chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assitant and refers to a 3 month old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 15-AUG-2018, the patient was vaccinated with an expired ROTATEQ lot # M040271 with expiration date on 30-APR-2018, oral for prophylaxis (dose was not reported). However, no adverse effects were reported.
nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced NASAL CONGESTION (nasal congestion). At the time of the report, NASAL CONGESTION (nasal congestion) had resolved. Not Provided          No concomitant details were provided Treatment details include Nasal Saline and Unspecified nasal drops   This case was linked to US-MODERNATX, INC.-MOD-2021-062583. This case was linked to MOD-2021-062583.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: receptor: AE outcome and treatment details updated. Patient decline further follow-up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062583:
A report has been received from a Health Professional concerning a male patient, who had been receiving FLUMIST QUADRIVALENT            (INTRANASAL), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST QUADRIVALENT (INTRANASAL) started on 15-Jan-2016 for INFLUENZA.  The patient experienced ARM SWOLLEN (Preferred Term: Peripheral swelling), LEG SWOLLEN (Preferred Term: Peripheral swelling) and PAIN (Preferred Term: Pain). The outcome of the events ARM SWOLLEN, LEG SWOLLEN and PAIN was unknown. The reporter's description of the event(s) was as follows: It was reported that on July 30, 2014 the patient was seen by Dr. for an injury to the right ankle with swelling and pain. The patient also has shortness of breath with moderate physical activity. No information on medications. The report was considered to be non-serious.
From initial information received on 06FEB2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 38 year old female patient received a 8.34 ml dose of IMOGAM USP, lot number X0480-2, administered in the left and right buttocks, route of administration not reported, and a dose of IMOVAX Rabies lot number T1099-2, administered intra-muscularly in the left deltoid on 12DEC2003. Two days later, on 14DEC2003, the patient developed vertigo, tinnitus, loss of balance, fatigue and malaise. She did not experience any rash, myalgia or fever. Reportedly, the symptoms are not improving or exacerbating since the onset date. Diagnostic studies are pending and it was reported that nystagmus was present. The patient received another in the right deltoid on 15DEC2003 as well as a lot dose of IMOVAX RABIES, lot number W1419-3, expiration date December 2005, administered intra-muscularly in the right deltoid on 26DEC2003 and a 1cc dose of lot number W1419, expiration date 05DEC2006, administered intra-muscularly in the left deltoid on 08JAN2004. The patient's pre-existing medical history includes pituitary micro-adenoma, which has not changed in size over the past five years. Reportedly, the patient has not experienced any reactions following prior immunizations. The patient did not recover from these events. Additional information has been requested.
Intense soreness at sight of injection to the touch lasted 2 days - followed by intense itching - had to use BENADRYL for 4-5 days. Malaise within hours - chills  - shooting pains in arms and joints. Had 2 previous bouts of Lyme and shooting pains down arms successfully treated with doxycycline took 2 round of Lyme vaccine and on record found got Lyme disease
Local site reaction reported 09-28-17 (2) days after injection given 09-26-17 redness at injection site -> has gotten better ea. day since initial reaction 09/27-17
2nd dose of Pfizer COVID-19 vaccine was given to patient after he got 2 Moderna COVID-19 vaccine doses in March 2021. Patient did not disclosed that he received 2 other previous COVID-19 vaccines.
Student received injection of Pfizer on 08/16/2021 and on 09/17/2021 he received a dose of Moderna.
pt recvd vax& exp rash on face & trunk; taken to MD for eval poss allergy to vax;
PATIENT'S HUSBAND STATED HIS WIFE FELT PAIN AT TIME OF INJECTION THAT CONTINUED. SHE SAW HER DOCTOR ON 10/30/17. HE SAID HE DID NOT BELIEVE THE INJECTION WAS TOO HIGH. HE DID NOT THINK IT ENTERED THE BURSA. HE GAVE A STEROID DOSE PACK WHICH RELIEVED THE PAIN. A FEW DAYS AFTER FINISHING THE DOSE PACK THE PAIN RETURNED. SHE THEN SAW THE DOCTOR AGAIN ON  11/15/17 AT WHICH TIME SHE PRESCRIBED DICLOFENAC GEL WHICH HELPS WITH THE PAIN, BUT RETURNS LATER.
24hr post vax entire deltoid red, warm, hard lump just below inj site;resolved in 4 days;
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Patient details added. Suspect batch number and indication were updated. Expiration date added for suspect drug. On 08-Jun-2022: Follow-up received contains no new information.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition and medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified) that underwent supported temperature excursion. No adverse experiences reported. No further information provided. No product quality complaint reported. This one of several reports received from the same reporter. Additional information has been requested.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 84 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 043620A), in right arm and on 10Nov2021 as dose 2, single (Lot number: 046c2119), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphedema" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Other medication were taken in 2 weeks. Anti viral product used for COVID 19 treatment was Paxlovid. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device date: 05Jul2022.
