chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. 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.
Small bump appeared on her face; Started getting bigger and red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Small bump appeared on her face) and SWELLING FACE (Started getting bigger and red) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Small bump appeared on her face) and SWELLING FACE (Started getting bigger and red). At the time of the report, ERYTHEMA (Small bump appeared on her face) and SWELLING FACE (Started getting bigger and red) 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 medications was not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079727 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: follow-up received and does contain non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079727:Second dose
pt had a positive COVID test on 1/13/22 in the nursing home; per death certificate, pt's cause of death was COVID 19 and she passed away in the nursing home
Patient experienced fever, vomiting, diarrhea, jaw locked, major  migraine, weakness
sore throat, congestion, aches negative 2/1 fully vax no booster
headache; fatigue; blood pressure has gone up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 27Mar2021, outcome "unknown", described as "blood pressure has gone up"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning, 60-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history included rheumatoid arthritis, hypertension and allergies to diphenhydramine and meperidine.  No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a  60-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 041L20A), and who experienced the serious unlisted event of anaphylaxis-like symptoms.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
pt recv vax 23SEP97 & 25SEP97 pt exp sz;hands & legs were curled for 30min;
Information has been received from a physician concerning a 7 year old male who on 03-FEB-2004 was vaccinated with the first dose of MMR II. On 24-APR-2007, was vaccinated with the second dose of MMR II. On 07-DEC-2009 the patient experienced mumps. The patient had a fever of 101.2 F and had a parotitis. On 02-DEC-2009 the patient was diagnosed with mumps. On 02-NOV-2009 the blood work was done and the results indicated IgM was 1:20:00, and IgG was 1.43ND. The outcome of mumps was unknown. Follow up information was received which reported that patient on 04-DEC-2009 developed mumps which was diagnosed at the same date. The patient was afebrile. It was reported that the patient also had lower jaw pain. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Discomfort and warmth at inj site. Step sibling with same reaction to same imm today.
Temp excursion, unknown if administered; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Temp excursion, unknown if administered). The outcome of the incorrect storage of drug 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: 25-APR-2023 The reporter was the medical assistant, reported that on April 19, 2023, excursion of the product was occurred, which was not too long, it was for short time. The reporter hung up the call abruptly, thus limited information. The product was excursed, which led to incorrect storage of drug. The reporter consented to follow up.
INADVERTENTLY VACCINATED BEFORE 12 YRS OLD. UNABLE TO REACH CONTACT WITH INFO PROVIDED. WRONG DATA ENTRY SUSPECTED.
12/26/22  I had a severe sore throat, felt feverish, joint and muscle pain. I took an at home COVID test which was positive. I called my doctor?s office and was prescribed Paxlovid. I started taking the Paxlovid for the five days.  I still felt bad after taking the Paxlovid. I continued to have a horrible sore throat; I could barely drink. I could barely swallow a pill; my throat was so swollen which lasted for three or four days. It was four weeks before I began to feel like myself again.
Severe Chills (no fever), body aches, severe  joint pain Lasted for about 6 hours
Shot hurt immediately 4:00 pm by 11:00pm my neck, arm, and hand hurting very badly by 12:00 midnight have severe pain and my hand is paralyzed this continues until 2:00 am pain began to lessen around 3:00 am was able to go to sleep . My neck and hand continued to hurt for 2 days . My arm hurt for 5 days .
High fever up to 104 degrees for 4 days after receiving injection. Required IV therapy for dehydration
fever, up to 101, tiredness, pain & induration measuring 43x40mm w/erythema lt deltoid following Td vax induration measured on18AUG93;tx APAP, cool compresses improved on 20AUG93;dec pain & induration;
Information has been received from an office manager concerning a kindergarten age patient who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (lot#s not reported) in the lateral thigh, MMR II (MSD) (lot#s not reported) in the lateral thigh and KINRIX in the deltoid all at the same time. She stated that these are the three standard immunizations given for children of kindergarten age. In the process of trying to narrow down which inoculation was causing the reaction, they moved the injection site of the KINRIX to the deltoid. Subsequently the patient developed cellulitis at the injection site. The office manager stated that it didn't appear that the patient previously reported had a reaction to VARIVAX (Merck), the patient had a reaction to the KINRIX. No medical attention was sought. At the time of this report, the patient had recovered from cellulitis at the injection site. This is one of several reports from the same source. Additional information is not expected.
