chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; Dose 1: Janssen (J&J), dose 2 and dose 3: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 15:00 as dose 2 (booster), single (Lot number: FG3527), in right arm and on 18May2022 at 14:30 as dose 3 (booster), single (Lot number: FM9992) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 25Mar2021 at 15:00 as dose 1, single (Lot number: 1808978), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Nov2021, outcome "unknown", described as "Dose 1: Janssen (J&J), dose 2 and dose 3: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral drug Paxlovid from 09Nov2022. Clinical course: Treatment of COVID-19 with Paxlovid. Relapse 4 days after last Paxlovid pill on 14Nov2022. Stuffy nose, running nose, no energy, slight headache.
Naseated; Hardness was the size of a palm; Was Tingling; Little bump on arm; Itchy; Slight headache; Throbbing; Arm felt weaker; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Was Tingling), INJECTION SITE MASS (Little bump on arm), VACCINATION SITE INDURATION (Hardness was the size of a palm), PRURITUS (Itchy) and HEADACHE (Slight headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included BIOTIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Was Tingling), INJECTION SITE MASS (Little bump on arm), VACCINATION SITE INDURATION (Hardness was the size of a palm), PRURITUS (Itchy), HEADACHE (Slight headache), PAIN (Throbbing), NAUSEA (Naseated) and MUSCULAR WEAKNESS (Arm felt weaker). At the time of the report, PARAESTHESIA (Was Tingling), INJECTION SITE MASS (Little bump on arm), VACCINATION SITE INDURATION (Hardness was the size of a palm), PRURITUS (Itchy), HEADACHE (Slight headache), PAIN (Throbbing), NAUSEA (Naseated) and MUSCULAR WEAKNESS (Arm felt weaker) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
One week after receiving the Janssen Covid-19 I developed a crushing/squeezing/contracting sensation underneath my left lowest rib. The first night it hit, I could barely sleep as it felt like something was moving underneath my rib. It also felt like I had swallowed something and it was stuck underneath of my rib. The size of a walnut. I had never felt anything like this before. The next day the rib itself became very sensitive to touch. I went to my doctor who ordered an XRay, at first he thought it looked like I had a rib injury. Over the next 3 weeks I had to lie down after every time that I ate, because the contracting sensation was so intense. I tried to use NSAIDS to relieve the sensation but they didn't do anything to help. After several weeks of varying intensity of the contracting/squeezing sensations under my rib, it started to become more painful. The area affected seemed to have grown. It felt like something was stuck underneath my rib the size of my palm, and the radiating pain was much larger now. The sensation radiated across my left side and wrapped around to my upper back. I had a hard time wearing a bra. I went back to my doctor, who took more XRays that showed nothing. He believed it not to be serious, but at this time I was in a lot of pain, and worried. He ordered a CT Scan. It also came back with no additional findings. He recommended I see a spine and nerve specialist for an intercostal nerve injury. I went home and tried to endure the injury. I ended up going back after developing shortness of breath upon exertion. My primary doctor now order an MRI. The MRI did not show any further injuries, or concerns. I am no 4.5 months out and I have days were it is not as painful, but the contracting and squeezing sensation, I feel throughout the day, every day. The spine and nerve specialist said that I developed Intercostal Neuralgia from either an unknown cause, or for an anatomical issue with my rib. The thing is I never had any of this prior to the vaccine. I know in my heart that the vaccine cause damage to my nerve pathway that runs underneath the rib. I can only pray that this subsides, because even as I sit her typing this, I feel the contracting sensation underneath my ribs. It is awful!
