chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough infection; Breakthrough infection/ COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "Breakthrough infection"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "Breakthrough infection/ COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the patient was diagnosed with COVID-19 prior to vaccination, but was tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from an office manager via company representative referring to a 7 year old patient of unknown gender. The patient had no medical history, concomitant therapies or past drug reactions/allergies. The patient's concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a Oka/Merck VARIVAX, in one leg, intramuscular, (strength, dose, lot # and expiration date were not reported) for prophylaxis.  Other suspect therapies included MERCK STERILE DILUENT in one leg, intramuscular, (strength, dose, lot # and expiration date were not reported); and poliovirus vaccine inactivated (unspecified) in one leg, intramuscular, (strength, dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2018 (also reported as "At an unspecified time in the last 3 weeks"), the patient experienced tenderness, warmth, swelling and a "hard" lump at injection site (injection site pain, injection site induration, injection site mass, injection site swelling and injection site warmth). Per office manager, the company representative stated that treatment was given and it was ice on the injection site. The outcome of injection site mass, injection site induration, injection site swelling, injection site pain and injection site warmth was unknown at the time of the report. The reporter did not assess a causal relationship between the aforementioned events and Oka/Merck VARIVAX or MERCK STERILE DILUENT.
The patient presented to my office on 3/30/11 with two days of a rash. The rash was papules, pustuled and crusted lesions in dermatomal distribution consistent with herper zoster.
Head ache, joint pain, tiredness, loss of appetite,  and dizziness for about 12 hours.
Information has been received from a nurse concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with one improperly stored dose of GARDASIL (dose, strength, lot# and route were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
6 days after shot, my arm is swollen, sore and has a fever. Redness is spreading.
swelling on her hands and arms; had a red rash on her hands and arms; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her hands and arms) and RASH ERYTHEMATOUS (had a red rash on her hands and arms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on her hands and arms) and RASH ERYTHEMATOUS (had a red rash on her hands and arms). At the time of the report, PERIPHERAL SWELLING (swelling on her hands and arms) and RASH ERYTHEMATOUS (had a red rash on her hands and arms) outcome was unknown.            It was reported that patient had received 3rd and 4th boosters. No concomitant medications were reported. No treatment medications were reported.
3 weeks post immunization the patient developed pain in his left arm where the vaccine was given.  He stated that there had been swelling in that area.  Upon examination there is a subcutaneous granuloma measuring 1.5x2.5cm.
Inadvertently given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) had resolved. 2 patients who inadvertently received their booster dose from an expired lot. Question was raised for its effectiveness.No concomitant medications were provided.No treatment medications were provided.Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow up contains non significant information.
starting morning after vaccine: extreme fatigue chills / hot flashes (temp was up .7 degrees from normal) sore arm  starting 24 hours after vaccine: - bad diarrhea - urination interruptions, taking a long time to vacate  - cognitive numbness / severe brain fog / disinterest - loss of appetite  - swollen sinuses  all of this was very bad for 4 days, improved a bit each day since but the cognitive stuff and loss of appetite still not fully resolved   starting second night, sleep effects: 1) hallucinations upon awaking from sleep periodically through the night - example: seeing dotted lines moving on the back of my eyelids  2) extremely disturbing nightmares  3) both arms falling dead asleep from shoulder to hands during sleep 4) very shallow rapid breathing also all very bad for 4 days and mostly resolved now except the breathing at night is still shallow and rapid but not as bad as first 4 days
Pt was found unresponsive in his crib the morning after his vaccinations, emergency services called, patient pronounced dead at hospital
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Additional Details: Patient received the vaccine and waited the 15 minutes but after 10 minutes passed out, she hit her head on the floor, 911 was called and she was taken away for observation. Patient was alert and doing well.
