chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Soreness in arm; Fever 102.6 F; A spontaneous report was received from a Consumer concerning herself, a 58 year old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fever 102.6 F/ Pyrexia, Body aches/ Pain, Soreness in arm/ Pain in extremity.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were unknown.  On 15 Feb 2021, approximately one day prior to the onset of events, the patient received their second of the two planned doses of mRNA-1273 (batch number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced fever 102.6 F, body aches and soreness in arm. No Laboratory investigations were provided. No Treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events Fever 102.6 F/ Pyrexia, Body aches/ Pain, Soreness in arm/ Pain in extremity was considered unknown.  Based on sender comment, Soreness in arm change to Vaccination site pain and Listed in RSIs
My intraocularpressure in my right eye was40mmHg.  My left eye was 14mmHg.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 21Apr2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 29Mar2021 at 13:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Apr2021 at 14:00, two days after the second vaccination, the patient went for a regular eye exam (no complaints/symptoms). Her intraocular pressure in the right eye was 40mmHg and left eye was 14mmHg. The patient has never had elevated IOP.  Her exam showed no obvious signs of glaucoma. The doctor has no explanation and the vaccine was the only thing they could think it would be.  The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of intraocular pressure in the left and right eye which included treatment with glaucoma drops and was taken 2x/day for 1 week and 1x/day for 1 week. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event- intraocular pressure in the right eye was 40mmHg and left eye was 14 mmHg was recovered in 2021.
24 hours after DTAP-IPV, developed red, raised rash around injection site. Very itchy, not painful. No other symptoms.
Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping.  Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days
20 min after injection throat got very dry & felt like I couldn't swallow. Took a BENADRYL 25mg & within 20 min symptoms started to resolve.
Patient received pneumococcal vaccine on 10/8/15 during hospital stay for surgery. She was discharged on 10/8/15 and she presented to the ER on 10/10 with complaints of pain at injection site and reported fever of 102.5F. At the ER, her temperature was 102.7F and she was diagnosed with cellulitis in upper arm at injection site. She was treated with IV antibiotics and discharged on 10/12/15.
This spontaneous report was received from a nurse practitioner and from a reporter (role unspecified) from the nurse's healthcare facility and refers to a 10 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 28-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, 0.5 ml, subcutaneously in left arm (lot # M005972, expiration date: 02-FEB-2016). There were no concomitant therapies reported. The administered dose of VARIVAX was reported to be stored on unknown dates at 8.6 degrees Fahrenheit (F) for 1 minute, 6.5 F for 1 minute and 47 F for 1 hour and 40 minutes. No previous excursions were involved. The temperature excursion was detected with a data logger. No product quality complain was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter has no further information.; Sender's Comments: US-009507513-1610USA014546:
1st dose 19Dec2018, has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th December 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-APR-2022 Reporter's comment: Pharmacist reported a patient received the first dose of Shingrix and had not receive dose two. The reporter only agreed to follow-up telephonically. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
This is a spontaneous report from a contactable consumer reporting for his wife. A 57-years-old, female patient received the first dose of PREVNAR 13 via an unspecified route of administration in Apr2017, single dose (in late evening, did not have exact time to provide), for routine vaccination. Vaccination Facility Type: Pharmacy/Drug Store. Relevant medical history included asthma (diagnosed 40 years prior to this report). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none; additional vaccines administered on same date of the Pfizer suspect was none. In Apr2017, the patient experienced knot at injection site, rash and flu like symptoms. The events required a visit to physician office. The outcome of the events was unknown; it was further specified that the reporter "did not know outcome since he was not sure what would be considered lasting effects". The information on the batch number has been requested.
