chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (She felt sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The patient's past medical history included Sciatic hernia (Chronic sciatica with 3 bulging herniated disks on oxycontin), Heart attack, Alzheimer's disease and Schizophrenia. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL, SIMVASTATIN, SERTRALINE HYDROCHLORIDE (ZOLOFT), DIAZEPAM and OXYCODONE HYDROCHLORIDE (OXYCONTIN) 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (She felt sore). At the time of the report, PAIN (She felt sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that she had been previously put on a medication for schizophrenia, and had seen 12 psychiatrists at a nearby clinic. No history of bipolar disorder, or seizures.  No treatment medication was provided.   This case was linked to MOD-2021-421493, MOD-2021-421460 (Patient Link).
Dizzy/vertigo, nausea, body aches, felt feverish, lowgrade temp of 99, extreme fatigue
TERRIBLE RASH ON UPPER THIGH, 12-14 INCHES IN THE UPPER BODY, DEEP RED RASH WITH LITTLE SPOTS BY THE BREAST BONE, AREA UP AND AROUND NECK WAS ITCHY AND PRESENTED WITH RASH AND SEVERE ITCHINESS; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cll(chronic lymphocytic leukemia) with no complications presently, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced terrible rash on upper thigh, 12-14 inches in the upper body, deep red rash with little spots by the breast bone, area up and around neck was itchy and presented with rash and severe itchiness. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) something may have touched the skin, and Skin patch test (NR: not provided) skin had a reaction to an ingredient in a topical product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible rash on upper thigh, 12-14 inches in the upper body, deep red rash with little spots by the breast bone, area up and around neck was itchy and presented with rash and severe itchiness on 01-SEP-2021. This report was non-serious.
Pt called me to report she got the flu 4-5 days after she got the vaccine. PNEUMOVAX was administered at the same time.
Pt stated that the needle looked bigger but assured her that it's the same size as last yr. She couldn't really relax her arm when the vaccine was given and told her there's a bit of swelling but should be ok. After leaving the room, male companion came and said she's on the floor. Went to check her and told her 911 is being called. She was sweating and shaking when EMT came. After 5 mins, Pt came back to the pharmacy and said she was fine. They left to go home.
TWO DAYS POST INJECTION, SITE BECAME RED, PAINFUL, INFLAMED TO THE SIZE OF A LARGE GRAPEFRUIT.
Swelling, redness at site right deltoid.  Complained of body aches.  Patient was prescribed Cipro 500mg 2 times a day for 7 days.  Tylenol 500mg every 4 hours as needed.
Beginning 2/27/21 patient developed chills and fatigue.  Chills, fatigue and myalgia which have gotten a bit worse every day since.  He is reporting very deep muscle pain in both legs and both arms.  March 4, 2021 (today) symptoms are still moderate.
Pfizer-BioNTech COVID-19 Vaccine EUA: After the post-observation period, vaccine recipient got up to use the rest room and collapsed on the floor. EMS evaluated the patient (vitals, blood sugar) and observed the patient for an additional 30 minutes. Vitals were within normal limits. They were able to leave the site in the wheelchair to their car.
Neck pain; Tingling all over body; achey/weakness all over; achey/weakness all over; severe headache; Fatigue; Lack of appetite; Fever ~100 degrees Fahrenheit; Upper central back pain; Lingering fatigue randomly throughout the following couple days.; inability to lift either arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Jun2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history included thalassemia (low iron due to small blood cells, similar to anaemia), adult acne, allergy to latex and vinyl. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included escitalopram (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), cyanocobalamin (VIT B12) and zinc (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if on going. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13May2021 at 18:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient also took previously morphine (MANUFACTURER UNKNOWN) and hydromorphone hydrochloride (DILAUDID) on unknown dates and experienced allergy. On 03Jun2021 at 20:00, for 24 hours, the patient experienced neck pain, tingling all over body and felt as though body got hit by oncoming traffic, achy/weakness all over, inability to lift either arm, severe headache, fatigue, lack of appetite, fever approximately 100 degrees fahrenheit, upper central back pain and lingering fatigue randomly throughout the following couple of days. On the same day, the patient underwent body temperature test and the result was approximately 100 degrees fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events neck pain, tingling all over body, achy/weakness all over, inability to lift either arm, severe headache, fatigue, lack of appetite, fever approximately 100 degrees fahrenheit, upper central back pain and lingering fatigue were resolved with sequelae on an unknown date in Jun2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low; Vaccine administered to 45 patients past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F low) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. As per the provider the vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. Moderna doses Stored in standard freezer. Date Stored in Standard Freezer was on 31-mar-2021. No treatment medication was reported.
