chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at the injection site; discoloration; blisters in between her toes; she noticed a blood blister; extremely sore; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in Arm on 28Aug2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. On an unspecified date in Sep2021, the patient experienced redness at the injection site and on an unspecified date in 2021 the patient experienced extremely sore, discoloration, blisters in between her toes and she noticed a blood blister. Therapeutic measures were taken as a result of redness at the injection site. The patient stated she received her first dose of the Pfizer-BioNTech Covid-19 vaccine on 28Aug2021. She stated she had tremendous anxiety about the vaccine and the vaccination provider did it high on her arm. She believed that where they vaccinated her she was surprised she did not have a giant bruise. It was extremely sore, which was fine, and there was no redness initially. A week later, to the day, her fiance noticed at the injection site (of the patient) there was a quarter size red mark but it was not itchy. It was flush with the skin, not swollen, and took a week to fade. It left a light tan mark like if they burned their hand and it healed to turn tan. She called the pharmacist and they said they have gotten reports of that. The discoloration was just how the area healed. She stated on her left toe, medially, the area that makes contact with the pointer and she noticed a blood blister. She stated it could be from shoes or flip flops, but it was a popped blood blister. She stated it was in an odd place where you can get a friction blister. If she didn't get the vaccine, she wouldn't had given it a second thought. She stated she had super sensitive skin but no other blisters or petechiae. She stated she was connecting the dots of the blood blister on her foot being potentially from the vaccine. The doctor was not helpful, but she let it go as that. She wanted to know if that could be from the vaccine or if it was a contraindication to the second dose. Therapeutic measures were taken as a result of redness at the injection site that included, she took Benadryl and used a steroid cream. The patient recovered from the outcome of the events redness at the injection site on an unspecified date and the outcome of the events extremely sore, discoloration, blisters in between her toes, she noticed a blood blister was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Within one week of getting the shot, I developed full-blown pneumonia. Had to spend one week in the hospital with a fever of 103 some days. Between the time that I got the shot and the onset of pneumonia, I was not exposed to any potential carrier of it. I never had pneumonia before in my life. I lived by myself in an apartment as I had just moved and did not even know anyone. THE SHOT GAVE ME PNEUMONIA despite the fact that the hospital denied it over and over again.
Patient presented with warm, reddened, swollen right upper extremity.  Physician ordered Keflex 250 mg QID x 7 days, 1% Hydrocortizone cream BID x 3 days, Benadryl 25mg Q 8 hrs PRN and RTC 1-2 days of increase in symptoms.
administrative error, dose 2 given 1 week to early, pt has not reported any adverse side effects
Information has been received from a physician concerning a 9 year old male who on 9/23/96 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 3/27/01, the patient developed breakthrough varicella characterized by very few spots with one definite pox-like lesion. Unspecified medical attention was sought and the patient subsequently recovered from the breakthrough varicella. Additional information has been requested.
2 weeks after event 5/11/07, 2 cm by 2 cm swollen indication on Right thigh vaccine Dtap was given
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 17-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018, status albumin: recombinant human albumin (rHA)). Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported.    This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
chills, fever, hot flashes, fainting, fast heart rate, dizziness, nausea, sore arm, weakness of muscles, headache
Pimple like spots on lips, cheeks, chin and chest; cold sores; This non-serious case was reported by a consumer via sales rep and described the occurrence of pimples in a adult male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number MC355, expiry date 30-JUN-2024) for prophylaxis.   On 25-OCT-2023, the patient received FluLaval Quadrivalent (right deltoid). On 28-OCT-2023, 3 days after receiving FluLaval Quadrivalent, the patient experienced pimples (Verbatim: Pimple like spots on lips, cheeks, chin and chest) and cold sores (Verbatim: cold sores). On 29-OCT-2023, the outcome of the pimples was resolved (duration 1 day). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the pimples and cold sores to be related to FluLaval Quadrivalent.     It was unknown if the company considered the pimples and cold sores to be related to FluLaval Quadrivalent.   Additional Information: GSK Receipt Date: 01-NOV-2023 It was reported that patient had Pimple like spots on lips, cheeks, chin and chest. All pimples flared up for about 24 hours but then went away with the exception of 4 on the lip which acted similar to cold sores.
flu-like symptoms come and go; flu-like symptoms 11 days after receiving 1st dose; flu-like symptoms 5 days after receiving 1st dose; flu-like symptoms 2 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms 2 days after receiving 1st dose), INFLUENZA LIKE ILLNESS (flu-like symptoms come and go), INFLUENZA LIKE ILLNESS (flu-like symptoms 5 days after receiving 1st dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms 11 days after receiving 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms 2 days after receiving 1st dose). On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms 5 days after receiving 1st dose). On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms 11 days after receiving 1st dose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms come and go). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms 2 days after receiving 1st dose), INFLUENZA LIKE ILLNESS (flu-like symptoms 5 days after receiving 1st dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms 11 days after receiving 1st dose) had resolved and INFLUENZA LIKE ILLNESS (flu-like symptoms come and go) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse effects reported; patient received improperly stored VARlVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, medical history and drug reactions was not provided.     The excursion started on an unknown date in April 2019. Temperature 7.7 Fahrenheit (F) with time frame 30 minutes and previous temperature excursion was in range of 6F to 14F for 188 minutes. Data logger involved. The sterile diluent was properly stored. On 01-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (second dose, lot number R020650, expiration date 18-JUL-2020; frequency and route were not provided) for prophylaxis (product storage error). No adverse effects were reported.
