chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient who on unspecified date was vaccinated with a dose of PNEUMOVAX. Subsequently, the patient experienced "induration on his deltoid and erythema". It is unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from a physician on 07-APR-2009. It was reported that the 50 year old male patient with bronchitis at the time of vaccination, who on 18-DEC-2008 was vaccinated in the left deltoid with one dose of PNEUMOVAX (Lot # 657526/055U) at 2:00 pm. On the same day, in the evening, the patient felt sick and had fever, Thursday night and Friday. The patient had chills and spot where shot was given was red, hard swollen. The patient started feeling better on 20-DEC-2008 and improved from there on. The patient had a greater than palm sized area of swelling. redness, pain and induration. This reaction was much more than physician usually see with immunization. There was no airway obstruction, no other rash/skin changes. This is one of two case from the same source. Additional information is not expected.
pt recv vax 4AUG97 & devel hives;hives cont for the next 2 days;pt was not hosp;
Patient lost consciousness two times, one on 06/28 and the second one on 07/15. First time patient felt dizzy/nauseous, blurred vision (loss of color), loss of hearing, and then loss of consciousness. The patient woke up 5 minutes after. Patient felt slight confusion with no adverse effects after. Second time patient almost lost consciousness three times before finally losing consciousness. First time patient loses consciousness for less than 3 seconds before waking up. 3 minutes later patient felt dizzy before losing consciousness for less than 3 seconds. 6 minutes later patient felt dizzy before losing consciousness for less than 3 seconds. Less than 1 minute later patient felt dizzy and nauseous before losing consciousness for 1 minute. After waking up patient felt slight confusion with no adverse effects.
I received injection at approx. 1:30 on 02/20/21.  No issues.  At around 5-6PM started to feel tired.  Went to bed around 9 PM.  Woke at around 4 AM to go to bathroom felt fine upon awakening,  Once in bathroom felt nauseated, and dizzy.  Washing hands felt REALLY nauseated, next thing I know, my husband is hovered over me, as I had passed out unconscious onto bathroom floor.  I landed on my left side.  No blood.  Started immediately with visiable chills, and fever accompanied by headache and dizziness.  Fever lasted until Wednesday mid morning.  Dizzy lightheadedness, and Headache is still on going.  Primary care Dr. had X-rays, and MRI to rule out broken bones and/or concussion.  Tests confirmed I had not broken anything, and I had not a concussion.   Dr. suspects the issues I am experiencing are from vaccine reaction.
Pt returned to the pharmacy on 4/28/14 b/c a red, circular, growth/rash appeared on her arm. Pt states she felt fine and she wasn't even sure when it happened but she felt it on her arm today (4/28/14). Pt has no fever or other symptoms beside spot on arm.
BACK PAIN; PAIN IN LEFT SIDE OF CHEST; ARMS PAIN; BODY PAIN/EXCRUCIATING PAIN; FELT SO SICK; CHILLS; NAUSEA; TIREDNESS/EXHAUSTED; BURNING SENSATION ON RIGHT ARM; COLD AS INSIDE AN IGLOO; DIZZINESS; ABDOMINAL PAIN; PAIN IN THE BONES OF THE CHEST; BURNING SENSATION ON RIGHT ARM THAT EXTENDED TO ABDOMEN; SWEATING; HEAVINESS IN RIGHT ARM; TIGHTNESS ON THE RIGHT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 158 pounds, and height was 159 centimeters. The patient's concurrent conditions included hereditary condition called g6pd, type 2 diabetes, osteoporosis, allergy to sulfa based meds, allergy to soy, non smoker, non alcohol user, and tetracycline allergy, and other pre-existing medical conditions included there was no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported. On 2021, the subject experienced tightness on the right arm. On 2021, the subject experienced sweating. On 2021, the subject experienced heaviness in right arm. On 27-APR-2021, the subject experienced abdominal pain. On 27-APR-2021, the subject experienced pain in the bones of the chest. On 27-APR-2021, the subject experienced burning sensation on right arm that extended to abdomen. On 27-APR-2021, the subject experienced dizziness. On 27-APR-2021, the subject experienced cold as inside an igloo. On 27-APR-2021, the subject experienced felt so sick. On 27-APR-2021, the subject experienced chills. On 27-APR-2021, the subject experienced nausea. On 27-APR-2021, the subject experienced tiredness/exhausted. On 