chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-MAY-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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 01-JUN-2016, only days after being vaccinated, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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.
Extreme joint pain left leg and both shoulders. Nausea Fever 101 degrees F 2 fainting episodes - 1 quit breathing short time Low blood pressure
Narrative:  A 70yo female with PMH of Bilateral Knee Pain She received  Pfizer COVID - 19 vaccine per policy and protocol first shot on February 6, 20221 and the second shot February 27, 2021 No adverse Event reported
Received immunizaton left deltoid: 7/30/04. Site warm, edematous. LUE circ 29cm. RUE circ 26 cm
Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date August 2021) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Menveo. On 23rd September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: It was reported that the patient had received an expired dose of Menveo, which led to expired vaccine administered. The reporter consented to follow up.
Exposed to chickenpox from daycare on 1-9-17. Patient came in 1-11-17 to office with bumps on arms, face, body x 2 days. Patient attends daycare.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (Lot #Exp, dose number were not unspecified) on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that an unspecified pharmacist might have administered ZOSTAVAX in loose skin area and not in subcutaneous tissue area, no adverse effect reported. The outcome was unknown. Additional information is not expected.
Approx 3 in diameter raised edema, warm to touch pt c/o pain/itching to site, in no s/sx of resp distress, inst to administer 2 tsp Benadryl every 6-8 hours, Ibuprofen 3 tsp PO every 6-8 hours and alternate warm/cold compress and to call back or return to clinic if no improvements
Moderna COVID- 19 Vaccine EUA: Three days after vaccination patient reported rash on chest, back, and legs. No itching reported. Patient advised to use antihistamines if itches and to return to clinic as needed. Two days later patient reports rash has not improved and has developed runny nose, sneezing, nasal congestion, mild cough, and cold symptoms: denies itching, fever, sore throat, shortness of breath, changes in taste or smell, and pain. Patient diagnosed with mild COVID-19 and being managed at home.
After 2nd shot, sore arm and achy joints for about 2-3 days.  Then, about 5 weeks, developed headaches, ear aches and achiness in neck and lower skull.  Then about 6 weeks later (3/29/21) got dizzy and felt no energy, still had headaches, slight ear aches and achiness in neck and lower skull.  Lasted about 3 days but seems to be better (took Meclazine starting on 3/30.    This all concerned me until I saw my chiropractor today (3/31) and he told me 2 of his patients had dizziness too.  They took Benedryl and that helped immensely.  They told him that they looked it up and dizziness can be a an adverse reaction to the Covid vaccs.  I looked it up on FB and saw that dizziness can be a reaction although the timeline for it to happen varied greatly - from immediately after to 3 weeks after.  In my case it's about 6 weeks after.  Felt ok in between the vacc #2 and first reaction of sore arm.  5 weeks after til next reaction of achy neck, skull and earaches.  6 weeks after Vacc # 2  til dizziness.
He had a fall with right arm fracture. Treated with Tylenol initially until he received an x-ray. The doctor placed him in a sling and sent for ortho consult. He was also dx with an upper respiratory infection a few days after the fall.
After routine administration of IM injection with 1 inch needle, patient had clear fluid leaking from injection site.  I was unable to determine if fluid was vaccine or interstitial fluid or the amount of fluid.
vomited; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "vomited"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "diarrhea". Additional information: She had vomited four times after she received the first dose on 16Mar2021 and she's now having bad diarrhea. A week ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT; TIRED; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT) and FATIGUE (TIRED) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced IMMUNISATION REACTION (PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT) and FATIGUE (TIRED). At the time of the report, IMMUNISATION REACTION (PATIENT HAD REACTION AFTER FIRST COVID VACCINE SHOT) and FATIGUE (TIRED) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No concomitant medication were reported.  On unknown dates, the patient experienced got second booster off humira medication for two weeks before and after (Inappropriate schedule of product discontinuation).  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient has temperature and pain in left arm at vaccine site. Red and warm, itchy (scratch marks) to use Tylenol for pain and fever and ice pack to area
Fatigue, cold legs, flu like symptoms, heavy feeling in head and neck, body feels warm. P 8, BP 96/58. Dx: imm. associated myalgia. Watch for GBS Syndrome. 10/07/07-spoke with reporter, patient had a full recovery, no adverse effects other than myalgia. No GBS.