No adverse effect reported; one dose of an improperly stored vaccine ROTATEQ to one patient; This spontaneous report was received from a nurse and concerns to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  lot # R030924 and expiration date 10-JUL-2020, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 0.24 degrees Celsius (multiple) for 5 hours and 30 minutes, as recorded by a data logger. There was no  previous temperature excursion. No adverse effect reported.
New onset bilateral Ear fullness and doubling of volume of high pitched dog whistle like preexisting baseline bilateral tinnitus ears  associated with more difficult hearing in noisy environments, sleep. Interference, distraction with trying to rest or meditate. Tinnitus will increase if tired, too many computer  demands, idiopathic, weather change and if over worked. Pressure in ears and fullness increases without reason. So far sleep helps   Unchanged problem from start 8 months ago in end DEC 2020.
The flu shot caused sickening headache, fever, body aches and debilitating hip pain (esp. at the rear of the hip). After several days the adverse effects mitigated; however, although the hip pain decreased, it persists.
Narrative:  COVID infection following COVID vaccine series 03/18, Pfizer, dose #1 04/08, Pfizer, dose #2 11/01, Pfizer, dose #3 COVID swab, result: detected 12/21 pt cc: cough and sore throat exposure: wife & daughter 12/23 pt admit to ED cc: " 2 days ago he has been with sore throat and nonproductive cough" dx: LOS: 1 day 12/23 SARS-COV-2 Variant Sequencing: pending 12/24 CXR impression: No acute cardiopulmonary disease.
Moderna, incessant ear ringing.   My ears ring all of the time. This was my 3rd dose. They did ring after the second shot for a few months, but not as badly.
This spontaneous report was received from a female consumer of an unknown age, via a company representative. medical history and concurrent conditions were not reported. On 24-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. On 26-MAR-2014, the patient developed a red, slightly itchy oval that was 1.5 by 2.5 inches at the injection site. On 27-MAR-2014, the oval had grown to 2.5 by 4 inches and she had put ice on it that night. ON 28-MAR-2014, the redness had gotten lighter and she put ice on it that night as well. On 29-MAR-2014, the color was barely discernible. At the time of the report the outcome was recovering. Additional information has been requested.
Patient states that when she got home after receiving the vaccine, she had nausea, vomiting, and diarrhea. Patient states there is no reaction at the actual injection site. Patient states she also had a rapid heart rate. On 3/20/15 patient stated she felt fine, but that the symptoms lasted most of the night.
A report was received from a health professional on 10/21/2002, concerning a 24 month old female vaccinee who inadvertently received the Fluvirin vaccine on 10/21/2002. On 10/21/2002, a 24 month old female vaccinee was inadvertently administered the Fluvirin vaccine.  The vaccinee had not received a previous influenza vaccination.  The vaccinee had not showed any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1 01/06/2003 The reporter stated that the vaccinee was given the incorrect dose, the vaccinee was less than 8 years old and was given the dose for vaccinees greater than 8 years old.  The parent was notified, but the vaccinee had experienced no adverse reaction 72 hours after the vaccination.
Vaccine was administered in my right arm, at 1:10 PM. Around 6:00 PM I started to experience sharp pains in the rib cage on my right side. They are not persistent.
Product storage error; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  This case contains information for patient 36 out of 100 patients reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
Swollen left arm, both shots same arm (Oct 27-28 all day and night). Rash on left arm, rash on both breast. Still there Nov 3rd- Flu like symptoms, fever aching body.
this evening I took off my shirt and I just so happened to feel my arm and felt an area that was warm to the touch, and with an abnormal texture. The area was bright red and bumpy. It is slightly itchy and slightly uncomfortable.
The patient has bruise and constant shoulder pain. The swollen, bruise and pain remains after three weeks of vaccinations. The patient consulted her primary doctor. The doctor diagnosis that this was from vaccine.
