chrisvoncsefalvay/vaers-outcomes huggingface dataset:
frozen shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIARTHRITIS (frozen shoulder) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 06-Nov-2023, the patient experienced PERIARTHRITIS (frozen shoulder). At the time of the report, PERIARTHRITIS (frozen shoulder) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication not reported.   The patient got frozen shoulder because a dose of the Moderna Covid-19 vaccine was given too high. He had a Physician recommend that he receive the Spikevax 2023 2024 vaccine in his thigh.  Treatment medication not reported.  Company comment- This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the non-serious unexpected AESI periarthritis on an unknown date after a dose of SPIKEVAX NOS vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported patient got frozen shoulder because a dose of the Moderna COVID-19 vaccine was given too high. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Mom reports within 1 hr after receiving 1st flu vaccine- patient stopped breathing. Mom Did chest compressions x2. Took to Hospital and was completely normal.
I got covid in late December and this was just like it: temperature spiked to 102, splitting headache, chills. (to be clear, I'm the patient, not a healthcare provider)
gradual onset of paresthesias in both feet, both hands progressing to weakness in both legs with inability to stand over a course of 4 days. needed treatment by intravenous gamma globulin for 5 days.
On Nov. 6th I was administered the flu vaccine at my job....It was given to me around 6:30am..around 3:30pm - 4:30pm I started breaking out in sweat. I was hot then cold...My teeth was knocking I was so cold. My temp. got up to 101 before I started taking tylenol. The symptoms last about 3:30pm til about 8:30pm when I finally feel asleep. I felt awful. My wife tells me I was having a diffcult time breathing in my sleep.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
5 min after shots, developed hives: throat itching, itching all over.  Benadryl 25mg per mouth with good results.
Information has been received from a health professional concerning a 43 year old male with an allergy to peanut butter and a history of negative titer for varicella (0.91), who on 06-NOV-2007, was vaccinated in the right deltoid with varicella virus vaccine live (Oka/Merck) (lot#654752/1257F). On 17-NOV-2007, it was reported that the patient developed a chickenpox like rash that started on his chest, moved to the back and to the arms, neck and face. It was reported that he had over 100 lesions and the rash was described as papules. It was reported that some of the papules were scabbing over. There was no reported fever. The patient had no previous vaccination history. It was reported that the patient sought unspecified medical attention and was to be followed by the physician. At the time of this report, the patient was reported as recovering. A product quality complaint was not reported. Additional information has been requested.
This non serious case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 248530). A 51-year-old female patient had received an intramuscular injection of FLUZONE SV 2005-2006 USP, lot number U1775AA on 13 October 2005 at 12:00 pm and three and a half hours later, she experienced nasal congestion (coded by VAERS as rhinitis), an over production of sputum, conjunctivitis and shortness of breath. The patient recovered from the event (date of recovery not reported). No additional information was provided. Documents held by sender: None.
Information has been received from a licensed practical nurse concerning a 40 year old female patient who in 2006 was administered a series of RECOMBIVAX HB (dose unknown, lot # not provided), and on 15-AUG-2011 the patient was vaccinated with RECOMBIVAX HB, intramuscularly (Lot number 0869AA is an invalid lot number for RECOMBIVAX HB, EXP 01-NOV-2013). The nurse noted this patient "did not develop adequate titers to a previous series of RECOMBIVAX HB in 2006". Nurse reported the patient developed a "pea-sized knot" where RECOMBIVAX HB was administered on 15-AUG-2011. The nurse did not know when this "pea-sized knot" developed. The patient sought unspecified medical attention and had not recovered from "pea-sized knot" at the time of the report. Out come of "did not develop adequate titers to a previous series of RECOMBIVAX HB in 2006" was unknown at the time of reporting. Additional information has been requested.
