chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/30/10, patient was sent to ED from the primary care physician office for severe shortness of breath. The patient is a relatively healthy gentleman with history of non-insulin dependent diabetes mellitus and hypertension. In ED, he was diagnosed with severe anemia, elevated LFTs and was admitted. Patient received PRBC transfusion. He was diagnosed with autoimmune hemolytic anemia. Although patient had leukocytosis, he did not show other signs of infection. The patient had not started any new medication other then receiving INFLUENZA vaccination 2 weeks prior. His home medications included glyburide, FLONASE, aspirin and metformin. Metformin 850 mg PO tid was discontinued at admission as potential cause for hepatitis and autoimmune hemolytic anemia. INFLUENZA vaccination was also considered as potential cause. Patient had been on metformin for 10 years. Hepatitis A, B, C were negative. SOLUMEDROL and danazol were started during hospitalization. H/H and LFTs improved. Patient was discharged home on 12/6. Metformin was not restarted.
Day received: tenderness only at the injection site Day 1 : 4cm round reddened area - not itching  Day 2: 10cm round reddened, angry site, welted, itching - took Benadryl and stared Prednisone 10mg  for left knee effusion (arthritic flare)  Day 3: 10cm round reddened, but improved, welted, itching site - continued with Benadryl and Prednisone Day 3: evening: Bright red, angry, hot, welted, itching , pain, started itching all over, no other redness noted. Notified PCP, sent photo and was advised to go to ED.   Saw by ED MD, had 1 dose of Keflex, Benadryl  Day 4 morning: Itching all over,  site color improved but intense itching and welt. Notified MD again, stopped Keflex and started Doxycycline. Continued with Benadryl, Prednisone and Doxycycline - continued to itch all over - no redness, site is light pink but larger - up to 12cm - made appt with allergist Day 5: (held Benadry and Prednisone for MD appt) Itching all over continues with no redness, site is pink, welted and continues to intensely itch, saw allergist, arm was welted during visit and increased redness. Took Allegra in MD office - helped with itching but completely gone - all over itching, no redness, site is pink itching improved but not gone.
Lump on the chest; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Lump on the chest) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (Lump on the chest) and FATIGUE (Fatigue). At the time of the report, NODULE (Lump on the chest) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: ICEPACK   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: On 27-FEB-2021, patient received first dose on left arm and experienced Lump on the chest and was Fatigue. Treatment used was Icepack.
Erythema, edema right shoulder and upper arm (2/3); increased warmth, non-tender; 1 blister X 2 where bandaid was; non-blanching; + induration over deltoid area of right arm.
no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 2 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left vastus lateralis at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Pt had a witnessed fall post vaccination. Per mother, pt complained of being dizzy and fell. Staff witnessed patient falling from standing to ground, and hit her head. Pt was awake and alert upon RN reaching at side. Pt was following commands. Pt stated she was dizzy and nauseated prior to syncopal episode. Maintaining C-spine precautions d/t posterior head and midline neck pain and tenderness. Team alert was called. To ED via stretcher with medics
Vaccination failure; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER730), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8734), in right arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Sep2015; SIMVASTIN, start date: Sep2016, stop date: 01May2022; CLARITINE, start date: Jun2017, stop date: 01May2022. The following information was reported: COVID-19 (medically significant) with onset 11May2022, outcome "not recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: Product: COVID 19 Treatment, brand: Pfizer Paxlovid, treatment start date: 02May2022, treatment stop date: 07May2022. Patient received other medication in 2weeks was multi vitamin, start date: Jan2022 and stop date: 01May2022. Patient tested positive for COVID 12May2022 with runny nose and sneezing. Patient had no known allergies.
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot# M017983, expiration date 30-MAY-2018, lot# M028323 expiration date 26-SEP-2018, lot# M034780, lot# M041212, lot# M042853 (expiration dates were not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported.  This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004395: US-009507513-1708USA004394: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004408 : US-009507513-1708USA004409:
Pt received MCV 4 immunization on 1/31/12, on the next morning 2/1/12 she had a 1-2" red, swollen area at site of injection & pain; she treated area with a cool compress & TYLENOL as instructed, she also  took BENADRYL. The next morning 2/21/12, the redness, swelling & pain had enlarged to the entire upper (L) arm. She went to the dr. on 2/4/12 & dr felt it was a reaction to one of the proteins in the immunization (clinic). She was instructed to continue TYLENOL and BENADRYL but to use a warm compress instead of a cool one. She began to feel some relief by Sunday 2/5/12 & has continued to get better since & problem is now resolved.
Around 4pm, I had severe chest pains. I thought I had a heart attack. I called the ambulance and spent time in the ER. I was then told I had a perforated ulcer. Then I had surgery.    In 2014, I did have gastric bypass surgery done and was later told the perforated ulcer is sometimes a result of the gastric bypass surgery.
