chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-NOV-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-SEP-2016, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. 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. Additional information has been requested.
Patient reported she  first noticed symptoms the morning after the immunization (approximately 8am). Initial symptoms were red splotches around the injection site and slight soreness. The next day symptoms had advanced to a red circular raised area,  was hard/firm to the touch, and continued soreness to the affected area. The patient stated the area was "the size of a half dollar. Patient reports no other signs or symptoms.
The shot was given up by my shoulder. About 3 days later, I noticed my arm had swollen from my shoulder to down a little pasted my elbow to my forearm. I have noticed the swelling is slowing in spreading down my arm. It is currently about halfway down my forearm.
Severe right arm muscle pain and both arms shoulder joint pain.  Difficult to sleep.  Took 1 Aleve 4/27/2022 at 2 PM, 1 at 3:30 AM 4/28/2022 and one again at 12:45 PM 4/28/2022.  Chills and fatigue.  I had similar pain and fatigue after the 2nd shot, but it didn't last this long.
sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) 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.  No concomitant and treatment medications were reported.
First flu shot given 11-18-12 approx 110 pm. Patient reported feeling lightheaded, dizzy, no itch, redness, rash or change in breathing reported. Recommended watching in area until sx resolve. 70% better after 15 min. After 40 min still no sign of anaphylaxis S.S. Left store. I checked in 2 1/2 hrs later, husband reported "she was very much better, all time."
6-22-12 Admin Pneumo vaccine LA SQ. 6-23-12 Area red, swelling gave antibiotic. 6-24-12 ER temp. IV.
Information has been received from a registered nurse via Poison & Drug Center and refers to a 16 month old male patient. The patient's relevant medical history included otitis media and he had "no active problems". The patient's concomitant medications included a course of amoxicillin started on 21-NOV-2016 for otitis media. On 28-NOV-2016, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneously, once, lot # M028546, expiration date 07-JUN-2018 (anatomical location was not reported), for routine health care. The dose of vaccine had undergone a temperature excursion on an unknown date. The patient had no relevant laboratory values. The patient did not experience an adverse reaction and no treatments were provided. At the time of the report, it was unknown if the patient continued to receive VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000108: US-009507513-1612USA000174.
Patients received first dose 0.25ml  from Red Cap adult vial; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patients received first dose 0.25ml  from Red Cap adult vial) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patients received first dose 0.25ml  from Red Cap adult vial). At the time of the report, INCORRECT DOSE ADMINISTERED (Patients received first dose 0.25ml  from Red Cap adult vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  The patient received Moderna COVID-19 vaccine from a vial with red cap and a label with light blue border.  No Treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-609133 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-609133:CMOD22-03372- crosslink (2 year 11 months old patient), Same reporter
Patient was inadvertently administered a dose of Zostavax (not indicated for pediatric patients), instead of a second dose of varicella. No adverse effects were observed. Patient's mother was notified and informed by physician that a second dose of varicella was not required. Patients mother was advised to watch for any site redness and to report to the physician any adverse reactions.
10/20/08 1650 Flu vaccine given to patient.  10/21/08 called to report went to ER by 1830 10/20 due to dizziness, shortness of breath, vomiting and rapid heart rate.  Arm swollen and tender.  IV fluid given discharged by 2130.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. This is one of several reports received from the same source. No further information is available.
Fever, Chills, Extreme Fatigue, Sweats, Severe headache, Joint and muscle pain/aches for 24hrs
MIld soreness in shoulder; COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and ARTHRALGIA (MIld soreness in shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D [VITAMIN D NOS] and ATORVASTATIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced ARTHRALGIA (MIld soreness in shoulder). At the time of the report, COVID-19 (COVID) and ARTHRALGIA (MIld soreness in shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Diagnosed with Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.  Company comment: This case concerns a 68 Y/O M with an unexpected event of COVID-19 and expected event of arthralgia. Event onset 14 days after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 20-Sep-2022, non-significant correction was performed to update case level seriousness.; Sender's Comments: This case concerns a 68 Y/O M with an unexpected event of COVID-19 and expected event of arthralgia. Event onset 14 days after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
fatigue, muscle pain, headache, chills, fever, joint pain, nausea, injection site pain and soreness.
strong headache; a lot of shortness of breath; lungs full of fluids; stomach sickness; lost of smell; This is a spontaneous report from a contactable Nurse (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 14:00 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, asthma, diabetes. Known allergies: ranitidine/metformin. No pregnant. The patient's concomitant medications were not reported. No covid prior vaccination.No other vaccine in four weeks. Historical Vaccine included first dose bnt162b2 at 58 year old for covid-19 immunisation, first dose lot number=EN6199, administration date=10Mar2021, administration time=02:00 PM, vaccine location=Left arm and experienced headache, shortness of breath and body pain. The patient experienced strong headache, a lot of shortness of breath, lungs full of fluids, stomach sickness, lost of smell on 05Apr2021 with outcome of recovering. The event was serious due to life threatening. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Betamethasone 6mg/ml=3ml/ predinisone 40mg x 4. No covid tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021444473 Same patient, different shot/event
Phone call from Mother on 10-18-16 reporting child's Lt. arm has hives, unknown duration. Reports red, not, raised from shoulder to elbow. ENP gave antibiotics and steroid.
Mother states rash began on sides of face and injection sites and spread. Rash was red and raised. No fever, knots on injection sites. The date 2/21/03. Was seen by MD on 2/24/03 and was issued Z-pack.
