chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given SC instead IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4755H, expiry date 9th June 2023) for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Shingrix (subcutaneous). On 2nd August 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022  Reporter's Comment: The reporter reported that, a customer stated that Shingrix was given to her subcutaneously and wanted to know if she needed another dose. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a customer stated that Shingrix was given to her subcutaneously, which led to intramuscular formulation administered by other route.
Vaccine administered 10/30/14 - AM. Patient started c/o symptoms 10/30/14 PM - which include fever, chills, sweats, arm pain - RT. Upon PE on 11/3/14 - vaccination site significantly swollen, red, hot to touch, very painful to touch. Treatment - BACTRIM, BACTROBAM, naproxen. Call if worsens.
This information was received from manufacturer on 07 June 2007 under the manufacturer number WAES0705USA03292. "Information has been received from a physician, concerning a 17 year old female patient, with a drug hypersensitivity to clindamycin/benzylperoxide (BENZACLIN), who on 15-MAY-2007 was vaccinated with Gardasil (Lot #656371/0181U). Concomitant therapy involved an ear irrigation at the visit, and also included ADACEL, cetirizine hydrochloride (ZYRTEC) and vitamins (unspecified medications, over the counter). The physician reported that the patient "Seemed fine" immediately after the vaccine was administered, but 5 to 10 minutes later when she was checking out, the patient "fainted and almost hit her head on the counter;" she was unconscious for a few seconds. The patient was taken to the emergency room for evaluation and was released and considered to be recovered on the same day, 15-MAY-2007. The physician considered the event of "fainted and almost hit her head on the counter," to be disabling/incapacitating, and an other important medical event. Additional information has been requested."
cold; stuffiness; This case was reported by a consumer via call center representative and described the occurrence of cold in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cold and upper respiratory tract congestion. On an unknown date, the outcome of the cold and upper respiratory tract congestion were recovered/resolved.   It was unknown if the reporter considered the cold and upper respiratory tract congestion to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient's husband. The patient experienced cold and stuffiness in her upper respiratory tract but it did not last over 7 days. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix refer case US2019080546, reported by same reporter.
Information has been received from a registered nurse concerning herself on an unspecified date she was accidentally vaccinated with PNEUMOVAX 23 (Lot# not provided) "instead of a TB test". She subsequently developed injection site redness. On an unspecified date she recovered from the events. Additional information has been requested.
Developed red rashes on the left ankle and blotch on inside of upper right thigh 10 min after the shot. Inflamed and red and itchy. Next morning, got cold sores in the mouth, and more rashes on the leg, the rashes are now climbing up. Used little bit of cortisone cream - by night time, rash had spread on both legs and arms. Affecting her joints now. Took 1 tab of ZYRTEC.
Numbness in face. Not completely numb, but enough that it is noticeable. Also, lips feel full and tingly, but are not noticeably larger.  I first noticed this event approximately 72 hours post injection. I experienced the usual chills, fatigue, headache for approximately 36 hours following injection.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Chills, Fatigue, Swollen and tender left axilla/gland area Narrative:
Dyspnea Narrative: Pt with PMH of pulmonary fibrosis. Seemed to worsen after administration of COVID vaccine Pt. required increased O2 needs. Ct showed worsening fibrosis and lung function tests showed decreased FEV1 and FVC.
pt states that the following day after the vax she was feeling fine and then noticed a red rash under her left arm and around the the left breast, upper stomach area and her back.  The redness seams to be spreading. She says it reminds her of a sunburn. Pt taking Benadryl for her symptoms and will call her PCP.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable).    No concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit and all the vaccines were viable.  No treatment medications were provided.
Sore arm; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included foot pain and breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the right arm. The patient experienced sore arm for few days after receiving 1st dose of Shingrix. The reporter consented to follow up. This case has been linked with case US2019168158 reported by the same reporter.
Pt developed hives, several hours, post vax. Presented to ER with total body urticaria. No respiratory involvement. No wheezing. Treated with Epi 1:1000 0.1cc sq and Benadryl 12.5mg PO.
after 1 day fever to 103 F, rash started 05/25/05. Also now has cold and ROM DX past week.
A nurse reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/16/00. On 11/28/00, she developed soreness at the injection site and pain in her arm with movement. Follow up information received on 01/03/2001 indicated the patient recovered.
Increase in muscle pain in the pelvic that is getting worse after getting the vaccine; Increase in muscle pain in the pelvic that is getting worse after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) and MYALGIA (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Muscle pain.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) and MYALGIA (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) and MYALGIA (Increase in muscle pain in the pelvic that is getting worse after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI case, TCR attached, It was reported that the event muscle pain was pre existing and her PCP is taking care of it and that it had nothing to do with vaccine.
