chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.). At the time of the report, RASH (bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-322568.
LOW BACK PAIN; HOT FLASHES; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced low back pain. On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-APR-2021, had not recovered from low back pain, and the outcome of hot flashes was not reported. This report was non-serious.
Chills, Body aches, malaise, and enlarged left axillary lymph node (still enlarged). No treatment sought.
After I took I got the shot Gardisal a month later I started to get bumps around my genitals.
Pt developed a 10mm induration on the back of the left arm at the site of the injection. The area was discolored, painful, and itchy.
I was given both the seasonal flu and also the pneumonia shot in the rt arm in the same place. My upper arm began to hurt and slightly red that evening. The next morning I had a swollen red area which increased to approx. 5x6 inches lasting several days, decreasing after the third day. I also had a fever of 102.8 F all that day and the next. The third day it was down to 100 degrees. I am concerned that the reaction was possibly because both vaccines were virtually given together. I have never had much of a reaction to the seasonal flu vaccine. This is the first time for the Pneumonia vaccine. Being together I don't know the cause for the reaction. I would have visited the doctor had it not been on the weekend.
Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022; We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient date of birth reported as 18 Mar in an unspecified year. No concomitant medications were reported. Patient received booster dose. It was reported that the vial was initially stored in the refrigerator was on 31 Mar 2022. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up information received contains no new information.
patient experienced severe right arm pain where we injected pneumovax 23. specifically she has red blotches, itching, swelling, pain localized mainly in front of arm, hives on area where we injected and surrounding area. only hives on right arm and shoulder area. Reaction has been going on for 2 days and injection was on 11/20/2020. she is feeling much better today on 11-23-2020. Patient took benadryl.
Soreness at injection site disappearing after 4 days.  Strong shooting pains in left quadriceps lasting 5 days with decreased frequency and intensity on subsequent days.
12 hours after the vaccine I had chills and body aches.  The next 24 hours I had a mild fever, chills, body aches, and was mildly dizzy.  I was very sore and lethargic.  There was no treatment pursued other than rest at home and fluids.  I did not see a doctor.  I felt normal the next morning.
Light headed, cold sweat, pain from left shoulder to neck, headache, nausea, vomiting and fatigue.
Pt developed dry cough, low grade temperature 100.2 on 7/18/21. He has had a runny nose and mild skin achiness
patient broke out in hives from head to toe; a breakthrough itching; red marks on skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (patient broke out in hives from head to toe), PRURITUS (a breakthrough itching) and ERYTHEMA (red marks on skin) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 034C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (patient broke out in hives from head to toe), PRURITUS (a breakthrough itching) and ERYTHEMA (red marks on skin). At the time of the report, URTICARIA (patient broke out in hives from head to toe), PRURITUS (a breakthrough itching) and ERYTHEMA (red marks on skin) had not resolved.            No concomitant medications were reported. Treatment medication included Antihistamines daily. 10 days after vaccination events were started.   This case was linked to MOD-2021-435530, MOD-2021-435507 (Patient Link).
Day 9 same hot red injection site with the addition of two baseball size hot red swollen areas below then on day 10 they were softball size then on day 11 they are one huge hot red swollen area with a more blanched center and the injection site above is still red itchy and hot
her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in; Fatigue; arm hurt only for 2 day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt only for 2 day), BREAST TENDERNESS (her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt only for 2 day), BREAST TENDERNESS (her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (arm hurt only for 2 day) had resolved, BREAST TENDERNESS (her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in) had not resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
PATIENT EXPERIENCED SEVERE BODY ACHES, A SIGNIFICANT RASH AT INJECTION SITE, AND SWOLLEN GUMS LASTING FOR SEVERAL DAYS FOLLOWING VACCINATION
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
8 hours after vaccination, became very lethargic, weak and got a fever of 103.2 degrees Fahrenheit.  Was getting the chills followed by hot flashes. Woke up next morning (today) still with a 100.7 degrees Fahrenheit fever. Took Tylenol when symptoms started to occur.
Eleven days following the Booster injection vaccine I developed a severe rash of hives. Location of hives was on back, trunk, stomach, wrist, etc. Called my Doctor and texted Doctor photos. Was informed to take Benedryl. Lasted for months.
Fever started quickly after shot, then nausea and vomiting, Irritability, fatigue and random bursts of crying. And now a runny nose. On day 4 and still fatigued with low grade fever.
The patient received 0.5 mL dose of Moderna for their 1st booster dose. No Adverse reaction was reported.
