chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer(patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9264, Expiration date: unknown) via an intramuscular route of administration in left arm on 28Jan2021 at 9:30 am as single dose for COVID-19 Immunization. The patient's medical history included Osteopenia(ongoing) diagnosed 20 years ago, patient had allergies with grasses, trees, and dust. The patient also allergic to penicillin and Succinylcholine, which is a muscle relaxer. The patient clarified she shouldn't say allergic, but more so hypersensitive. The patient reported that she took nothing but over-the-counter supplements. On 06Feb2021 patient experienced localized, large red spot where she received the injection, Headache and Nausea. The patient also stated that 9 days after vaccination she developed "COVID arm", she clarified it was a localized, large red spot where she had received the injection, she had no reaction or redness or anything else when she received the injection on 28Jan2021. After 9 days of vaccination, on 06Feb2021 (Saturday)the patient first noticed the spot at the injection site she also had a headache and nausea. She was actually awakened at 2am on 06Feb2021 by the headache. She did not notice the spot at the injection site at this time, but she wasn't looking for it. Caller didn't notice the spot until taking a shower. She confirms she recovered completely from the headache and nausea on 08Feb2021 and the spot was also gone. The patient did not require hospitalization. The outcome for the events was recovered on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
significant rigors, severe headache, felt feverish, but no fever for about 12 hours
Achiness, fever, headache, swollen lump in left armpit, selling, red and hot to the touch at injection site, dizziness
Tachycardia- heart rate up to 140. Hypertension- blood pressure 134/110. Shakes. Sweats. Lightheadedness. Dizziness. Numb/tingling extremeties. Nausea.
administered far too up high my arm, almost next to my shoulder blade; hit a bone instead of a muscle, so high up; did not felt right; Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 24Mar2021 (Lot number: ER2613) at the age of 59 years as dose 1, 0.3 ml, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "administered far too up high my arm, almost next to my shoulder blade; hit a bone instead of a muscle, so high up"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "did not felt right"; PAIN (non-serious), outcome "not recovered", described as "Sore". Therapeutic measures were not taken as a result of wrong technique in product usage process, feeling abnormal, pain. The Consumer (patient) stated, "I had my shot yesterday, my first dose and it was administered far too up high my arm, almost next to my shoulder blade and I am worried about the effectiveness. I thought she hit a bone instead of a muscle, so high up. That's it, I still got the band aid on where it is and I got my card and I got the name of the hospital where it was administered." When asked if have any question regarding the concern, consumer stated, "Oh yes mam because I went to a nursing school years ago and she did not administered it correctly. I know what I am talking about, now just to get some RN, I got a medical sciences degree in RN (Further clarified as consumer hence not captured in tab) but I know what I am talking about. LOT numbers is ER2613. Expiration date was provided as Jul2021."(Further not clarified hence not captured in tab). : Consumer stated, "I had the shot at 10:10 yesterday and it did not felt right from the very beginning and at 9 0' clock last night I was trying to call you guys. It was not in the correct way you know, at 9 0' clock last night, I tried to call Pfizer but no one was there to answer the call.  No follow-up attempts are possible. No further information is expected.
Aching in joints, pain at injection site, tiredness, Fever over 101 degrees.
This is an initial case report reported by a healthcare professional on 30.Aug.2012 and forwarded by Crucell, no: CVAE-033-2012. A spontaneous report was received and concerns a 25-year-old male patient who, on 25.Aug.2012 received the first dose of VIVOTIF (batch no: 3000132). The patient's medical history was not provided. Concomitant medication included prednisone. On 25.Aug.2012, following administration of the first dose of vaccination, the patient experienced hives. The patient did not take any more of the vaccine. The outcome of the event was not reported. The event was considered non-serious.
Case number PHEH2012US020839 is an initial spontaneous report received from a medical assistant on 06 Nov 2012: This report refers to an 11-year-old male patient. His vaccination profile was up to date. He received only the MenCYW-135 liquid conjugate component of MENVEO vaccine (batch number M11052) intramuscularly in to the left deltoid on 08 Oct 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. He did not plan on leaving country and would be offered the booster dose at 16 year wellness examination. He was concomitantly also vaccinated with GARDASIL (other manufacturer, batch number: 0636AE) intramuscularly in to the right deltoid along with BOOSTRIX (other manufacturer, batch number: AC52B081BA) intramuscularly in to the left deltoid on 08 Oct 2012. No adverse event was reported. The reporter stated that the error was noted in the late afternoon on 08 Oct 2012.
Rash one week for vaccine on right breast, right lower abdomen, left forearm, and left hand. Area is red and itchy.