Started getting symptoms on the right side - both front and back - upper quarter of body and all the way under the ar. Red dots and painful to the touch  - with clothes, even when the wind blows. Over time it has gone down. I took the Epsom Salts with the hemp helped a lot. The doctor  - said there was nothing he can do. He said the viral medicine can only be taken when the day it starts and not three days later (when I saw him). It's almost gone now.
Sharp pain for 10 minutes following injection. A Pain I had never felt before. Almost fainted because of pain. Then after 10-15 min, the pain disappeared. Then, 1 to 2 weeks later, I started feeling a lingering pain around the injection site. it has been 4 months now and I still feel pain, from time to time, on my upper arm. Pain does not go down the arm, it stays around the injection site.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of VAQTA (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up was received from a medical assistant and refers to a 3 years old patient of unknown gender. On 23-JUL-2014 the patient was vaccinated with a dose of VAQTA lot # K007791 and expiry date 22-AUG-2016 (dose, route not reported) that on 10-JUN-2014 had been exposed to 51 degrees. Fahrenheit for 51 minutes and on 18-JUL-2014 to 48 degrees Fahrenheit for 24 minutes.  This is one of several reports received from the same reproter. Additional information is not expected as no follow up was obtained.
Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph nodes began afternoon 1/14/21
Onset approx. 24 hours after immunization: Chills & sweats, body aches, injection site pain/redness/swelling, denied anyphylaxis.
2/21/06 received YF vax by Thursday morning she noticed red, raised, 5mm diameter bumps about 3-4 around waist and 4 cm each shin.  She denies any respiratory symptoms. She states that bumps are very "itchy", looked like "flea bites" and resolved by Sunday 2/26.
Following vaccination, the same day the pt cried for 6 hours. No treatment was given. The outcome is resolved. The most recent information received on 3/27/00 reports the condition of the pt as resolved.
Skin rash in the neck looking like Shingles.  Headache.  Chills. Body ache.
Information has been received from a female consumer concerning her daughter who on an unspecified date was vaccinated with a dose of MMR II several years ago. Subsequently several years ago she had a bad reaction to the MMR II. No further information is available.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Additional Details: patient complained of lightheadedness and then vomitted about 2 minutes after administration of the second dose, father stated this lightheadedness without vomitting happened on the first dose as well
This spontaneous report was received from a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL lot # K023432 with expiry date on 18-JUN-2016, (strength, dose, route and anatomical location not reported). No adverse effect was reported and no product quality complaint was reported. Temperature: 9 Celsius degrees. Time frame: 40 hours. Was it administered (AE)? Yes. Previous temperature excursion? No. Was call because of a "data logger"? No. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female who, at "10 years old", in approximately 2001 was vaccinated with a first dose of Recombivax HB (manufacturer unknown). Subsequently the patient experienced a serum sickness type reaction with a high fever, chills, and myalgia. The patient was vaccinated with a second dose of Recombivax HB (manufacturer unknown). After the second vaccination the patient experienced a serum sickness type reaction with a high fever, chills, and myalgia. The duration of the reactions were not known. It was reported that the patient was fully recovered as of 27-OCT-2006. Unspecified medical attention was not sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 55.04.  No concomitant medications were reported.  On 03-Apr-2021, 20 vials were moved to clinic.   The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 03-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
8/6/15 Patient called c/o arm pain, body aches, fatigue, headache, swelling/warm to touch at site, cold/flu like symptoms, unsteady gait, lower extremities sore. Per patient applied cold compress with minor relief.
