chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week after the jab started noticing I had a lot of rashes, elevated body temperature. I assumed it was a dust mite allergy which I have had in the past but its hasn't affected me in 3 years. I though it could be a new allergen so I changed my diet. It existed whether I was at home or outside. I didn't take note of it so I took antihistamine, fexofenadine 180mg. After a few months the symptoms receded and I didn't notice it didn't correlate it to the vaccine at the time. On 12/21/2021 I got my 3rd dose overseas and that is when, about 5 days to a week after that, I got hives again that were more severe. I went to the doctor after trying to change the environment and habits but that didn't work. They initially suspected an auto immune disorder but test came back negative. After that I went for a full work up and the provider indicated that he saw a few patients that have had the same symptoms after the 3rd dose.  He informed me to continue taking the fexofenadine. I was referred to a skin specialist but I had to come back to the area so I couldn't attend. The blood test indicated that there was some allergen trigger. I got a prescription for fexofenadine and XYZAL. I started taking the XYZAL because the other medication wasn't working as well.
This 74 year old white  male received the Covid shot on  1/28/21    and went to the ED on 2/13 /21  with the following diagnoses listed below. U07.1 - COVID-19 chest pain
Symptoms - Fever, body aches, swollen lymph nodes, nausea, headache, chills  Treatment - Tylenol and rest
Redness; Itching (localized allergic reaction) at shot site; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 22May2021 at 09:15(at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hay fever, and patient was allergic to fenugreek. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 09:15(at the age of 48-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021, on day 3 of the shot the patient experienced, 2 diameter redness and itching (localized allergic reaction) at shot site. It was unknown if therapeutic measures were taken as a result of adverse events. The clinical outcome of the events redness and itching at vaccination site was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Serious swelling and redness to left arm around injection area neck ache and stifness. flu like cold like symptoms no fever
Widespread severe hives over entire body due to no other allergy exposure, beginning on day 11 post booster shot through day 15
I received the injection on 2/1/21 and on 2/14/21 a 3 x 2 inch red hive like area covered the injection site.  It felt warm to the touch and was red and itchy.  It ached a little bit and is better today 2/15/21 but is still there - not as red and not as itchy but still swollen. slightly.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date (reporter a few years ago) at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that after the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was administered, the patient's skin was raised, it looked like 3D. The outcome of the event was unknown.
26 y/o male came to covid clinic today for first dose Moderna. Pt denied any hx of allergies or adverse rxn to vaccines in the past. After 10 minutes of vaccine administration, pt became dizzy, pale, and clammy. Pt said he didn't have breakfast. Primary RN gave 4oz apple juice. 2min later primary RN reported trembling of extremities and head.  LOC for <1min. VS as follows: BP 109/75, HR 84, O2 98%. Blood sugar 109. BP standing 111/75 then 101/62 after 5min.  Pt briefly assessed by MD; OK to go home; MD Recommendation: eat breakfast before second dose.
fainted after administration; This spontaneous report has been received from a physician referring to a male patient of unknown age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose details were unknown) intramuscularly for "prevention of human papillomavirus (HPV) diseases."  On an unknown date the patient experienced "fainted after administration" (syncope). Treatment was not given. The patient sought medical attention.  The outcome of syncope was reported as recovered. The causality between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, fainted after administration was determined to be medically significant.
Received vaccination on 2/2/21 @ 0900.  Immediately afterwards he said he was in excruciating pain.   He reported he went to his primary care provider later that afternoon.  He was examined clinically and was told that the shot was administered too high up in his arm in the Gleno Humeral Joint.  He was advised to take over the counter pain medication and to call if he needs something stronger.  He was given a follow up appointment on 2/5/2021 with the provider. He was told to monitor for infection in the next 48 hours and they are hoping it did not go into the joint capsule.  Continued to have severe pain.  Went to orthopedic specialist the next day.  Admitted to hospital for pain control and steroids.  MRI of shoulder inconclusive, but think severe bursitis and being treated as such.  Discharged from hospital and resting at home.  Arm range of motion at 80%-hoping to return to work in 2 weeks (firefighter/EMT).