Lost hearing in my left ear around March 9. Went to doctor 3/19 and began oral steroids.  Second dose of vaccine administered 3/20.  Hearing did not improve so returned to doctor 3/26 and was given steroid shot to ear.  Hearing was restored briefly until 4/13. Returned to doctor 4/14 and was given steroid shot to ear and oral steroids.  Given a second steroid shot 4/19.  Hearing restored 4/26.  (2021)
NOSE CONGESTION; BLOTCHING THAT STARTED WELTING UP; FEVER; LIP TINGLING; EARLOBE ITCHY; LEG CRAMPS; JOINT PAIN; RASH ON STOMACH; CHILLS; HEADACHE; RAPID PULSE; ELEVATED BLOOD PRESSURE; THROAT IRRITATION AND FULL; UPPER PALATE INFLAMMED; SWALLOWING TIGHT; BURNING IN TONGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included sleep apnoea, and concurrent conditions included osteoarthritis, hypothyroidism, asthma, emphysema, and generalized rash, and other pre-existing medical conditions included denies history of seasonal allergy. allergies to Zithromax, avelox, neomycin eye drops, choloanphenocol. generalized rash to each. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included tiotropium bromide for emphysema, and asthma, levothyroxine sodium for hypothyroidism, and diphenhydramine hydrochloride. On AUG-2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative.  On 06-APR-2021, the subject experienced rapid pulse. On 06-APR-2021, the subject experienced elevated blood pressure. On 06-APR-2021, the subject experienced throat irritation and full. On 06-APR-2021, the subject experienced upper palate inflammed. On 06-APR-2021, the subject experienced swallowing tight. On 06-APR-2021, the subject experienced burning in tongue. On 06-APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 154/100 mmHg, and Pulse rapid (NR: not provided) 60 to 100 beats /min. On 07-APR-2021, the subject experienced lip tingling. On 07-APR-2021, the subject experienced earlobe itchy. On 07-APR-2021, the subject experienced leg cramps. On 07-APR-2021, the subject experienced joint pain. On 07-APR-2021, the subject experienced rash on stomach. On 07-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 07-APR-2021 03:30, the subject experienced fever. On 08-APR-2021, the subject experienced nose congestion. On 08-APR-2021, the subject experienced blotching that started welting up. Laboratory data included: Blood pressure (NR: not provided) 146/86 mmHg, Body temperature (NR: not provided) 98.7 F, and Heart rate abnormal (NR: not provided) 76. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid pulse, leg cramps, and joint pain on 07-APR-2021, was recovering from headache, elevated blood pressure, throat irritation and full, upper palate inflammed, swallowing tight, burning in tongue, lip tingling, earlobe itchy, rash on stomach, and fever, and had not recovered from chills, blotching that started welting up, and nose congestion. This report was non-serious.
Zoster like rash, limited in dermatome distribution, began 4 days after shingles vaccine administered at a pharamcy. Resolved after course of Valtrex.
Around 03/01/2023, I began having a lot of upper respiratory issues. Itchy eyes, coughing, and sneezing. The pollen count went up and I went for a walk on 03/05/2023. From 03/06/2023-03/08/2023, my symptoms got worse. I couldn't sleep and was coughing and wheezing. On 03/08/2023, I ended up going to see my primary care physician who prescribed steroids, montelukast, TESSALON PERLES, I'm also taking ROBITUSSIN, DELSYM, and FLONASE nasal spray. Since beginning the medication, the cough is not as deep, and the wheezing isn't as bad. I've been able to sleep better but am still experiencing symptoms.
Case received from a nurse on 26.Apr.2011 and forwarded by Crucell Vaccines Inc.: A spontaneous report was received and concerns a 34-year-old female patient who received VIVOTIF (batch number unknown). She took the first dose of VIVOTIF on an unspecified Thursday in the evening. On Friday evening, the day after VIVOTIF administration, the patient developed a rash on her legs. The patient called the clinic and was told to discontinue the VIVOTIF. The reporting nurse was to administer the injectable vaccine to the patient. At the time of this report, the outcome was unknown. The event was considered non-serious.
3 days after the shot he had a  grand mal seizure lasting 3 minutes; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation. Medical history included seizure and epilepsy. The patient's concomitant medications were not reported. An adverse reaction happened with her disabled son and she can't complete the report now because she has to go to the doctors. She wants to know if she could call back. He lives upstate in a residential home, one of the first places to give vaccines and she called them several times to say they needed to report it. He has epilepsy and 3 days after the shot he had a grand mal seizure lasting 3 minutes, he has not had a seizure that long in over 2 years. He has not had a seizure since then. She stated it was the pfizer covid 19 vaccine. She spoke with his neurologist and he said it probably triggered it. If he was to get vaccinated again like if he needed a booster. This happened on the second dose. She told them that it was considered an adverse event. If he ever needed to go for a booster since he has epilepsy she would go to his doctor and make sure his medication was at a higher level so maybe he would not have a seizure the second time. No further information provided. People with seizures should know this could give you a seizure. He usually has 30 second seizures, last year he had 2 seizures in the whole year both 30 seconds. The event outcome was unknown.  Information on the lot/ batch number has been requested.
