chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection she had a bruise like 1.5 inches long/ she had a knot as wide as a baseball now; injection she had a bruise like 1.5 inches long/ she had a knot as wide as a baseball now; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech COVID-19 Vaccine, lot/batch number and expiry date not reported), via an unspecified route of administration on 11Jan2021 at single dose, for Covid-19 immunisation. The patient's medical history concomitant medications were not reported. On 11Jan2021 she received the vaccine and within hours of that injection she had a bruise like 1.5 inches long and had not seen that anywhere in the material. She knew it could swell, but she had a knot as wide as a baseball now. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA277269 (same reporter). This case involves a 4 years old patient (age not reported) who received vaccine QUADRACEL that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via intramuscular route in the left thigh. It was a case of actual medication error due to product storage error. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nausea/upset stomach x 2-3 days. Weakness/fatigue x 2-3 days. Flu-like symptoms x 2-3 days. Bruised/swollen arm(s) x 10 days. No treatment outside, rest.
I have received my Pfizer COVID vaccine and Booster shot. My wife and I are working with a fertility doctor and they needed to complete a semen analysis. My sperm count was very low. I had had a semen analysis prior to COVID and my sperm count was fine. I think this needs to be looked into. I can be reached by phone. I am willing to submit documentation.
I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful  triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.
Numbness in fingers and dizziness immediately after shot. Pain in left arm and right jaw for 2 days, numbness in fingers and toes, tenderness and pain at injection site 2 days later that does not go away even with ibuprofen. Still experiencing symptoms now.
1st dose a year go, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received  a year ago .).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:  05-DEC-2022 Reporters comment: The reporter was the patient brother and he reported that the his brother got first shingrix shot a year ago and has not received the second shingrix shot. No further information reported to the agent by the patient. The reporter declined to give any further contact information and ended call promptly The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination
10 hours: body aches and chills. No fever. 14 Hours:  Fever of 102.0 oral. Extreme body aches, dizziness, nausea. 24 hours: Fever of 100.4. Muscle aches. 36 hours: Fever of 99.4. Feeling better but fatigued. 48 hours: Normal temp, feeling good. Red spot on arm.  Arm is tender.
Patient woke up before midnight with pains in both arms, feeling unable to move either. Patient called 24 hour pharmacy and after taking ibuprofen and TYLENOL pain was still too intense to sleep. Pain eventually went away next morning before noon with no residual pain.
pt recv vax 6OCT98 & 8OCT98 pt devel inj site vesicles & papules;
This report described the occurrence of chest pain in a 30 y.o. female who was vaccinated with Hep B vaccine recombinant (Engerix-B). This report was received from a PT and has not been verified by a physician or other health care professional. The subject's medical history, concurrent medical conditions, and concurrent medications were not specified. On 9/13/02, the subject received her first injection of Hep B vaccine recombinant (Engerix-B). On the same date, the subject reported heart palpitations, chest pain, and back pain, which she described as thought she was "being punched from both sides." The outcome for this event was reported to be unresolved.
6 hours after my shot My skin was on fire, bloutish, and sick at stomach. Took 2 Benadryl and after 20 minutes started claiming down. Took another Benadryl and went to bed.  Next day [Friday} felt itches and I took 1 Benadryl and it was under control. Saturday around 6 PM my skin is on fire .....bad... head to toes, sick at my stomach, stuff nose. Took to Benadryl, started washing myself with a wet face cloth, no relief, got in a cold shower and it seemed to make it worse. Took another Benadryl . No relief. Got to the Emergency room around 7:45 PM
Racing heart rate, dizziness from this symptoms. Smoke smell, which I continue to smell to even now as I type this note.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient stated that she experienced some intermittent pain running up the side of her neck after receiving the Pfizer vaccine. The pain seemed to eventually resolve itself after some time had passed. Upon leaving, I suggested that the patient visit her MD or urget care if the issue did not resole shortly. I followed up with the patient a couple hours later, and she indicated that the pain had resolved itself and it was just a little sore.
Completed Pfizer Booster on 01/11/2022 at 11:00AM and on 01/12/2022 noted extreme tenderness behind left ear over inner ear. Area is enlarged/swollen compared to right side with no apparent redness. Described as very tender like a very bad bruise.