Felt very sick; headache; hot under the injection site; fever; swollen under the injection site; red under the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot under the injection site), VACCINATION COMPLICATION (Felt very sick), PYREXIA (fever), VACCINATION SITE SWELLING (swollen under the injection site) and VACCINATION SITE ERYTHEMA (red under the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot under the injection site), PYREXIA (fever), VACCINATION SITE SWELLING (swollen under the injection site) and VACCINATION SITE ERYTHEMA (red under the injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt very sick) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 15-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot under the injection site), VACCINATION COMPLICATION (Felt very sick), VACCINATION SITE ERYTHEMA (red under the injection site) and HEADACHE (headache) outcome was unknown and VACCINATION SITE SWELLING (swollen under the injection site) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
BELL'S PALSY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 in total, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date 2021, the patients head started to hurt on one side of her face and she was in hospital because she was having a stroke but it turns out she got Bell's Palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210451954- COVID-19 VACCINE AD26.COV2.S-BELL'S PALSY. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Breakthrough case admission after three vaccines Moderna 1/23/21 Lot# 029L20A;  Moderna 2/20/21 Lot# 024M20A;  Moderna 12/7/21 Lot# 012H21B
redness below the injection site; upset stomach the day after the injection; swelling below the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema, upset stomach and swelling. On an unknown date, the outcome of the erythema and swelling were recovering/resolving and the outcome of the upset stomach was not recovered/not resolved.   It was unknown if the reporter considered the erythema, upset stomach and swelling to be related to Shingrix.  Additional details were received as follows: The patient experienced redness and swelling below the injection site and an upset stomach the day after the injection. The patient did not consent to follow up. This case has been linked to cases US2019AMR234253 and US2019228120, reported by the same reporter.
Second dose of Pfizer vaccine. That evening developed head numbness and tingling with tingling of extremities and lips. Weakness and loss of strength followed by persisting light headedness. Reporting since receiving vaccine "lungs feel full of fluid"
Mother states no sxs noted until "two months" after shot on May 26, 2004. Mother noted "small, hard spot on right thigh on 7/12/04." Nothing else there, no redness. First week of August, took to doctor. Only knot under skin, still no redness. Doctor stated to just monitor. Took to doctor 2 weeks after that visit. Now red, hard, bigger. Doctor struck with needle only blood came out. Put on Augmentin BID x 10 days. Today 9/8/04, mother states area drained "pus" this AM. Advised to notify doctor and watch for red streaking.
headaches, elevated blood pressure (had to increase lisinopril to 20 mg, still after 3 weeks blood pressure is over 130)
CLIENT STATES THAT ON THE DAY OF THE VACCINE BEING ADMINISTERED TO HER, THE NURSE GIVING THE SHOT USED A STABBING TECHNIQUE IN HSR LEFT UPPER ARM. STATES SHE ASKED THE NURSE WHY DID SHE GIVE HER SHOT THAT WAY AND WAS TOLD THAT THIS IS THE WAY THAT SHE WAS SUPPOSED TO GIVE IT. CLIENT STATES THAT S DAYS LATER SHE WOKE UP TO A SWOLLEN ARM AT THE INJECTION SITE AND IT HAS NOT GONE AWAY SINCE THAT DAY. SHE PRESENTED TO OUR FACILITY ON 08/11/2023 AT WHICH TIME i MEASURED THE AREA NOTING IT TO BE APPROXIMATELY 2 AND A HALF INCHES WIDE AND 3 AND A HALF INCHES LONG. NOT WARM TO TOUCH JUST SWOLLEN. STATES SHE HAS BEEN TO THE ER 2 MONTHS AGO FOR ANOTHER REASON AND THE ER DOCTOR NOTICED THE AREA BUT NOTHING WAS DONE ABOUT IT AT THAT VISIT. SHE HAS ALSO BEEN UNDER THE CARE OF 2 DOCTORS REGARDING HER RIGHT SHOULDER BECAUSE OF A FALL ON THAT SHOULDER. BOTH DOCTORS HAVE SEEN THE LEFT ARM BEING SWOLLEN AND ARE CHECKING TO SEE WHAT CAN BE DONE ABOUT IT BECAUSE CLIENT STATES THAT SHE HAS BEEN TOLD IN TIMES PAST THAT SHE COULD NOT GET A MRI DONE WITH HAVING THE PACEMAKER.
Chills, shakes.  Lasted from 7 PM until bedtime.  Warmed up in bed.  Woke up feeling drowsy all the next day. I took an extra strength Tylenol about 8 PM the night of the chills.  That helped some.