Tested positive for COVID-19; Tested positive for COVID-19; Could not properly sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Apr2021 (Lot number: EP6955) at the age of 32 years as dose 2, single and intramuscular, administered in arm right, administration date 08Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "not recovered" and all described as "Tested positive for COVID-19"; PYREXIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Chills/Shivering"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Fatigue"; INSOMNIA (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Could not properly sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: Covidt test type post vaccination Nasal Swab, covid test name post vaccination COVID-19 Antigen, covid test date=22Dec2021, covid Test result=Positive]. Therapeutic measures were taken as a result of covid-19, pyrexia, chills, fatigue, insomnia.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Advil treatment for the adverse events. Prior to vaccination patient was not diagnosed with COVID-19.  No follow-up attempts are needed. No further information is expected.
After the 1st dose, I had a headache, sore arm, sore joints and fatigue for exactly a week after the shot was administered.  It's been a week since dose 2, and my side effects have been worse. Migrane, body aches, arm soreness, fatigue, cough/hoarse/post nasal drip and having chills to feeling like I was burning. It started when I lost my voice about 3 hours after injection, and worsened over the following 3 days before starting to get better a few days ago Still have a headache and am sore, though, with hoarseness in my voice and a dry throat. Trying to sleep for longer and drink plenty of water.   Went to the Dr. due to spitting blood on Thursday morning. Was informed it was just post nasal drip, but still had to have an EKG done due to a racing heart. Everything looked fine, but I've been in contact with them re: my symptoms in the following day.  Glad to be doing my part for public health, but these have gone on awhile!
p/vax pt devel green, bloody diarrhea, vomiting & fever;pt hosp & tx w/IV Rocephin;infant was discharged from the hosp w/in 3 days;mom reported that daughter did not have a bowel obstruction;
Within 12 hours, high fever of 102, extreme muscle aches and swelling and pain at injection site.  Axillary lymph node and left breast swelling with pain radiating down entire left side of abdomen. Axillary node and breast symptoms persist six months later.
Developed fever 10/24/07. Seizures 11/6/07. Hospitalized in PICU 11/6 - 11/16/07. Diagnosis viral encephalopathy and seizures.  11/07/2007 MR received for an ER visit 11/2/2007 and admission DOS 11/06-16/2007 with a Primary DX: Viral Encephalopathy.  2' DX:  Seizures. Child initially presented to ER on 11/2/07 with c/o increased sleepiness, low grade fever. Pt had had abdominal pain and fever a few days ago but this was resolving. Pt lethargic and difficult to arouse on PE. DX: Hypoglycemia.  Dehydration. Given IVF with dextrose which perked pt up and pt was D/cd. Returned to ER on 11/6/07 with c/o R-sided convulsions where the head deviated to the L.  Pt had been experiencing some bizarre behaviors in recent days.  Pt was unresponsive upon EMS arrival and continued to have seizure activity in ER.  Upon PE pt was extremely agitated with slurred speech. Pt started on anti-epileptic meds.  Facial twitching and leg jerking noted during admission as well as altered mental status and agitation. Pt having difficulty with sleep, only sleeping 3-4 hrs after medication.  Pt developed a rash with itching. Pt was in PICU until 11/13/07 then transfered to medical floor, the d/c on 11/16/07.
Exactly 1 week after getting my second Pfizer Covid dose I hadn what I consider now to be, an IBS flare. I was very close to going to the ER because the diarrhea and and stomach sensations were so painful. I've never experienced anything like that before. I've had a few episodes since then as well and have begun to work with doctors to figure out what is going on.
Patient is a 13 yo female with PMHx of migraine who presents for ER followup. Patient was last seen in office on 9/5/17 for her WCC. Patient was in her usual state of health. Patient received her HPV vaccine during that visit. She later went to cheerleading practice with no issues. Later that day, she developed a migraine. She took Imitrex but had several bouts of emesis. Mother reports she had 12 episodes of vomiting within an hour period, mucous, nonbilious, nonbloody. Patient then around 10pm developed whole body jerking, trouble speaking, and not responding verbally. Denies bowel or bladder incontinence. Parents called 911. Patient was taken to Hospital ED.