stabbing pain in his left arm /  arm pain lasted a week to a week and a half; numbness in his left ring and pinky fingers / numbness lasted 2.5 to 3 weeks; fatigued /  fatigue lasted all week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 24th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm, numbness in fingers and fatigue. On 29th January 2021, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the pain in arm and numbness in fingers were recovered/resolved.   It was unknown if the reporter considered the pain in arm, numbness in fingers and fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter is the patient's wife.  The patient received his first dose in the week of November 25th 2020 in the left arm. He had a very sore left shoulder for a week following that dose (for tolerance refer US2021053253). He received his second dose on Sunday 24th January 2021 also in the left arm and 5-6 hours after administration he had a stabbing pain in his left arm and numbness in his left ring and pinky fingers. The arm pain lasted a week to a week and a half. The numbness lasted 2.5 to 3 weeks. He was fatigued and slept all day Monday. The fatigue lasted all week and was better by Thursday and resolved by Friday. Did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053253:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2021AMR053770:Same reporter US-GLAXOSMITHKLINE-US2021053271:same patient, same reporter, 2nd dose
Itching and rash. Some swelling to the left arm under the injection site. Appears like photos previously shown on news regarding "covid arm"
She has not had the second dose. (1st dose 01Mar2021/PRD 15Apr2021); She has not had the second dose. (1st dose 01Mar2021/PRD 15Apr2021); received the first dose of the Pfizer COVID 19 vaccine on 01Mar. She tested positive for COVID on 18Mar; received the first dose of the Pfizer COVID 19 vaccine on March 1st. She tested positive for COVID on March 18; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 01Mar2021 (at the age of 60-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received 1st Pfizer dose on 01Mar2021 and tested positive for Covid on 18Mar2021. On 22Mar2021 she received the antibody infusion and was wondering if she should receive the 2nd Pfizer shot. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Patient received 2nd shot in series on 7/3/18 said she had arm soreness, and discomfort, also chills and night sweats for 48 hours, and I told her that was ok and expected, but the main concern was a rash that the patient has developed around her neck. Patient did not have rash after 1st dose of SHINGRIX that she received at pharmacy on 3/8/18 that was confirmed by patient before dose was administered. Confirmed No other symptoms or reactions except rash around neck. Advised patient to reach out to her physician if other symptoms arise. Patient said that she is feeling fine now (7/6/18), no more fever or chills just the rash. Of note patient said she has gotten a similar rash in the past when she has had a viral infection in the past.
COVID-19 positive after receiving Pfizer COVID-19 Vaccinations; COVID-19 positive after receiving Pfizer COVID-19 Vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Lot number: GJ3275) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart issue" (unspecified if ongoing), notes: he's a heart patient; "immunocompromised" (unspecified if ongoing), notes: she is immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 positive after receiving Pfizer COVID-19 Vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: back in Dec (date incomplete); Negative, notes: Tested negative after a couple days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reported that 24 hours after 1st covid dose she developed hives on her arms and legs. Pt also noted several lumps in her arm, R deltoid area and experienced pain in her R arm which she described as feeling like the muscles were being torn. Symptoms did resolve on their own.
Patient arrived to ED complaining of shortness of breath. Patient code blue due to asystole and intubated. No ROSC. Pt deceased.  Unknown which Covid vaccine patient received (if Moderna or Pfizer) but daughter of patient stated he received second dose day prior.
Information has been received from a Nurse Practitioner concerning a female patient in her 70's who was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported that the patient who received the injection experienced "arm swelling at the injection site." The patient sought unknown medical intervention. No further information was provided. The outcome was unknown. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK5730), in left arm, on 26Jan2021 as dose 2, single (Lot number: EL0142), in left arm and on 20Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 45 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive; (01Aug2022) Negative; (23Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Anti-viral details for COVID 19 treatment included Paxlovid, treatment start date: 28Jun2022, treatment stop date: 02Jul2022. COVID-19 infection on 27Jun2022. Tested positive 28Jun2022, started Paxlovid for 5 days and stopped 03Jul2022, then tested negative on 01Aug2022 and now again positive when tested on 23Aug2022 event start date was 23Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
A non-serious, spontaneous report of "inadvertently gave FLUMIST that had been exposed to room temperature for 48 hours" has been received from a registered nurse concerning a 39-year-old female. On 22-Oct-2009, the patient was "inadvertently given FLUMIST that had been exposed to room temperature for 48 hours." There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Hospitalization for generalized weakness/recurrent falls and COVID-19 positive on dates  4/26/2023- 4/28/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Information has been received regarding a case in litigation regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. In October 2016, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On unknown date, the patient experienced shingles and in approximately January 2017, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the outcome of herpes zoster, pain, condition aggravated emotional distress and vaccination failure was unknown. The reporter considered herpes zoster, pain, condition aggravated emotional distress and vaccination failure to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Large hive covering arm between shot site and elbow. Itches really bad and arm still sore. Left breast swollen
Patient recieved vaccine on 10/18/08 at our store flu clinic. She said that the following day when she woke-up her right arm was very red, warm, and swollen from the shoulder to her elbow. She took Benadrly and Ibuprofen for the swelling and pain but it did not seem to help. She came into the pharmacy on sunday 10/19/08 to show me her arm and I referred her to EPN Urgent care accross the street to have them take a look at it. They told her that she should continue to take Benadryl and Ibuprofen and that it did look like cellulitus but they did not think it was bacterial. They also told her to follow-up with her PCP if it did not provide any relief or got worse after 2 days. Patient stopped by pharmacy yesterday and stated that it was really not getting any better, from my perspective it appeared the same, and she was going to call her PCP to make an appointment. I called the patient today to see what if any progress was made and am currently waiting to hear back.
Patient with self-reported history of anxiety, syncope and near syncope with medical procedures/needles. Complained of feeling anxious, light-headed, jittery after vaccination.  Became pale,  placed in a supine position, provided oral fluids, including fluids with sugar, VS stable, hypotensive to 77/57, pulse ox 99%, blood glucose 185, NSR on monitor reported by EMT on site.  Husband called, patient declined EMS transport, was able to ambulate with supervision to husband's car, husband transport to local ER in private vehicle.    Follow up with patient <24 hrs post vaccination: patient reported feeling better.  Admitted she was anxious about receiving vaccination since appointment was made one week ago.
HOT AND COLD CHILLS; MUSCLE ACHES; JOINT PAIN; SEVERE MIGRAINES; RHEUMATOID ARTHRITIS; ASTHMA; SHORTNESS OF BREATH.
Severe extensive redness, pain, swelling at the injection site. I have had chills and fever of 101.
Fever to 102 starting evening of 10/15/10 with redness, painless swelling, warmth of injection site right arm - size 10 X 13 cm. Patient states, improving. Will follow up with PCP. 10/19/10.