chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriasis.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient experienced PSORIASIS (PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK). At the time of the report, PSORIASIS (PSORIASIS ACCELERATED/ GETTING WORSENED/ STARTED TO COME BACK) outcome was unknown.            No concomitant medications were reported. For co-suspect Humira  80mg/0.8ml daily dose was reported as Citrate Free, On day 1 (80 mg) with no causality reported. For co-suspect Humira  40mg/0.4ml daily dose was reported as Citrate Free, Day 8 (40 mg) and Citrate Free (40 mg,1 in 2 week)  with no causality reported. No treatment medications were reported.
This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. On 07-AUG-2017, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # M041990 and expiration date 28-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered dose of vaccine experienced the temperature excursion from 9 to 25 degrees Celsius (11.1 C) for 1 hour and 31 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008849.
Initial and follow up information has been received from a licensed practical nurse concerning a 48 year old white female with diabetes mellitus II, hypertension and an allergy to morphine, who on 09-OCT-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL first dose of PNEUMOVAX (Lot # 651401/0619F).  There was no concomitant medication.  On 09-OCT-2006 the patient experienced extreme injection site pain several hours after the vaccination.  She also developed mild swelling.  It was also reported that she could not even lift her arm.  The patient was prescribed acetaminophen (+) hydrocodone bitartrate (LORTAB) for pain.  Follow-up information from the nurse confirmed that the patient complained of extreme pain at the injection site less than or approximately 6 hours after immunization.  She also experienced decreased range of motion and stiffness in the muscles of her left arm.  The patient was reported as recovered on 12-OCT-2006.  Additional information has been requested.
LDT sore no swelling or redness, chills, t100; pt exp blah feeling & chills;
First dose I had a sore arm, low grade temp and headache. ((2/12/21). Second dose, (3/16/21), I have a sore arm, accompanied by a red  rash at the injection site, and it is also very hard and warm to the touch. I would say the rash is about the size of a softball. I have a temperature of about 100 for the last 48 hours.  Chills and body aches along with fatigue. Very similar to the flu.
At site of injection- left Arm very painful & has large swollen red circular rash which is very warm to touch and burning sensation  I also Felt feverish had chills was achy tired  Spent most day in bed
This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-MAR-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # K018142, expiration date 10-APR-2016 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
LEFT ARM SWOLLEN AND ITCHY FROM INJECTION SITE, MUSCLE & BODY ACHES, HEADACHE, LOSS OF APPETITE, CHEAT PAINS, TIREDNESS,CHILLS, JOINT PAIN, SWOLLEN LYMP NODE IN ARM PIT AND FEVER
numb his hands were numb, and his one leg is numb; Pain in arm; This is a spontaneous report from a contactable consumer (brother). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot, Expiration date and NDC number: Unknown), via an unspecified route of administration in left shoulder on 21Apr2021 (at the age of 21-year-old) as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. On an unspecified date in Apr2021, the patient experienced numb his hands were numb, and his one leg is numb. The reporter stated as, "my brother he was started numb his hands were numb, and his one leg is numb, and yesterday night he was even feeling pain in his arm but he just took a sleep because we couldn't contact anyone it was closed so he slept and today morning the pain was gone but the numbness was still there, so it was kind of change because none of us had this reaction". No investigation assessment reported. Outcome of the event pain in arm was recovered and another event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who received 0.5 ml fourth dose of vaccines PENTACEL (The Hib Lot # C5576AB. The PENTACEL Box Lot # C5576AB. PENTACEL Box NDC# 49281-510-05, The PENTACEL Vial NDC# 4928151005, Diluent DTap/Ipol Lot # C5447AA and the DTap/IPOL NDC# 49281-560-05) instead of KINRIX on 12-Dec-2018 via intramuscular route in the right deltoid. It was also reported that the child received an extra HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the child has only gotten 3 PENTACELS. Concomitant medications included MMR for Immunisation; VARICELLA VACC. for Immunisation; and FLUZONE QUADRIVALENT 0.5 ml  for Immunisation. On 12-Dec-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5576AB via intramuscular route in the right deltoid. On an unknown date, the patient received a dose of suspect KINRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to wrong vaccine administered and Extra dose administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient reported acute right, upper quadrant pain and right-sided pleuritic chest pain on morning of 8/6/2021.
