chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (R.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient with no drug reactions/allergies and no pertinent medical history who on 21-DEC-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 670654/0785AA) (dose and route were not reported) and subsequently determined that she was pregnant. There was no concomitant medication. The patient's last menstrual period was in October 2011. Expected date of delivery is in July 2012. There was no adverse effect reported. The patient sought medical attention by a follow-up visit. No lab diagnostics studies performed and no treatment was given. Outcome was unknown. Follow-up information was received from the registered nurse on 09-JUL-2012. Registered nurse reported that the patient never came back to the clinic for any follow-up and did not have any information regarding pregnancy outcome. She stated there was no forwarding HCP on record at the center. Case lost in follow-up. Additional information is not expected.
Got an unusual sunburn on her face while at school - which burned really easily. When it peeled. Underneath was pure white skin. She was then sent to dermatology, when she was later (October 26, 2011) diagnosed with auto immune disease Vitiligo. She went through about a year or 2 of laser light therapy to get rid of it and it never got better. The doctors were baffled as to how she could get it as there is absolutely NO family history of Vitiligo. They said that it was not normal for her to get such a thing and that she didn't match any of the characteristics relating to getting this. Since then she has to stay out of the sun or she burns and blisters. She has very extra sensitive skin ever since.
Pt c/o lightheadedness 15 mins after receiving vaccine. She denied any medical history and noted that she did not have anything to eat this morning, last meal night. She was assessed and monitored by NP, EMT and paramedic. Initial BP - 161/98, HR - 92, 99.
Myalgia, Fever C/O "FLU LIKE SYMTPOMS, BODY, NECK ACHES, OVERALL FATIGUE, DIFFICULTY CONCENTRATING, SLIGHT FEVER, EXTREMELY TIRED, BONE PAIN IN FEET AND SHINS. DISPO: WENT HOME, RESTED, TOOK APAP, SLEPT, MUCH IMPROVED Narrative:
Patients didnt get their 2nd shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked restart series, or just gave the 2nd dose if it had been over the year mark. The reporter did not probe any further but health care professional did give permission for follow up via postal. The reporter consented to follow up.
I looked at the box that had the flu shot and mistaked the number of the month. I told the doctor after it was administered but mom already had left and she called her to inform the mother what happened.
Patient had 2 inch diameter around injection site that was red, swollen, warm to touch. Started in the evening after receiving her flu shot. Patient took TYLENOL 10/22/18 to treat the pain. When she came into pharmacy, nurse instructed patient to use ibuprofen and a cold compress to help with swelling and to refer to primary doctor if symptoms worsened.
deaf in one ear with 80% hearing loss; This is a spontaneous report from Pfizer-sponsored program. A contactable physician (patient's mother) reported that a 16-year-old female patient received meningococcal group b rlp2086 (manufacturer unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced deaf in one ear with 80% hearing loss. The patient had a MRI with no lesions showing, blood work was pending, suspect the cause was idiopathic. The outcome of event was unknown.  Pfizer is a marketing authorization holder of meningococcal group b rlp2086 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.
Patient stated having neurological adverse effects including neuropathic pain, optical complaints,  and parethiesias.
She started getting symptoms around 2AM with a high fever of 101.6. I did give her children's TYLENOL. She now has a runny nose and sneezing. She is also having trouble sleeping. I took her to a facility and had a rapid COVID-19 test that was positive.
Patient complains of injection site pain, body aches especially legs, nausea, headache, fever of 100 degrees F and chills.
This spontaneous report as received from a pharmacist via company representative refers to a 55 year old female patient. In July 2012 the patient was vaccinated with ZOSTAVAX (lot number not provided). In January 2013 the patient had discovered that she had breast cancer. The patient had started chemotherapy as treatment for adverse event. The patient had sought unspecified medical attention. The outcome of adverse event was unknown. Upon internal review, breast cancer was considered as to be medically significant event. Additional information has been requested.