Drank a lot of water; Sore shoulder; Injection site was really sore until next morning; Tired; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Drank a lot of water), ARTHRALGIA (Sore shoulder), VACCINATION SITE PAIN (Injection site was really sore until next morning) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus. Concomitant products included LISINOPRIL, OMEPRAZOLE, CALCITRIOL, BUDESONIDE and VITAMINS NOS for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced THIRST (Drank a lot of water), ARTHRALGIA (Sore shoulder), VACCINATION SITE PAIN (Injection site was really sore until next morning) and FATIGUE (Tired). At the time of the report, THIRST (Drank a lot of water), ARTHRALGIA (Sore shoulder), VACCINATION SITE PAIN (Injection site was really sore until next morning) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported.  Patient weight was 139.  She states after first shot she had sore shoulder, injection site was really sore until next morning, tired, drank a lot of water.   This case was linked to MOD-2021-403187 (Patient Link).
Patient received Moderna COVID vaccine on 1/26/21 and 2/23/21. On 1/24/22, patient admitted to our inpatient facility with sepsis secondary to UTI (urinary tract infection) due to urinary indwelling catheter and acute on chronic heel ulcer, right, with fat layer exposed. Patient was also found to be COVID positive upon admission. As of today (1/27/22), patient is still admitted in the med/surg unit and just underwent below the right knee amputation. No respiratory symptoms from COVID.
Contracted Covid after receiving vaccination. Contracted chills, fever; sense of smell was effected and felt very sluggish.
16OCT devl difficulty breathing & cough productive of clear mucus; afebrile; over weekend, clammy & weak & had cold sweats upon exertion; seen by MD 19OCT cxr dx of bronchial pneumonia, WBC nl treated w/ATB & Robitussin;
4:30 pm about 30 minutes after injection I started to experience an accelerated heartbeat. For the next 30 minutes, my heart rate would accelerate and then slow back down. The accelerated heart rate wouldn?t last longer than a minute. I unfortunately was not able to track the actual heart rate.  A little after 5:00 pm, my heart rate went back to normal and I did not experience another accelerated heart rate.
Headache and blurred vision with vomiting the first 10 days following shot then 14 days following shot, severe right leg pain treated at  ED. Treated pain at ED with dilaudid and prescription sent home for Flexeril, prednisone, lidocaine patches and Naprosyn.  PVL complete and negative for blood clot. Weakness following ED visit in bilateral legs and feet. Awaiting referral for neurologist and ortho. Pcp appointment within week of discharge of ED
Rash, ErythemaMultiform, rash lower legs and to mid thighs. H/O post reactive strep arthritis Narrative:  Her rheumatologist thought her skin reaction was related to the vaccine.
HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medications were reported. No treatment information was provided.
Severe arm pain hours after injection. Lasted for two days  Nauseous and vomiting day 2 and 3 with headache
Started with mild headache around 7:00PM, increasing in severity through the night. Chills/feverish beginning 8:00PM Severe chills/vomiting 11:00 PM Woke following morning with headache Symptoms resolved by 11:00AM following day
Pt presented to the clinic for a flu shot and booster COVID 19 vaccine. Flu shot given without incident, but at 9:30am, NP inadvertently gave Pfizer COVID 19 bivalent peds 0.3mL to pt. Pt tolerated both vaccines well and left the clinic. NP contacted her manager when she realized her mistake, and then notified the pt (2:20pm). Pt states he is doing well and was understanding of the mistake. NP informed pt to f/u as needed and that he may be contacted as a result of this error. Pt verbalized understanding.
