chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cough; Achy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (Achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and MYALGIA (Achy). At the time of the report, COUGH (cough) and MYALGIA (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (Achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and MYALGIA (Achy). At the time of the report, COUGH (cough) and MYALGIA (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Administered Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva652a, expiry date 28th February 2023) and (batch number amva652a, expiry date unknown) for prophylaxis.   On 26th July 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 26th July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The pharmacist technician reported on 27th July 2022 that a patient was administrated with Menveo on 26th July 2022.  The vaccine was reconstituted with sterile water.  No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was vaccinated with Menveo which was reconstituted with sterile water, which led to Wrong solution used in drug reconstitution.
pt rcvd vax; 1 mo after vax, pt had (.25cm) a red, raised nodule at inject site;
Headache; nausea; loss of smell; congestion; runny nose; cough; body aches; I feel sometime hot sometime I feel chill; I feel sometime hot sometime I feel chill; feel cold; Back pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0187), at same age, as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history includes coronavirus infection. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0167), for covid-19 immunisation. Patient was experiencing symptoms like she did when she previously had the coronavirus infection and wanted to know if it could be side effects of the vaccine or if she was infected again.  Her symptoms included headache, nausea, loss of smell, congestion, runny nose, cough and body aches. Patient felt sometime hot sometime she felt chill, she felt cold she felt like that way too. She got a congestion and later be headache and cough then after Friday it's getting worse and worse like she start feeling lot of headache yesterday and then nausea and back pain, the cold and the hot and have a lot of cough. For anatomical site of vaccine, consumer stated, for first dose on the left and second dose on right. The outcomes of events were unknown.
pain that comes and goes; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200120237 (Pfizer).  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "pain that comes and goes". Therapeutic measures were taken as a result of pain.  Additional information: Reporter states, patient had a booster shot on 07Jan2022, and on today the 21st he still has pain almost every day, which he has been taking tylenol and still the pain comes and goes. Patient has been worrying about maybe they gave him the wrong dose or something. Patient when he will get to speak to someone regarding his issue, which is pain, ongoing pain, which he wants to know if this part of a regular dose or if something might have happened mistakenly like being given 3mL instead of 0.3mL. He says he also wants to know if there would be adverse effects if given that way mistakenly. He says he would like to know if it is normal and to expect pain that comes and goes for more than two weeks now.  Follow-up attempts are completed. No further information is expected.
on Aug 3rd 2023, a 4 months old female baby received by error Kinrix to continue Dtap and IPV series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2024) for prophylaxis.   On 03-AUG-2023, the patient received Kinrix. On 03-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: on Aug 3rd 2023, a 4 months old female baby received by error Kinrix to continue Dtap and IPV series). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2023 Nurse reported that a 4 months old patient received by error Kinrix to continue Dtap and IPV series.  This was her second dose on the series. The reporter consented to follow up. The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
This spontaneous report as received from a nurse practitioner refers to a 6 year old female patient with food allergies, atopic dermatitis and eczema. Approximately in 2013, the patient was vaccinated with a dose of M-M-R II (dose, frequency, route of administration, lot# and expiration date were not reported). There was no concomitant medication. Approximately in 2013 (reported as in the fall of 2013 after receiving M-M-R II, the patient experienced anaphylactic reaction. It was reported that the patient's throat closed up, she had shortness of breath and hives. There were no laboratory tests performed. No product quality complain (PQC) was involved. The outcome of the adverse event was not reported. Causality assessment was not provided. This is one of several reports received from the same reporter and referring to the same patient. Additional information has been requested.
"throat feels tight" - no obvious signs of distress.    Benadryl 50mg Po given and discharged at 1040 feeling better
Patient developed chills, fatigue, subjective fever and myalgias the evening of vaccination. 2 days later he developed severe left wrist pain as well as edema. Vitals were stable. Labs showed elevated D-dimer at 1.43. CBC, BMP and uric acid were all WNL. US of upper extremity showed no DVT. ROM greatly impaired in left wrist due to effusion.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, arm pain Narrative:
Secondary lesions x2 to lateral right arm; 2 cm in size; secondary lesion to right anterior thigh. 4-5 cm in size.
First day, muscle pain in arm that lasted a day. Fourth to Sixth days, full body muscle aches, joint pain all over, severe chills, fever of 100.1 (normal temperature runs 97.9).
Caller received the first dose of Pfizer's COVID vaccine and experienced heavy menstrual bleeding; The caller hasn't had a period in 5 years, she is post menopausal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Mar2021 (Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. Medical history included post menopausal for 5 years from 2016, Hashimoto's disease. The patient's concomitant medications were not reported. The patient got her shot on 30Mar2021 and then she didn't notice any side effects, but right now in 2021 she's having menstrual cycles, a lot of bleeding. She experienced heavy menstrual bleeding. The patient hasn't had a period in 5 years, she was post menopausal. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient had a rash develop after covid vaccination. Per doctor notes 4/5/21; Rash was red, raised, small dots over abdomen, torso, back, and axilla. Not pruritic or painful. Not similar to hives. No sors in her mouth. Rash is now completely resolved
Symptoms of body aches and chills then felt like throat was closing partially for a couple of hours, now breathing fine
Patient received third Pfizer booster instead of the recommended Pfizer Bivalent. No adverse reaction reported by the patient.
pt recv vax. pt devel inject site rxn with redness, itching & a knot.this is 1 of 4 patients from this site and lot# to report adverse reactions.