As a result of the injection, I have a lump, swelling,  stiffness,  clicking sensation, and tenderness in the affected right and left thumb.  I am unable to bend my thumbs.  In addition, I have a terrible spine, cervical, and back pain.
Varicella-like rash appearing on torso, groin, and upper thigh with 50+ lesions.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
New diagnosis breast cancer diagnosed 6/24/2021. Triple negative Invasive Mammary Carcinoma with pleomorphic lobular features
I asked him how did he do on the first shot. He said he did fine just the sore arm.
took the Shingles shot and ended up with Shingles, suspected vaccination failure; 2 friends who took the Shingles shot & both ended up with severe cases of the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received the shingles shot and ended up with severe case of shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case had been linked with case US2021AMR091431, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR091431:same reporter (patient 1 of 2)
pt recv vax 23MAR99 & broke out w/a rash & hives on body 29MAR99;
Severe headache that woke me from sleep at 15 hours post vaccination; then at 24 hours post vaccination, typical side effects began with chills, aches and tiredness.  However, at 28 hours post vaccination, my fever climbed to 102.  I had such severe body aches, I needed assistance to get up and was nearly impossible to walk or move. I had no appetitie. I decided to take 2 extra strength tylenol to aid in the fever/chills and severe headache.  Unfortunately, two days prior to vaccine, I was diagnosed by CT scan that I had a kidney stone.  It was being treated with Toradol, which I only took at bedtime with the also, prescribed Flomax.  The Toradol did little to assuage my body aches, incidentally  My fever only came down to 101.4 .  It remained between 101.4 and 102 until 48 hours post vaccination, when it finally went down to 99.2.  I could only get out of bed to use the bathroom.  I drank at least 2.25L of water daily because I was flushing a kidney stone, so my fluid intake was very strong.   I knew that many of my friends/relatives have had the 2nd shot, so I messaged with them, but nobody had had a fever over 102.  I knew if I did not take anything, it would've easily been 103F.  I was confused and couldn't gather my thoughts.  Things had to be repeated to me, but fortunately, I slept a lot and the worst of the symptoms was during my sleep at night and I had horrid nightmares.  By 56 hours post-vaccination, I could function, but I was severely exhausted.  By 72 hours post-vaccination, I had tried to resume low level activity, but was too exhausted and took a 3 hour nap in addition to sleeping 12 hours/night since I had the vaccination 5 days ago. My arm is still very sore, but not as immobile as first shot.  I still have very little appetite and my headache lasted 3 days. I'd consider myself general recovered from the worst of the fever, body aches and fatigue.
7:20 AM - 10 minutes after taking thyroid medication, developed low blood pressure, low heart rate, cramping abdominal pain, chills and hypothermia.
Severe headache in temple; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache in temple) 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 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HEADACHE (Severe headache in temple). At the time of the report, HEADACHE (Severe headache in temple) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was reported that patient was asking if is it safe to take Tylenol for headache.
Rash develop on chest, tickling in throat, as well as raspy. Waited 30 min. Began to get pale. Tongue got swollen with strawberry tongue look. With little blisters on tip on tongue. Stomach ache. Itchiness all over body about 2 days later.  12/18- started feeling burning pain on top of both her hands. the top of both of her hands became very red, and scaly.
Came in on 8/16/02 complaining of headache, fever of 103F and aching left arm sore. Had TD on 8/15/02. Seen in office with questionable virus or reaction to TD. No swelling or redness. Viral infection R/O reaction to TD.
Pt called today stating that Lt deltoid was swollen, redness and hot to touch. Pt is 28 weeks pregnant.
Metallic taste; Dry mouth in her mouth; experiencing a metallic taste was reported as worsened.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination: 67-years-old). The patient medical history and concomitant medications were not reported. The patient adds that she thinks her COVID vaccine was actually in May2021, in her planner she has that she got a shot on either 05May2021 or 06May2021 but she doesn't know if that is for her 1st dose or her 2nd dose. The patient received dose 1 of bnt162b2 for covid-19 immunisation on an unknown date (Time the Vaccination Was Given: It was around 3:00 in the afternoon for both of the doses, Anatomical Location of Administration of Pfizer vaccine considered as suspect: She thinks they were both in her right arm but she doesn't remember). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced metallic taste, dry mouth in her mouth and experiencing a metallic taste was reported as worsened on an unspecified date. The events did not resulted in emergency room or physician office. Outcome of the events were unknown except metallic taste which was not recovered.  Follow-up (21Jul2021): This is a follow-up spontaneous report from a contactable consumer.  Information on the lot/batch number has been requested.
Abscess at injection site, observed at office 01/25/13. Treated with topical and oral antibiotics.