18:52 PM  Pt began to feel a rapid heart beat & saw that on the side effect profile on paper.  Now she feels the same -normal.
MILD FEVER; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced mild fever. Laboratory data included: Body temperature (NR: not provided) 99.4-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fever was not reported. This report was non-serious.
Fever, chills, nausea, dizziness for 3 days following injection. Injection site red and swollen 8 days after injection.
A non serious spontaneous report of administration to a 21 month-old male was received from a pediatrician's office. 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. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Sore arm, headache, fatigue onset a few hours after vaccination. The next day swollen and sore lymph nodes added. The day after that, symptoms began to slowly subside, lasting through 2/16.  Mild but tolerable symptoms popped up and went away through 2/26. On 2/27 an intense headache came on before bed. 2/28 I was so sick, I slept through the day. Fever, exhaustion, chills, loss of appetite, dizziness, muscle weakness, complete loss of appetite (no nausea). These symptoms have been persistent since. My energy level is up enough that I'm awake for more of the day, but still in bed.
I had vaginal bleeding starting on the day after my shot.  I had an ablation a year ago and haven't had bleeding since, until after the shot.
Given only the liquid portion; Given only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th August 2022, the patient received the 2nd dose of Menveo. On 19th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was an assistant manager. The reporter reported that the patient received only the liquid portion of the Menveo vaccine. The reporter stated that this was the patient second dose of the Menveo series. No lot number available and no further details provided during the call. The reporter did consent to follow up. Additional supportive information: The liquid portion of the Menveo vaccine was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Itchy throat; BP 161/107 > 149/87; increased heart rate; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy throat, increased heart rate and blood pressure increased.   The patient's medical history included hypertension, allergy to shellfish and seasonal allergies. Concomitant medication as per the reporter was amlodipine.  On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient experienced itchy throat, increased heart rate and blood pressure increased. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, itchy throat, increased heart rate and blood pressure increased was considered resolved on an unknown date.; 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.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT EXPERIENCED FLU LIKE SYPMPTOMS.
Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on 30-May-2023).    No concomitant medications were provided. Dosage text for suspect drug reported as unknown. No treatment medication was provided. This case contains information for the 1st of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728274 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728274:Same reporter
This spontaneous report was received from a 68-year-old male patient and refers to himself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-DEC-2018 (reported as yesterday), the patient was vaccinated with a dose of PNEUMOVAX 23 in the left shoulder muscle (dose, route of administration, lot # and expiration date were not provided) for pneumonia prevention. On the same date, approximately one hour after being administered the vaccine, the patient had some routine blood work drawn around his left elbow area (results were not provided). On the same date (reported as later that night), the patient's left area where he got the vaccination shot became surprisingly sore. No treatment was given to the patient. The patient did not seek medical attention. The outcome of the event was reported as recovering. The relatedness between the event and PNEUMOVAX 23 was not reported.
Severe generalized headache, pressure/squeezing in nature with nausea and extreme fatigue x 28 hrs.
pt recvd vax; w/in 5 min of vax, pt devel shortness of breath, chest tightness, wheezing, hyperventilation, tingling hands & was anxious & crying; tx w chlor-trimeton; was taken to ER & pt was experiencing anxiety attack & not anaphylaxis;
earache; headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (earache) and HEADACHE (headache) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (earache) and HEADACHE (headache). At the time of the report, EAR PAIN (earache) and HEADACHE (headache) had resolved.            No concomitant medication were provided  Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-034458 (Patient Link).
Got punched at SPV site and blister popped. Multiple lesions around SPV site and down arm. Also with a lesion on outer lower right eyelid and nostril. Saw optometry- treated with Emycin for possible blepharitis. Follow up one week later eye lesion clearing, cont emycin for one more week. No worsening. No other follow up. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since unknown dates improperly stored doses of VAQTA (pediatric doses) were administered to unspecified patients. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Ringing in both ears,  like high pitch electronic whine, continuous 24 hrs per day non-stop
Beginning the night of the vaccine, I had most of the expected reactions. Redness, swelling, pain at the injection site, stiff arm, slightly elevated temperature (no true fever), aches, and fatigue. Most resolved within 2-3 days.  I was vaccinated 9 days ago, and the following symptoms persist: redness and itching at the vaccination site and a hard lump at the vaccination site. Despite being expected reactions, The concern is their persistence so long after the 1st vaccination. I have not yet received a 2nd dose.
