chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Gluten sensitivity (Gluten allergy) and Allergy (sea salt allergy).    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 HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).). At the time of the report, HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) to be not related.    No concomitant medication was reported. The dosage text of the suspect was reported as unknown. HCP reported that the patient actually did not have reaction to or after the Moderna Covid19 vaccines. The patient was concerned with allergies and if they were in the new vaccine. HCP checks and reports that the patient already received a Bivalent vaccine last fall so they should be good.  No treatment medication was reported.   This case was linked to MOD-2023-724815 (Patient Link).   Reporter did not allow further contact
Acute pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXCARBAZEPINE for Epilepsy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above included, on 26-Jul-2021 Follow up received and contains No New Information.
Vaccine (Hib) was given at 10:18 and pt had rash with mild hives that started at 10:23. At 10:38, the rash was still only mild (scant) and at 10:45, the rash and hives were gone except on the bottom of pt's feet and slight on his back. At 11:50, the rash came back on front of his chest, back and legs. At 11:55, the doctor ordered Benadryl X 2 days. At 12:45, the rash almost gone. Pt discharged home with instructions to go to ER or call 911, if the baby becomes worse with rash of if any respiratory problems occur. On 7/30/01 at 08:30, the parent of the baby stated that his rash and hives have been all gone since Sunday.
Within 15-minutes of vaccination, the patient reported feeling nauseous. EMS monitored the patient's condition on-site.
This was was second vaccine, my first one was 03-05-2021. The first one caused a very sore arm mainly, some roving warm feelings in legs . This second vaccine yesterday made me ache ll over like the flu, my hip bones and bones in arms and legs hurt, so much so that I was in bad shape at work by 5 pm for sure, and I felt like I had the flu by evening. I  was bedridden and slept bad,  felt numbness in my left arm to hand, and could not move, bone pain, headache, took Tylenol. Both times I had odd  warm feelings.
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the third of eight reports. A patient of unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
pt. was sitting in chair and had a syncopal episode, fell out of chair, pt. became aroused within 5-10 seconds,  pt. skin pale, cool, clammy, team alert called, pt. taken to ED for observation.  Initial heart rate 33
Due to Administrative ERRORS,  This Pt second COVID vaccine was given early. Vaccine Administrative @ Drive- through Dose #1 17 Feb 2021- SIDE EFFECTS: NONE Dose #2 02 MAR 2021- SIDE EFFECTS: MALAISE Both Doses given in L Deltoid Member Advised of error and Revised CDC guidance of 20210210 with patient. No Additional Dose indicated.
Patient describes tingling/numbness in shoulder developing a week after shot. Notices pain when head is turned to the right that goes down his arm on right side.
p/vax pt was very unsteady on feet;medical attention sought & pt was dx w/ataxia d/t varicella vax;a small rash or lesions was also noted @ that time;
Information has been received from a physician concerning a 60 or 62 year old male patient with chronic obstructive pulmonary disease (COPD), who on approximately 17-FEB-2010 was vaccinated with a dose of PNEUMOVAX. Concomitant medication included unspecified antibiotics and steroids for COPD. On approximately, 27-FEB-2010, "2 weeks ago", the patient was hospitalized for difficulty breathing and an exacerbation of chronic obstructive pulmonary disease. On 01-MAR-2010, upon discharge from the hospital, the patient was inadvertently administered a second dose of PNEUMOVAX. A few hours later, the patient developed  a fever of 103 F with redness and swelling at the injection site. On 02-MAR-2010, the patient was seen in the doctors office due to the high fever and was readmitted to the hospital with a diagnosis of possible pneumonia. At that time, the reporting physician was notified of the re-vaccination with PNEUMOVAX, and feels that the re-vaccination may be the etiology of the current symptoms. Additional information has been requested.
4 puffy red welts about 1 inch each across upper chest and neck as well as whiteheaded small pimples. Extremely itchy. Also in b/of right arm near elbow.
Rash on chest and upper arm, painful swelling of shoulder, and a swelling on neck.
Patient reported she developed left arm redness, swelling and tenderness at deltoid injection site approximately 1-2 hrs after her vaccination (8/17/22).  Patient reported redness growing, tactile temp and area of discoloration so went to Urgent Care 2 days later (8/19/22). Diagnosed with cellulitis vs. adverse reaction.  She was prescribed Benadryl and betamethasone cream 0.05%. She was also given a prescription for Doxycycline to take if the redness/swelling did not improve. Pt reported that the symptoms improved and did not need to take oral antibiotic after 24 hours on Benadryl/cream.
Patient came in with two younger siblings for vaccination. I handed-off 3 pre-filled vaccinations: two doses were Pfizer pedi-doses with orange sticker to distinguish them from adult dose (purple sticker). The sticker came off while handling patient's paperwork at work station, and got stuck to the table. I failed to realize the pedi-dose was picked-up and administered to patient. I immediately went to dispose the empty syringe when I realized the syringe did not have its sticker. I then checked remaining two syringes and realized I still had the adult dose. I accidentally picked up pedi-dose. I immediately reported to an on-site doctor, who investigated to see if dose was valid. The doctor then talked to patient's mom and told her that dose was valid. Her son could get the adult Pfizer for his second dose and order a blood draw to check for COVID-19 immunity.