We had a dose administered from a vial that was opened yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported. This case concerns a patient unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The events occurred  on the same day after unspecified dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Information has been received from a health professional concerning a patient in Kindergarten or first grade who was vaccinated with a dose of Varivax. On 02-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
60F with history of hypertension and diabetes who presented with dyspnea and hypoxia. She was diagnosed COVID positive the day prior and had been released home from ER but returned due to worsening symptoms. CXR on admission did show bilateral infiltrates. She was started on decadron and remdesivir on admission. She had very slow improvement and was requiring 4L of oxygen. On 10/31 case was reviewed by Dr  of pulmonary - decadron was increased to 20mg daily and she was placed on a 7 day course of zosyn. Chest CT did not show a pulmonary embolism. Over the past week she has had continued gradual improvement. She is now on room air; I had already arranged for home oxygen so will keep this at discharge as she may still need with activity. I have tapered her decadron down to 10mg daily for the past several days, and at discharge will taper her to off over the next 10 days. She should isolate until 11/13.    On admission blood cultures noted to have probable contaminant. She did receive a course of zosyn as above.     She may resume her usual hypertension and diabetes regimen at home.     Occasional what sounds like hemorrhoidal bleeding noted. Has had prior colonoscopy in 2020. Can followup outpatient.
I was pruning a tree one week after my booster shot. I became very weak and dizzy, could not stand up. I sat down, crossed my legs and drank electrolytes as instructed by my doctor for dysautonomia, but my heart continued to race and I felt very ill for about 1/2 hour. I called someone over to help me get onto my bed to lie down. I was still blacking out, heart was racing and by now I was hyperventilating. I was very disoriented. Called 911 for ambulance. I was stabilized while on the way to the hospital. I did not have anxiety.
Within 4 hours, post vax, spiked fever of 102 and broke out in a rash and eyes were swelling. Went to MD the next day and was dx'd with diffuse rash. Suspects reaction to immunizations, although, not sure which one. Advised to avoid second MMR.
she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at all; she had achiness; she knewshe had a high fever; Sweating; unbelievable fatigue/she was really tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in the right arm, on 04Mar2021 16:30 (at the age of 66 years old) at a single dose for covid-19 immunisation. This was administered as a pharmacy/drug store. Medical history included asthma for a very long time and overweight. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular route in the right arm on 30Jan2021 (at the age of 66 years old) at a single dose for covid-19 immunization. She did not have any problems with the first dose. The patient had no additional vaccines administered on same date of the Pfizer vaccine. There were no prior vaccinations within four weeks. The patient reported she was really tired after receiving her second COVID-19 Vaccine on 04Mar2021, saying she slept unbelievably good the night of 04Mar2021. On 05Mar2021, the patient experienced she had instantly come down with unbelievable fatigue, she wanted to sleep a lot, she had no energy at all (if she tried to do something, she would have to lay down afterwards), she had achiness, she knew she had a high fever, even though she did not check her temperature, she knew her fever was high because she was sweating but it was nothing she was worried about. She stated she was concerned about the unbelievable fatigue she was experiencing. Her tiredness had improved some, and her achiness resolved about the second day (unspecified date in Mar2021). She stated her fever went away in two days (unspecified date in Mar2021). Reported the pharmacist told her to take TYLENOL after the second COVID-19 Vaccine. She bought a bottle of TYLENOL while she was at the drug store, but she decided not to use the TYLENOL for the symptoms. Reported she didn't take her PROLIA injection in Jan2021 because she didn't want it to interfere with her upcoming COVID-19 Vaccine. She said she self-administered her PROLIA injections, and hadn't restarted it at this time. All the events did not require a visit to emergency room or physician office. Outcome of the events fatigue, she wanted to sleep a lot, she had no energy at all was recovering. Outcome of the events achiness, fever and sweating was recovered on unspecified date in Mar2021.   Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296202 same reporter, drug and events, different patient
itching on my left thigh; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on my left thigh) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 026C21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE for an unknown indication.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced PRURITUS (itching on my left thigh). At the time of the report, PRURITUS (itching on my left thigh) outcome was unknown.            Concomitant medications includes Anti Itch Cream .  Treatment medications were not reported.   This case was linked to MOD-2021-291378 (Patient Link).
