chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain approximately 3 days after vaccination; patient presented to hospital approximately 3 weeks after these symptoms started.  Was started on Xarelto in the hospital.
Information has been received from a nurse in a physicians office concerning a 8 year old male with no per existing allergies or medical conditions who on 12/2/1997 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient developed a very severe case of chickenpox. Unspecified medical attention was sought. It was reported that the patient recovered. No product quality complaint was involved. The nurse also reported that the patients other three siblings developed chickenpox (WAS0505USA01477, WAES0505USA01835, and WAES0505USA01836). Additional information has been requested.
This spontaneous report was received from a physician refers to eight patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature minimum 30F, 32.7F, 33F, 92.5 hours, because of data logger) RECOMBIVAX HB lot # L019298, expiry date 22-JUN-2017 (dose, frequency and route of administration not reported). Previous temperature excursion was reported as no. No adverse events reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
experienced small amount of pain at the injection site of left shoulder/his coworker experienced similar side effects with the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced small amount of pain at the injection site of left shoulder/his coworker experienced similar side effects with the Pfizer COVID-19 vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
It has been 45 days since the patient's first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 45 days since the patient's first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 45 days since the patient's first dose). On 10-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 45 days since the patient's first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: No newinformation.
Right arm swelling from the shoulder to the elbow with pain radiating to the fingers.  My arm became extremely hard and very painful and couldn't sleep during the night due to the pain.  Along with that nausea began before going to bed. The nausea and pain continues today (12/17/21).  On a scale of 1-10, last night the pain and nausea was a 10  with today (12/17/21) being a strong 8 with the addition of a strong medicinal aftertaste.
pt rcvd vax; pt devel rash which became a skin lesion at injection site; RN stated it looked like small pox; lesion persisted 3 years later;
The patient received the vaccine and 4-5 minutes later he fell out of his chair, facedown. He appeared to be convulsing. He was pale, diaphoretic, and disoriented. His blood pressure was 76/36 and his pulse was 84. Radial pulse was 2+. EMT was called. His EKG appeared to have a slight elevation in his inferior leads. He and his guardian deny any significant history. Upon discharge with EMT, the patient was alert and tolerating liquids well. The patient's guardian states that he has had a similar reaction prior when he was the age of 6. She states that he also felt slightly lightheaded from the first Pfizer vaccination.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium
Rash that does not go away , which spread to the back.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that does not go away , which spread to the back.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash that does not go away , which spread to the back.). At the time of the report, RASH (Rash that does not go away , which spread to the back.) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
I received my second Pfizer COVID-19 vaccine on 4/23.  Symptoms began on 4/26 and worsened, slowly, over the course of the next three days.   My symptom included a pain behind my right ear and partial paralysis of right side of my face including forehead, eye, and mouth.  I called my primary care physician who sent me directly to the Medical Center in for a stroke evaluation including various blood tests. No imaging was performed.
Likely cellulitis of right thigh. Developed redness, swelling, warmth on the night after the vaccines were administered. No fevers. On exam has irregular area of warmth, induration and erythema.
Extreme chills, migraine, fever,and nausea. We gave her ibuprofen and have her under a heating blanket. She is sipping water.