Heart racing; Freaking out; Feeling like she was dying; Not functioning well; A spontaneous report was received from a healthcare facility staff member (United States) concerning a 28-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced her heart racing, was freaking out, and was feeling like she was dying.   The patient's medical history included a heart murmur, panic attacks, post-traumatic stress disorder, pneumonia and diarrhea.   Concomitant product use was denied by the reporter.   The patient received their first of two planned doses of mRNA-1273 (LOT# 025J20A) on 29-Dec-2020 intramuscularly in the for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 29-Dec-2020.  Approximately 2 hours after vaccine administration while driving to another job, she experienced her heart racing, said she was freaking out and feeling like she was dying.  She stated that her heart rate, at one point, reached 142 beats per minute and also stated that her pulse-oximetry remained between 97-98%.    Three days later on 01-Jan-2021, she reported still having these symptoms, however, they were more spaced out.  She stated that at one point, she had experienced panic while showering and said that she has not been functioning well.  Patient said that she has had a lot of anxiety about the pandemic.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, her heart racing, was freaking out, and was feeling like she was dying, was not provided.   The outcome of the events, her heart racing, was freaking out, and was feeling like she was dying, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of panic attacks, PTSD and heart murmur confounds causality. Patient said that she has had a lot of anxiety about the pandemic which is risk factor for panic attack.
pt recv vax 2PM 430PM sudden onset moaning, fussiness, limpness, eyes roll-no sz, pale-green color, sleepiness; 600PM sx suddenly resolve & t102 seen in ER nl exam;
Patient slipped and fell 15 mins after vaccine as she was leaving the pharmacy. Patient did not believe it was related to vaccine administration and that she just slipped.
Information has been received from a physician concerning a male in his 40's who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 651572/0741R). Subsequently the patient developed redness at the injection site. Also, the patient's whole arm turned red. The physician gave the patient antibiotics to help with the redness. At the time of this report, the outcome was unknown. Additional information has been requested.
T103 x 24hr;devel rash on face/neck which spread to trunk arms 7 legs;some complaint photosensitivity, dec appetite, stomach cramps;rash looked like a measles rash;
Employee received flu vaccine on 09/26/2017 at 7:30 am. At 8:00 am, employee reports having a progressive headache, felt very ill, dizzy, cold sweats, shaky and nauseated. She was unable to work which prompted a visit to APRN, on 09/28/2017. APRN diagnosed as "dizziness, likely adverse reaction to influenza vaccine" and prescribed prednisone tab 20 mg daily for 5 days, Zofran for nausea and meclizine for dizziness. A note was given to this nurse stating employee is "ill, likely reaction to influenza vaccine. I would recommend that she not take influenza vaccine in future."
This spontaneous report as received from a registered nurse refers to her 12 year old granddaughter with no pertinent medical history and no drug reactions or allergies. In July 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). There was no concomitant medication. The nurse reported that starting in August 2014, the patient experienced abdominal pain and bouts of nausea. The patient was hospitalized on an unspecified date and had MRI conducted which showed the patient had swollen abdominal lymph nodes. The nurse stated that the patient was hospitalized another unspecified time and had exploratory surgery and had her appendix removed in order to treat the symptoms but it did not do any good. The nurse reported that the patient went to emergency room 4 or 5 times and in and out of the hospital due to abdominal pain and a buildup of fluid in her abdomen. The nurse stated that the doctor did so many tests including an upper and lower scope (results not provided) but still it could not be determined what the cause was. The nurse stated that they were holding off on giving the patient the second and third doses of GARDASIL (also reported as therapy discontinued), just in case GARDASIL caused all these issues. At the time of the report, the patient had not recovered from the adverse events. Upon internal review appendectomy was considered to be medically significant. Additional information has been requested.
Runny nose, sneezing, coughing, wheezing, headache, aching joints, intestinal pain, low energy.
PATIENT PREVIOUSLY RECIEVED 1 DOSE OF PFIZER VACCINE (12/29/2020-LOT EJ1685) PATIENT ALSO RECIEVED A DOSE OF MODERNA VACCINE (4/19/21-LOT 007B21A).FACILITY SPOKE TO A PRESCRIBER AT THE HEALTH CLINIC AND THEY ADVISED THE PATIENT TO START OVER SINCE PFIZER DOSES WERE NOT AVALIABLE AND THAT THEY WOULD NEED TWO DOSES OF MODERNA.
Skin rashes a few days after taking the vaccine. Torso region, multiple rashes, reddish/rose coloration. Similar to pityriasis rosea disease Gibert, however they do not itch and I've never had this disease before.