11/6/22 That morning I had a stuffy nose and sore throat. My husband had tested positive, and I tested negative. I tested with a home test and was positive. Drank a lot of water, was seen by an APN and started Paxlovid that evening. I did not feel any worse for a few days, just tired.  By the sixth or seventh day, I felt completely normal. I tested again on 11/10/22 and was negative.  I feel fine, back to normal.
large patch of psoriasis on his arm above the elbow, typical psoriasis on his palms and his hands flared; peel crack get nasty; big chunks of skin that crack; Initial information received on 14-Jan-2021 regarding an unsolicited valid non-serious case received from physician.  This case is linked to case 2021SA011846.  This case involves adult male patient of unknown age who had large patch of psoriasis on his arm above the elbow, typical Psoriasis on his palms and his hands flared (psoriasis), peel crack got nasty (skin exfoliation) and big chunks of skin got crack (skin fissures), after receiving INFLUENZA VACCINE or PNEUMOCOCCAL VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspects INFLUENZA VACCINE produced by unknown manufacturer or PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur [lot numbers and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (as reported last year), the patient developed large patch of psoriasis on his arm above the elbow, typical Psoriasis on his palms and his hands flared (psoriasis), peel crack get nasty (skin exfoliation) and big chunks of skin that crack (skin fissures)  (non-serious) (Unknown latency),  following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for all reported events.  There will be no information on the batch number to be requested for this case.
Second Moderna dose given too early, first dose given on 12/20/22 second given 1/11/23 (requires 28 days between doses).  Dose will need to be repeated in 28 days.
7 month old baby came in for 4 month vaccines. At the time of the incident i did not realized that the vaccine was expired. Gave patient a expired vaccine.
Patient underwent a left lower extremity bypass (common femoral to profunda femoris endarterectomy with vein patch angioplasty, left common femoral to above-knee popliteal artery bypass with reversed great saphenous vein; left great saphenous vein harvest, left anterior accessory saphenous vein harvest). She tolerated the procedure well and without complication. Discharged home.
pt recvd vax & exp burning & swelling @ inject site which required tx w/ice; w/in several hrs of vax sx subsided; The nurse then switched to a different lot# of vax & the sx did not recur; no further details were provided;
Information has been received from a doctor of pharmacy (Pharm.D.) for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 16 year old female patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). The reporter stated that the patient was administered VARIVAX (Merck) and was subsequently determined to be pregnant 2 weeks later. It was reported that the patient had a negative pregnancy test on the date of administration of the VARIVAX (Merck) but a pregnancy test 2 weeks later was positive. The patient sought medical attention, it was an office visit. Update (10-JUL-2013): A phone call was made to the doctor of pharmacy regarding the anonymous patient to pregnancy outcome information. Without patient identifiers, he could not give any information. The doctor of pharmacy stated he did not recall the patient in question. The case was lost to follow-up. Additional information is not expected. No further information is available.
Case number PHHY2011US69747 is an initial spontaneous report received from a nurse on 25 Jul 2011. This report refers to a 51 years old male patient. He was vaccinated with 0.4 ml (underdose) of MENVEO (batch number: A100053) intramuscularly on 11 Jul 2011. No other adverse event was reported.
Rt arm is red, swollen, has a fine rash & itches; has had no treatment;
I have flu symptoms; my arm is red and itchy; my arm is red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I have flu symptoms), PRURITUS (my arm is red and itchy) and ERYTHEMA (my arm is red and itchy) 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 INFLUENZA LIKE ILLNESS (I have flu symptoms), PRURITUS (my arm is red and itchy) and ERYTHEMA (my arm is red and itchy). At the time of the report, INFLUENZA LIKE ILLNESS (I have flu symptoms), PRURITUS (my arm is red and itchy) and ERYTHEMA (my arm is red and itchy) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.  Treatment medication was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Patient developed on site rash which has spread in her arm, Feeling dizzied and nausea, vomiting, headaches
Patient called pharmacy complaining feeling sick for 3 days prior. we contacted her doctor and informed him of the possible reaction to the vaccination. Doctor spoke with patient about reaction. Patient was admitted to ER on 5/20 and treat with fluids and prescribed Valtrex for shingles.  The thought is that the immune response might have triggered the shingles virus.