27-APR-2021, the subject experienced burning sensation on right arm. On 10-MAY-2021, the subject experienced body pain/excruciating pain. On 11-MAY-2021, the subject experienced back pain. On 11-MAY-2021, the subject experienced pain in left side of chest. On 11-MAY-2021, the subject experienced arms pain. Laboratory data included: Chest X-ray (NR: not provided) Negative for heart attack, and ECG (NR: not provided) Negative for heart attack. Treatment medications (dates unspecified) included: ketorolac tromethamine, paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from abdominal pain, chills, pain in the bones of the chest, dizziness, tiredness/exhausted, nausea, body pain/excruciating pain, and cold as inside an igloo, and the outcome of burning sensation on right arm that extended to abdomen, felt so sick, pain in left side of chest, arms pain, heaviness in right arm, burning sensation on right arm, sweating, back pain and tightness on the right arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
The pt got Tetanus toxoid on 7/1/04 and the same day, she claimed that she had some tiny papular lesion in both sides of the hands, basically on both thumbs going to the metacarpal area to the wrist bilaterally. It became darkish. At the beginning, she had some pain in the right elbow and the next day she had the pain on the let side of the shoulder secondary to the shot. Since then the spots have been spreading and becoming quite dark. No associated itchiness, burning sensation, numbness. No systemic symptoms as fever, headache, body ache, muscle ache, back pain, neck pain, rashes, nausea, vomiting, diarrhea, weight loss, night sweats.
Bell's Palsy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   21-JAN-2013, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented bell's palsy. As a direct and proximate result, the patient had and would be continued suffer ongoing injuries, including but not limited: mental and physical pain and suffering: medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medication, and supplies. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of bell's palsy to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of bell's palsy was considered to be medically significant.
the other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine.; This is a spontaneous report from a contactable consumer (patient). This case is for patient 2 of other 2 patients. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced the other 2 patients that were diagnosed with shingles after receiving the covid-19 vaccine. on an unspecified date. The outcome of the events was Unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856878 Same reporter/drug/AE, different patient
OXIDIZED LOW DENSITY LIPOPROTEIN ABOVE 2500; This spontaneous report received from a parent concerned a 19 year old male with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in the first week of APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, 15 days after the vaccination, the patient had a wide blood test and a few days later the head doctor called via phone to the parent and told that he hasn't seen such results in his professional experience and advised to take the patient urgently to a cardiologist. On an unspecified date in APR-2021, the patient had the main extreme problem with the marker called oxidized low density lipoprotein above 2,500 and its normal range is 10-170, where 200 would require medication and diet. The patient repeated the test again with another lab and laboratory data included: Oxidised low density lipoprotein (NR: not provided) results were about the same as before. The parent reported that the consequences of these results are bad and requested immediate help. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of oxidized oxidized low density lipoprotein above 2500 was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210601449 and 20210601430.; Sender's Comments: V0: 20210601462 -Covid-19 vaccine ad26.cov2.s -Oxidized low density lipoprotein above 2500. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Covid arm. Rash surrounding injection site on arm appeared 7 days after vaccination. Itchy, red, swollen, hive like.
Patient received 1 covid vaccine of Pfizer (1/7) and 1 covid vaccine of Moderna (2/22)
A male patient experienced flu-like symptoms, headache, joint pain, and fever, after receiving his second dose the RabAvert for prophylactic vaccination and inoculation against rabies (dates unknown). The events are assessed as possibly related to RabAvert.