I received the shot in my left arm very high up on the arm.  In just a few hours, I started having symptoms of rotary cuff injury.  (I had surgery on both shoulders for rotary cuff so I definitely know that pain.)  Today, three days after the injection, I am still having pain and have to use my right arm to lift the left.    Also, the vaccine I received is Pneumovax 23 25 MC G/0.5ML INJ
No additional AE details; Improperly stored VARIVAX administered; This spontaneous report has been received from a certified medical assistant, concerning a 4-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. The patient's birth weight was reported as 6 pounds and 11 oz.  On 14-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (second dose) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis.   The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022. No previous temperature excursion was reported. No additional adverse events were reported. It was also mentioned that the patient experienced a "device or device component malfunction" (Discrepant information).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004:
Recalled product administered; Red egg shaped mush on arm; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, recalled product administered and red egg shaped mush on arm.  The patient's medical history was not provided. Concomitant product use, within two weeks of vaccine administration included, pneumococcal vaccine polyvalent.  On unknown date, the patient received their first of two planned doses of mRNA-1273(Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. Vaccine lot 041L20A was recalled.  On 02 Feb, almost two weeks after vaccine administration, the patient reported a red egg shaped mush on her arm that was not painful. Patient believed this was due to her physician not waiting two weeks until administering her pneumococcal vaccine polyvalent.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, recalled product administered, was considered resolved. The outcome of event, red egg shaped mush on arm, was considered not resolved.; Reporter's Comments: This case concerns a female patient, who experienced a product administration error - recalled product administered and a non-serious unexpected event of rash on arm. There was no AEs associated with product administration error- recalled product administered . However, the event of rash on arm occurred 2 weeks after mRNA-1273 (Lot# 041L20A) administration. Based on the current available information and temporal association between the use of the product which is recalled vaccine and the start date of the event rash on arm , a causal relationship cannot be excluded, noting the concomitant use of pneumococcal polyvalent vaccine.
miscarriage; vaccinated with GARDASIL-9 and subsequently had fertility issues/She had a miscarriage; This spontaneous prospective pregnancy report was received from a medical student via a company representative referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, strength, lot # and expiration date were not reported) for prophylaxis.  Subsequently the patient had fertility issues. She had a miscarriage (vaccine exposure during pregnancy). The last menstrual period (LMP) the estimated date of delivery (EDD) was not provided. The pregnancy outcome was miscarriage and the fetal outcome was congenital anomaly.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and abortion induced was not provided.  Upon internal review, the miscarriage was determined to be medically significant.  The case is cross referenced to the case 2109USA006148 due to Parent-Child Link.  ; Sender's Comments:  US-009507513-2109USA006148:
Patient has redness and swelling at injection site. She is also experiencing blisters and itching at injection site.
Information has been received from an immunization official healthcare worker referring to multiple unspecified patients of unknown age. On an unknown date the multiple unspecified patients was vaccinated with GARDASIL (dose, frequency, route and lot# were not reported), which were stored improperly. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.
Patient has some behavior changes, redness and swelling to the site. Patient was also complaining that all sounds were "too loud". Symptoms resolved in about 24 hours.
Patient reports having a fever of 101-102 F and feeling lethargic in the afternoon on Tuesday, 10/22/19. On Wednesday, 10/23/19, she developed a rash on her left bicep area which wrapped partly around the arm. The rash did not resolve on its own, so patient went to doctor on Friday, 10/25/19, presenting with symptoms of rash that was painful with swelling and warm to the touch. She was prescribed cephalexin as a treatment for possible cellulitis. Since starting the antibiotic, patient reports that her condition is improving as of follow up call with her on 10/30/19.
Patient presented to ED from PCP with transaminitis. She had been experiencing 2 weeks of fatigue and nausea prior to her presentation. Laboratory evaluation revealed AST 780 and ALT 786. Acetaminophen levels were undetectable and acute viral hepatitis panels were negative. Patient was diagnosed with autoimmune hepatitis in 2010 and treated with a 6 month course of prednisone followed by taper. Her current presentation is believed to be a flare of this condition and possibly incited by her recent vaccination.
