chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a newborn (numbered 132). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 26-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Pt's right arm swelling/red/inflamed and left arm has a spot (side-arm) that also hot, red and swelling. He has pain. Recommended to put ice to soothe the inflamed muscle/arms. 11/9 called pt. said it's better and will continue put ice on. 11/13 called pt. Pt said it's all OK now.
3 weeks after 2nd dose I began to have headaches and pains in my head that lasted for three weeks. I also had two episodes of confusion. The first was May 23rd,  I could not place my surroundings. The second occurred on May 30th, I could not remember which hand I wore my wedding rings.
Asthma exacerbation had severe wheezing 10/3 -10/14 - 5 days of prelone then 10/5-10/10 20 mg BID.
I have not had a cycle/period in 6 years and I suddenly had a full  period beginning 6/16 and its still going. Previous periods were only about 3 to 4 days. I wasnt going to report it but I shared the sudden onset with friends and several replied how a handful of women they know experienced the same sudden onset after years without.
Following first dose of COVID-19 vaccine patient stated that she felt "faint". Patient was given two ice packs, juice and a private room to recover in.
MMR Administered on 2/25/2010 Rash appeared 10 days later on 3/8/2010 Vaccine Provider:  Merck  After waking up from her nap, patient had a highly visable rash on her back, stomach and forehead as well as other parts of her body (diaper area), upper legs.  The rash was less apparent on her lower (after knee)legs and feet.  She woke up from her nap crying for 45+ minutes consistently (very unusual for her).  She was also acting lethargic - not focusing like normal-like she was daydreaming/couldn't concentrate.  I checked on her at 2:30 am the next morning and I was unable to wake her up. I touched her hand and she didn't move it.  I noticed it was very cold.  I listened for breathing, couldn't hear anything.  I touched her back and did not feel any movement/breathing so I picked her up.  She did not move and felt stiff like she was dead.  I shook her at least 3 times to wake her up.  She did not move.  Her eyes were closed.  I screamed for my husband to call 911.  I said call 911, I think patient is dead.   (it was the worse moment of our entire lives).  After my husband started calling 911, my daughter opened her eyes.  She didn't say anything and was lethargic (deer in the headlights).  After a few moments, she made some noises and we put her down and she started to walk but she would bump into things -like she was off balance, but was playing like she normally would.   We took her to the ER and were then admitted to the hospital for observation.  It was a horrible experience for all of us.
Temp for 4 days above 101.6, rash all over body starting at day 10 post shots, inconsolible crying, slapping at head, mood changes
The first time her arm was red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The first time her arm was red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN, MESALAZINE (LIALDA) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced ERYTHEMA (The first time her arm was red). In January 2021, ERYTHEMA (The first time her arm was red) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-330737 (Patient Link).
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022) and NO ADVERSE EVENT (No Adverse reaction) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022). No concomitant medications were provided by the reporter. The vial was initially stored in the refrigerator on 30-Jun-2022 and Dates of administration of vaccine was given as 01-Aug-2022, 02-Aug-2022, & 05-Aug-2022.The vial  did not undergo any temperature excursions. No treatment medications were provided by the reporter. It was unknown whether the patient experienced a similar event in the past. It was unknown whether patient seek medical care.
A week after the Varicella vaccine was given to my daughter, she had a high fever. After giving her over the counter MOTRIN and TYLENOL, her fever would not go down. I called the Dr and was told to take her to the ER if it would not go down. Her fever had gone as high as 104, but only went down to 102. She was taken to the Emergency Room at Hospital and was diagnosed with pneumonia. I did not know that this was a rare side effect of the vaccine until recently. I was told to report the incident.
Narrative: Patient with breakthrough covid infection. 2 doses of moderna vaccine received previously. Treated with monoclonal antibodies.
After the second COVID vaccine on 4/11, pt has become allergic to almost all foods, with reactions described as dizziness, swelling, throat swelling, a rash, and abdominal bloating
03/15/2021: Scheduled/planned left total knee arthroplasty. Patient remains admitted, but no complications/adverse events noted.
I am having a severe reaction to the shot.  My arm is in a constant state of pain and I have a golf ball size hard area that is swollen and emitting heat.
Patient had no adverse event or outcome. After administration, was discovered that vaccine refrigerator was out of temperature range. Patient is notified and offered re-vaccination.