On 07/07/2022 I woke up early in the morning with a fever of 104.3. The next day, I had terrible body aches, headaches, nausea, dizziness, ear pain, absolute exhaustion, congestion, chills, seating, coughing, and sore throat. I took Tylenol Extra Strength which hardly had any effect. I called my doctor who advised that I go to a local urgent care clinic where I was tested for COVID-19 with a PCR test. I received positive results that evening and I was prescribed Paxlovid. My neighbor picked up the prescription but it was too late in the day to begin taking it. So I began to take the medication on 07/09/2022 that morning. My symptoms began to improve shortly after. My fever broke, I still had congestion, ear pain, headache, coughing, sore throat, congestion and drainage, but it was much less severe. I never felt well while taking Paxlovid but I felt better. I continued treating symptoms with Tylenol Extra Strength as needed. I began to feel better, but then experienced a rebound of COVID. I went in to see my doctor and he confirmed that I had a rebound. My blood pressure was high when I went in to my doctor who advised that I monitor my oxygen and call for emergency care if it gets too low. I've also been experiencing nerve pain in my hands and feet throughout my illness.
Shortness of breath; Throat closing on injection side only; Erythema on injection arm; Allergic reaction to the flu vaccine; This spontaneous case was received on 05-Oct-2023, from other non-healthcare professional (consumer) via Regulatory Communications (reference number: SEQW23-03021), and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 09-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, and anatomical location: not reported) for influenza immunization. The batch number reported was 308434.   On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced allergic reaction, and developed erythema on injection arm, throat was closing on injection side only, and experienced shortness of breath.  On an unspecified date, the patient called pharmacy who told her to take Benadryl (diphenhydramine hydrochloride). The patient took Benadryl, and the reaction was gone the next day.  On an unspecified date, the patient recovered from the events.  The reporter assessed the events to be related to Flucelvax Quadrivalent. The patient reported having an allergic reaction to the flu vaccine.  The case was assessed as non-serious.  Company comment: The patient was vaccinated with Flucelvax Quadrivalent. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced dyspnoea, throat tightness, erythema and hypersensitivity. The patient called pharmacy who told her to take Benadryl (diphenhydramine hydrochloride). The patient took Benadryl, and the reaction was gone the next day. Causal role of the suspect vaccine is unassessable for all events, due to insufficient information about temporal relationship.; Reporter's Comments: The patient reported having an allergic reaction to the flu vaccine.; Sender's Comments: The patient was vaccinated with Flucelvax Quadrivalent. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced dyspnoea, throat tightness, erythema and hypersensitivity. The patient called pharmacy who told her to take Benadryl (diphenhydramine hydrochloride). The patient took Benadryl, and the reaction was gone the next day. Causal role of the suspect vaccine is unassessable for all events, due to insufficient information about temporal relationship.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 9 year old daughter who experienced bleeding and watery discharge from the right nostril.  At 9 years of age, the pt received a dose on 12/12/03.  The pt had no history of nose bleeds.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  On 12/12/03, about thirty minutes after Flumist administration, the pt started bleeding from the right nostril (epistaxis).  A compress was applied and after about three minutes the bleeding stopped.  The father stated that since then, the pt has had some watery discharge from the right nostril.  No additional information was available at the date of this report. Follow-up information received from the patient's physician provided vaccine lot number and concomitant medications. Concomitant Therapy: Concomitant therapy included Poly-Vi-Flor (ascorbic acid/ergocalciferol/nicotinamide/potassium flouride/retinol/riboflavin/thiamine hydrochloride). Event Details: On 12-Dec-2003, about thirty minutes after Flumist administration, the patient started bleeding from the right nostril (epistaxis). A compress was applied after about three minutes the bleeding stopped. The father stated that since the, the patient has had some watery discharge (rhinorrhoea) from the right nostril.
Side effects occurred - 15hr low grade fever (100-101) Headache, fatigue
Pt was given vaccine from a vial that had not been reconstituted.   Advised monitoring for ADE's (none noted at time of admin.).  Additionally recommended follow-up with pediatrician and pharmacy if significant ADE's.