PT STATES THAT HE HAS HAD ARM PAIN NOT JUST AT THE INJECTION SITE BUT HIS WHOLE ARM SINCE 2 DAYS AFTER BEING VACCINATED
Fever of 101.7 or 8.; swelling around the injection site; injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue"; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue"), PYREXIA (Fever of 101.7 or 8.) and VACCINATION SITE SWELLING (swelling around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Dysmorphism (dysmorphia with calcium deposits in muscle) and Arm fracture (At first injection, her right arm was broken and dislocated.). Concurrent medical conditions included Immune system disorder NOS.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 23-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue"). On an unknown date, the patient experienced PYREXIA (Fever of 101.7 or 8.) and VACCINATION SITE SWELLING (swelling around the injection site). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injection to the medial left thigh about 3 inches from the groin either subcutaneously or into "soft tissue") had resolved and PYREXIA (Fever of 101.7 or 8.) and VACCINATION SITE SWELLING (swelling around the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged.       Concomitant medication was not provided.  Patient reported that the vaccine was documented incorrectly as being injected into her anterolateral thigh instead of her medial thigh.   Treatment medication was not provided.   This case was linked to MOD-2021-276022 (Patient Link).
Large local redness and swelling around injection site. 8 mm diameter. Some blistering noted Atarax syrup given; Ice applied.
I've been boosted once and got covid; I've been boosted once and got covid; This is a spontaneous report received from a non-contactable nurse from medical information team. The reporter is the patient. A male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've been boosted once and got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Product: COMIRNATY. Question: Your not going to use anything with my information are you? The only part I don't like is the part that you will share my information with other companies. Will you erase my information?  I don't want Pfizer sharing my information. Caller is a RN that wishes to remain anonymous. I've been boosted once and got covid and now trying to decide to get second booster or wait until the one that covers the two or three variants. Question: When will the booster for Covid be available to cover the three new variants?  I've been boosted once and got Covid and now am trying to decide to get second booster or wait until the one that covers the two or three variants. The new vaccine that is coming out in the fall. You don't have any recommendations for someone trying to decide do you?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected BNT162b2 (COMIRNATY) in this patient cannot be completely excluded.  However, vaccine efficacy varies from one patient to another and can be affected by different factors. Further information like vaccination date and COVID infection date and co-suspect covid-19 vaccines (manufacturer unknown) needed for better medical assessment.
POSSIBLE INCORRECT ROUTE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced possible incorrect route. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible incorrect route was not reported. This report was non-serious.
Pt died at Hospital 5 days after imm received no adverse reactions reported after immunizations given. Baby reported to have fallen off of couch on June 24th and put to bed with a bottle propped. No obvious signs of trauma or aspirations. No problems that day besides some congestion. Has a history of being seen in the ER for febrile seizures never reported at the health department. Child was going the next day for 9 month old check up. No history of of problems with any vaccine.
Symptoms: Facial cellulitis, rash.  Description: Symptoms started with pain at the shot site on the 1/14, then shooting pain to the nick area (like nick pain) on 1/15 I noticed swelling in my face and jaw below the ears area, over that weekend my face swell more, no fever, just a feeling of higher temperature (as if I was having hot flashes). I seek  medical treatment at an urgent care on 1/18/2021, was prescribed antibiotics and followed up couple of days later with PCP on  1/22/2021 who extended my antibiotics treatment. The facial swelling improved.
0.25 ml fluviron given.  Rec 74 yrs.  No reaction.
patient experienced pain, & swelling in his left arm that spread to medial portion of the forearm; patient experienced pain, & swelling in his left arm that spread to medial portion of the forearm; This spontaneous report was received from a physician via a company representative referring to a 75-year-old male patient.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On 24-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (lot # S002582 with expiration date 10-AUG-2020; dose and route were unknown) for prophylaxis at his upper left arm. On the same day, the patient experienced pain, & swelling in his left arm that spread to medial portion of the forearm. On 26-JUL-2019, the patient visited physician office for medical attention and was treated with prednisone and benadryl. There was no lab diagnostic/study.The patient was recovered from the adverse events (AEs) on unknown date in 2019. The causality was not provided.
She experienced extreme dizziness, and the room was spinning. This resolved when she laid down for a few minutes, but continues when she gets up. Her daughter treated her with meclizine, which helped the dizziness, and reached out the PCP. They informed her if she is still having symptoms 72 hours after the vaccine to reach out to the PCP again.