Headache Body ache Swollen lymph node under armpit (left) Swelling/ redness injection site Dizziness
exposed to Covid positive patient; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of Covid19 vaccine on Dec2020 and was due for his second dose  on 07Jan2021 (reported as today, day 21).  However, his wife contracted Covid19 tested positive on 01Jan2021. He wanted to know when he should get his 2nd dose, having been exposed to Covid positive patient on Jan2021 and >21 days. His wife tested positive for Covid last Friday and he was on isolation/ negative on PCR. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
hemorrhaging/bleeding; Throwing up blood; Pure blood coming out in his stool; hives; sweats; extreme stomach ache; achiness; diarrhea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2022 and was forwarded to Moderna on 22-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (hemorrhaging/bleeding), HAEMATEMESIS (Throwing up blood) and HAEMATOCHEZIA (Pure blood coming out in his stool) in a 64-year-old male patient 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 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (hemorrhaging/bleeding) (seriousness criterion medically significant), HAEMATEMESIS (Throwing up blood) (seriousness criterion medically significant), HAEMATOCHEZIA (Pure blood coming out in his stool) (seriousness criterion medically significant), URTICARIA (hives), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (extreme stomach ache), PAIN (achiness), DIARRHOEA (diarrhea) and CHILLS (chills). At the time of the report, HAEMORRHAGE (hemorrhaging/bleeding), HAEMATEMESIS (Throwing up blood), HAEMATOCHEZIA (Pure blood coming out in his stool), URTICARIA (hives), HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (extreme stomach ache), PAIN (achiness), DIARRHOEA (diarrhea) and CHILLS (chills) outcome was unknown.            No treatment medication information was provided. No concomitant medications were provided.; Sender's Comments: This is a spontaneous case concerning a 64-year-old male patient with no medical history reported, who experienced the serious unexpected events of Haemorrhage, Haematemesis, and Haematochezia(seriousness criterion medically significant).On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine). All events occurred on an unknown date. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
GOT COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207496.
Got flu shot 10-7-13 0730. Upon waking 10-8-13 noticed arm was swollen, red, and warm to the touch. On 10-9-13 arm seemed very itchy at the site of injection.
4/3/21 at 0052 during Q15 rounds the patient was found laying awake on the floor next to his bed.  He denied falling.  Vitals showed BP 95/57, Temp 96, O2 sat 77%.  He was evaluated and transferred to an acute care hospital with cardiac specialty.  He was found to have elevated triponin and chest x-ray showed lung infiltrates; COVID test was negative.  Diagnosis was MI and pnuemonia.  He received a right coronary artery stent. The patient was intubated on full ventilation support.  On 4/4/21 the patient went into cardiac arrest 3 times and was resuscitated.  On 4/5/21 his condition declined and he went into cardiac arrest again and was resuscitated around noon.  The patient died in acute care on 4/7/21 at 0608.
Mom stated pt had bad reaction but refused appt for pt to be seen. Mom was called on date of report and stated area had resolved.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE STABLE ANGINA CHRONIC HYPOXEMIC RESPIRATORY FAILURE
12/22/21: He states he has been feeling poorly for the past few weeks.  His primary complaint is progressive weakness with nausea, vomiting, diarrhea and muscle aches.  He denied any complaints of shortness of breath, cough, sputum production, fever or chills.  He admits he has not been taking adequate fluids or nutrition over the past week or so.  His wife convinced him to come to the emergency room for further evaluation.  He tested positive for COVID-19.  Upon arrival in the emergency room his temperature was 98.7° F.  His oxygen saturation was 97% on room air.  His CXR showed patchy atelectasis in the left lower lobe.
flu like symptoms lasting about 24 hours for some patients after either first or second dose; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report.. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter stated that flu like symptoms lasting about 24 hours for some patients after either 1st or 2nd dose of Shingrix. No other information was provided.
Vaccine given on 11/1. By at least 10 days later explosive smelly stool started up to 4x day. Diarrhea continued when vomiting of solids started & now vomiting of formula.
Patient fainted and lost consciousness for about 30 seconds after receiving vaccine. When patient regained consciousness , she was alert and coherent. She was able to hold a conversation until the emergency personnel arrived. They took vitals and she was released to go home without further treatment.
Vaccine Administration error .   The Pfizer COVID 19 vaccine for 12 and older purple cap was drawn up in a syringe on 12/08/21. at 4 P.M.  scheduled to expire at 10 P.M. on 12/08/21.  The syringe was left in the refrigerator at the end of the day instead of being tossed out.  The next day on 12/09/21 the vaccinator administered the vaccine to the patent on 12/09/21 at 10 A.M.  Per the CDC's vaccine administration error and deviation sheet it instructs to call the manufacturer  I called Pfizer and spoke to Pfizer's medical outreach team .  Interaction# 00509123.  Off label information.  Not the recommenation.  Per Pfizer physical and stability studies.  The Pfizer COVID 19 vaccine maintains stability in the syringe in the refrigerator for 24 hours.  Do not have to revaccinate the patient.   The vaccine was in the refrigerator for 12 hours.
