chrisvoncsefalvay/vaers-outcomes huggingface dataset:
with 5 doses of Pfizer vaccine/ tested positive for Covid after the holidays; with 5 doses of Pfizer vaccine/ tested positive for Covid after the holidays; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3(booster), single (Batch/Lot number: unknown) and as dose 4(booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lyme" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "with 5 doses of Pfizer vaccine/ tested positive for Covid after the holidays".  The patient was generally heathy and active male with 5 doses of Pfizer vaccine. He had mild symptoms (cough) tested positive for Covid after the holidays, he did complete a regimen of Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
sensitivity, headache, fever, sore arm, muscle aches, tired, shivering, nausea
Information has been received from a nurse concerning a male child who was vaccinated with ROTATEQ (no details about when or how many doses).  The patient was admitted to the hospital for 24 hour observation for rotavirus and to receive IV fluids for rehydration.  The child had a positive stool culture for rotavirus.  The reporter considered the event of rotavirus to be an other important medical event.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested.
Patient received ZOSTAVAX on 9/25/13. On 9/27, she noticed a rash on her left ankle. The rash did not hurt or itch. It was red and pin-point in appearance. Later, she noticed an itchy rash on her left arm.
Got a headache soon after shot. But woke up the next morning with a sore arm, and a knot and redness at injection site. With my head feeling a little hazy with slight headache
Initial report received from a healthcare professional on 18 October 2013. A 32-year-old female patient had received a dose of FLUZONE ID, (batch number - UT4721BA) intradermally in left deltoid on 16 October 2013. The patient's illness at the time of vaccination was none as per reporter and had no known allergies. On 16 October 2013, 2 days after vaccination, the patient had a swollen, axillary lymph node. Laboratory details and corrective treatments were not reported. At the time of this report, the patients had not recovered from the event. Documents held by sender: none. Follow-up information received on 28 January 2014: The patient had no illness at the time of vaccination and no noted allergies and no lab tests were performed. The patient recovered within 2-3 days (unspecified date).
Information has been received from a 42 year old female consumer. In Nov-2001, she received a dose of Flu-shield (2001-2002 formula). Six weeks post-vaccination, she developed blurry vision. In Jun-2002, at 43 years of age, she was diagnosed with multiple sclerosis. She indicated that she has received injections of influenza vaccine in 1999 and 2000 without problems. No further info was available at the date of this report. These events were considered medically important (OMIC).
Around early April, about a week and a half after my second vaccine shot, I started to experience very bad pain in the left and surrounding area of my chest. I noticed my heart seemed like it was racing quickly, and while sleeping, it would wake me up at various times.  I went to ER to make sure I wasn't having a heart attack, and while my vitals appeared normal, the pain and racing continued at various times. I went to see a cardiologist as well as my PCP.  At the time, no one acknowledged that the vaccine was related to it the symptoms. As a young, healthy male, who exercises and workouts and never experienced chest pain before in my entire life. It is now June and adverse symptoms still linger.
they have like sores on their lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: FL0007) at the age of 7 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LIP PAIN (non-serious) with onset 10Jan2022, outcome "recovered" (2022), described as "they have like sores on their lips".  Additional information: No Lab test within 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200112958 Same product and event, different patient
pt recvd vax & became pregnant;pt subsequently elected to terminate the preg around gestational wk 8 or 9;
Pt recv vax on 1/9/98; on 1/14/98 pt exp  headache, diarrhea, nausea, dyspepsia, swollen hands &feet, muscle weakness of arms &legs; dx=cytomegalovirus
fever, body aches; hot and cold flashes; muscle stiffness; headache, dizziness, symptoms lasted 3 days. To self treat I rested and drank lots of orange juice
After 30 h of injection, swelling in arm pit and left shoulder started. The pain kept getting worse and continues until tonight (84h post injection). There is lot of heaviness now in the entire portion and pain extends upto the upper portion of the chest now. The swelling in the arm pit is not allowing me to lift my left hand at all.
A patient  was given a dose of vaccine on 10/1/22. An email was sent down from our pharmacy corporate  on 10/12/22 stating that the pfizer pediatric vaccine with above lot had been recalled and to dispose all doses. Another email was sent on 10/25/22 requiring  any doses administered on or after 10/1/22 of said vaccine to be reported to VAERS. The patient's guardian has not called to report any adverse events.
Patient reported pain at injection site night after receiving  injection , after midnight noticed "red stripe" from site of injection running to left upper arm , left axilla, left chest, and swelling of left pectoral muscle, contacted clinic 2/15/2022 to report reaction, says is getting better, had contacted his PCP but appointment was canceled due to provider illness, re-scheduled in  6 days  , patient refused to give name of provider, has  his cell number, requested patient contact his PCP to be seen sooner and inform them of reaction. Recommended he go to ED if condition worsens,  I have never seen this patient , he is not a tribal member no a patient at this clinic, says his PCP was seen here only for Covid Vaccination..