Oval  shaped Itchy Red rash at injection site.  2 x 3 inches in size
Stiff neck; Extremely nauseous; A lot of drainage; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the right arm on 07Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced stiff neck, extremely nauseous, a lot of drainage and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events stiff neck, extremely nauseous, a lot of drainage and extreme fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt called Wed 8/31 w/complaint of: low grade fever, brain fog, heart palpitations. PCP is aware of RXN and told patient to continue to monitor; did not express concern. Self reported by patient. Patient stated that she has been run down lately.
She got her first dose on 01-29-21. 28 from that day would be 2/26/21. But she got the second dose on 01-12-21, which was only 14 days after the first dose.
Lump in arm, rash that is growing , swelling of lymph nodes under arm pit, elbow pain, rash happened right away and is continuing to grow
Lethargy; Chills; Fever; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Non-company suspect drugs included: upadacitinib (oral, batch number: 1140288 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On MAR-2021, the patient experienced lethargy. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, chills, and fever on 2021. This report was non-serious.
swelling fingertips to wrists resembled person w/arthritis, swelling @ elbow & inj site;
tachycardia; chest pain; This is a follow-up spontaneous report from a contactable consumer. This contactable consumer (Patients parent/guardian) reported in response to Non-HCP letter via follow-up letter which included that:  A 12-year-old consumer (patient) of unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0173) via intramuscular route of administration on 14May2021 at 14:00 hours in left arm as dose 1, single for COVID-19 immunization. Medical history of the patient and prior vaccinations was reported as none. Concomitant medication included lisdexamfetamine mesilate (Vyvanse) taken for attention deficit hyperactivity disorder. On 05Jun2021 at 12:00 hours patient complained of chest pain and rapid heartbeat. Symptoms subsided before confirmation by parent/guardian. On 07Jun2021 patient complained of chest pain and rapid heart rate. Confirmed with oximeter device (171 beats/min) which subsided after 5-10min. Urgent care visit did not result in any findings and heartrate was normal. On 08Jun2021 patient underwent EKG for which results were normal. On 12Jun patient complained of rapid heart rate confirmed with oximeter (130 beats/min). The events required emergency room visit. Patient received follow-up visit with pediatrician. On 14Jun2021 echocardiogram was normal. On an unknown date in 2021 tachycardia recovered. The outcome of chest pain was unknown.  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information was expected.
Some sort of dream flash back/as no real events; Some sort of dream flash back; Nauseous be at the same time of event; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Some sort of dream flash back/as no real events, flashbacks), NAUSEA (Nauseous be at the same time of event) and FLASHBACK (Some sort of dream flash back/as no real events, flashbacks) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced ABNORMAL DREAMS (Some sort of dream flash back/as no real events, flashbacks), NAUSEA (Nauseous be at the same time of event) and FLASHBACK (Some sort of dream flash back/as no real events, flashbacks). On 03-Jun-2021, ABNORMAL DREAMS (Some sort of dream flash back/as no real events, flashbacks), NAUSEA (Nauseous be at the same time of event) and FLASHBACK (Some sort of dream flash back/as no real events, flashbacks) had resolved.        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 treatment information was provided.
I took the booster shot now; booster shot brought up the creatinine number 25% again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization; Bnt162b2 (dose 2), for COVID-19 Immunization, reaction(s): "the creatinine level of the Kidney number got increased by 25% got worse". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I took the booster shot now"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "booster shot brought up the creatinine number 25% again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that, I took the Pfizer shot first and second shot and after the second shot the creatinine level of the Kidney number got increased by 25% got worse and then it got better after a month or two. I got a question for you. Is this one of the side effects because I am trying to find out is this one of the side effects. Booster shot brought up the creatinine number 25% again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L010595 with expiration date of 12-NOV-2016; strength, dosage, frequency and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain and swelling in the Right axilla and right breast with radiating paint o the right elbow, right wrist and thumb from 10/2/2021-10/10/2021. Ecchymosis in the Right axilla and right lateral breast area from 10/3/2021- 10/8/2021.