Muscle soreness at injection site and same side shoulder Fever 99.3F Chills Fatigue Runny nose
PANCYTOPENIA; CRITICAL THROMBOCYTOPENIA; 3 CARDIAC EVENTS; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; SKIN STARTED TO FALL OFF; HAIR FELL OUT; NO LONGER ABLE TO WORK OR TAKE CARE CHILD; CERVICAL LYMPHADENOPATHY; This spontaneous report received from a patient via a company representative via social media (J and J corporate) concerned a patient of unspecified age, sex, race and ethnicity. 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, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient was almost died, had 3 cardiac events, postural orthostatic tachycardia syndrome (POTS), dysautonomia/ autonomic nervous system (ANS) dysfunction, pancytopenia, critical thrombocytopenia, cervical lymphadenopathy, skin started to fall off, hair fell out, and no longer able to work or take care child, and was hospitalized for five months.  As per reporter, "I almost died. This has taken everything from me, I am pending disability, no longer able to work or take care of my child, my hair fell out, my skin started to fall off, I have had 3 cardiac events large enough to hospitalize me. I will not be silenced anymore. After the shot I suffered from POTS, dysautonomia, ANS dysfunction, pancytopenia, critical thrombocytopenia, and cervical lymphadenopathy, spent the last 5 months in the hospital in the fight for my life, doctors still have no solution, every treatment that was supposed to work makes everything worse. Most doctors are silenced with threats to their job security if they admit the truth, other than the very few that tell the truth and try their hardest to help you, but they can only get so far before hitting the red tape. They are silencing us, there is many more than just me". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no longer able to work or take care child, hair fell out, skin started to fall off, 3 cardiac events, postural orthostatic tachycardia syndrome, pancytopenia, critical thrombocytopenia, and cervical lymphadenopathy. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221257532- pancytopenia, critical thrombocytopenia, 3 cardiac events, postural orthostatic tachycardia syndrome, hair fell out, skin started to fall off, no longer able to work or take care child. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221257532- cervical lymphadenopathy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
booster/ should have been INFANRIX/PEDIARIX was administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on an unknown date at 2 months of age), Pediarix (received 2nd dose on an unknown date at 4 months of age) and Pediarix (received 3rd dose on an unknown date at 6 months of age).   On 7th July 2021, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 7th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 details were provided as follows: Historical medication included first three doses of Pediarix at 2, 4 and 6 months of age. The patient received the fourth dose of Pediarix instead of Infanrix, which led to wrong vaccine administered. The health care professional's office had not yet contacted the patient/ parent of patient, resolution unknown. This case was linked with US2021152840, US2021152836 and US2021152833, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152840:same reporter US-GLAXOSMITHKLINE-US2021152836:same reporter US-GLAXOSMITHKLINE-US2021152833:same reporter
SCRATCHY THROAT; LITTLE CHILLS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 59 year old female of unspecified ethnicity. Initial information was processed along with the additional information received on 07-MAR-2022. The patient's height, and weight were not reported. The patient's past medical history included: In 2019, the patient got covid-19, received an antibody infusion in JAN-2020 and had no other illness at that time, and concurrent conditions included: high blood pressure, alcohol user, non-smoker, and sciatic nerve. The patient had no known allergies.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin was not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced scratchy throat and had tested positive in a PCR (polymerase chain reaction) test which indicated suspected covid-19 infection (mild), and suspected clinical vaccination failure (dose number in series: 1). On 08-DEC-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm for prophylactic vaccination. Concomitant medications included paracetamol (Tylenol) and other anti-inflammatory drugs for sciatic nerve. On 31-DEC-2021, few weeks after receiving the booster vaccination, the patient had taken a covid-19 virus home rapid test which was positive, and had scratchy throat which indicated suspected covid-19 infection, and suspected clinical vaccination failure (dose number in series: 2). The patient's entire family had tested positive. On 02-MAR-2022, the patient was exposed to a peer who had tested positive for covid-19 and the patient experienced scratchy throat, and little chills (dose number in series: 2). The patient had not taken a test for covid-19. The patient stated that she had covid-19 three times so far. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, scratchy throat and little chills was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000220543. This case, involving the same patient is linked to 20220314408 (dose number in series: 1).; Sender's Comments: V0: 20220312273- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient reports 1 day after injection, she developed pain and expanding erythema at site of injection with rigors, fevers to 103 F, myalgias, transient numbness of hands and feet. She went to ED on 7/25 where she also had hypotension and tachycardia. Physician concerned for severe sepsis secondary to cellulitis vs post-pneumococcal severe hypersensitivity reaction. She was started on broad spectrum antibiotics cefazolin and transitioned to vancomycin and ZOSYN. After 24 hours, the rash had improved proximally with reduced erythema but had worsening erythema inferiomedially and distally not past the elbows. Pain at site of injection continued to be significant.
contrast taste in her  mouth, generally felt yucky; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (contrast taste in her  mouth, generally felt yucky) and VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-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 TASTE DISORDER (contrast taste in her  mouth, generally felt yucky) and VACCINATION SITE PAIN (sore arm). At the time of the report, TASTE DISORDER (contrast taste in her  mouth, generally felt yucky) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Difficulty breathing, Red/Flush face. Epi pen administered, Benadryl, prednisone.  Patient was monitored for 1 hours post inccident.
"Moderna COVID-19 Vaccine EUA" Expected side effects (swelling, pain, tenderness) immediately after injection subsided after 3 days.  7 days AFTER administration of first dose, developed itching, redness and swelling again at the injection site.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength and lot number were not reported). Co-suspect or concomitant therapies were not reported. On an unknown date, after receiving ZOSTAVAX the patient developed lesions and itching patches (rash) on unspecified location. At the time of the report, the outcome of rash was unknown. The causal relationship between the event and vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Parent provided picture of indurated red area soft ball size on L deltoid on 4/22/16. Using Benadryl and cool compresses.