No additional AEs were reported.; Medical assistant reported that a 4 month old patient received PROQUAD.; This spontaneous report was received from other health care professional concerning to a 4-month-old patient of unknown race and gender.   The patient's pertinent medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot number X18576, expiration date: 05-JAN-2025, administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
The next day woke up and my stomach overly upset. I feel like a pain and have to go the bathroom, took Nexim didn't work. The pain in mid-section of the stomach by the belly button. I called the doctor - took meds and improved and I didn't have to go the hospital. It lasted 2-3 days.
Had the Moderna vaccine on 1/12/21 and started with mild itching sensations on the palms of my hands on 1/14/21.  This became worse between 1/21/21 through 1/25/21 with intense itching, burning sensation, palms turning red, feeling "lots of cuts" through out my hand and developing small lumps through out my palms and in between my fingers.  This also spread to my feet but not as severe and not as long (a couple of days with intense itching and small lumps).
1/21/21 received vaccination, 1/22/21 started having body aches, cold, flush feeling, fever as high as 101.4, sinuses inflamed, stuffy, arms hutting, weak, headache
4:09 PM patient passed out at discharge desk after having had his 2 vaccines & was assisted to floor by his mother.  Was out for a minute & came to after smelling ammonia inhaler.  BP-110/60 P-86 was seen by Dr. - no treatment needed.  Left in stable condition.
About 3/4th of outer upper right arm had redness/swelling/red rash that felt warm to the touch. It started on 3/7/18 mid-day and worsened over the day. Patient saw MD on 3/8/18 and MD gave oral antibiotic to treat.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: patient recovered from the vaccine, had to visit the ER for benadryl and epinephrine
Suspected Bell's palsy...MD felt symptoms were consistent (left side of face impacted, including ability to blink left eye)...treated by MD with prednisone and Valtrex.
On Friday, August 27, 2021 at 10:58am, 69 YO M was given a third dose of Moderna vaccine. The vaccine administered on 8-27 was withdrawn from a vial that had been punctured on 8-26 at 8:28am.
About 7 days after the smallpox vaccine pt. described chest pain starting at work and progressively getting worse. Fever x 101 degrees & headache. Went to ER and was given shot relieving all pain. Was diagnosed with information in and around heart.
receiving doses after its beyond use date (11 feb2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date (11 feb2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date (11 feb2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date (11 feb2022)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vial was initially stored in the refrigerator on 11-Jan-2022. Beyond use date reported as 11-Feb-2022.  The vial does not undergo any temperature excursions.   No treatment medications was reported.   This case was linked to MOD-2022-573737 (Patient Link).
aching; throats really hurts when she swallows; she is congested; Feels bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "Feels bad"; PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "aching"; NASAL CONGESTION (non-serious) with onset Oct2022, outcome "unknown", described as "she is congested"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "throats really hurts when she swallows". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that she got the Pfizer COVID-19 Vaccine booster dose last Monday and she feels bad, she had real bad sore throat and she is congested and sort of achy. She said that her throat really hurts when she swallows and she is asking if it is really a side effect of the vaccine and I gave her the number of Pfizer Medical Information department as well. It was reported that she never had flu shot.."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221531 similar report from same reporter;
Received a Shingles shot last year with no side effects. This year I received a flu shot and within 10 days I developed a case of Shingles. I am a healthy 75 yr old female and do not believe this was a coincidence but rather a catalyst that awakened the virus that was introduced with shingles shot. I have had flu shots for the past 20 yrs with no reactions. After suspecting this is what occurred, I found many people that have experienced this exact scenario on the internet. I am now truly wary of ever getting another flu shot and am still suffering much pain from this case of shingles after 3 weeks. I was treated with an antiviral and still taking Neurontin. I think this may be a serious problem for people being advised to get a Shingles shot and flu shot.