Patient wanted me to inform that when he received the first dose of the shingrix he had a severe reaction to the medication that hospitalized him due to high fever and delirium. He also experienced lymph node involvement in the armpit that swelled and bruised, he has felt general malaise for several days longer than normal
Soreness; headache; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old male patient received the second dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown), via an unspecified route of administration on 02Feb2021 at 06:15 AM at a single dose on the left arm in the workplace clinic for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 at 07:15 AM on the left arm for COVID-19 immunization. The patient experienced soreness, headache and fatigue on 03Feb2021 at 10:00 AM. The patient did not receive treatment for the events. The outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient, who on 12-NOV-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 670216/0464AA, expiration date 31-MAR-2013) when pregnant (believed to be in the early second trimester). The patient was in a detention center when the vaccine was administered. The patient had an office visit with the physician that was following her pregnancy since the VARIVAX (Merck) was administered. The last menstrual period was approximately in July 2011 and the estimated delivery date would be in approximately April 2012. No adverse event was reported. Follow-up information has been received from a health care worker concerning the patient. It was reported that the patient was released from the center while pregnant and had no information to report about her pregnancy outcome. No further information was available. Additional information is not expected.
wk p/vax 17FEB pt began to have aching in both knees;pt knees would buckle when got up;8MAR felt hot & w/fever; 14MAR lt leg began hurting;foot cool;cold sensation in toes;pain from thigh to toes;lt knee drained size of football;limp
under the weather; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (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: MALAISE (non-serious), outcome "unknown", described as "under the weather".  Additional Information: Caller mentioned that she received her 1st dose of the Pfizer COVID vaccine on 18Apr2021. She was supposed to receive her 2nd dose on 9May2021 but was rescheduled to 11May2021. She was not able to come in on 11May2021 because she was under the weather. She would like to schedule an appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, erythema, warm to the touch, started MOTRIN, BENADRYL and cool packs.
I woke up in the morning and I felt very bad upon arriving at my School where I work was tested for COVID-19 and my test was positive.
Lightheaded with flushing of skin, tingling in hands and itching all over.
PATIENT COMPLAINED OF STIFF NECK, NECK PAIN, FATIGUE, MUSCLE PAIN, JOINT PAIN, FEVER, CHILLS, NAUSEA.
Pfizer-BioNTech COVID-19 EUA After receiving the vaccine, during observation period (about 10 minutes after the dose administered), patient became tachycardic and nauseous. Patient was brought over the the ER at 7:05 am with non-intractable viomiting with nausea.  Ondansetron inj 4mg IVP x1 given at 7:40am, at 7:45am   P 135/95;  P 105 ; R 20; WBC 16.2 Patient felt better, tolerating PO, asymptomatic and discharged home at 8:34am
Pregnancy; Pain at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at the injection site) in a 28-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney stone on 01-Jan-1997. Concomitant products included FISH OIL from 20-Jan-2021 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 20-Jan-2021 to an unknown date for Pregnancy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 18-Oct-2021. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound abdomen: Baby healthy.         No concomitant medications were provided No treatment information provided
Heat, redness, sore, and swelling at injection site (right arm). Also had chills and fatigue.
This spontaneous report was received from a Certified Medical Assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concurrent conditions was reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of M-M-R II lot number # M039913 with expiration date 26-SEP-2018, lot # M022407 with expiry date 02-MAY-2018; dose, route and frequency were not provided) reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 42 minutes. There was previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011097: US-009507513-1706USA002251:
about 15 min after the injection patient felt faint, became pale and had a seizure. He regained consciousness and had an additional seizure.  The two episodes and recovery time took about 30 minutes.