Vaccinee rec'd a series of 3 doses AUG89, SEP89, FEB90-Glutteus) & when tested 5 months later (?JUL90), p/needlestick, had no antibodies-"no seroconversion." Event also occurred p/4th inject JUL90 (IM deltoid).
pt recv vax;devel flat red rash w/ fever,lasted 48hr; 2 wk p/ vax devel fluid filled vesicles;fussiness, pox scabbed over by 3rd day; rash & sx lasted 5 days total;
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as "since 05-OCT-2016"), the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL 9 lot# M007764 with expiration date: 30-JAN-2018 and M009378 with expiration date: 23-APR-2018 (dose and route of administration were not reported). Administered doses of GARDASIL 9 underwent temperature excursions at 35 Fahrenheit degrees, for 45 hours. There were no previous temperature excursions. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a 59 year old female patient concerning herself. The patient had allergic reaction with tetanus toxoid (dose, frequency and manufacturer were unspecified) and experienced swelling, soreness, limited range of motion and itchiness sometime in 1972. The patient had no pertinent medical history. On 09-FEB-2015 the patient was vaccinated with PNEUMOVAX 23 injection (dose, lot#, route and strength were not reported). The patient concomitantly (on 29-FEB-2015) received suspect therapy ZOSTAVAX injection (dose, strength, lot# and route were not reported), which was other-than-indicated in the prescribing information in the patient's left arm. After receiving PNEUMOVAX 23 the patient experienced swelling, soreness, limited range of motion and itchiness of her right arm from 10-FEB-2015. The patient also stated that she experienced the same adverse events with ZOSTAVAX. BENADRYL (dose, strength, frequency were not reported) was given as treatment for the adverse events. There were no lab diagnostics studies performed. The patient had sought medical attention via office visit on 13-FEB-2015. Outcome of the adverse events was reported as not recovered. Causality between the events and PNEUMOVAX 23 and ZOSTAVAX was not provided. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, unspecified number of patients were vaccinated with unspecified doses of GARDASIL 9 lot# L011846, expiry date 16-JUN-2017 (dose, site and route of administration were not reported). No adverse effect were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
5 minutes after shot was given and patient sat down to be monitored patient complained of not feeling well. Called 911 and ambulance was sent. Patient went with them to the hospital. Patient never loss concious or needed extra care. Monitored and gave water (all she wanted).
Sudden sensorineural hearing loss in right ear 1.5 months after receiving 2nd dose
pt recvd vax;day of dose 2,exp itching which,when scratched,devel into hives;tx dph; not subsided;
Pt received an influenza and HIB vaccine at 11:45 AM on 11-19-10 and had seizure - like activity at 12 AM 11-10-10. Seen at E.R.
patient experienced COVID Symptoms; patient experienced COVID Symptoms; This is a solicited report based on information received by Pfizer from regulatory authority (MFR Control No.: 21K-163-4111720-00).   A contactable consumer (patient) reported that a 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly on 07Aug2021 (Batch/Lot number was not reported) at age of 25 years old as a single dose, 2nd dose intramuscularly on 28Aug2021 (Batch/Lot number was not reported) at age of 25 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient's medical history was not reported. There were no concomitant medications. The patient experienced covid symptoms in 2021 with outcome unknown. The action taken in response to the event for adalimumab was dose not changed.   Solicited report from the (country) by a consumer of a 25 years old female with an event Of non-serious covid symptoms with Humira (adalimumab). There was no reported Medical history. In 2021, the patient experienced covid symptoms. Pfizer biontech covid-19 Vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 07Aug2021, she received first dose covid-19 vaccine manufactured by Pfizer biontech. On 28Aug2021, she received second dose covid-19 vaccine manufactured by Pfizer BioNTech. Causality for Humira(adalimumab): The reporter's causality for the event of covid symptoms was not provided.  The reporter's assessment of the causal relationship of all event with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.
BULLSEYE-TYPE RASH AT INJECTION SITE THAT IS LARGE, PAINFUL, AND HOT TO TOUCH.  PAIN RADIATES DOWN THE LEFT ARM.