angio edema; This case was reported by a other health professional via call center representative and described the occurrence of angioedema in a adult female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, less than a year after receiving Engerix B, the patient experienced angioedema (serious criteria GSK medically significant and other: ER visit required). On an unknown date, the outcome of the angioedema was recovered/resolved.   It was unknown if the reporter considered the angioedema to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported, however the patient could be 36 or 37 years old. On an unknown date in 1992, the patient had a severe reaction after receiving dose 2 of Engerix-B vaccine, the patient developed angioedema and required visit to emergent care. It was reported that this was part of the patient history. The patient reported this event and all the follow up was reported to the Center for disease control (CDC) in 1992 after it occurred.  The reporter did not consent to follow-up. No further details were provided.
booster; I woke up with a big red bump where I got the shot and yesterday I still have the bump and today I still have the bump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received third dose of bnt162b2 (BNT162B2, Batch/Lot number: FG3527) administration date 19Nov2021 as DOSE 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Nov2021, outcome "not recovered", described as "I woke up with a big red bump where I got the shot and yesterday I still have the bump and today I still have the bump"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster".  Additional Information: Consumer stated that just wanted to talk about the side effects that had after getting the booster shot. Got the booster shot on Friday, did not had any reaction to it and then on Saturday, woke up with a big red bump where got the shot and yesterday still had the bump and today still have the bump so wanted to know if this was a normal side effect and if it will the bump go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscles on the left side of face felt tense; About 72 hours ((afternoon of 4/19) after thevaccination) started to feel a numbness in the left side of face, from  chin up to undereye area; About 72 hours ((afternoon of 4/19) after thevaccination) started to feel tingling sensation  in the left side of face, from  chin up to undereye area; The left side of  face hurts; Face almost like it bruised; Approximately 48 hours after the vaccination, started feeling a slight numbness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 16Apr2021 at 14:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, eczema and allergy to tree nuts. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ) from unknown date as birth control and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 12:00, approximately 48 hours after the vaccination, the patient started feeling a slight numbness in left arm. On 19Apr2021, about 72 hours after, in the afternoon, the numbness from arm was still there, and the patient also started to feel a numbness/tingling sensation in the left side of face, from chin up to undereye area. It felt similar to when come off of numbing after a cavity filling at the dentist. That evening, the numbness in arm and face had still not subsided and when touched the left side of face hurt, almost like it felt bruised. On 20Apr2021, muscles on the left side of face felt tense, when smiled it felt like there was resistance on the left side of face vs. the right. This improved gradually over the following weeks, but have some residual muscle tenseness at the time of this report (15May2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events approximately 48 hours after the vaccination, started feeling a slight numbness in left arm, about 72 hours ((afternoon of 4/19) after the vaccination) started to feel a numbness in the left side of face, from chin up to undereye area, about 72 hours ((afternoon of 4/19) after the vaccination) started to feel tingling sensation  in the left side of face, from  chin up to undereye area, the left side of  face hurts were recovered with sequalae on 20Apr2021 , the patient was recovered with sequalae from the event face almost like it bruised on an unknown date in 2021. The patient was not recovered from the event muscles on the left side of face felt tense at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a Licensed Practical Nurse, concerning a female patient, who on an unknown date was vaccinated with a dose of GARDASIL (dose, route and lot not provided). On an unknown date, the patient developed bell's palsy after administration of GARDASIL. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information has been received from the Licensed Practical Nurse, concerning an 26 year old patient. The nurse stated that the patient received her dose of GARDASIL at another physician's office. Additional information has been requested.
At 09:30 patient received #1 dose of Moderna Vaccine. At 9:52 am, she complained of being dizzy and flushed chest.  She asked for a Benadryl as she has taken it before after certain medications.  50mg of Benadryl given with water.  Nurse had patient lay down on couch.  The symptoms resolved enough for patient to leave clinic, however today (4/7/2021) is out sick from work with flu-like symptoms.  Call attempted today at 1:00 pm to follow up and obtain more detail, however unable to reach and no voicemail set up.
Chemical taste in mouth; This is a spontaneous report from a non-contactable other hcp (patient). A 51-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231, expiry date not reported), via an unspecified route of administration on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced chemical taste in mouth on 13Jan2021 14:00. The patient did not have COVID prior to vaccination and has not tested positive post vaccination. The patient was recovering from the event.   No follow up attempts are possible. No further information is expected.
Janssen COVID-19 Vaccine EUA Moderate case of shingles, left flank. Vesicular rash appeared July 1, visited urgent care to confirm and was treated with antivirals.