressively got more red throughout the day. (Has pictures) - was seen at Urgent Care on 1/30/2021 @ approx. 4:00pm. Given Prednisone 20mg tablets to be taken 3 tablets/day for five days and Benadryl. - woke up on 1/31/2021 with faint rash but greatly improved after antihistamine and steroid dose.
Initial unsolicited report received from a pharmacist in the United States on 19 Oct 2016. This case involves a 76 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI712AA, expiration date- 25 May 2017) intramuscularly in right deltoid on 14 Oct 2016. The patient illness at the time of vaccination was reported as none. And preexisting physician diagnosed allergies include allergy to erythromycin, the patient birth defects, medical conditions and Any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 14 Oct 2016, same day after the vaccination, the patient reported that she have red bumps on both arms (Rash papular). The patient Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
I have taken medication for Hypothyroidism for 35+ years and have controlled it with a dose of 150 mcg of Levothyrozine per day.  Since receiving the Janssen COVID 19 vaccination, my hypothyroidism is out of control.  I am currently taking 250 mcg per day.  I have to get blood work done again on August 12, 2021 to see if the 250 mcg is controlling my condition. I see my doctor on August 16, 2021, at which time he will either increase the dosage again or leave it at 250 mcg per day.
Itching; Inappropriate Age at Vaccine Administration; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (1st dose received on an unknown date, refer linked case US2020AMR002254).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced pruritus and inappropriate age at vaccine administration. On an unknown date, the outcome of the pruritus and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose at 39 years old, which led to inappropriate age at vaccine administration. The patient experienced itching after receiving 2nd dose of Shingrix. This was a medication error with adverse event No further details were provided.
The morning after vaccine, my arm was sore. Pain at the injection site with swelling and a hard area underneath arm on the armpit. I did get chills, tiredness, achiness as well. I went to my doctor and the size has lessened some on 4/27/2022 and the pain is not as severe. The doctor did state it could take about 2 weeks to go away. My doctor told me that it was an inflamed lymph node. The injection did feel like it could have been off center. This definitely felt different than my other injections.
Redness, soreness, warmth for 24 hours starting 24 hours after vaccination.
Patient received a dose of Pfizer vaccine where the dose exceeded beyond use dating (BUD) as determined by manufacturer by 5 days.  As advised by Pfizer, they recommended that he receive an additional dose of vaccine as soon as possible to ensure appropriate protection.  Patient was given this information and will schedule if feels it is necessary.
temperature is down to 100; horrible headache; nausea; fever 102.9; chills; severe arm pain,body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe arm pain,body aches), BODY TEMPERATURE (temperature is down to 100), PYREXIA (fever 102.9), CHILLS (chills) and HEADACHE (horrible headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, CYCLOBENZAPRINE, DULOXETINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and OXYCODONE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (severe arm pain,body aches), PYREXIA (fever 102.9) and CHILLS (chills). On 04-Feb-2021, the patient experienced BODY TEMPERATURE (temperature is down to 100), HEADACHE (horrible headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (severe arm pain,body aches), BODY TEMPERATURE (temperature is down to 100), PYREXIA (fever 102.9), CHILLS (chills), HEADACHE (horrible headache) and NAUSEA (nausea) outcome was unknown.
Burning of underarm and left part of stomach. This went on for 1 week before my PCP. They took X-ray scans because of the stabbing pain. They came back negative and ran blood tests for internal bleeding. Then they scheduled an MRI which came back negative too. I got with a neurologist and they said I have nerve damage. This has been over the course of 3 months.
Fever 99.7; This case was reported by a consumer and described the occurrence of fever in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol), gabapentin and hydrocodone.   On 4th January 2023, the patient received Shingrix. On 4th January 2023, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comments: This report was submitted via the customer via reporting system. The patient stated that she had fever 99.7 degree Farhenit from: 4 Jan 2023 to ongoing Shingrix vaccine manufacturer, unspecified expiry date of Shingrix vaccine was unknown. The reporter had consented to follow-up.