chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hrs later fatigue, headache, body aches. 48 hrs later body rash all over torso back neck.
I had flu symptoms.  numb tingly limbs and was very irritable.  Kind of paranoid. I also did not get very much sleep. maybe 6 hours over a 48 hour period.
nausea, injection site swelling/pain (pain radiating down to elbow), itching, tiredness/lethargy
Experiecing severe pain from shoulder down to fingers. Specifically in the left arm, but the right are is also affected. Patient had difficulty moving arms without pain and sleeping was also difficult. Right arm resolved by day 8, left arm no improvement after 2 weeks.
Strong fever for 1 day  Weakness for 2 days  Pain on the arm for 4 days
no additional adverse events reported; she did not screw the needle on the syringe good enogh and of the vaccine spraying out of the patient, only partial dose was delivered; This spontaneous report has been received from Licensed practical nurse concerning to 5-year-old unknown gender patient. The patient's current conditions, medical history and historical drug were not reported. No concomitant therapies were provided.  On 01-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, (lot #U016064 and expiration date since it makes match with the autopopulated expiration date 20-MAY-2023) (strength, route of administration, and indication were not provided).   It was reported that while was prepping a dose of virus vaccine live (oka/merck) (VARIVAX), the nurse did not screw the needle on the syringe good enough and when was administered the vaccine to the patient, only a partial dose (unknown amount) was delivered due to some of the vaccine spraying out of the hub where the needle attaches (underdose). No additional adverse event reported.
Within a few hours, his arm (at injection site) was red and swollen. The redness went away but the arm swelled at injection site as well as down both sides of the same arm. He came in the pharmacy today (5 days later) and he has a large knot at the deltoid (injection site). He has good range of motion and it is not painful. I told him to put ice on it for ten minutes at a time several times today.
2 attempts were made to administer the vaccine intradermally.  No wheal was produced either time. Medical Director consulted and order was given to administer .3ml  of the vaccine subcutaneously.
sore throat, cough, headache, fever (temp was 99), chills, body aches, loss of taste, loss of smell, nasal congestion. starting 12/18/21
Immunizing technician incorrectly administered the Bivalent vaccine instead of the monovalent vaccine for pts. 1st dose of primary series. Tech did not document Lot and Expiration date on the database prior to administration and only realized error was made after the fact. Pt was notified. Pt feels fine and does not want to pursue further action. RPH contacted Pfizer and CDC. Per Pfizer- do not repeat 1st dose. Per CDC: ok to give bivalent as 1st dose of primary series. Subsequently CDC recommended to give monovalent vaccine as 2nd dose followed by bivalent vaccine in 2 months as booster dose.
Extreme vomiting 15 hours - same as 2nd dose - dehydration extreme - dizzyness and disorientation.  Cold sweat 48 hours, could not get warm not matter what.  extreme exhaustion,  lack of appetite,  persisting exhaustion and lack of appetite for 4 days post vaccine.
Erythematous and pruritic rash on face and neck.  Currently being treated with prednisone taper.
unable to thermoregulate, headaches, muscular aches, severe tiredness, swollen lymph glands under arm on left side
Throat and chest spasms; Throat and chest spasms; Lower lip and jaw swelling; Lower lip and jaw swelling; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration on 08Feb2021 02:45 PM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 70 Years. Facility where COVID-19 vaccine was administered was at the Hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included 6 Autoimmunes, asthma, diabetes 2, Celiac, depression, anxiety, Extra allele on chromosome for histamine production, Genetic extra histamine production, allergic to many meds, foods and environmental. Concomitant medications included certolizumab pegol (CIMZIA); pramipexole dihydrochloride (MIRAPEX); desvenlafaxine succinate (PRISTIQ); olmesartan medoxomil; All were taken for an unspecified indication, start and stop date were not reported. On 08Feb2021 14:45, the patient experienced throat and chest spasms with delayed lower lip and jaw swelling several hours later even with 50 mg Benadyrl. Swelling receded 36 hrs later. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Therapeutic measures were taken as a result of the events with 50 mg Benadryl repeatedly. Outcome of the events was recovered on an unknown date.  Information on Lot/Batch number was available. Additional information has been requested.