Slightly odd, maybe dizzy; headache; Migraine with aura; Light flashes; Sudden loss of vision; foggy vision; migraine with aura; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE WITH AURA (migraine with aura), PHOTOPSIA (Light flashes), BLINDNESS (Sudden loss of vision), VISION BLURRED (foggy vision) and MIGRAINE WITH AURA (Migraine with aura) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021 at 11:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE WITH AURA (migraine with aura). On 27-Apr-2021, the patient experienced PHOTOPSIA (Light flashes), BLINDNESS (Sudden loss of vision) and VISION BLURRED (foggy vision). On 04-May-2021 at 2:30 PM, the patient experienced MIGRAINE WITH AURA (Migraine with aura). On an unknown date, the patient experienced DIZZINESS (Slightly odd, maybe dizzy) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at a dose of UNK, bid. On 17-Apr-2021, MIGRAINE WITH AURA (migraine with aura) had resolved. On 04-May-2021, MIGRAINE WITH AURA (Migraine with aura) had resolved. At the time of the report, PHOTOPSIA (Light flashes), BLINDNESS (Sudden loss of vision), VISION BLURRED (foggy vision), DIZZINESS (Slightly odd, maybe dizzy) and HEADACHE (headache) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication were reported.  Patient reported of being nearsighted and wears usual glasses.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Added patient's demographics, treatment drug and events(migraine with aura, dizziness and headache). Updated outcome of events from unknown to resolved. On 19-Jul-2021: FU Received - No new information was received.
pt recvd vax; Lt deltoid area felt sore; has erythema at inject site 3"x2"; enduration w/ sl elevation; 15nov94 felt warm that evening & thru nite;
Within 10 hours, she had a fever of 103, aches, nausea, and flu like symptoms. Last 48 hours. Around hour 60, she bled extensively even thought her period had stopped days prior, the point it soaked her clothes in one hour. Then the bleeding stopped. Later that morning, she started to experience her heart racing. Her watch registered heart rate jumping to 140-180 at rest. She has chest pain, tightening in her chest, becomes short of breath, describes that she feels like someone is pulling the breath back out of her throat as she tries to breathe, feels disoriented for a moment until the feeling passes. Happens at rest and can happen as she is talking mid sentence. The pain in her chest has woken her up out of her sleep.
I received my second dose of the covid vaccine on Friday May 14 at 10am in my left arm about 3 inches above my BCG vaccine scar that I received when I was 6 months old. About 18 hours after receiving the second covid dose, my BCG scar is red, inflamed, and sore to the touch. When touching the scar, it feels almost as though there is a small ball under the skin.
This spontaneous report was received from a Registered Nurse regarding her two sisters of unknown age. On an unspecified date a year ago (approximately in March 2012) the patients were vaccinated with ZOSTAVAX (lot number and expiration date not provided) (dose, and anatomical location not provided). No other co-suspects or concomitant medications were reported. The Nurse reported that on an unknown date her two sisters experienced a mild rash on their backs and shoulders after receiving ZOSTAVAX. Both patients were reported as recovered from the mild rash on their backs and shoulders. VZVIP Packet was not offered. No treatment information or laboratory diagnostic test results were reported. This is one of several reports from the same reporter (MARRS 1303USA009926). Additional information is not expected.
I contracted COVID-19 on 07/05/2022 with symptoms of runny nose, sneezing, congestion, dizziness, sore throat, fever of 101.5, cough, body aches, loss of taste, loss of smell, and fatigue. I was prescribed Paxlovid on 07/07/2022. I was ill for 7 days before my symptoms began to resolve. I am still experiencing lingering symptoms of fatigue, blood sugar drops to lows causing shakiness and dizziness.
Soreness in arm and neck, high fever. Normal temperature is 96, fever up to 102.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction and was hospitalized for 2 days post vaccination.  No further details were available. The reporter did not consent to follow-up.