Red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose.; Shingles on left thigh-mild about 3 months after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 14:00 (Lot number: EW0150) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: penicillin" (unspecified if ongoing); "Allergies: shellfish" (unspecified if ongoing); "Allergies: dairy intolerance" (unspecified if ongoing); "asthma", start date: Mar2017 (ongoing), notes: current, Illness/AE: Asthma, Pertinent Details: QUAR 80 mcg 2 puffs 2x/day; "ibs" (not ongoing), notes: recovered; "celiac" (unspecified if ongoing); "chronic fatigue" (not ongoing), notes: recovered. Concomitant medication(s) included: QVAR taken for asthma; VIT D3; FOLATE; INFLUENZA VACCIN, administration date 01Oct2021. Past drug history included: Allergies: celiac (gluten), reaction(s): "Allergies: celiac (gluten) allergy"; Macrodentin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302, Location of injection: Arm Left, Date: 12Mar2021, Time: 2 pm, Route of administration: Intramuscular), administration date: 12Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset May2021, outcome "not recovered", described as "Red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose."; HERPES ZOSTER (non-serious) with onset 2021, outcome "not recovered", described as "Shingles on left thigh-mild about 3 months after second dose". The events "red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose." and "shingles on left thigh-mild about 3 months after second dose" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of erythema, herpes zoster.  Additional information: Red blood spots on left forearm begin bright red, disappear in a few days and turn brown a few months after 2nd dose. Once appeared on right forearm. No pain or itching. Just bright red small spots appear singly and in clusters-ranging between tiny pinpricks to 1/2 inch in diameter Shingles on left thigh-mild about 3 months after second dose. Patient was not covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
I received my 2nd booster of the Pfizer Covid-19 vaccine on 9/7/22. I developed painful sores on the left side tip of my tongue and one on the lip of my mouth.
Resident received Pneumovax 04/03/06 0.5cc IM injection in left upper arm on 4/5/06, area observed 13cm x 14cm was red, swollen. Resident complained of soreness in area. Reaction reported by nurse on 4/5/06.
Initial report 5received from a non-health care professional (consumer) on 16 OCTOBER 2013. A 47-year-old male patient, with history of allergy to procaine and cortisone, had received a dose of FLUZONE, in left deltoid region on 14 OCTOBER 2013 (batch number and route of administration were not reported). It was reported that, on 05 OCTOBER 2013 the patient experienced 1/8" diameter redness, scab will not heal for 2 weeks. The patient got dizzy a couple of times, heart ped up 3-4 times the first week after the vaccine, now resolved. Correction treatment was not reported.   At the time of this report, the patient was not recovered from the event. Documents  held by sender: None.
pneumonia; congestion; coughing; sore throat; This is a spontaneous report from a contactable consumer. This consumer reported for a 97-year-old female patient (mother). This 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6200), dose 1 , single dose via an unspecified route of administration in the right arm on 18Feb2021 for COVID-19 vaccination. Medical history included COVID-19 on an unknown date in Oct2020, colon cancer, congestive heart failure and had a pacemaker.  Concomitant medications were not reported. On 24Feb2021  the patient had pneumonia, congestion, coughing and sore throat. She was on oxygen and does not use it all the time and guaifenesin (MUCINEX). Treatment was received for pneumonia, congestion, coughing and sore throat.  The clinical outcome of pneumonia, congestion, coughing and sore throat was not recovered.
Anaphylactic reaction - swollen lips, decreased mental status, hypoventilation. Aborted with SC Epi followed by IV Benadryl and steroids. Nurse follow up on 06/08/04 states: Rash, erythema, vomiting. Medical record states stupor, tachycardia, anaphylaxis, vasodilate. msv
Developed mild, Lt jaw swelling after anthrax vacc #1, treated as dental infection. Developed marked (L) jaw swelling after anthrax vacc #2, treated an angioedema - observed overnight in ward & treated w/antihistamines/parenteral steroids.