Patient presented with c/o generalized itching while waiting in observation. Patient noted to be flushed with generalized hives, but denies any c/o dyspnea, cottonmouth, or difficulty swallowing. RN suggested PO benadryl and was okayed by supervisor. Patient consented and received PO benadryl at 1735. Patient was cleared to go home by site supervisor, RN, at 1805 but some symptoms still persisted. Patient instructed to take additional benadryl at home as needed and follow up with PCP for any additional concerns. Patient verbalized understanding.
Pt recvd vax in 1987 & devel arthralgia & myalgia; No further details were provided;
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Patient was staying in store for mandatory 15 min wait period. patient fell in the back of the store complaining of severe dizziness.  fall was not seen by store personel. I (pharmacist was called) 911 was immediately called as injuries were unknown from both fall and the nature of the reaction to the vaccination.  patient complained of some tingling of the lips but refused epinephrine shot.  as dizziness subsided, patient experienced severe nausea and some shivering.  EMS arrived shortly after.  patient refused transport, yet did allow monitoring in the Ambulance.  Results unknown.
Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night after shot due to headache and inability to get comfortable
reported on 17Apr2021 -after receiving vaccine her arm is sore; had a red spot at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (reported on 17Apr2021 -after receiving vaccine her arm is sore) and VACCINATION SITE ERYTHEMA (had a red spot at injection site.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (had a red spot at injection site.). On 17-Apr-2021, the patient experienced MYALGIA (reported on 17Apr2021 -after receiving vaccine her arm is sore). At the time of the report, MYALGIA (reported on 17Apr2021 -after receiving vaccine her arm is sore) and VACCINATION SITE ERYTHEMA (had a red spot at injection site.) had not resolved. Not Provided
October 4 months after the 2nd shot of Pfizer, I was hospitalized and diagnosed with paracarditus and inflammation of lungs, plura-paracarditus. 2 Days to diagnose and rule out infections. Negative for covid 19 as they tested me immediately. Symptoms started with back pain for 1 day then left shoulder pain for 1 day and it then moved to pain in my throat and chest. This was quick and sharp pains in throat. I checked into er that night. Exact dates I don't remember but discharged 10/13/2021.
Bad headache, body aches and pains, quite fatigued, very sore injection site on arm
pts arm hurt immediately after taking the vax.  Later that night her legs were feeling very heavy, her arm still hurts, joint pain in both hands, slight fever, has body aches and pains.  On 5/12/21 they contacted her PCP and was told to give them a call back if her symptoms get worse.
Tingling of toes and finger on the on side of body vaccine occurred, light headed, HEAD ACHE
Passed away with an hour to hour and 1/2 of receiving vaccine; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away with an hour to hour and 1/2 of receiving vaccine.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient passed away within an hour and a 1/2 of receiving the vaccine. Per the nursing home staff, they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given. The patient was 14+ days post COVID.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   The patient died on an unknown date. The cause of death was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of death (unknown cause). The event occurred  an hour to hour and 1/2 after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.  However, Per the nursing home staff, the patient was 14+ days post COVID and they did not expect the patient to make it many more days. The patient was unresponsive in the room when the shot was given.; Reported Cause(s) of Death: unknown cause of death
Patient had stated she was eligible for her 2nd booster shot and had forgotten that she got one in april. Vaccine was given at improper interval.
possible cellulitis; adm to hosp; responded to ATB; 28DEC94 no response to f/u request;
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL3302, via an unspecified route of administration in left arm on 05Feb2021 10:15 at a single dose for covid-19 immunization in a military base at age 47 years old. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on 05Feb2021 10:15. The event was reported as non-serious. No treatment was received from the adverse event. The patient recovered from the event on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
No adverse event from vaccine - but was given the old version as a booster rather than new bivalent one. Was informed by corporate to revaccinate same day with correct vaccine or in 2 months and he chose to get revaccinated with bivalent form same day.
Caller stated he recceived his 1st vaccine on 4/23/2021 around 2pm and about 1pm today 04/24/2021 he began having chills and injection site pain. He just took his temperature and was noted to have a  T of 101.0. Caller advised to take tylenol or Ibuprfen and maintain hydration. Also caller was informed if fever persists to call his PCP or seek in-person medical care. RN 4/24/2021 @1855
AFTER ABOUT 5 MIN POST ADMINISTERING THE COVID VACCINE, PATIENT STARTED TO FEEL DIZZY AND LIGHTHEADED, SKIN FELT pale CLAMMY BUT ALWAYS WAS conscious. Gave him a water and drink and a candy. after about a min or 2 he started to feel better. Requested to stay for additional 5 min to make sure he was feeling better.