Both my knees have swollen to a point where it is very painful to walk. Fever of 101.8 Sore throat. Mental confusion. Loss of sense of balance, seeing items that are not really there.
worsening of dizziness; headache worsened after vaccination; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 22Apr2021 and second dose on 11May2021 (Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included accident on an unspecified date, dizziness, and ongoing atrial fibrillation. Concomitant medications included and apixaban (ELIQUIS) taken for atrial fibrillation. The patient experienced worsening of dizziness and headache worsened after vaccination on an unspecified date. The clinical course was reported as follows: The patient stated he is kind of at a loss because he has been dizzy since getting the vaccinations altogether and stated he was involved in an accident before receiving the vaccine and he has always been dizzy but it has gotten worse. He felt like it was a merry-go-round dizziness. His pharmacist changed him from apixaban to a different medication and he is tired of being dizzy. He was already experiencing headache even before taking the vaccine but it got worsened after getting the vaccination. The clinical outcome of worsening of dizziness and headache worsened after vaccination was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
101+fever; Very tired; very weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101+fever), FATIGUE (Very tired) and ASTHENIA (very weak) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced PYREXIA (101+fever), FATIGUE (Very tired) and ASTHENIA (very weak). At the time of the report, PYREXIA (101+fever), FATIGUE (Very tired) and ASTHENIA (very weak) was resolving.            Concomitant information was not reported.  Treatment information provided included lots of rest and water.   This case was linked to MOD-2021-025653 (Patient Link).   Reporter did not allow further contact
Next morning- was limping- complained of pain- by evening he could barely walk. Swelling was 3 times the normal size of the right thigh and the knee was also swollen- not red- slightly warm to the touch. No fever. Some vomited. Still has swelling not quite as big.
Swollen upper arm, soreness at sight of injection, redness, heat generating from area. These symptoms have persisted for over 24 hours, almost 48 hours after administering injection.
This spontaneous report as received from a medical assistant referring to an adult patient of unknown demographics. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Patient received her flu vaccine and an hour after she states that it was itching. as the day and night went on it got really swollen and tough as well as redness. She states that it was still very itchy and hurt to the touch.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/17/2023 HYPONATREMIA R09.02 HYPOXIA 4/25/2023 HYPONATREMIA
Light post menopausal bleeding several weeks after first injection. Extreme heavy post menopausal bleeding/clots starting 2 weeks after second injection. Painful breasts and painful cramping.
Pain: neck, shoulders, arms and hips. Noticed more pain in morning after sleeping. started taking  Motrin unti office visit with the Dr.  on Aug. 19th, 2021. Possible Arthritis. Was seen by an Orthapedic Sergon on Aug. 30th, 2021. Diagnosed with PMR from results of blood test. CRP: 3.80 SED RATE: 42 PERSCRIBED 40 MG. PREDNIZONE. Pain resolved.  Curently taking 10 mg. Prednizone. Still have muscel pain but tolorable.
Information has been received from a nurse practitioner concerning a 2 month old female who was vaccinated PO with her first 2.0 ml dose of ROTATEQ.  Subsequently "24 hours after vaccination, the patient became febrile, fussy and developed severe diarrhea."  The patient sought unspecified medical attention and was subsequently "admitted to the hospital for 2 days."  A stool specimen was performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
flu like sx, nausea, dry heaves, tenderness, swelling @ site of inj & lt arm pit & lt side of neck;
This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big large red circular spot underneath the injection site exactly one week after getting the vaccine/Redness/erythema), PAIN (just a little ache) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20 and 029L20) for COVID-19 vaccination.  The patient's past medical history included Hay fever. Previously administered products included for an unreported indication: Bisacodyl on 12-May-2004. Past adverse reactions to the above products included Paresthesia oral with Bisacodyl. Concurrent medical conditions included Birth control, Hypothyroidism and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2004 to an unknown date for Allergy, ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) from 01-Jan-2004 to an unknown date for Birth control, LEVOTHYROXINE SODIUM (SYNTHROID) from 08-Jan-2015 to an unknown date for Hypothyroidism. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (big large red circular spot underneath the injection site exactly one week after getting the vaccine/Redness/erythema), PAIN (just a little ache) and HYPERSENSITIVITY (Hypersensitivity reaction). At the time of the report, RASH ERYTHEMATOUS (big large red circular spot underneath the injection site exactly one week after getting the vaccine/Redness/erythema) and HYPERSENSITIVITY (Hypersensitivity reaction) outcome was unknown and PAIN (just a little ache) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information were not provided. This case was linked to MOD-2021-023115, US-MODERNATX, INC.-MOD-2021-023115. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19 Apr 2021 contains no new information. On 27-Jul-2021: Significant follow up received on 27-JUL-2021 updated patient demographics, suspect dosage regimens, relevant medical history, concomitant medications and new event Hypersensitivity reaction.; Sender's Comments: MOD-2021-023115:Crosslinked: Same reporter/different patient (Reporter's case) US-MODERNATX, INC.-MOD-2021-023115:Same reporter/ Different patient (Neighbor case).