stomach bug; had history of 2 radioactive ablations; had history of 2 radioactive ablations; like a dysentery; constant diarrhea; completely exhausted/tired; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EH9899, expiration: 31Mar2021), via an unspecified route of administration in left arm on an unspecified date at a single dose for COVID-19 prophylaxis.  Medical history included ongoing Barrett's esophagus, ongoing esophageal hernia, 2 radioactive ablations, ulcer, ongoing high cholesterol, ongoing arthritis, and ongoing esophageal problems.  She has had a lot of esophageal issues, had history of 2 radioactive ablations. Concomitant medications included ongoing omeprazole for esophageal problems, ongoing atorvastatin to prevent high cholesterol, and ongoing paracetamol (TYLENOL) for arthritis. The patient reported that she received the vaccine on Saturday morning at 0900 (unspecified date). The patient's arm hurt on 16Jan2021. On 17Jan2021, she has had constant diarrhea. She is not panicked. She wants to know if this is from the vaccine or if she has a stomach bug. She was completely exhausted on 17Jan2021, and her arm hurt so bad. She stayed in bed. She is not as tired now.  She said that her arm hurt with the flu shot and other shots too (unspecified date). She said that she was not worried about it. With regards to diarrhea, she said that Sunday was like a dysentery, but it is a little bit better today. She is not going out or exercising because she is tired. Her second dose supposed to be on 06Feb2021. She said that she does not like medication or shots. The patient is recovering from events constant diarrhea (like a dysentery) and completely exhausted/tired; recovered from arm hurt on 18Jan2021; while unknown outcome for the remaining event.
pt recv vax & 4-6mo p/vax pt exp visual change;pt was hosp;pt was found to have a demyelinating disease;MS was confirmed by a brain biopsy;MD does not think the MS is r/t vax;
physician ordered the medication due to the 18 years old nonpregnant female having a low white blood cell count with no reported adverse event; Initial information received on 11-Aug-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2022SA336909(CLUSTER).  This case involves 18 years old female patient for whom physician ordered the medication due to the 18 years old nonpregnant female having a low white blood cell count with no reported adverse event for vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date the physician ordered the medication due to the 18 years old nonpregnant female having a low white blood cell count with no reported adverse event (intercepted product prescribing error) (unknown latency) for HIB (PRP/T) VACCINE. Nurse wanted to know if it could be administered to someone who was 18 years of age as the package insert states 1-5 years of age and if there is a change in dosing for the older child.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
NEUROPATHY 3/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
She has chronic urticaria; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; She threw up for the first time; She is is extremely tired; stomach cramping/stomach was hurting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration for COVID-19 immunization as a single dose on 08Apr2021. The patient's medical history and concomitant medications were not reported. She stated she had a reaction to her second dose of the vaccine that she received on Thursday, 08Apr2021. She has chronic urticaria so her allergist expected she would have some kind of reaction. Friday her stomach was hurting, she had extreme nausea and pain and broke out into full hives. She took a Benadryl and then took another and the hives subsided in an hour and a half. She has had stomach cramping, diarrhea and nausea since last Friday. She threw up for the first time about an hour and a half ago. She is extremely tired. She stated she called the doctor and the doctor told her to call Pfizer and we would tell her what to do. The caller asked if these symptoms are normal and asked for treatment recommendations. The outcome of event hives was recovered and outcome of event for vomiting was unknown. The outcome of other events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
"can't lay down on a pillow," there is tingling of the head/nerve sensations; "head can't lay down on a pillow,"; was unable to fall asleep; This case was reported by a consumer and described the occurrence of tingling in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced tingling, head discomfort and trouble falling asleep. The patient was treated with trazodone and melatonin. On an unknown date, the outcome of the tingling, head discomfort and trouble falling asleep were recovering/resolving.   The reporter considered the tingling, head discomfort and trouble falling asleep to be possibly related to Shingrix.  Additional details were reported as follows: The case was reported by the patient himself. The patient experienced adverse events within a week after 1st dose of Shingrix. The patient stated that he could not lay down on the pillow, there was tingling of the head, nerve sensation and that he was unable to fall asleep. The patient then had Trazodone and Melatonin to calm things down. The patient had visited the health care professional (HCP) and was told that everything looks good. The patient thought the adverse events might have been caused from the Shingrix vaccine because of the timing of the vaccine as well as information that he found online. The patient would follow up with the HCP details for safety to contact. The reporter did not consent to follow up.
Patient received the vaccine 12 hours after puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine 12 hours after puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine 12 hours after puncture). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  After 12 hours the vial was punctured and was given to 3 patients. The patients received the booster dose of 0.25 ml. The vial was initially stored in the refrigerator on 10-Nov-2021 and  was first punctured on 22-Nov-2021 at 09:02 hours.
A report was received from a health care professional on 11/26/03 concerning a 14 month old female vaccinee who was inadvertently administered Fluvirin vaccine 11/26/03. On 11/26/03, the vaccinee was administered 0.25ml Fluvirin. No adverse effects were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.