Injection site hot; Tiredness / fatigue; Injection site red; Vaccination site itching; Every muscle in her body is hurting, muscle pain; legs started to hurt really bad; they're numb; she could not really walk; feet are still really hurting; is like her whole body is just hurting; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting) and PAIN (is like her whole body is just hurting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis (The patient had pretty severe osteoarthritis and did not have pain since December.). Concomitant products included GABAPENTIN for Leg cramps, SUMATRIPTAN for Migraine, TRAMADOL, QUETIAPINE FUMARATE (SEROQUEL) and ROPINIROLE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (severe headache). On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting), PAIN (is like her whole body is just hurting) and MYALGIA (Every muscle in her body is hurting, muscle pain). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot), FATIGUE (Tiredness / fatigue), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PRURITUS (Vaccination site itching). The patient was treated with CORTISONE for Osteoarthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (legs started to hurt really bad), HYPOAESTHESIA (they're numb), GAIT DISTURBANCE (she could not really walk), PAIN IN EXTREMITY (feet are still really hurting), PAIN (is like her whole body is just hurting), VACCINATION SITE WARMTH (Injection site hot), FATIGUE (Tiredness / fatigue), HEADACHE (severe headache), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PRURITUS (Vaccination site itching) and MYALGIA (Every muscle in her body is hurting, muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added events such as Injection site red, injection site hot , itching, fatigue added.
TESTED + covid 8-5-22;  came to ER on 8-27-22 with resp distress and shortness of air.  Had been in skilled nursing facility and arrived via ems.  unresponsive that morning with worsening shortness of breath.  Hypoxic  on 100% nonrebreather.  DNR status, comfort measures . .  she expired 8-27-22.
Left arm where received MMR and dTAP vaccines has scaly skin, blisters. Large amount of left upper extremity affected. Not tender, not febrile, otherwise acting well.
Prolonged screaming and crying occurring 4 hours after vaccine administration. Seen in ER; temperature 99.8 No other physical findings. No redness or swelling at vaccine site.
pt. presented to ED with symptoms, SOB, cough and 85% Room air; pneumonia due to COVID
By the evening of the day I received my second dose I had a mild headache.  The next morning I had a severe headache and chills which lasted until evening of the day after my vaccination.  By the morning the second day after my vaccination I was fine with no issues
kept breaking up during the night on full body sweats; had one weird heart beat just one time; very very nauseated; whole upper arm including the injection site was in pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (kept breaking up during the night on full body sweats), HEART RATE ABNORMAL (had one weird heart beat just one time), NAUSEA (very very nauseated) and VACCINATION SITE PAIN (whole upper arm including the injection site was in pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included TIMOLOL for Glaucoma, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid therapy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERHIDROSIS (kept breaking up during the night on full body sweats), HEART RATE ABNORMAL (had one weird heart beat just one time), NAUSEA (very very nauseated) and VACCINATION SITE PAIN (whole upper arm including the injection site was in pain). On 18-Mar-2021, HYPERHIDROSIS (kept breaking up during the night on full body sweats), HEART RATE ABNORMAL (had one weird heart beat just one time) and NAUSEA (very very nauseated) had resolved. At the time of the report, VACCINATION SITE PAIN (whole upper arm including the injection site was in pain) had not resolved. 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.   Other concomitant medication included high blood pressure pill.   No treatment information was provided.
Information has been received from an approximately 69 year old male consumer, who on an unspecified dates was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported). The consumer reported that in approximately 2010, he experienced shingles after receiving a dose of ZOSTAVAX (Merck). The consumer said he had previous cases of shingles before. Follow up information has been received from the consumer indicating that he received the vaccine at a pharmacy and that he understood he should had waited 6 weeks after an episode, he was not told or did not ask. The consumer reported that he was vaccinated days after the outbreak-shortly thereafter he experienced 2 short outbreaks. Then he was symptoms free for 1 year since he had had 3-4 episodes not as profound as original. The consumer would like to know for a possibility of a booster. No further information is available.