Initial report received from a consumer's mother on 22 May 2011. A baby boy (age not reported) received on an unknown date (dose 3) an injection of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, manufacturer and lot number not reported. The patient's mother reported that after the patient received his third shot, 30 minutes later he started hitting his head in the mother's shoulder so hard. The seizures got so bad that he would have up to 100 a day. The doctors told the mother that it wasn't from the shot but she knew that her child was perfect until then. "They also told me that he would be dead by the time he was 1. My son is 25 years old now, he is mentally disabled and will be with me from now on. He now has about 4 seizures a day, so he is better. The doctor could not tell me for sure that the shot didn't cause my son to turn out like that, so both my girls did not get the shot and they are fine. It has been a living hell for 25 years watching your child jerk his insides out and you can't do a thing to help. The government made me give him that shot then said I had no proof the shot did it. I guess you can figure out what I think about this shot". The outcome was reported as not recovered. Documents held by sender: None.
Menstrual cycle was supposed to start 11/21/21 (according to app tracker). Menstrual cycle was delayed and did not begin until 12/6/21. PMS symptoms extended from 11/21 through 12/6. Next period began on time - 1/5/22
Within 7-9 days of receiving first dose of vaccine, patient developed diffuse, large hives over her arms which spread to her face, trunk and lower extremities. Hives ranged from pinpoint to quarter sized, weeping present. Patient complained of diffuse itching and some myalgias, but denied throat swelling, difficulty breathing. She was given prednisone and hydroxyzine for management.
t101-103.6 AX, t102-104 oral, arms sl red & painful; pt given APAP & cool baths & mom called MD; fever 101 lasted 4 days/stiff sore arm resolved 1 1/2 days;
Information has been received from a mother concerning her daughter who on 31-MAR-2008 was vaccinated with first dose of GARDASIL (Lot # 659180/1758U).  Concomitant therapy included a dose of VARIVAX (Lot # 658287/1173U) (MSD) on 31-MAR-2008 and Acne cream.  Subsequently the patient began to lose hair after her first vaccination.  The patient was vaccinated with the other doses of GARDASIL as follows:  2nd dose (Lot # 656371/0181U) on 24-OCT-2008, and 3rd dose (Lot # 661953/1130X) on 21-MAY-2009.  Other concomitant therapy included influenza virus vaccine (unspecified) on 24-Oct-2008.  The patient didn't seek medical attention.  At the report time, the patient was not recovered.  Additional information has been requested.
On January 4, 2021, started having events of not being able to speak, move or move y eyes, lasting 2-15 minutes, daily. Emergency room visit on January 6, r/o stroke- ruled out. On Jan 7th met with pcp, ordered MRI and see neuro. # trips to see 3 different neurologists multiple EEGs.  Final diagnosis, Non-epileptic seizures, reason unknowm.
Hours after the vaccine, my arm was sore; however, on Sunday night (2 days after the vaccination), I noticed that there was a mango shaped swelled area around the injection site. It was red and warm.  The area got bigger over the next few days and also became itchy.  The redness and the swelling lasted approximately 5 or 6 days.  The itching remained, though it's lessened.  It's still a little itchy at times today (3/15).  (Just for background info, after the first vaccination, in the same arm, my arm was sore and there was a small bruise around the injection site. However, I noticed no swelling, redness, warmth, or itchiness.)
Patient was admitted as inpatient on 10/19 with Covid. complex medical history including dementia, HTN, constipation, and hypothyroidism, admitted with acute hypoxic resp failure d/t COVID-19 infection .  Palliative Care was consulted to assist with goals of care and to transition to comfort focused care at the end of life.
Diarrhea; very sick/very ill; just not feeling well/feel very ill; Very weak; feel like she want to throw up; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 26Sep2021 (at the age of 72-year-old) (Lot Number: FF8334) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, on Sep2021 (at the age of 72-year-old) (Lot Number: FF2588) as single dose for covid-19 immunization and no adverse event. The patient experienced diarrhea, very sick/very ill, just not feeling well/feel very ill, very weak on 28Sep2021 07:30; feel like she want to throw up on 28Sep2021. She has a reaction from the shot she had Sunday. She was having a reaction to it. She was having diarrhea. She was very sick, very weak, very ill. She had not been this ill in a long time. She just got her shot Sunday afternoon. She had got diarrhoea, she was very ill. She was just not feeling well. She had been ill since 7:30 the morning. She had diarrhoea all morning and she felt very ill. She felt like she was going to throw up right now. She felt like she want to throw up. This was really bad diarrhoea this morning that's how bad the diarrhoea is. She chew some Pepto Bismol tablet (Treatment). She had diarrhoea. It's not working exactly because she was just in near about 10 minutes ago. The outcome of the events was unknown.
arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021294101 Same reporter, drug, and event; different patient;US-PFIZER INC-2021297074 Same reporter, drug, and event; different patient
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus that is ongoing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus that is ongoing). At the time of the report, TINNITUS (tinnitus that is ongoing) had not resolved.            No concomitant medication was reported. No treatment information was provided.
Pt came on Friday morning and presented a swollen half dollar sized nodule on the back of her arm. Beyond the nodule red blotchy patches surrounded 3/4 of the back of the arm. Pt referred to PT 1st where she received prednisone 20mg to take 3 TS QD x 7 days.
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 10-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot numbers, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.