-4 PM: intense headache -11:30 PM chills, uncontrollable vomiting -1:00 AM dizzy, fading consciousness, full-body tingling, paralysis and stiffness of legs, difficulty breathing  -2:30 AM entered ER: blood tests, Tylenol, 2 IVs -7:00 AM discharged from ER -symptoms persisted the next two days, slept most of the day
Patient filled out paperwork stating she had never had any other covid vaccines, this was her first injection, medical staff interviewed with routine questions and patient denied being previously vaccinated. Day 1 and Day 2 post vaccination phone calls have been made, and patient is stable and stated no complaints other that some flu like symptoms. Covid + April 2020, received Pfizer Dec 2020, Received Moderna July 2021
vaccinated with Johnson and Johnson. Cough, sob, loss of voice, Has history of Asthma.
Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.
About 10 min after 1st dose Moderna Covid-19 vaccine, patient notes he felt "woozy." denies nausea, lightheadedness or diaphoresis. Offered water, engaged in conversation. After about 2 min, patient notes he feels back to normal. Left with caregiver.
Local rxn including rash which extended fr site down to elbow; Adenopathy in inject site area; Pt started on Augmentum for poss early cellulitis on 21MAR90; Recovered w/in 4-6days;
Headache; Runny nose; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RHINORRHOEA (Runny nose) and SNEEZING (Sneezing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inflammation and Iron high.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), RHINORRHOEA (Runny nose) and SNEEZING (Sneezing). At the time of the report, HEADACHE (Headache), RHINORRHOEA (Runny nose) and SNEEZING (Sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Ibuprofen for headache.
Breakout on his face / shingles/chickenpox virus; Lesions themselves are not painful / the postherpetic pain is; Redness (from top of left shoulder to the elbow); Chills; Headache; This case was reported by a consumer and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, 1 days after receiving Shingrix, the patient experienced erythema, chills and headache. On an unknown date, the patient experienced shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valtrex). On 31st July 2020, the outcome of the erythema, chills and headache were recovered/resolved. On an unknown date, the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, erythema, chills and headache to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on upper left arm. The day after getting Shingrix, the patient experienced redness (from top of left shoulder to the elbow), chills, and headache which lasted two days. Less than 6 months after receiving Shingrix, the patient experienced a breakout on his face that he describes as the shingles or chickenpox virus. The patient initially thought it was adult onset acne, but it spread from the right side of his face to the left side. He reports that the lesions themselves were not painful, but the postherpetic pain was. The patient had seen his HCP and was advised to not get the 2nd dose of the vaccine until the outbreaks stops. HCP prescribed Valtrex that he was still currently taking (day of reporting was his fourth day on Valtrex). On the day of reporting, the patient noticed that there were spots on his left arm, left inner elbow, and on his stomach as well. However, he stated the outbreak was primarily isolated to his face.  Not all information was available. The reporter consented to follow up. The patient gave permission to follow-up with their HCP and provided the contact information. The patient was unable to provide HCP's email or fax at the time of report.
Pt stated soreness and pain RUE started around 10 P.M on 9-21-17. Decreased ROM continued with pain saw Dr. instructed to do ROM and warm moist compress continuous to do as Dr. prescribed and ROM is returning still has some pain and soreness but is less.
I have had small patches of an absence of pigmentation prior to being vaccination and have had past bloodwork that indicated I have an autoimmune disorder. But after my 2nd vaccine my skin started losing pigment rapidly and the Doctor confirming it was all around my lymph nodes. So at all points of my lymph node sites I have 8" wide area of pigment loss. The back of my hands and top of my feet. I've seen a Rheumatologist and Dermatologist. I was given a steriod cream but that doesn't work. They said I had an autoimmune response to the vaccine due to potential predisposed condition to begin with.  It came on very suddenly after the vaccine and continued to spread rapidly.
Sore Arm; Rash on the arm/rash from his knees down; had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE REACTION (had a reaction) and RASH (Rash on the arm/rash from his knees down) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (had a reaction). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and RASH (Rash on the arm/rash from his knees down). The patient was treated with CORTISONE at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE REACTION (had a reaction) and RASH (Rash on the arm/rash from his knees down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information also included Anti-histamines.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: Added event.