Pt received first two Gardasil without incident. Gardasil #3 given 6-14-07. Following administration pt lost consciousness and was assisted to laying position on exam table by nurse. Pt was non-responsive, clammy, and had weak thready pulse. LOC resolved after 35-45 seconds. Pt had persisting dizziness and discoloration. Pt was unable to come to standing position after approximately 45 minutes lying. Pt was transported to ER via stretcher (we're located in the hospital) due to persisting dizziness and circumoral pallor. Was given Zofran IV in ER and released home.
PATIENT STATED THAT EARLY IN EVENING SWELLING AND TENDERNESS BEGAN ON INSIDE OF ARM, ABOVE ELBOW. SAME ARM AS FLU SHOT GIVEN, PERCEIVED AS ALLERGIC REACTION. ADVISED ICE PACK/COLD COMPRESS. PATIENT CAN NOT TAKE NSAIDS. BY TIME REACTION WAS SHOWN TO ME, ABOUT 48HR AFTER INJECTION, SYMPTOMS WERE GETTING BETTER. LESS TENDER.
BREAKTHROUGH COVID: FULLY VACCINATED & BOOSTED COVID POSITIVE. Patient was admitted to the hospital with multiple medical problems COVID 19 causing acute tracheo-bronchitis/pharyngitis,  Atypical chest pain. Pt presented to the emergency room with cough, sore throat, fever, chest pain for about 3 days.  He was vaccinated for COVID-19.  His COVID-19 test was positive.  He was noted to have oxygen saturation now of 99% on room air.  He is afebrile.  Patient was seen and evaluated by IM and multiple consultants including ID, after a aggressive medical management patient has improved clinically feels better and ready for discharge. Patient has been cleared by ID to transition to p.o. OMNICEF/ Medrol Dosepak. No additional treatment indicated for COVID-19.
Arm became red, swollen, rash present and patient couldn't lift arm. Only lasted a few days then was fine.
Myalgia, Arthralgia, Fever, Fatigue, chills Narrative: Fever 101, myalgia, arthralgia, fatigue, chills; alternated Tylenol and ibuprofen; recovered within 72 hours.
3OCT98 pt devel rash @ inj site which spread to arms, legs, face & a few spots behind ear;there were some discrete & indiscrete papules on legs & face;pt to MD office 5OCT98 & 6OCT98 & dx poss pap acrodermatitis or Gianotti-Crosti synd;
lump below injection site; redness below injection site; head ache; This spontaneous case was reported by an audiologist and describes the occurrence of VACCINATION SITE MASS (lump below injection site), VACCINATION SITE ERYTHEMA (redness below injection site) and HEADACHE (head ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included LETROZOLE (FEMARA) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 11-Apr-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 11-Apr-2021, the patient experienced HEADACHE (head ache). On 12-Apr-2021, the patient experienced VACCINATION SITE MASS (lump below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, HEADACHE (head ache) had resolved. At the time of the report, VACCINATION SITE MASS (lump below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that patient took second dose did great and not even sore arm was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up included outcome of events were updated and second dose information added On 16-Jul-2021: Follow up included no new significant information
This spontaneous prospective pregnancy report as received from a Nurse Practitioner, via company representative, referring to a 18 year old pregnant female patient. The patient's medical history included asthma. Concurrent conditions and concomitant medication were not provided. On 05-OCT-2016, the patient inadvertently received a dose of GARDASIL 9 injection, 0.5ml, lot # M009378, expiration date 23-APR-2018, 0.5 ml, intramuscularly, instead of Tdap. Nurse practitioner stated no adverse effects were reported. The patient became pregnant with last menstrual period (LMP) of 21-MAR-2016 and estimated date of delivery (EDD) of 26-DEC-2016. Initial exposure to GARDASIL 9 was at 28 week(s) and two days. The pregnancy outcome was pending. There was no product quality complaint involved as the Nurse Practitioner stated there was no product confusion between the GARDASIL 9 and TDAP. Additional information has been requested.
PATIENT WAS ADMITTED TO ER FOR  ALTERED MENTAL STATUS  / UTI  SEPSIS  WITH SEPTIC SHOCK / COVID AND COVID   PNA   PATIENT WAS ADMITTED TO ICU AND DIED .   POA WISH TO WITHDRAWL EXTRME MEASURES
patient received 1st dose  of  moderna vaccine on 3/11/21 at clinic.  He had an appointment previously scheduled for his 1st dose to be given on 3/16/21.  He was brought to the vaccine clinic and received a dose of moderna on 3/16/21.
temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) human recombinant albumin (rHA) (route of administration not reported), lot # T009929 and expiration date 16-SEP-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion from -14 to -10 degree Celsius (°C) maximum -9.5°C for a total of 38 hours and 30 minutes beginning on 28-JUL-2020; no previous temperature excursion were reported.  The call was made due to a digital data logger.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014689: US-009507513-2008USA014694: US-009507513-2008USA014701: US-009507513-2008USA014711: US-009507513-2008USA014749: US-009507513-2008USA014777: US-009507513-2008USA014788: US-009507513-2008USA014790: US-009507513-2008USA014792: US-009507513-2008USA014795: US-009507513-2008USA014797: US-009507513-2008USA014811: US-009507513-2008USA014817: US-009507513-2008USA014843: US-009507513-2008USA014853: US-009507513-2008USA014856: US-009507513-2008USA014858: US-009507513-2008USA014861: US-009507513-2008USA014867: US-009507513-2008USA014877: US-009507513-2008USA014881: US-009507513-2008USA014883: US-009507513-2008USA014886: US-009507513-2008USA014889: US-009507513-2008USA014898: US-009507513-2008USA014914: US-009507513-2008USA014934: US-009507513-2008USA014947: US-009507513-2009USA000057:
Patient reports she had pain instantly at the time of the injection 11:00am.  At 12 noon she reports the pain started getting worse. Now at 3:15pm she reports her arm hurts and her neck is now stiff, she cannot move her neck.  She rates the pain as "9" with 0=no pain and 10=unbearable pain.   Reviewed with her PCP,   had her go to the ER to evaluate.  Instructed she have someone drive her to the ER.
21APR95 pt woke up from afternoon nap w/welts on trunk, abd, & lt leg, welt on chest w/blister in center; mom denies fever; presented to clinic 21APR95 1655 hr & sent to ER & Med ctr;
After vaccination child looked fine and sat in chair. At 10:30 fell or slid out of chair to floor. Color dusky pale, child lethargic and complaining of abdominal pain. Denied pain in any other parts of the body. Vomited 1 time, pulse 68. 9-11 called at 10:40 and transported to ER at 10:50 by ambulance.
injection site was swollen and warm; injection site was swollen; injection site was warm; Initial information received on 14-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional via phone via call center.  This case is linked to case 2020SA360527.  This case involves three patients of an unknown age and gender who experienced injection site was swollen and warm (vaccination site inflammation with symptoms of vaccination site swelling and vaccination site warmth), when they received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patients medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date in beginning of Nov-2020, the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number: QFAA2016, expiry date: 30-JUN-2021) via an unknown route in the deltoid not otherwise specified (NOS) for prophylactic vaccination.  On an unknown date in Nov-2020, the patient developed a non-serious injection site was swollen and warm (vaccination site inflammation with symptoms of vaccination site swelling and vaccination site warmth) after few days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Narrative Log: MA (medical assistant) states doctor ordered four boxes of FLUBLOK. Dr. used the first box on 10 patients. Seven out of the 10 patients had severe reactions to it. The patients usually get their flu vaccines and they never had a problem with it in the past. Dr. refused to use any more of the ones we purchased. I reached out for about returning the three unused boxes and caller said call you guys directly to see if the vaccines can go back to you. Caller states no patient demographics are currently available as Dr. is out of the office and he has the information. I believe he (Dr.) said 4 of the patients ended up with a rash near the injection site and down the arm. Those patients were treated with Hydrocortisone cream. The other 3 patients it almost felt like an infection. The injection site was swollen and warm for almost 2 weeks. This happened in the beginning of November and all the patients have recovered. They want to return the 3 unused boxes. Whether product is available for return: Yes, 3 boxes are available for return. Therapy Date: Beginning of November. Dr. usually gives it on the left unless the patient is a lefty (implied left handed patient). Strength: Standard. Indications: Immunization Event Information. All 4 boxes have the same lot number, expiration date, Caller states none of the patients were pregnant.   Sill Using Product: No.  No laboratories details reported.   The patients were treated with oral antibiotics (corrective treatment).  On an unknown date in 2020, the patient recovered from the events after almost 2 weeks.
On 10/5/07 patient received final dose (#5) of Rabivert for post-exposure. Had initially reported during assessment that no side effects were noted after prior administration on 9/21/07 upon receiving invoice for insurance - patient reported.
1 or 2 minutes after shot started feeling dizzy.  Heart rate felt like it dropped and blood pressure felt very low.  Vision was dark and I spent most of the time concentrating on breathing.  I did not lose consciousness or pass out at any time.   I was with my wife and children so they were able to give me the timeline.  My wife noted I started sweating after about 5 minutes.  The symptoms peaked at about 10 minutes and faded slowly after that.  Because I felt like the worst of the event had passed we did not report the event at the time.  When we got home I laid down for about an hour.  My shoulder started hurting about this time as well.  I feel I was recovered from the initial symptoms within 2 days.  My shoulder was in pain for about 3 days, with the first two days being much worse than the third.
Rash on body excluding head, face and bottom of feet - started 7 days after flu and shingles shot on September 21st, 2015. Rapidly increased in severity - visited dermatologist on Oct 1st 2015. Prescribed steroid cream for itching.
April 18, 2022 got up with a loose cough, the next day I felt very ill two days later went to urgent care and  tested positive for Covid.
This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 39-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. No adverse events were reported after the vaccine administration. The reporter assessed this case as non-serious. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (39-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2021-395985 (Patient Link).