Legal report of a male patient who experienced mercury poisoning coincident with Certiva. Between 12/1999 to 9/2002, the patient received Certiva vaccination for immunization. On an unreported date, the patient experienced mercury poisoning, which led to toxic neurological effects. Pertinent laboratory test, diagnostic procedure, medical history or concomitant medication information was not provided. The patient was a child. The event of mercury poisoning was considered medically significant (OMIC).
Swollen under arm lymph nodes, headache, cough, runny nose, stiff neck, nausea, join pain, fatigue, and malaise.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021, 2/21/2021, and 8/31/2021. Pt. w/PMHx of unifocal langerhands cell histiocytosis, pulmonary fibrosis and emphysema s/p bilateral lung transplantation 1/2019. Hx Covid-19, dx'd on 11/4/21 tx'd w/monoclonal antibodies on 11/6. Admitted on 11/08 tx'd with remdesivir, decadron and IVIG, d/c'd home on 11/14. Admitted 11/20 for acute on chronic respiratory failure with hypoxia secondary to Covid pneumonia and CKD. Tx'd w/azithromcin,  meropenem, and methylprednisolone. Underwent prolonged mechanical ventilation x13 days. Expired 12/06/21.
Pain in the arm that has moved from my outer arm to my inner arm and my arm pit. The pain has lasted a week, so far, although it has improved day by day. Numbness of right wrist that lasted 2 days. On the evening of day 2, after the vaccine I experienced a low-grade fever of 100 degrees, nausea and chills. This had resolved by the following morning.
mild reaction 2 hours after vaccinations, mmr, varicella, and hep a given, areas of injection was red, hot and swollen.  after 15 - 20 minutes are less redness and swelling advised to follow up 24 hrs.  follow up next day and adverse reaction with swelling and redness in upper thigh are resolved.
developed pericarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191).  A patient (no qualifiers provided) of an unspecified age and gender received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for Covid-19 immunization.  The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "developed pericarditis". Caller stated that patient took Pfizer COVID-19 vaccine and the booster and developed pericarditis, and was asking if there is a coloration or not. Agent reports caller refused to give any information for name or contact details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Severe, Additional Details: Pt experienced lower back pain, difficulty breathing, dizziness, light headed, shaking more than normal, cold, felt like she was fainting
Patient had itching and swelling at injection site on (L) deltoid. The area was warm to touch. Patient. BP was elevated with being incoherent. Was treated with cool compress and 1 ml of Benadryl & MDP
Triaged by Dr via telephone and advised to go to emergency room. Patient was triaged by Dr.
Pt rec'd vaccine on 10/2/14. Friday 10/3/14 site of vaccine was red and warm to touch. Patient was placed on Prednisone and Amoxicillin. Patient had allergic reaction to Flu vaccine per Dr.
From the time of injection until 8 pm the following day, I experienced soreness and swelling at the injection site and muscle aches in my left arm.  On Friday night March 19, I felt mildly nauseous and experienced a very mild low grade fever from 8 pm to 10 pm.  On Saturday March 20, I experienced the following symptoms from 2 pm to 8 pm: low grade fever, chills, fatigue, headache, and it also affected my vocal cords.  My voice returned to normal around 8 pm, when the other symptoms subsided.
2 shingles vx 3 years ago, just diagnosed with shingles again/ suspected Vaccination failure; Just diagnosed with shingles again; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (occurred in February 2020, refer case US2021AMR210321).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the two shingle vaccines 3 years before the date of reporting and have just been yet again diagnosed with shingles. The patient asked was there something wrong with the vaccines why was this happening. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210321:Same reporter.
Patient was given the 0.5mL instead of the 0.25mL FLUZONE. CDC informed me there is no reaction to the patient.
Unable to breathe for a few minutes; Chest pain; Joint pain; Pain at the injection site; A spontaneous report was received from a consumer  concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pain, pain at the injection site, chest pain and unable to breathe for a few minutes..  The patient's medical history, as provided by the reporter, included gallbladder surgery and allergy to lentils. No relevant concomitant medications were reported.  On 6 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient experienced the event(s) joint pain, pain at the injection site, chest pain and unable to breathe for a few minutes.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 6 Mar 2021 the outcome of event, unable to breathe for a few minutes was resolved. On 8 Mar 2021 the outcome of event, joint pain, pain at the injection site, chest pain was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
17 year old patient received the first dose; A spontaneous report was received from a pharmacist concerning a 17-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history, was not  provided by the reporter. No Concomitant medications reported   On 28 Jan 2021, the patient received his first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   They noticed that the dose was administered to a 17 year old patient and only when the patient came for the second dose on 25 Feb 2021, however, they did not administer the second dose.  Action taken was unknown.  The outcome of product administered to patient of inappropriate age was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 028L20A) with no associated AEs reported.