Patient received both vaccines on 07.06.2021. Approximately 2 hours after she started having vomiting and abdominal pain. She preceded to the ER and was found to have  gallbladder inflammation with evidence of chronic cholecystitis. Patient had a laparoscopic cholecystectomy on 07.07.2021.
Patient was given FLUVIRIN vaccination on 10/12/2011 to right IM arm. Called pharmacy on 10/25/11 and complained that her arm was still hurting so bad that she could no raise it. (see back). Talked with the patient on 10/25/11 in the evening. She said she did research in the web and said it was common to have pain. Also said she had a doctor's appointment on 10/26/11. Asked the patient to call the pharmacy and let us know what the physician said. Patient called again on 11/4 and wanted to file an official complaint. Her arm is still hurting but she has not as of then seen a physician.
she woke up and threw up; had diarrhea all day long; fever; tired; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 23Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she had the first dose of the vaccine on Saturday (23Jan2021) at her school she works at; she did not feel any side effects that day. On 24Jan2021 she felt tired; and on 25Jan2021 she woke up and threw up, had diarrhea all day long and had a fever. She referred to her doctor who gave her "something to stop the throwing up." The patient was told by her doctor that only 1% experience her side effects and to contact Pfizer; the patient wanted to know if that was true and how long did the side effects typically occur. The clinical outcomes of tired, she woke up and threw up, had diarrhea all day long and fever were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Within 2 hours of receiving the vaccine injection in my left arm, i began to experience a numbing sensation on my left cheek and within another hour or so the numbing sensation was around my left eye.  The next day the numbness was still there on my cheek, however it was no longer around my eye.  The second day after the injection the numbness is almost completely gone, but is still slight and only about the size of my finger tip.  I had a virtual video conference with my family doctor, and she has stated it appears that it was most likely an adverse side effect from the vaccine.  She asked that i report this via the VAERS website.
left axillary swelling, febrile, chills, full body discomfort, headache mostly resolved after 24 hours
Significant pain, no swelling, bruising, or redness. Pain goes up to the neck muscle and down to the elbow. Pain woke her up at night. Aching, sick feeling. Followed up with Provider, and Provider felt it was a reaction to the vaccine. Recommended to not have another flu shot.
Around day 2-3, started having left eye spasm and has now been about 1 week and still having left eye spasm
Son received first dose 08Aug2021, tested positive 19Aug2021; This is a spontaneous report from a contactable consumer (Patient). An unspecified age male patient received received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 08Aug2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. On 19Aug2021, the patient tested positive. Recovered no symptoms gone through isolation, even though antibodies don't make sense why.-  Declined to complete a report at this time. Unable to obtain further details. Provided caller with phone number (withheld), and the hours of operation prior to the transfer. Warm transfer from agent (withheld). The outcome of the event was recovered on an unknown date Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A physician reported that a 2 month old male received Acel-Imune, IPV and Comvax on 8/24/99 and that same day, developed "knots" and an injection site reaction characterized by redness and warmth at the site. The physician noted that this event was related to Acel-Imune; IPV and Comvax were administered in the opposite arm. The infant recovered. This is 1 of 5 pts from this facility who had an adverse experienced following receipt of Acel-Imune. MANUFACTURER'S COMMENT: The reporter indicates that 5 pts experienced an adverse event; however, only 4 pts have been identified. An additional report will be generated when identifying information is provided.
This spontaneous report was received from a 64 years old female patient with sulfa allergy regarding herself. The patient's medical history included Hashimoto's thyroditis. On 09-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose and route not reported) in her right arm. No concomitant medications were reported. On 09-JAN-2013, approximately 4 hours following administration of a dose of PNEUMOVAX23 the patient right arm began to hurt from "shoulder to fingertips". Consumer reports that the pain was excruciating initially and had diminished somewhat in intensity. Consumer reports that over time her arm began to hurt only from shoulder to elbow and that at the time of the call it only hurt near the shoulder joint. Consumer reports that the actual injection site never hurt. Consumer reports that on an unspecified date in November 2012, she received doses of influenza vaccine and whooping cough vaccine brand names and manufacturers unspecified into the right arm. Consumer reports that she treated the pain in her arm by use of over the counter analgesics, topical creams such as Biofreeze, Blue cold gel, tiger balm and by use of a hot water bottle all of which diminished the intensity of the pain temporarily, but did not resolve it. The outcome of her right arm began to hurt from "shoulder to fingertips" was reported as recovering. The relatedness for her right arm began to hurt from "shoulder to fingertips" was unknown for PNEUMOVAX23. Patient sought medical attention(office visit on 11-JAN-2013). Additional information has been requested.
Chills, low grade fever, headache, arm soreness, body aches. Started around 7-8pm and lasted through the night. Headache and arm soreness still present in the morning.