Swollen lymph nodes neck, (L) armpit + shoulder Rash - Red blotchy rash all over chest, Abdomen + Back
Case number PHEH2015US020038, is an initial spontaneous report from a nurse received on 06 Oct 2015. This report refers to a 2-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 158105) intramuscularly on 06 Oct 2015. No adverse event was reported.
On 5/30/2021, client received her first dose of Pfizer COVID vaccine lot # EW0187 exp. 8/2021 at 3:15 pm on her left arm notified EMT at 3:19 pm that her left arm feels like "asleep" such as when you get anesthesia. Lead nurse  assessed and interpreted for the client since client is speaking for the rest of her remaining observation. Client denied shortness of breath and no edema or redness observed on her left arm. She said she had no history of allergies to medications or any history of reactions to any past vaccines received. At 3:24 pm, she described her left arm numbness and pain at a 6/10 and continued to feel her left arm as asleep which started at her shoulder and go down to her arm. EMT  took her vitals every five minutes as follow: 3:19 pm-blood pressure (BP) 148/96, heart rate (HR) 84, oxygen saturation (O2) 98 %, respiration (R) 14; 3:24 pm-B2/94, BP 154/94, HR 78, O2 98 %, R 14; 3:30 pm-BP 152, /94, HR 78, O2 98 %, R 14; 3:35 pm-BP 144/92, HR 88, O2 97 %, R 14; 3:46 pm-BP 146/92, HR 87, O2 99 %. At 3:45 pm, client continues to feel the same numbness on her left arm and starts to feel "cold" on her left arm.  At 3:47 pm, client stated her arm is still not improving but it wasn't getting worse either. Lead nurse educated client on the severe adverse reactions to observe and to seek immediate medical attention as needed at home as well as emergency precautions given to client if her left arm numbness/pain is not improving or getting worse. At 3:50 pm, client stated "I feel fine to go home" and said someone is driving her home. She left Clinic with a steady gait and in no distress.
Child broke out with red, raised rash this AM. Has low-grade fever. Seen in physician's office for dx this PM.
Red rash appeared 7 days post vaccination, has continued for 5 days so far.  Rash has grown in size from about 1/2 inch to 4 or more inches in diameter. large, warm and flat rash on upper left arm at injection site.  Rash has spread to underside of upper arm and unto forearm but appears "lacey" and is raised.  Mild itchy.  Swollen lymph node notice on 2/23/21 in left armpit.  This is 11 days post vaccination.
Pt's nose started getting itchy 5-10 min after injection. I asked her to stay for 30 min just to observe. A few minutes later she reported her feet feeling numb/tingly as well.  We gave her some water because she said her mouth was dry. Shortly after she felt weak and faint, as well as flushed.  We had her lay down with an ice pack but she said it wasn't improving as asked for us to call 911.  Tried to make contact with her the next day but had to leave a voice mail.
full body rash with itching including the soles of her feet, palms of her hands, and in her ears; itching; hives; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH PRURITIC (full body rash with itching including the soles of her feet, palms of her hands, and in her ears), PRURITUS (itching) and URTICARIA (hives) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RASH PRURITIC (full body rash with itching including the soles of her feet, palms of her hands, and in her ears), PRURITUS (itching) and URTICARIA (hives). At the time of the report, RASH PRURITIC (full body rash with itching including the soles of her feet, palms of her hands, and in her ears), PRURITUS (itching) and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD21-039588, MOD-2021-028455 (Patient Link).
The next day he started feeling bad.  That Thursday he started feeling dizzy felt that way for two days.  Sunday he started to feeling better and has since been diagnosed with Vertigo.  Feels as though the earth is moving all day until he falls asleep.  Unable to talk for long periods of time.
Information has been received from a nurse practitioner concerning a 15 month old male with a history of developing a rash, at 12 months of age, post vaccination with hepatitis A virus vaccine (unspecified). On an unspecified date, the patient was vaccinated with Varivax and subsequently developed respiratory distress. The patient was hospitalized for an undisclosed period of time for the event of respiratory distress, which was considered life threatening. At the time of reporting the patient had recovered. Unspecified medical attention was sought. There was no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Reporting physician indicated that 50% of employees who recvd a series of 3 Engerix-B inject have no detectable titers;