Stabbing abdominal pain for a week that was diagnosed as shingles 3/15/21. Recurrence of trigeminal ear pain 2 days after shot. 102 fever the whole day after the shot
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 01-JUL-2010, the patient was vaccinated intramuscularly with the first dose of 0.5 ml GARDASIL 9lot # not reported). On 06-AUG-2012 the patient was vaccinated with the second dose of GARDASIL (lot # not reported). No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
APPROXIMATELY 20-25 MINUTES AFTER INJECTION, PT WAS STILL IN THE BUILDING VISITING GRANDMOTHER AND PASSED OUT IN SEPARATE LOBBY. HE HIT HEAD ON COUNTER TOP AS HE FELL. HE WAS WALKING BEHIND HIS MOTHER AND SHE DID NOT SEE HIM PRIOR TO FALLING. HE WAS UNCONSCIOUS FOR APX 3-4 MINUTES. WHEN HE DID RESPOND, HE WAS VERY LETHARGIC AND THEN BECAME NAUSEATED AND VOMITED X1. GRANDMOTHER STATES HE WAS LETHARGIC FOR THE REST OF THE DAY.
mom states pt cried p/vax @ top of lungs x 1 hr; slept x 1 hr-awake crying again very painful to move-encouraged to notify MD;
Patient states feeling achy the next day. Patient cannot confirm if patient has a fever. In addition, patient states having diarrhea and cold sweat since one day post vaccination until today/now (12/22/22 to 12/26/22). Patient states feeling very tired/weak and unable to eat or drink normal amount of fluids (today patient had a cup of Jello and 1/2 bottle of water). Patient took 1 dose of OTC pepto bismol. Due to patient's age, duration of diarrhea and decreased fluid/food intake, pharmacist advised for patient to seek urgent care. Patient states waiting for advice nurse to call back.
Breakthrough case admission after 2 vaccines Moderna 8/2/21 Lot# 052C21A;  Moderna 8/30/21 Lot# 017E21A
Some of the vaccine went dribbled down arm; too much leakage as if syringe leaked; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Some of the vaccine went dribbled down arm) and SYRINGE ISSUE (too much leakage as if syringe leaked) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C03C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced UNDERDOSE (Some of the vaccine went dribbled down arm) and SYRINGE ISSUE (too much leakage as if syringe leaked). On 30-Apr-2021, UNDERDOSE (Some of the vaccine went dribbled down arm) and SYRINGE ISSUE (too much leakage as if syringe leaked) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to MOD-2021-191547 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains no new information On 29-May-2021: Follow-up information received on 29-May-2021 and contains no new information On 31-May-2021: Follow-up information received on 31-May-2021 and contains non-significant information
Information has been received from a registered nurse concerning a patient of unknown age and gender. On 10-NOV-2014 the patient was vaccinated with an expired dose of MMR II (lot # not reported, expiration date 18-OCT-2014), 0.5 ml, subcutaneously. No adverse events were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
1/15 vaccination 1/22 At 3am, I woke up and my R arm burned and itched so bad. I went to brush teeth and saw arm; swollen R arm, tender to touch, and tingle if raised. I called my PCM. Set up a telehealth appt. She looked at it and stated to take a antihistamine. By Sat morning, it was gone.
Resident had an Anxiety attack, passed out approx 5 minutes after administration. Vital signs were taken, blood pressure & pulse elevated, temperature & oxygen levels okay. Patient was sweating. Approx 2 minutes later, patient became alert & oriented x4. Patient stated that she has a fear of needles. Patient relayed having similar symptoms in the past. Patient has hx of hypertension. No further care given.   911 was called at the time the patient became unconscious. EMS arrived approx the same time as the patient becoming conscious. EMS ran vitals. EMS did not transport. Patient is stable and walking. Patient left location after 30 minutes of monitoring.
Sept 7, starting itching/tingling on my face, midday, not bad or consistent.  Colored my hair that night, using same product I've used for 15-20 years. When washing off my face near hairline and neck was red and tiny bumps, it itches all night. Wednesday the 8, I could hear my heartbeat in my left ear, usually happens with headache in both ears, but no headache and only in left ear. All day Wednesday, Thursday, Friday I scratched uncontrollably til I bled, on my neck, face, arms and legs.  Hydrocortisone cream didn't help, my only relief was from hand sanitizer wipes.  That weekend I took some Benadryl but could only take at night, by Monday I tried otc allergy pills while at work but the made me super drowsy, even tho they were non drowsy meds.  Some, very few of the itchy patches I had have went away, like on my nose and ear love have went away,  all other spots are trying to heal but when one starts itching it's like a domino effect, they all do, do I without knowing scratch off the scabs. Now a large itchy rash has developed on my back as well. I'm currently using Benadryl topical cream but it wears off sooner than it should. I haven't had any major physicals symptoms that are ER worthy, it's just super irritating with no end in sight
Her Husband was unable to wake her  the the next morning 03/04/21 0730 ,she would not respond to him , finally he was able to get her sitting up but she would never open her eyes or talk ,he took her to the hospital where she was admitted.
This spontaneous report was received from a registered nurse referring to a 4 month old patient of unknown gender. Concurrent conditions or pertinent medical history were not reported. On 18-FEB-2016, the patient was inadvertently vaccinated with an expired dose of oral, ROTATEQ (lot # K004795, expiration date: 11-FEB-2016) (dose and frequency were unspecified). Concomitant medications were not reported. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.