chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGRAVATED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous neck injury, recent knee surgery, and shoulder injury, and concurrent conditions included penicillin allergy, use reading glasses, and headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced blurry vision. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced head to toe soreness. On 13-MAR-2021, the subject experienced weakness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache aggravated. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021, was recovering from weakness, nausea, blurry vision, headache aggravated, vomiting, and stomach upset, and had not recovered from head to toe soreness. This report was non-serious.
This case was reported by a physician, via a GSK representative, and described the occurrence of diarrhea in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX (details unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced diarrhea and dehydration. The subject was hospitalised. At the time of reporting the events were resolved. The physician reported that diarrhea had been observed in several (approximately 5 to 10) subjects following the 1st dose of ROTARIX (see case ID A0951278A for details). One infant had been hospitalized for dehydration due to severe diarrhea (this case).
Information has been received from a pharmacist concerning a "greater than 65 years" pt wit a medical history of "compromised" immunity who on 23JUL2003 was vaccinated wit a second dose of pneumococcal vaccine 23 polyvalent. It was also noted that the pt's immunity was compromised and the "the revaccination was needed. On 23JUL2003, the pt developed injection site rxn; with redness and swelling of the entire arm". the pt was seen in the ER and released. Unspecified medical attention was sought. There was no product quality complaint involved. No further pt information was available at the time of this report. Additional information has been requested.
15 minutes after getting it I could feel my tongue in my mouth and then about an hour after vaccine my tongue swelled and so I told my doctor and they told me to get some allergy medicine at pharmacy. After that I had extreme body aches and my arm was sore. I kind of felt like someone punched me in the back. The body aches lasted probably about 6 days and then I would say tongue swelling was off and on for two weeks so it wasn?t super consistent but I was also taking the medicine.
pregnant and had vaccine administered; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and had vaccine administered) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  The patient's past medical history included Gallbladder removal. Concurrent medical conditions included Constipation. Concomitant products included DOCUSATE SODIUM (COLACE) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and had vaccine administered). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and had vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information was  provided.  The patient's estimated date of conception was 4-Sep-2020.  On an unknown date, patient's genetic testing was negative.
she had neck and back cramps; she had back cramps; itching; hot arm; swollen arm; can't move her arm; tiredness; vomiting; diarrhea; terrible headache; can't sleep; dizziness; everything hurts; her lungs hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm) and PERIPHERAL SWELLING (swollen arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN and DULOXETINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt). At the time of the report, MUSCLE SPASMS (she had neck and back cramps), BACK PAIN (she had back cramps), PRURITUS (itching), FEELING HOT (hot arm), PERIPHERAL SWELLING (swollen arm), LIMB DISCOMFORT (can't move her arm), FATIGUE (tiredness), VOMITING (vomiting), DIARRHOEA (diarrhea), HEADACHE (terrible headache), INSOMNIA (can't sleep), DIZZINESS (dizziness), PAIN (everything hurts) and PULMONARY PAIN (her lungs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Two incidences of COVID; Two incidences of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in Jul2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "EGFR exon", start date: Jun2022 (unspecified if ongoing), notes: EGFR exon, 20 insertion in Jun2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Two incidences of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Unknown results, notes: two incidences of COVID (Jan2022 and Jul2022); (Jul2022) Unknown results, notes: two incidences of COVID (Jan2022 and Jul2022). Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: No Covid prior to vaccination. Patient received 1st booster Dec2021 and had two incidences of COVID (Jan2022 and Jul2022). Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hard red golf ball sized lump in pt. left arm at injection site producing some heat. Pt. reports it had "gone down" compared to what it was over the weekend. Pt. will give it time and return to clinic if condition worsens.
Pfizer vaccine booster dose was given, within 12 hours the patient experienced a severe flare of RA along with fever and chills. 2 weeks later RA is still flared and patient reports daily fevers that are alleviated by APA. Patient also had worsening thyroid function following dose 1 and 2 of the Pfizer vaccine.
Had Flu shot 11/8/10 in left deltoid - hurt immediately. Gradually got worse over 3 wks - hurts to raise arm. Tender deltoid muscle - no fever or signs of local infection. No hematoma.
Covid-19; Soreness of arm at injection site after vaccinated for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and VACCINATION SITE PAIN (Soreness of arm at injection site after vaccinated for Covid-19) 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) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Pre-filled pen. On an unknown date, the patient experienced COVID-19 (Covid-19) and VACCINATION SITE PAIN (Soreness of arm at injection site after vaccinated for Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving and VACCINATION SITE PAIN (Soreness of arm at injection site after vaccinated for Covid-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. 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.