Develop muscle pain, headaches, chills, bodyaches, and fatigue.  Headaches, fatigue and chills have lasted 5 days.
developed a rash on the trunk of my body/with a much milder version of the same rash; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 37-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3248), via intramuscular, administered in Arm Left on 24Mar2021 13:30 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203), via intramuscular, administered in Arm Left on 02Mar2021 13 :30as dose 1, single for COVID-19 immunisation. On 26Mar2021 when patient woke up morning rash covered trunk her body pain got more as day went on and travelled to neck Rash was flat, red and spotty but was not raised. The rash started milder and then got more red as the day went on. The outcome of event was recovered on an unspecified date in 2021.
A little less than 24 hours post administration patient presented with fever 102.9, "tight" feeling in chest and rigors Gave 650mg of Acetaminophen, 800mg of Ibuprofen, 50mg Benadyl IM and ice packs to grin/axilla  Patient responding- fever decreasing
COVID-19 (Runny nose, congestion, fever, sore throat); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 (Runny nose, congestion, fever, sore throat)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 (Runny nose, congestion, fever, sore throat)). At the time of the report, COVID-19 (COVID-19 (Runny nose, congestion, fever, sore throat)) outcome was unknown.            The patient hadn't taken any other medications/products within 2 weeks of starting COVID-19 treatment. Treatment information was not reported.  Company Comment:  This spontaneous case concerns a 40 year-old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40 year-old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
None reported. The patient received a vaccination administered on 10/24/23 lot W019533 expiration 9/30/23. No adverse events. Contacted Merck and their in-house stability data supports the potency of the vaccination 30 days after the expiration date.  The vaccination therefore is fully potent until 10/30/23. Guidelines state a titer can be drawn and dose repeated if necessary. Dr. is planning on drawing a titer as patient has had a poor response in the past.
I noticed a rash  across my ribs from one side to other flat non itchy rash across my stomach; One side form my  left side of my waist to right side like under my breast right to my navel right in that area; This is a spontaneous case received from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot: EL9266) via an unspecified route of administration on 15Mar2021 as DOSE 2, SINGLE (age at vaccination 70-year-old) for COVID-19 immunisation. The patient medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included METOPROLOL 25 mg for blood pressure from unspecified date in 2020 to unknown stop date. The patient historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot: EN5318) via an unspecified route of administration on 22Feb2021 for COVID-19 immunisation. On 17Mar2021, the patient reported that she noticed a rash across her ribs from one side to other, flat non-itchy rash across her stomach and one side form my left side of my waist to right side like under my breast right to my navel right in that area. Therapeutic measures were taken as a result of the events which included treatment with Benadryl cream. The outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
Swelling in lower left neck, just above collarbone. I believe this is a nymph node. On day one of this reaction (Sunday, Dec 5, 2021), it was puffy and tender and made it uncomfortable for me to move my neck from side to side. Today, day two of reaction (Monday, Dec 6, 2021), it is more swollen, noticeably puffy, red, and now actively  hurts. Treatment on Sunday included warm, wet compress, followed by dry heat from a heating pad, alternating with breaks in between. Monday had no treatment until evening, post-workday, when I re-applied a heating pad. No relief yet.
Approximately 5 min after vaccination patient felt dizzy. After approx 10 min after vac pt wanted to use restroom - as he stood up, he got dizzy and fell (parents and I caught him) as soon as he was laying down, he was conscious, had pt wait for another 20 min, gave him water.
This spontaneous report as received from a nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of PROQUAD lot #, expiration date unknown by reporter (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 6 degree Fahrenheit (F) to 14 (F) for 1 hour. There was no previous temperature excursion and data logger was involved. Sender's Comments: US-009507513-1708USA009722.
MD ordered for patient to receive 1st dose of primary series of pfizer covid vaccine.  pt received bivalent dose of pfizer covid vaccine.  reported medication error to physician.  pt did not complaint of or presented any adverse reaction to the medication. pt was discharged home.  Per cdc guidelines we will complete the series using the following recommendations: ?If a bivalent Pfizer-BioNTech vaccine is administered in error for a primary series dose: Do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as a primary series dose. Continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Pfizer-BioNTech vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series).?
Patient describes sore arm the same day. Swelling starting the next day. She complains for injection site redness and swelling the size of a baseball which is hot to the touch.
Dark brown almost black urine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: CHROMATURIA (non-serious) with onset 13Feb2022, outcome "unknown", described as "Dark brown almost black urine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 5 minutes after giving baby Pentacel, Prevnar and Rotavirus immunization, spasms of the lower jaw noted and baby would cry.
Patient described pain at shoulder going down all the way to the fingers on the left arm after getting vaccinated by our Pharmacist intern. Patient cannot move the left arm currently (about 21 hours post administration)