Patient received Moderna mRNA vaccine on 6/17. She no-showed to her 2nd dose appointment on 7/15. After attempts to administer 2nd vaccine in clinic, plan developed to administer 2nd dose at her home. The writer of this incident requested a dose transfer from another Harbor site but neglected to indicate that the patient needed Moderna. Pfizer dose was dispensed to home care nurse, who gave it to the patient at 11:00am today (9/29). The patient was observed for 20 minutes by the nurse with no adverse symptoms.
Left arm: big circular skin rash, covers 1/4 of his arm. Right cheek: dark purple, shingle-like spots, as big as an eraser with 2 addition smaller spots. Lower right back: big birthmark-like rash, covers 1/4 of his back, skin is raised.
4 cm round erythematous, indurated area on left thigh at site of injection/ Approx 1 wk after shots. Itch, non tender. No fluctuance.
Moderna COVID- 19 Vaccine EUA Pt with history of allergies and asthma and prior reaction to first dose of COVID vaccine presents to ED with numb lips and "throat tightness" after receiving 2nd dose at 1005 AM on 3/17/21.   About 20 minutes following her vaccination, patient began to develop perioral numbness and mild throat tightness. She states it was similar to prior vaccine reaction, but less severe. She pre-medicated with famotidine 40mg, prednisone 30mg, and cetirizine 20mg last night and this morning, per plan from her allergist. Following development of symptoms, she was given 0.3 mg epinephrine IM in the field. Currently she denies difficulty breathing, chest pain, dizziness, fevers, chills, N/V.  In ED, Given 60 mg solumedrol and 25 mg IV benadryl. Follow up evaluation with minimal improvement in symptoms at 1300. Subsequent evaluation at 1415 with new diffuse itchiness throughout body, similar throat tightness, with report of mildly more labored breathing. No rashes or increased work of breathing on exam, vitals remain reassuring. Given development of itchiness, ordered additional dose of epinephrine 0.3 mg and will continue to monitor.  On re-evaluation, patient with persistent pruritus however no new or worsening throat swelling, difficulty breathing, shortness of breath.  Patient did not have abdominal pain, nausea or vomiting.  Patient given additional dose of Benadryl, discharged home with clear return precautions.  Patient has EpiPen at home, will continue to take prednisone as an outpatient  Of note, after patient received first dose of COVID vaccine on 2/17/21, patient developed similar throat tightness and perioral numbness
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from Office-staff. This case involves a 23 years old female patient who experienced itchy at site as well as whole body and swelling, hard-red and hot at site as well as whole body, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1813 (expiry date, route, dose and site of administration were not reported). On an unknown date, patient developed a non-serious itchy at site as well as whole body (itching lasted one week) and swelling, hard-red and hot at site as well as whole body of an unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Relevant tests were not reported. Final diagnosis was swelling, hard-red, hot and itchy at site as well as whole body. It was not reported if the patient received a corrective treatment. The outcome of the events were reported as unknown. List of documents held by sender- none.
exposed to COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to COVID) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced EXPOSURE TO SARS-COV-2 (exposed to COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was reported. Patient was fully vaccinated and was exposed to COVID with no symptoms.