"Per FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and agency instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes".
Initial report received on 25 September 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12 month old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3926AC received on 12 July 2011, and lot number C3930AA received on 13 September 2011 and 14 November 2011 (route and sites of administration not reported). The subject developed a cough on 21 May 2012, approximately 6 months after the last dose. On 09 June 2012, he developed a paroxysmal cough without a whoop. He also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 13 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 13 June 2012. The subject was not hospitalized. At the time of final contact on 19 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Daughter only had a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. This case was reported for reporter's daughter. The daughter only had a sore arm from Shingrix vaccine. The reporter did not want to provide her address or any additional information. The reporter did not consent to follow up. This case has been linked with US2021156443, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156443:Same reporter. Son in law case.
Patient developed hives at site, redness, itching, warmth, and shortness of breath, Saturday. Took BENADRYL and symptoms mostly resolved. Still some mild redness.
Child received DAPTACEL on left deltoid 7/24/02. Here today with red, swollen, upper left arm area warm non-tender. No fever, measures 142mmx 125mm. MD advised cold compresses, Benadryl and Tylenol. She opted to treat with Keflex x 5 days due to symptoms.
Beginning approx 24 hours after 2nd vaccination- began to feel flu like symptoms, dizzy, nausea, fever. This progressed to pain in every part of my body. When I touched anything it was like needles. When I laid down it felt like a bed of nails.  Severe pain in muscles, joints, head, everywhere. I was fatigued, lethargic, in pain, alternated between feverish and chills. I laid down and didn't get up for 12 hours. I truly felt I would die from the pain.  I was tired, but couldn't sleep due to pain. 12 hours later, at approx. 3 a.m. the pain subsided.  The next day, while still fatigued and drained I felt better. I've had headaches off an on since.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and  narrative updated.
Chills and intense shaking. Unable to get warm.  Couldn?t get out of bed because I was freezing and shaking
This spontaneous report as received from a registered nurse refers to a currently 1 year old male patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, during the process of withdrawing the reconstituted VARIVAX (lot # N034553; expiry date: 05-DEC-2019) for prophylaxis from the vial into syringe, "it just sprayed like an aerosol can all over nurse's hands, arms and the counter top, very little liquid went into syringe", due to which, the patient missed his dose during the office visit (accidental exposure to product, drug dose omission). A 25-gauge 5/8 inch needle and 3cc syringe was used which was inside the vial when the leaking occurred and the product vial was pierced with once. The syringe needle was free of any obstruction and was below the liquid line. The spray was from the vial and was forceful. The sterile diluent (MERCK STERILE DILUENT) (unknown lot and expiration date) used for reconstitution was stored at a temperature between 2 Celsius (C) to 8C. Very little was withdrawn in the syringe since most of the product sprayed on the nurse and counter top. It was reported that the reporter already disposed of sterile diluent (MERCK STERILE DILUENT) and syringe. She only had the VARIVAX vial that could be retrieved from the office. A Product quality complaint was filed.
Fatigue, all over muscle stiffness and soreness. Before the shot I jogged and walked 7 miles. Now i can't even go a block. Or 1/4 of a block.
2FEB97 t99.4, moist cough, SOB-med given 3FEB97 x 2wk;18FEB97 proventil given, robitussin/ceclor & flumadine x 7 days;no cult ordered;
SWEATING, NAUSEA, FEELING OF PINS AND NEEDLES IN HANDS, TUNNEL VISION, WEAKNESS,
Tenderness and pain at injection area, slight nausea, general muscle soreness, tiredness. Taking ibuprofen.
Patient has had extreme fatigue and cannot work since the vaccine. He complains of sweats and chills. He has dizziness and tinnitus. He has frequent tachycardia and was evaluated by a cardiologist. He has new back pain and occasional chest pain. His primary care provider referred him to me to see if this was related.
1 day after injection, pt had swelling, redness and warmth to left arm and soreness measuring 7.25cm x 7.5cm.