Baby was in inconsolable pain after waking from nap. Provided her with infant Tylenol to ease pain and crying and she was feeling better the next morning.
Patient presented to clinic on 3/3/22. She had developed a red rash on her trunk and abdomen, on exam was consistent with petechiae. She also had one nosebleed, vaginal bleeding in diaper during the week, and developed a bleeding laceration on her upper and lower lip after falling. She also had right forehead bruising. Patient sent to the emergency room.
Hives all over body after Menomune injection that lasted intermittently over 2 days.  No respiratory distress or localized reaction.  Saw primary care manager 2 days after hives appeared and sxs resolved.  No ER visit.
c/o h/a, sore throat, nasal congest & chills; no local reaction; BP nl; refused to give MD's name; dx URI & gave Keflex; did minor surgery removing several cyst;
No symptoms or side effects reported; HCP called to report improperly stored VARIVAX administered to a patient on 10/2/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-OCT-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, valid lot W022294, expiration date: 13-JUL-2023, administered for prophylaxis (strength and route of administration were not provided); diluted with sterile diluent solution for injection/infusion (strength, lot #, expiry date, route of administration, and indication were not provided) (Product storage error). Temperature excursion occurred as 32.04 Fahrenheit (F) for 8 hours. No previous temperature excursion was reported. No symptoms or side effects reported.
I had the JJ vaccine on 10/21/21.  Then I had the Moderna booster on 4/16/22, at around 5 pm.  I had diarrhea that night.  The next day, I had restrictive left arm movement, chills, fatique, restrictive neck movement, lack of energy to stand or hold my head, lack of appetite, and occasional sneezing.  The third day felt normal although mouth sore/blister started to occur.  The fourth day, skin blister spread from nostril to upper nose bridge area, and it has no sign to retreat yet as of today (the fifth day).  The injection site felt swollen under the skin and feel itchy mildly upon touching, but it does not affect movement.
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine.  Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
VACCINE ADMINISTRATION OCCURRED 8 +1/2 HOURS AFTER THE VIAL WAS PUNCTURED
This spontaneous report was received from a consumer via a social media site regarding her child (age and gender not specified) who received GARDASIL. Medical history and concomitant medications were not reported. The mother responded to a post that stated "Will you speak out on this? Our youth are having health ruined, too many have died". The mother responded "HPV vaccine has done this to my child". She did not specify what her child experienced. Additional information is not expected.
DX COVID-19  84-year-old male with a history of COPD .  He states that he decided to take a trip to visit his parents cemetery.  He states the day he was coming back he started getting a sore throat of the drive home.  The next day he was having some fevers and felt weak.  He is coughing he is getting more short of breath as the days went on.  He was tested for was found to be positive this past Thursday.  He continued to worsen and his oxygen saturations at home were going below 80.  He came to the hospital and was subsequently admitted.  He is currently on about 8 L of oxygen per minute. Patient was admitted to the hospital.  He was treated for COVID 19 pneumonia; (remdesivir and decadron).  He is followed by infectious disease and pulmonary as well as cardiology ( for elevated troponins).  He improved clinically and was discharged home with outpatient follow-up.
inflammatory reaction; burning; back pain; difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (ongoing), notes: Diagnosed in her 20s. There were no concomitant medications. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammatory reaction"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "difficulty walking".  Additional information: She said that for her it slowly started after the first vaccine, after the second dose over the next couple of months she became incapacitated. Brother has had the same issue, x-rayed by doctor and nothing was found wrong and was put on pain medications. Over the holidays her sister started having the same reactions and is now on cortisone injections, patient reported that the pain makes you walk funny and then from walking funny other things start hurting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported a painful/ itchy rash starting a day after the pt reported it not going  away for the past 2 days.
I received my 2nd covid vaccination on 01/11/21. I started feeling muscle aches about 2 hours after vaccination.  On Tuesday I went to work and was getting worse. on Wed, I have severe muscle aches, severe headache, abdominal pain, diarrhea.  on Thursday, I was feeling a little better and returned back to work on Friday
Patient said his arm swelled up and he got a rash on his arm. Then a couple of days later, he got a rash on his other arm and some other places on his body. He did not treat the rash with anything. He said the swelling on the arm went down but he still has places with a rash.