Red rash at site of injection. Checked it 3 days later & got better. Was not hot or raised. Pt. put ice on & took BENADRYL.
Fever; congestion; got sick with flu; This is a spontaneous report from a contactable consumer (husband). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got sick with flu, fever and congestion on Tuesday of last week (27Apr2021). She will be having her second dose. Wanted to know if it was okay to take the vaccine on Wednesday. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Renal Artery Thrombosis; Severe Back pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL ARTERY THROMBOSIS (Renal Artery Thrombosis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.  Concomitant products included LISINOPRIL and AMLODIPINE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 05-Apr-2021, the patient experienced RENAL ARTERY THROMBOSIS (Renal Artery Thrombosis) (seriousness criterion medically significant). 05-Apr-2021, the patient experienced BACK PAIN (Severe Back pain). At the time of the report, RENAL ARTERY THROMBOSIS (Renal Artery Thrombosis) and BACK PAIN (Severe Back pain) outcome was unknown.            On 05Apr2021, the patient was evaluated in the emergency room for back pain. On 16Apr2021, the patient was diagnosed with renal artery thrombosis approximately 40 days after receiving the second dose of the vaccine.   The patient was prescribed Eliquis 5mg bid by her Primary Care Physician.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
started getting dizzy; I have been so sick; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (started getting dizzy) and ILLNESS (I have been so sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (started getting dizzy) and ILLNESS (I have been so sick). At the time of the report, DIZZINESS (started getting dizzy) and ILLNESS (I have been so sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  They kept telling her it was something else.
Patient became very pale and whole body sweating. Patient reported ears ringing and black spot in vision. Also, said arms were tingling. lasted approximately 15 minutes
The patient received the vaccine at approximately 8 p.m. on March 16, 2021. She waited the 15 minutes and more in the waiting area with no adverse event taking place at the pharmacy. Later on overnight the patient experienced face swelling that continuously progressed for 48 hours. The swelling eventually subsided, but the patient has concerns about receiving the second dose and wants to know should she proceed with the follow up dose.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient, above 60 years of age, with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were not reported). Concomitant therapy was unspecified. On an unknown date, after vaccination, the patient experienced a mild local rash which was treated with hydrocortisone at an unspecified dose. The patient sought medical attention by calling the pharmacist. At the time of this report, the pharmacist did not have specific information to provide. The outcome of mild local rash was reported as recovered on an unknown date. Additional information has been requested.
pt recvd vax & 21JAN92 was afebrile, no overt s/sx of illness; mom later (3 days later) reports pt had been exposed to the flu; 24JAN92 4AM t104.2; adm to hosp 25JAN93 AM; mom reports also ill w/flu & sibling adm 26JAN93 to hos w/pneumonia;
I was just sitting at the dinner table, and I went to go scratch and on my collar bone on the left side. When I touched the collar bone area, it hurt. There was a little bump in that area. I took my finger and palpated through that area to see what it was and what I was feeling. I also had my boyfriend feel it as well. It might have been a little larger than a pea size. I definitely felt something that I had not felt before. It was sensitive to the touch. I waited a day but then I did make an appointment to go to the doctor to have it checked. I didn't think it had anything to do with the vaccine at the time, but I wasn't sure if it was something different. They did feel around and felt something, so they sent me for an ultrasound. They said it was in the area of the thyroid and they did the ultrasound. They said that if I felt anything larger or hurting more while waiting for my results, (my doctor also asked if I had received my vaccine, on the left side) she had read that there were cases of enlargement of the thyroid on the side of where the vaccine was given. They called me a few days later and let me know that there was nothing wrong. They said if anything changed to come back in. The doctor said in a couple months to come back in if it got worst. After about that time, I didn't feel anything anymore and they never did another ultrasound. And I have not felt anything since then.