Information has been received from a pharmacist concerning a 70 year old male with allergic reaction to CIPRO and hypertension who on 07-APR-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included LIPITOR, lisinopril and aspirin. Subsequently the patient developed pancreatitis and was hospitalized. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
rash / huge rash; rash was lumpy, hot and red and all over her arm; didn´t take part two; rash lumpy, hot all over her arm; This case was reported by a consumer via other manufacturer and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, erythema, feeling of warmth and incomplete course of vaccination. The patient was treated with topical steroid nos (Steroid Cream) and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the rash, erythema and incomplete course of vaccination were unknown and the outcome of the feeling of warmth was recovered/resolved.   It was unknown if the reporter considered the rash, erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose Shingrix vaccine and 2 weeks after the injection experienced huge rash, 4 times the size of what she got with the Pfizer and the rash was lumpy, hot and red and all over her arm from the injection site to her elbow. The reporter stated that she went to a dermatologist and they had not seen anything l ke that, it covered her entire arm, they had to give her a topical steroid cream. The reporter stated that she called the pharmacist and he said oh well it must be something else because they were going by the side effects listed and said it couldn't be that, the dermatologist took a picture and showed a picture to the Infectious Disease specialist and he said he was seeing patients react more than 10 days after the vaccine and he thought it was from the vaccine. The reporter also stated that it took another 2 weeks after started the steroid cream to go away, later on she saw a doctor friend and showed him the pictures and his wife was queen of allergies and they both looked at the pics and he said do not take part 2 because she could get a worse reaction and she could go in to anaphylactic shock, so she didn't take part 2, which led to incomplete course of vaccination. The patient went to her dermatologist in April for her rash and her told her to take Zyrtec 10mg twice a day for 2 weeks which was inconvenient because she was too tired, but it didn't help. No lot number expiration date were provided. The reporter asked her doctor what the ingredients for the Pfizer Covid Shot and Shingles shot were and maybe she was allergic to something in them, the reporter stated her doctor didn't have much information on the Covid vaccine ingredients. The reporter consented to follow up. This case has been linked with cases US2021AMR244072 and US2021AMR244219 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR244072:same reporter US-GLAXOSMITHKLINE-US2021AMR244219:same reporter
Initial swelling on fleshy past of upper left shoulder. A breakout of hives 10-12 inches below that on forearm. Itching and irritation followed for 4/5 days. Swelling and itching reduced to 0 by Hydrocortisone cream VSP 1%.
Information has been received from a registered nurse concerning a 28-month-old female with no pre-existing birth defects, medical conditions or known allergies who on 24-JAN-2003 was vaccinated subcutaneous in the left deltoid with her first dose of varicella virus vaccine (Oka/Merck) (lot # 640725/0788M). There were no illnesses at the time of vaccination. On 07-JUN-2004, the patient experienced a small outbreak (3-4) on chest, 4-5 more the next day with a fever. The patient was treated with Aveeno bath, calamine and Benadryl. No diagnostic labs were performed. On an unspecified date the patient recovered. Additional information is not expected.
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Nov 8, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 8, 2021, patient experienced product temperature excursion issue. On Nov 8, 2021, product temperature excursion issue: resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, there was excursion from the freezer on Oct 1, 2021. Storage condition at the time of the excursion was frozen. Maximum and minimum temperatures reached: Minimum: 4.2 degrees F; maximum 5.7 degrees F. Excursion duration: 6 minutes. This case linked to MOD-2021-383410 (patient link). Most recent follow-up information incorporated above included: On Nov 15, 2021: Follow-up received contained patient demographics, vaccine start date and dose details.
Pt. states that after receiving the 3rd dose of Moderna 01/20/2022, started experiencing symptoms that evening of faintness, fatigue, weakness, chills, excessive sweating, fever, and nausea. 01/22/2022 Symptoms subsided with congestion "feeling" lingering. No noted Primary visit/communications. (Wanted to note Blood Type RH-O Type)
I went to urgent care for abdominal pains. I was referred to hospital to get scans. The scans showed that I had a perforated sigmoid colon with an abscess. I had surgery to remove 10 cm of my colon, and now have a temporary colostomy.