Rash maculopapular; Pyrexia Information has been received from a health professional concerning a 25 month old white male with no known medical history or allergies who the morning of 12-SEP-2005 was vaccinated with 0.5ml SC first dose of varicella virus vaccine live (Oka/Merck) (lot#651047/0326R). Suspect vaccination that same morning included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot#649518/0154R). Suspect therapy included amoxicillin 250/5ml BID x 10 days which started on 27-SEP-2005. There was no illness at the time of vaccination. On 02-OCT-2005 (previously reported as approximately 03-OCT-2005) the patient developed a generalized, scattered red rash and a fever of 103 F. The fever was later described as 103.4F for three days on and off. The rash was later described as a maculopapular rash that was spreading to legs and thighs. It was noted that the diagnosis was to "rule out vaccine associated reaction vs. amoxicillin reaction". Unspecified medical attention was sought. The patient recovered on an unspecified date. there was no product quality complaint involved.  Additional information is not expected. Body temp 10/02/05 103.4F.
tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00068720) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Drug allergy.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test positive: positive Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Around 530PM on the day recvd. vax began to exp chills; As evening progressed chills worsened & temp became elevated; Over next two days, fever & chills gradually dec; Exp joint pain APR2-4th;
5-10 minutes after dose 1, the patient reported feeling very dizzy and a massive headache.  He stated that he never gets headaches and was on a pain scale of 7-8 at that time.  Vitals were taken. BP 135/86, pulse 91, temp 96.4. We dosed the patient with 1000mg of Tylenol at 3:05pm.  At 3:15, the patient stated that his headache had increased to a pain scale of 9.  He wasn't doing well so the staff laid him down.  At this point the staff felt it was a situation that needed more attention.  They took the patient to the ER where he was given saline and something for headache.  The also drew labs. Not sure what labs they drew.
Emergency room 1/11/21   Patient is a 72 year old female who presents with decreased level of consciousness.  The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver.  Nursing staff at the nursing home reports that she seems to be a bit less responsive today.  However, the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection.  Of note, her oxygen saturation on room air is 72%.  The patient is also febrile to 100.8°.  She was unable to provide any information and the aforementioned information is gathered from nursing home staff report.
Diehrea;Nausea; High fever 102; Chills; Body aches.
mild swelling of tongue & lips lasted till around 2pm but came back off and on till that evening  lie a wave passing thru my mouth.  Only other effect was around 5pm got the chills & didn't get warm till went to bed at 10pm.  End of tongue has not been same since like constantly irritated
Rash over body. Morbilliform, ( Maculopapular, red, raised ) itch
Face swelling and redness with lip tingling and tongue tingling later after eating a few bites of a home prepared meal that has been eaten several times before. Started eating around 7 pm, have picture of red and swelling face at 7:11 pm. Contents of meal were shrimp, homemade egg noodles, chicken stock, pork, and romaine.  No breathing problems and felt fine besides face warm ness and some anxiety over possibly developing a new allergy, as these symptoms were similar to my adult onset allergies to oysters in 2011. Sought remote care at 7:41, spoke to RN over phone who recommended a video visit, then after video visit was recommended to go to urgent care. Arrived at Urgent Care around 8:50 PM.   Had a steroid shot of solumedrol 125 mg to IM the left arm around 9 pm, then took some Benadryl and famotidine at urgent care. Picked up prescriptions for famotidine 7 days, prednisone 4 days, and Benadryl as needed.  Taking medications now with careful watching of potentially allergic reaction provoking foods such as shrimp, fish, nuts, and wheat.
Pt came in and stated that 2 months after ZOSTAVAX, she was dx with shingles. Pt had never had shingles disease before.
29 Jun 2011 Pt. develop swelling of both legs and testicle. Was seen in ER yesterday. Treated with BENADRYL and TYLENOL. Today swelling is gone. Baby develop diarrhea since yesterday afternoon x 5. Also having nasal congestion (has URI since 23 Jun 11), and expiratory wheeze -> bronchiolitis.
Chills; Soreness; Sore lymph nodes; Tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in left arm on 12Apr2021 (at the age of 38-years-old) at 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior and was not pregnant. The patient experienced chills, soreness, sore lymph nodes and tiredness on 12Apr2021 at 16:00. The patient had not been tested for COVID-19 since vaccination. No treatment was received for the events. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
soreness/tenderness; bruising around injection.; itching; bruising that radiated into her hand and wrist.; redness; soreness / and aching that radiated into her hand and wrist.; swelling; This case was reported by a physician and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received Shingrix. On 15th December 2020, 1 days after receiving Shingrix, the patient experienced erythema, pain and swelling. On an unknown date, the patient experienced injection site pain, injection site bruising, pruritus and contusion. On an unknown date, the outcome of the injection site pain, injection site bruising, pruritus and contusion were recovering/resolving and the outcome of the erythema, pain and swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site bruising, erythema, pain, swelling, pruritus and contusion to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced redness, soreness, swelling that lasted 2-3 days, then she began to experience itching, bruising and aching that radiated into her hand and wrist, also reports tenderness around injection site, soreness and bruising around injection. The patient reported event were mildly improving. The patient said aching was worse at night. The reporter gave consent to follow up.