As soon as I got the injection I felt my chest and throat tighten up, I was lightheaded and felt like I couldn't breathe. My BP was checked and at about 153/99 which is VERY high for me. My usual is about 100/80. I laid down and tried to relax and then I started feeling my arms and legs get tingly. I was not hyperventilating. After an hour I decided to try to drive home even though I just did not feel right. I had to pull over because I felt my heart rate going up and stopped and had fire fighters help me out. My husband drove me home and I really started feeling the tingling in my legs and still felt like I could not breathe. I emailed my doctor who blew it off as a panic attack. To this day I still have that feeling at random times.
ER visit and hospital admission with potassium level at 2.0 at admission had several admission and additional hospitalizations for the same drop in potassium that had never occurred before
At approximately 5:45 pm I did not feel well.  Could not say why.  I deteriorated from there and my husband took me to the hospital.  My LOC was greatly diminished and my blood pressure went very high.  No stroke noted.  It was then decided that I had a seizure related to the flu shot.  Saw my neurologist the next day and she agreed it was a seizure and started me on Gabapentin.
On 3rd day developed tinnitus in left year that has gotten progressively worse with headache.
tiredness,headache,musle pain, join pain,injection site swelling,injection site redness,feeling unwell,swollen,throat swelling,lost appetite.
No adverse event yet. Nurse gave #3 VARIVAX after pt had documented 2 previous doses.
Got the second dose of Pfizer on 8/27/21 at 2pm and today, 8/28/21 at 12pm, I briefly blacked out and fell/came to while falling and had a cold sweat for 10 minutes afterwards.  Have had mild headache/aches/chills/fever all day otherwise.
Enlarged and swollen left supraclavicular lymph node that was tender and painful to the touch. Started a few hours after vaccine administration for 1 week and has mostly resolved itself. Intense left ear pain radiating into left jaw, hearing loss and tinnitus in left ear, yellow discharge coming from left ear. Started 2-3 days after vaccine administration. Diagnosed with left ear otitis media ear infection. Pain has improved substantially after day 4 treated with oral Amoxicillin, ibuprofen, Tylenol, and Sudafed. Other symptoms improving but not resolved.
Presented on 02.02.2009 with rash and fever: had MMR and Varicella immunizations on 1.26.09; on 1.28.09 onset of fever up over 103 F and then treated with antipryetics and temp generally down during the day while on tylenol. But is continuing to have fever > 102 in PMs and is now pulling on her ears. Mental status normal except for wanting to sleep more during the daytime - but poor sleep at night. No urinary problems, no unsual emesis (1xd), no diarrhea. Rash started on 2.1.2009. On 02.02.2009 rash was diffuse in location and mostly truncal; color was mostly salmon; best characterized as macular.
states face flushed and reported alittle tightness in throat. declined staying for observation. No SOB, full speaking reported. 12.5 mg of Benadryl given  Narrative: Received Benadryl. refused to stay for observation.   Other Relevant History:
11 hours after shot chills and high temperature.  I couldn't sleep...I took something for the fever.  I was dizzy and nauseous. It was hard for me to leave my bed.  My joint felt inflamed.  Early this morning I fell asleep and when I work up at 11 am I was drenched in sweat.  My fever has come down but I still have a low  fever.
A booster shot given 1 month earlier (4 months after the 2nd shot). The immunizer contacted the patient's mom. No abnormal symptoms developed.
transient loss of vision L eye; Urinary retention; constipation; L arm swelling & pain; Episodic ptosis; L arm swelling & pain; fever; headaches; possible TIA; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye) and URINARY RETENTION (Urinary retention) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (possible TIA) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS TRANSIENT (transient loss of vision L eye) (seriousness criterion medically significant), URINARY RETENTION (Urinary retention) (seriousness criterion medically significant), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye), URINARY RETENTION (Urinary retention), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: increased (High) increased. On 02-May-2021, Faecal disimpaction: abnormal Fecal manual dis-impaction for 2 days.. In May 2021, Urine output: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  On 06-May-2021, the patient reported that she called 911 and went to the emergency room for possible TIA (transient ischemic attack).  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.