The pt received vaccine on 07/21. Today, she said she was experiencing a lot of pain on her arm and there was evidence of redness in the middle of her arm. She has been taking ibuprofen to relieve the pain. She said that she felt the pain a couple of hours after the vaccine but the pain is still going on until now.
Pt had a ALTE about 8 hours after shots and mom called 911 and pt admitted for observation and has been fine. S/s were turned blue and pale and was clammy. Admit MD thinks event due to nasal congestion per mom.
Patient received second dose beyond 25-35 days time interval; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose beyond 25-35 days time interval) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 025AUA and 939903) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis (Get bronchitis easily) and Asthma (Have asmah).   On 02-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose beyond 25-35 days time interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose beyond 25-35 days time interval) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-561925 (Patient Link).
This spontaneous report was received from a pharmacist, referring to a 19 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 07-FEB-2018, the patient started therapy with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). On 09-MAR-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported) and on 06-APR-2018, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). No adverse effects reported.
clots found in lungs; partial lung collapse; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Patient had no COVID-19 prior to vaccination. Concomitant medications included: VENLAFAXINE (other medication in two weeks) and birth control (unspecified). Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The patient had no other vaccine in four weeks. The following information was reported: PULMONARY THROMBOSIS (hospitalization, life threatening) with onset 28Jul2022, outcome "not recovered", described as "clots found in lungs"; PNEUMOTHORAX (hospitalization, life threatening) with onset 28Jul2022, outcome "not recovered", described as "partial lung collapse". The patient was hospitalized for pneumothorax, pulmonary thrombosis (hospitalization duration: 1 day). The events "partial lung collapse" and "clots found in lungs" required emergency room visit (reported as "Emergency room/department or urgent care"). Therapeutic measures were taken as a result of pneumothorax, pulmonary thrombosis and included Blood thinners and tons of er trips. Clinical course: Patient stated, "I got my last shot in Dec2021 and got COVID in Jan2022. Since then I have had a partial lung collapse as well as clots found in my lungs. There are no other factors that could have played a part in this as my healthcare provider believed this could be from my birth believed this could be from my birth control that I have taken on and off for years." Adverse event start date was reported as 28Jul2022 (pending clarification).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Day 1 (4:30 pm vaccination day).  Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 minute.  Later that day, overall feeling of unwell, short lived muscle weakness, tired, sore arm, anxiety, loss of appetite, odd, bubbling sensation in left leg, slight itchy skin mostly in legs and at injection site. Day two.  Unwell, nausea, loose stool in morning, anxiety, tired, slight sore arm, odd bubbling sensation in left leg, slight itchy skin, loss of appetite, red eyes, red itchy chin, slight itchy skin in legs and at injection site Day three.  Unwell, nausea, very slight sore arm, loose stool in morning, panic, tired, itchy red eyes, nausea, red itchy chin, slight itchy skin mostly in legs and at injection site, no appetite. Day 4.  Loose stool in morning, more energy but still tired, itching continue slightly on chin and injection site and legs, appetite returning, slightly tired, very slight sore arm. Day 5.  Woke up with indigestion, feeling unwell and tired, laid in bed and felt a jolt by means of noise in my head which only happened once and was quickly over, very slight sore arm, itchy at injection site, weird metal taste, upset stomach, leg and arm vein fullness Day 6.  Woke up tired with overall feeling of slight unwell but gained a good bit of energy as the day progressed, leg and arm vein fullness. Day 7:. Leg and arm vein fullness Day 8:. Non localized Itchy skin  Side note:. I'm beyond worried to get the second vaccination.
Patient slumped in chair. Her eyes were open and she was breathing normally but wasn't responding to me calling her name or asking her questions. I called out to the other pharmacist to call 911. There happened to be an EMT by the pharmacy who came over to assist. He took her pulse-ox and blood pressure. Oxygen levels were normal but had a difficult time getting a blood pressure the way she was in the chair. The ambulance came in and took her. At that time she was starting to talk a little. I followed up with her the following day 10/23/21 and she was fine. She had a workup at the hospital and everything was fine. They think it was anxiety.