Big blister on right ankle since 02/17/2021 minutes after my second vaccine dose
Information has been received from a pharmacist concerning a 65 year old male with type 2 diabetes, other unspecified medical conditions and a mild reaction to flu vaccine, who on 01-MAY-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 664029/0196Y), subcutaneously into the left arm. Concomitant secondary suspect therapy included simvastatin, (MSD), enalapril maleate (MSD) and hydrochlorothiazide (MSD). Other concomitant therapy included glipizide, metformin, ACTOS and antibiotics (manufacturer unspecified). On 01-MAY-2009, 3 to 4 hours after the patient received the ZOSTAVAX (Merck), he started experiencing swelling and pain on the injection site which lasted for 6 days. The patient also developed redness at the injection site. After that he noticed an egg size and shape swelling on the injection site and have rashes in it too. The patient also experienced pain in his shoulder joints and then later developed 2 chicken pox bumps on his chest. The pox lasted for 4 days. It was also reported that the patient had two lesions that were described as "pox" on his legs. The patient had x rays done and root canal one week before vaccination. At the time of this report the pain has lessened and the pox disappeared. The patient sought medical attention through a phone call. Additional information has been requested.
About 1 day after receiving the first dose of Moderna COVID19 vaccine, pt developed painful erythematous rash over much of L side of torso from sternum around L side to midline posteriorly.  There are some vesicles.  This appears to be about T6-T8 dermatome area. He is also having skin sensitivity in other areas where there is no rash (legs and R side of torso).
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from (PRIVACY) Moderna COVID-19 Vaccine (website:PRIVACY). Patient contacted on 12/4/2021 and no adverse effects reported.
Influenza Vaccine administered in LD on 10/21/08. Patient notified me on Oct. 22 that she had a stiff neck on Rt. side of neck, with fever. Please note inj. was given Lt deltoid. Self adm. Motrin with some effect, she did go to her PCP. She states she has no idea if it was related to vaccine, but thought she would mention it. DPH notified and said to report it as Adverse Event. Norvartis Man. also notified. Stiff neck did continue to improve every day but still present.
2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM,  LASTED LESS THAN 24 HOURS 2/18/2021 DAY OF INJECTION #2 - MILD SORE UPPER LEFT ARM RADIATED TO LEFT SHOULDER BLADE, USED TOPICAL       ARNICARE   FOR THE SORENESS WHICH  LASTED ABOUT 24 HOURS 3/21/2021  VERY SORE UPPER LEFT ARM, SUDDEN  "CHARLIE HORSE" RADIATED FROM  THE INJECTION SITE TO THE  LEFT       SHOULDER BLADE, LUMP/KNOT UNDER  THE INJECTION SITE ABOUT THE SIZE OF A WALNUT, USED ARNICARE AND       MASSAGE,  NO RASH OR VISIBLE BRUISING, SORENESS LASTED SEVERAL DAYS
Had normal range reactions with previous doses of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Had normal range reactions with previous doses of the Moderna Covid 19 vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 047A21A and 011M20A) for COVID-19 vaccination.     The patient had not ever tested positive for Covid19.  Concurrent medical conditions included Adhesive tape allergy (Allergy to adhesive in band aids). Concomitant products included ELAGOLIX SODIUM (ORILISSA), ESTROGENS CONJUGATED (PREMARIN) and PROGESTERONE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 an unknown date, the patient experienced IMMUNISATION REACTION (Had normal range reactions with previous doses of the Moderna Covid 19 vaccine). At the time of the report, IMMUNISATION REACTION (Had normal range reactions with previous doses of the Moderna Covid 19 vaccine) outcome was unknown.            Patient used Hormonal IUD. No treatment medication was reported.   This case was linked to MOD-2022-644939 (Patient Link).
can't lift it high/reach around my back; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had before).   In June 2022, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-AUG-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient got his or her shot 2 months ago of reporting date and he or she could not lift it high or reach around his or her back. It was miserable.  Additional Supportive Information: Follow-up would not possible as no contact details were available.
pt was given expired vaccine. vaccine expired on 7/7/22. this was pt second booster.  no adverse event occured. Pt was revaccinated for second booster.