Pt had no issues post vaccination in the clinic.  Patient left clinic asymptomatic.  That night patient had a stroke and was sent to hospital via EMS.  Patient remains in the hospital.
Information has been received from a pharmacist concerning a 73 year old male patient with a history of previous bouts of shingles who on 15-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck). On 24-JUN-2010 the patient had a mild outbreak of shingles post vaccination. The pharmacist stated the patient might have been on valacyclovir therapy the day before vaccination, and the patient continued valacyclovir therapy 9 days after the ZOSTAVAX (Merck) vaccination. The pharmacist stated the patient had a mild outbreak and did not have Neuralgia episode (like he usually does) before the shingles outbreak. The patient sought unspecified medical attention. At the time of the report, the patient status was unknown. Follow-up information received from the pharmacist on 06-JUL-2010. The pharmacist stated that the patient took MEDROL dose pack 5 days after receiving ZOSTAVAX (Merck). Follow-up information has been received from the pharmacist concerning the 73 year old male with a history of shingles (recurrent bouts for years) and unknown history of chicken pox (likely in childhood) and no known illness at time of vaccination who on 15-JUN-2010 at 11:00 AM was vaccinated subcutaneously at left arm with the first 0.65 mL dose of ZOSTAVAX (Merck) (LOT# 665514/0145Z). Concomitant therapies were unknown except VALTREX. On approximately 25-JUN-2010 at unknown time (previously reported as 24-JUN-2010), the patient came down with a case of shingles about 7-10 days after the vaccine. The patient noted the lesions were in lumbar-sacral area at the same site as recurrent infections in the past. He did not get his usual neuralgia, and he had fewer lesions than previous outbreaks. Patient also reported minimal pain and recovered. The pharmacist was not aware any relevant diagnostics test or laboratory data. The patient was seen for other pain and was prescribed a MEDROL dose pack 5 days post vaccination (MEDROL dose pack was 6 day treatment). On an unspecified date, the patient recovered from shingles. A specimen was not collected for PCR and no photo was taken. The pharmacist considered shingles to be an other important medical event due to the patient required medical/surgical intervention to prevent the adverse event. Additional information has been requested.
The pt woke up on 4/7/00 and noticed raised rash from neck to feet, worse around neck and knees. Very heavy rash, does not itch, no fever, but very achy.
Contracted COVID 19; Contracted COVID 19; Extremely tired and fatigued; Cough; Congestion; Headache; Fever; Chills; Body aches; Diarrhea; Loss of taste; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0158) via intramuscular route of administration in Arm Left on 09Apr2021 17:00 as DOSE 2, SINGLE, patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via intramuscular route of administration in Arm Left on 19Mar2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination the patient received other medications within 2 weeks of vaccination was Lipitor. Medical history included lymphoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported patient was not diagnosed with COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. On 07Jul2021 the patient experienced contracted covid 19, contracted covid 19, extremely tired and fatigued, cough, congestion, headache, fever, chills, body aches, diarrhoea, loss of taste patient had physician office visit for the events. The patient received treatment for rest all events was unknown and for vaccination failure, covid-19 did not received any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021. The outcome of the events vaccination failure, covid-19, fatigue, cough, nasal congestion, headache, pyrexia, chills, pain, diarrhoea, ageusia was recovering.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, from a medical provider, for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed a painful rash on her torso. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from the shingles and post herpetic neuralgia. As a direct and proximate result of these malfunctions, 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.
Rash began on face - under both eyes. Spread over face, behind neck, ears, on back, buttocks, and upper thighs. Went away without treatment. Returned much milder form 6 weeks later and again resolved without treatment. Testing performed by pediatrician and pediatric dermatologist - all tests normal - no known etiology for rash. Not returned since.
When vaccine was given, vaccine leaked out between the barrel and adapter.    There was no vaccine left in the barrel when removed from arm. Patient was given another full dose of vaccine to ensure completely vaccinated.