J96.00 ACUTE RESPIRATORY FAILURE 4/27/2023 ACUTE RESPIRATORY FAILURE R09.02 HYPOXIA 4/30/2023 ACUTE RESPIRATORY FAILURE
first dose on 20th May 2019 and 2nd dose in 8th June 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th May 2019).   On 8th June 2021, the patient received the 2nd dose of Shingrix. On 8th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The health care professional reported that, the patient had received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Patient presented  on 1/12/22 and stated he wanted a COVID vaccine but did not present a vaccination card at the time or indicated that he had a COVID vaccine historically.  Patient was vaccinated with pfizer vaccine and presented with a vaccination card.  Patient then presented to shelter for second dose of the pfizer vaccine series on 2/9/22.  Patient brought his vaccination card and was administered his second dose of pfizer vaccine.  After further investigation yesterday (2/17/22), it was discovered that the patient had received a pfizer vaccine on 12/2/21.  This means the patient received a total of 3 total doses within the last 90 days and patient is not immunocompromised.  Patient indicated no adverse reactions or events after the third dose.
Second dose of vaccine administered after excursion; First dose administered 11Mar2021,Second dose administered 16Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021). On 16-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vaccines were never checked for temperature throughout the day. It was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times. She reported that the average temperature was 82 to 88 degrees F in April.  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-250537 (Patient Link).
Swelling; Rash all over body with lots of itching; Hives; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Apr2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Apr2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included heart condition, high blood pressure, bronchial asthma, penicillin allergy, shellfish allergy (crab allergy) and mycotic allergy (mushroom allergy), all since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) on an unknown date for unknown indication and unknown if ongoing. The patient previously took Benadryl (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN)and experienced drug allergy, on an unknown date. On 12Apr2021, ever since the patient was vaccinated, the patient had a bad rash all over body with lots of itching, hives and swelling.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of a bad rash all over body with lots of itching, hives and swelling and included treatment with unspecified creams, prednisone, zyrtec (MANUFACTURER UNKNOWN) , and atarax (MANUFACTURER UNKNOWN) . The clinical outcome of the events a bad rash all over body with lots of itching, hives and swelling were not recovered at the time of this report.   The lot number for the vaccine, [PFIZER-BIONTECH COVID-19 mRNA VACCINE], was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning a female patient with no allergies, who on 06-MAR-2008 was vaccinated subcutaneously with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 655766/0038U). On 06-MAR-2008 the patient experienced cellulitis at the injection site. The patient went to the emergency room and was treated with antibiotics and was then released. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Patient developed persistent vomiting. 10 times. Seen in ER. Received IV fluids, zofran.
Chest pain on the left side near heart and is there everyday .  Hard to breath when working out (running).
I developed stomach cramps and discomfort, paired with some diarrhea. I also developed the worst heartburn/acid reflux I have ever experienced. Normally if I get heartburn it?s after a meal, but this was constant throughout the day and night. I am still feeling the heartburn, although it seems it?s not as bad as before. I also developed the worst depression and anxiety of my life. It hit me Friday, April 9 like a bag of bricks. I started crying out of nowhere. I have had intense depression since. The anxiety has been worse than the depression. Pretty much unbearable worry and panic. I have been waking up in the middle of the night around 4 am every night worried. Also when I wake up in the morning I wake up in a panic. The feeling has been terrible and also consistently present.
pt recv vax 29OCT96 & 30OCT96 pt exp rash & ecchymosis on both arms;
mom reported pt became very pale for 5-10mins-no diff breathing-no limpness, sz activity or any other sxs;this occurred approx 3 1/2-4hrs p/vax;T101 in ER;
On 2/12/99, the pt developed pain in his arm where the vaccine was administered. Additionally, the pt experienced a feeling of numbness in his index and 5th fingers. It was reported that the pt self treated with ginkgo biloba. Also, the physician reported that she did not think that she would give the third dose. Follow-up information from a physician reported that "2 weeks after event onset," the pt recovered.
4:30pm hot flashes and chills begin 5:45pm sleepiness, fever, sweating, headache and abdominal pain begin 6pm nausea begins and laying down doesn't help Unknown time between 6 and 7:45 Advil is taken 7:45 - 9:45pm sleep 9:45pm headache pain has centralized to one spot, no more nausea, still sweating with fever 11:30pm all symptoms except fever, nausea, and headache are gone. Remaining symptoms are less than they were.   Day after vaccine fever, nausea, and headache persist but are decreased by Advil and drinking pedialyte and sports drinks with electrolytes.   Day 3, only headache and fever occasionally return. No need for medicine, just taking constant electrolytes.
Fainted twice after receiving second shot.  Fainted on bathroom floor and hit head and back.  Achy, tired and sore afterwards.
C/O hives, itching, skin sore to the touch. Taking ZYRTEC and was seen by PCP and put on steroids.