Numbness in arm down to hand, vomiting, nausea, fever, chills, weakness in body, exacerbation of spinal pain from spinal block injection in January for c section.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years, experienced other anaphylactic shock, NEC (confirmed) (serious, since 01-Feb-2012, until 01-Feb-2012) while enrolled in the study. The patient was hospitalized for IV treatment which included: epinephrine (injection) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown); SOLU-MEDROL (IV) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown); BENADRYL (IV) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown). The patient also received MCV4P on 01-Feb-2012 (lot#U4259AA manufacture PCM), Tdap on 27-Jan-2012 (lot#AC52B075AA manufacture SKB), and influenza on 27-Jan-2012 (lot#UT423AA, manufacture PMC); PEDVAX on 01-Feb-2012 (lot#0231AA, manufacture MSD). At the time of the report the outcome of the AEs were: other anaphylactic shock, NEC: recovered/resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Concomitant medications within 42 days of vaccination: calamine lotion (topical) started on 14-Feb-2012, stopped on 10-Mar-2012 (dose, unit, frequency and indication unknown), Influenza Vaccine, DTP vaccine, IPV, Meningococcal Vaccine, PEDVAX-HIB. The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious  (Important Medical Events)).  This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the Adenovirus Vaccine.
She is breastfeeding and she was fine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (She is breastfeeding and she was fine) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (She is breastfeeding and she was fine). At the time of the report, EXPOSURE VIA BREAST MILK (She is breastfeeding and she was fine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 35-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified), hepatitis B vaccine for prophylaxis. The subject had no history of adverse events with previous vaccinations. The subject was not taking any concurrent medications and was noted to be "healthy". On unspecified dated the subject received the 1st dose, 2nd dose, and 3rd dose of a Hepatitis B vaccine (doses and manufacturer unspecified). A student health nurse reported that the subject did not respond to the initial three does series of the Hepatitis B vaccine. At the time of reporting, the subject had not experienced any adverse events. On 6 June 2007 the subject received a dose of Engerix B (1 cc), which was the 6th dose of a hepatitis B vaccine. The vaccine expired on 11 April 2007. At the time of reporting the outcome of the events was unspecified. Follow-up was received from a healthcare professional. The healthcare professional reported that the subject was completing his "number 6 dose of hepatitis B vaccine of a repeated series due to a negative titer after number 3 dose of hepatitis B" vaccine. The healthcare professional also reported that on 6 June 2007, an expired dose of Engerix-B was administered and that the expiration date was not verified before the vaccine was given. The subject was subsequently revaccinated.
Started feeling dizzy and nauseous on Monday 28Jun and has progressively gotten worse.; Started feeling dizzy; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 27Jun2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known drug allergies. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration on 04Jun2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jun2021, the patient started feeling dizzy and nauseous and had progressively gotten worse. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the dizzy, and nausea and included treatment with Zofran initially for nausea and started Valium. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling dizzy and nauseous and had progressively gotten worse were unknown at the time of this report.
received only the Shingrix diluent without reconstitution with powder.; received only the Shingrix diluent without reconstitution with powder.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the Shingrix diluent without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case has been linked with US2021126512, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021126512:Same reporter
Rec'd Engerix-B on 15NOV89, 19DEC89, & 27JUN90. Pt was a non-responder. No tx was given: outcome is pending.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 79 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2009, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUN-2012, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 31-AUG-2015, the patient was treated at the same clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt presented with acute altered mental status and headache with multiple episodes of emesis. Patient has a history of chronic headaches but these headaches were associated with multiple episodes of emesis and photophobia. On presentation, patient required intubation due to acute AMS.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 35-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. On 6 November 2012 at 12:15 the subject received a dose of FLULAVAL (3.5 ml, intramuscular, left deltoid) and experienced overdose. The recommended dose is 0.5ml of FLULAVAL. The subject was treated with TYLENOL. At the time of reporting the outcome of the injection site pain was unspecified.
Narrative: 01/06, Pfizer, dose #1 01/26, Pfizer, dose #2 08/25 pt cc: diarrhea, loss ot tase or smell, exposure: unknown 09/08 COVID swab, result: detected