Janssen Vaccine was given to 16 year old male.  Patient and legal guardian have been contacted.  There have been no sings of adverse events so far.
Fever of 102 appeared four days after vaccine was administered.  Fever lasted for 4 days, lingering around 100 - 101 degrees.    Red rash appeared 9 days after the vaccine was given.  Rash appeared on nape of the neck, and quickly spread to the back and stomach.  Rash on the nape was extremely itchy.  Low grade fever of 99-100 reappeared 12 days after the vaccine for two more days.
pt recv vax &NOV96 & later that evening pt exp itchy legs & hives on legs & arms;no further details were provided;
Two days after the first dose of the vaccine my left arm was dead. I could barely move my arm and it was very painful. It was from my elbow to my shoulder but there was no swelling. It was like that for two days and then it resolved. Thirteen weeks after the second dose I got a headache which continued for almost a week. My throat started to feel irritated. I went to a clinic and I was tested for Strep and Covid-19 and both tests were negative. It has been almost two weeks and I still have the headache which comes and goes during the day. It does not wake me up at night. It is a nagging pain that is roughly a 4 on the pain scale. I also still have the sore throat. I was Mucinex and Flonase and they do not seem to help. Tylenol does not work either. I don't normally have persistent headaches.
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for Autoimmune disorder NOS.     Concurrent medical conditions included Atrial fibrillation (A-fib), Lupus syndrome (Lupus) and Blood cholesterol abnormal (Cholesterol). Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, ROSUVASTATIN for Cholesterol, HYDROXYCHLOROQUINE for Lupus syndrome.    On 28-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Nov-2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2022, SARS-CoV-2 test: Positive. On an unknown date, Weight: Increased.         Patient received 1st dose on 15Jan2021 with Lot: 012L20A; 2nd dose on 16Feb2021 with Lot: 010M20A; 3rd dose on 25Oct2021 with Lot: 032F21A and 4th dose on 18Apr2022 with Lot: 005M21A.  Patient was allergic to a lot of things, so she had to wait the 30 minutes after 1st dose, but she was fine.  Patient had all her injection and booster. Patient had not taken any of the Paxlovid at the time of this report. Her symptoms started Saturday but she thought she just had a cold because all she really had was a runny nose.  Patient was much thinner when COVID pandemic had started however being home all the time and not doing anything she had put on a lot of weight. Patient was in the hospital the previous weekend and she believed that's where she had picked up the COVID-19.  Patient was diagnosed with COVID-19 after receiving 5 doses of the Moderna Covid Vaccine. It was reported that the packaging was sealed and intact.  No treatment medications were reported.
lymphadenopathy; very sensitive to touch; pain around the armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "b/l breast lumpectomy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunisation series complete but Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Nov2022 at 06:00, outcome "recovered"; AXILLARY PAIN (non-serious) with onset 02Nov2022 at 06:00, outcome "recovered", described as "pain around the armpit"; HYPERAESTHESIA (non-serious) with onset 02Nov2022 at 06:00, outcome "recovered", described as "very sensitive to touch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, hyperaesthesia, axillary pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks prior to the vaccination. No known allergies were reported.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe fever above 103F lasting > 4 days; Remedial treatment for fever using acetaminophen and ibuprofen.
young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.). At the time of the report, ILLNESS (young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a Nurse refers to an approximately 66 year old male patient. On 14-FEB-2014 the patient was vaccinated with ZOSTAVAX (lot # J011341, expiration date: 13-DEC-2014). Now the patient had a prescription for a MEDROL dosepack and had filled a prescription for amoxicillin (manufacturer unknown) on 11-MAR-2014. The reason the patient was prescribed these medications was not known by the nurse. The nurse stated that the patient also was started on a new medication, tamsulosin (manufacturer unknown) on 05-MAR-2014 for unspecified reason. On an unknown date, the patient experienced adverse event. On unknown date the patient sought medical attention with unknown method. The outcome of adverse event was unknown. Additional information has been requested.
Patient with onset of diffuse rash 24 hours post administration.  Benadryl PRN