Pt recvd vax 18JUN91 @ 10AM; On 19JUN91 mom notified clinic pt had t102, on 20JUN91 temp inc to 104; MD notified prescribed APAP & alcohol baths; pt also vomiting & MD prescribed warm 7UP; By 21JUN91 all sx had subsided;
Exteme pain on back right side of neck for several days.  Hives on arms and face on days 3 and 4. Dizziness on day 4. Shortness of breath on day 5. Nausea on days 5 and 6.
Pfizer-BioNTech COVID-19 Vaccine EUA Rash/hives, 2 Benadryl at 7:30P
Increased resting heart rate went up to 130 for 30 mins and my arms and legs, hands and feet were tingling and my mouth and throat went numb, vision changes
Pt recvd 2nd dose of vax on 23OCT92 & exp heaviness in arms & a sl h/a for 24 hrs; No further details were provided;
Arm swollen from elbow to base of neck.  Left Knee (knee replacement 9 months prior) swollen to the point as unable to straighten, also unable to bend past 90 degrees.
Headache, nausea, vomiting, low grade fever, diarrhea, dehydration, severe bone pain.  Symptoms began 10/30/2021 through  11/8/2021. Went to ER 11/5/2021 for IV treatment for dehydration.
Pt received Prevnar 20 in L arm on 10/11, presented on 10/17 with redness/pain/inflammation in left arm. When contacted on 10/18, reported no worsening, but still experiencing pain
3:35 PATIENT COMPLAIN  PALPITATIONS. BP 130/80 , HR 76, SPO2 96 4:00  PATIENT DENIES   PALPITATIONS AND ANY OTHER SIDE EFFECT AT THIS MOMENT. BP 128/72, HR 76, SPO2  96.
p/vax pt skin started to itch, became red, warm & swollen (only lt deltoid area);also pt felt intense pain under armpit;pt was seen by MD;pt recv epi & DPH;VS were monitored every 15 minutes for 1hr;
Patient describes arm swelling, lump, and pain which started approximately 9 days after injection.  Patient was seen by her provider and was advised to take tylenol.
low grade fever, 99.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for respiratory syncytial virus immunisation; for respiratory syncytial virus immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "low grade fever, 99.5". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: "Inquiry: Rsv vaccine side effects. I had the vaccine yesterday. My arm is not sore but i do have a low grade fever, 99.5. Is that a normal side effect? I did a covid test for safety and am negative. How long will the fever last? Is a low grade fever normal after the RSv vaccine?".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
On 02/15/2005, patient returned to the office mom reported temperature of 102 ath home that morning. Afebrile in office.
The evening 9:00 pm of the 04/04/2021. through 04/08/2021 chills, and very achy on 04/08/2021 around 9:00 am through 7:00 pm chills, achy, fever between 99.9 and 102 all day off and on.
sick; not feeling good; pain in her left arm from the top of her shoulder to her elbow; pain in her left arm from the top of her shoulder to her elbow; low grade fever; headache; so tired can barely make it up the stairs; weak; nauseated; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199; Expiration Date: Jun2021)), via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:20 (at the age of 41 years old) as, Single for covid-19 immunisation. Medical history included ongoing intracranial aneurysm 10 years. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. She reported that she was sick. She had her injection on 08Mar2021 and right away after she got the Covid 19 vaccine she told the person who gave her the vaccine that she felt nauseated, and that person didn't say anything. Then she's had pain in her arm from the top of her shoulder to her elbow and it has lasted over a week. Clarified arm she received the injection in, left arm. It is not fun. Then the next day she had a low-grade fever and she's had a headache every day and she's so tired she can barely make it up the stairs and she just doesn't feel good. She's still so weak and not feeling good and she has had these symptoms and her second dose is scheduled for 29Mar2021 and she's afraid to get that one. She's feeling rough enough, she can't take anymore. She heard the second Covid 19 vaccine is worse. When probing for specific event details she reports her nausea has improved but not completely. The pain in her arm is a lot better. The low-grade fever is gone. Sometimes the headache is worse than other times. She has a headache right now. The tiredness and weakness is constant she can't take it, it's so bad. With this headache she can't even think straight. She did get sick from the flu shot years ago and that's why she never got another one. But then her friends' parents, they went at the same time to get their flu shot and the following day they both came home sick at the same time. She says that's strange. She is really kind of antivaccination. The outcome of event nausea, pain in her left arm from the top of her shoulder to her elbow was recovering, Outcome of Low grade fever was recovered on 14march2021, Outcome of headache, so tired can barely make it up the stairs, weak, not feeling good was not recovered, outcome of sick was unknown.  No follow-up attempts are possible. No further information is expected.