24 after immuniz, started with hives over entire body. No resp difficulty. Unable to identify any other exposures, foods, meds, soaps, etc.
Noticed pain/burning/stinging sensation when urinating  and some blood from the vagina. Next day went to the GYN, I had vesicles in the vagina and outside.
Inability to take a full breath. Asthma inhalers, including steroidal ones do nothing for the first time ever. Condition persisted past 2 weeks, so visited ER. ER prescribed strong steroids as x-rays came back clean. Feeling better but not good.
Patient is now deceased, very likely from Covid-19, based on the positive test of her spouse, and very similar symptoms
This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered ROTATEQ (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Hemorrhoid; Minor bleeding issues/ hemorrhoid; Clot of blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Minor bleeding issues/ hemorrhoid) and HAEMATOCHEZIA (Clot of blood in stool) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rectal bleeding (10 years ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced RECTAL HAEMORRHAGE (Minor bleeding issues/ hemorrhoid) (seriousness criterion medically significant) and HAEMATOCHEZIA (Clot of blood in stool) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoid). At the time of the report, RECTAL HAEMORRHAGE (Minor bleeding issues/ hemorrhoid), HAEMATOCHEZIA (Clot of blood in stool) and HAEMORRHOIDS (Hemorrhoid) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  On unknown date, the evening after receiving the Moderna COVID-19 vaccine, the patient reported seeing a blood clot in the toilet. The patient stated it looked like hemorrhoids. The patient denied seeking medical care. The patient stated the bleeding is minor but at the time of this report, ongoing. The patient stated having similar minor bleeding approximately 10 years ago.  This case concerns a 63-year-old female with PMH of rectal bleeding had serious unexpected events of Rectal hemorrhage, hematochezia and non serious unexpected hemorrhoids. Event onset with unknown latency. after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old female with PMH of rectal bleeding had serious unexpected events of Rectal hemorrhage, hematochezia and nonserious unexpected hemorrhoids. Event onset with unknown latency. after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient states feeling of light headedness. Vital signs were checked at 12:20pm. Blood pressure was 115/69, Heart rate  of68, respiration 20 and sat 98%. Patient wanted to leave and was informed to go to ER if dizziness/lightheadness continues. Husband stated he understood as well.
Extreme irritability, thrashing, insomnia, possible seizure activity for 72 hours post vaccine.
wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant product reported by reporter.  Physician reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So, they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster. It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL. No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-646512:Master Case
30 days after the 2nd shot I had sudden and constant paresthesia in all extremities. Intermittent joint pain in my right ankle. Now 5 moths later I have the same symptoms but occasional muscle twitching.  This is very disruptive and have caused me to quit my job.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of MMR II (lot # K020189, expiration date: 11-SEP-2016) (strength, dose, frequency and route of administration were not reported). The temperature of the storage was 49F for 34.5 hours. There was no adverse effect reported. Additional information has been requested.
2:26pm 9/10/10 adm. Flu HD shot. 3 pm 9/10/10 she started feeling drowsy trachea swelling. 6 pm 9/10/10 daughter took her to ER.
Client become immediately nauseated and hot. Injection hurt at the site. At 0930 the next day received a call from mom stating client is still nauseated, site is red and painful.
Ringing of the ear starting day after vaccination and hasn't gone away for over 1 month.
Patient was vaccinated with Biothrax (AVA) on 17Apr2007.  He presented for medical evaluation on 25Apr2007 with an puritic red patch measuring 4-8 inches at site of vaccine administration.
Information has been received from a registered nurse concerning a 4 year old female with no allergies and an early medical history who on 08/27/2001 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant therapy.  The RN reported that on 09/12/2004, the patient developed bumps that were itchy but not opened.  There were several bumps on her forehead, a couple on her right thigh and some on her left arm.  On 09/14/2004, the patient was seen in the office, but no treatment was required.  At the time of this report, the outcome was unknown.  Additional information has been requested.