Information has been received from a physician via a company representative referring to 2 patients of unknown age and gender. Pertinent medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with PNEUMOVAX 23 injection (strength, dose, route and lot # not reported). No concomitant therapies were reported. On unknown dates, the patients experienced injection site swelling after receiving PNEUMOVAX 23. Both of the patients were in the doctor's office. The outcome of injection site swelling was unknown. Causality was not reported. Additional information is not expected because the reporter was not consented to be contacted.
very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Email
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I am still testing positive.  Clinical information included: Forwarded as an Adverse Event on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 Patient need to update your records on rebound COVID after taking your antiviral medication. In her small circle patient know 7 people that have gotten COVID again. I am was too see if I do my husband has it again and I am still testing positive. Patient never would have taken it if I knew that percentage of peoples that get it again. It should only be given to very high risk people.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.
received a booster dose one month earlier than the time line/received the booster 4 months and 10 days after the second dose; booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical in-formation team for a Pfizer sponsored program (159558). A contactable pharmacist reporting same event under the same suspect product for 2 patients. This is one of 2 reports.   A 34 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 28Oct2021 (Lot number: FF2593, Expiration Date: 16Nov2021) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 2), administration date: 29May2021, for Covid-19 Immunization; Comirnaty (Dose 1), for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "received a booster dose one month earlier than the time line/received the booster 4 months and 10 days after the second dose"; IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "booster".  Additional information: Pharmacist stated that patients received a booster dose one month earlier than the timeline and asks for any recommendations or side effects from it being early? the first patient is a 34-year-old male that received the booster 4 months and 10 days after the second dose. Pharmacist was informed about the Role of Pfizer Drug Safety. When probed for consumer's height and weight, Pharmacist stated, "I don't have that information." Anatomical Route of administration was Deltoid IM injection. The patient did not receive any vaccinations prior within 4 weeks. When probed for any other medical conditions, Pharmacist stated, "No, as far as I know, they are not immunocompromised." (Further not clarified, hence not captured in the tab). When probed if any laboratory tests, Pharmacist stated, "No, I don't know." QR Comment: AE Filed conservatively.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101484800 same reporter./drug/AE, different patient.
Information has been received from a consumer concerning her son who was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient developed little red bumps. Subsequently, the patient recovered from the little red bumps. No further information is expected.
This spontaneous report as received from a physician via a company representative and refers to a 44 weeks old patient. No medical history or concurrent conditions were reported. On an unknown date, when the patient was 44 weeks old, he or she was vaccinated with ROTATEQ dose 1. No adverse effects were reported. No further information was provided. Additional information has been requested.
COVID-19; Acute respiratory failure with hypoxia; Hyperkalemia; New onset a-fib
Clinical findings and symptoms compatible with transient synovitis of the left hip.  Onset with discomfort and difficulty with weight bearing; no fever and no other musculoskeletal or constitutional features.  Symptoms gradually improving over the course of the following week, though not yet fully resolved.  Currently with a mild decrease in internal rotation of the left hip.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL 9 was not reported. This is one of six reports received from the same source. Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014393: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA013057.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # K023621 and expiration date on 19-FEB-2016, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Heart attack a two weeks after 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-Year-Old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via unspecified route of administration in the left arm on 21Mar2021 at 12:45 PM at single dose, for COVID-19 immunization. The relevant medical history included diabetic and high blood pressure from unspecified date. Concomitant medications included insulin, empagliflozin (JARDIANCE), atorvastatin, lisinopril. No other vaccine in four weeks. The patient experienced heart attack a two weeks after 1st dose of vaccine on 06Apr2021 at 08:00 AM. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event). The patient had hospitalization for 3 days. The patient received treatment including stent for the event. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovered with sequel.
flu like symptoms; injection site is warm; coming over the knot; aches,pain; chills; its hard; itching around the site; swollen; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A, 008621A and 008621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain), CHILLS (chills), VACCINATION SITE INDURATION (its hard), VACCINATION SITE PRURITUS (itching around the site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain), CHILLS (chills), VACCINATION SITE INDURATION (its hard), VACCINATION SITE PRURITUS (itching around the site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states the fever and chills come and go.   This case was linked to MOD-2021-066815 (Patient Link).
pt recvd vax 144JUN95 & parent reported to MD 16JUN that large area surrounding vax site was red & swollen (welted);parent gave APAP since vax; afeb;reporter also states more frequent & larger inj site rxn are being reported w/this lot#;
aches in the lower back, followed by cold extremities shortly after in the early evening.  By midnight I had a fever over 102* and bad chills throughout the night with very little sleep.  the next day (Friday) I had a fever of 100* all day while on Tylenol and ibeprophin alternately.  I stayed home from work to try to rest, but was fatigued all day.  By Friday evening  I started regaining strength, aches subsided and temperature was back to normal.
Developed moderate swelling and tenderness on left tricep with blistering on L/nipple.  Ice to area for swelling.  Return to clinic if blistering continues.
First dose: headache, malaise Second dose: left arm sore, tender. Left arm swelled up to the size of a goose egg and I was unable to lift my left arm from my left side.  Low grade fever, body aches, eyes looked sunken in, felt exhausted. I felt like I had the flu. I missed three days of work after the second dose.    I took ibuprofen and iced the left arm and rested.  I never had a reaction to the influenza vaccination in forty years.  The first dose, I did not miss work. And the side effects went away the next day.