After receiving the vaccine the patient experienced the typical soreness in the right arm, but then had a fever (>100 degrees F), shivering, muscle aches, and a rash.  The patient says they tried calling the ER but could not get through.  The patient said 5/15/19 was when they felt much better although there is still a rash.
Developed type 1 diabetes after first HPV and severe stomach pain with recurrent vomiting and weight loss x >1 year after second.
Pt recv vax on 1/29/99; on same day pt exp fever, body aches, vax site sore & inflamed
Pt fainted after ~2-3 minutes of sitting on a bench. Moved to the floor and resting against hard surface. Pt was warm and sweating. Came back to in about 1 min. BP was normal. Gave water and food. Pt is resting until ride comes to pick him up.
Arthritis flared up again after the booster; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flared up again after the booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019FZIA, 007BZIA and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Patient further stated that he has a history of arthritis as well.).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ARTHRITIS (Arthritis flared up again after the booster). At the time of the report, ARTHRITIS (Arthritis flared up again after the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  This spontaneous case concerns a male patient of unknown age with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) arthritis. The event occurred unspecified time after both the second and the booster dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was positive since the event reoccurred after the second and the booster dose.  The benefit-risk relationship of drug is not affected by this report.  Patient also stated he was a senior citizen and did not want to disclose his age or DOB   This case was linked to MOD-2021-386226 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) arthritis. The event occurred unspecified time after both the second and the booster dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was positive since the event reoccurred after the second and the booster dose.  The benefit-risk relationship of drug is not affected by this report.
Red, raised, itchy, warm, hard spot at injection site. Started the day after as a dime sized spot, but then grew to a much larger area about the size of patients hand.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was mentioned that the vial was initially refrigerated on 17 Nov 2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events. No treatment medications were reported.
12/21 symptoms were achy light headed, swollen arm, blurred vision, vomiting, fever.  Vaccine given 12/18. She was tested  for covid 19 on 12/28 and was positive.
Muscle Seizures 5-6 hours post vaccine. Full body muscle spasms/seizures that lasted 5-6 hours. Ice cold extremities. Violent shakes. Migraines over the course of the following 4 days and a itchy rash over my face, neck and torso that lasted a full 2 weeks.
I experienced vertigo, dizziness, and off balance. This is unknown if the vaccine has caused the vertigo but I have not had vertigo prior to receiving any of my vaccines. I have been receiving EPPLEY treatment to help with the vertigo.
Patient presented the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was hyponatremia and intractable vomiting.
DOCUMENTATION NOTED IN 9/2009 OF PATIENT EXPERIENCING AGITATION S/P INFLUENZA VACCINATION
first dose and second dose caused some pain at injection site and flu like symptoms. However 2nd dose on day 3 developed a severe headache 8 of 10 pain and had night sweats
This is a spontaneous report from a Pfizer-sponsored program. A female of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On an unspecified date, the patient experienced that she has Epstein Barr Virus (EBV). The patient inquired if she can take the 2nd dose. The outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient developed several fever blisters along both lips and chin, also experienced fever, chills, and body aches lasting longer than 3 days
Anaphylaxis approximately 10-20 minutes after injection. Swelling and itching of eyes, nasal congestion, coughing, wheezing, difficulty breathing. O2 sat decreased 90% HR increased 183. Required oxygen, epinephrine, albuterol via nebulizer, transported to hospital emergency room via ambulance.
FEVER OVER 102 DEGREES FOR APPROXIMATELY 72 HOURS.  NAUSEA AND VOMITTING FOR OVER 72 HOURS.  UNABLE TO KEEP DOWN ANY LIQUIDS OR TYLENOL.  VOMITTING EVERY 15 MINUTES OVER A 5 HOUR PERIOD BETWEEN HOURS 48 AND 53.  FINALLY ABLE TO GET ACCESS TO ONDANSETRON TO ALLEVIATE VOMITTING AND KEEP FROM GOING TO URGENT CARE FOR DEHYDRATION.
Loss of hearing in right ear.  Hear nothing but white sound, and a sound like a metal cable clanging.  Primary care physician thought maybe it was a sinus infection,  since it just happened.  Put on first round of antibiotics on 5/11, and still no better, was put on 2nd round of antibiotics on 5/25.  Still no improvement on 6/9.  Ear canal is clean, and clear.