chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got patient for first time ever and still got the covid; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 08-Dec-2020.  This case involved a patient who got for first time ever and still got the COVID (coronavirus disease) (Covid-19), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.  On an unknown date, the patient got for first time ever and still got the COVID (coronavirus disease) (covid-19), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was Covid-19.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Temp 100 Could not get out of Bed trembling Chills/Sweats Weak headache (Bad) Slept on + off for 17 hours Dizzy
This is one case out of a cumulative total of 22 cases solicited from the Electronic Disease Surveillance System during the surveillance period from 01 January 2010 to 12 July 2011. These 22 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP-combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 12 July 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included one dose of DAPTACEL, lot number C3514AA received on 07 June 2011, and 3 doses of PENTACEL; lot number C3497AA received on 27 November 2009, lot number C3362AA received on 02 October 2009 and lot number C3304AA received on 31 July 2009 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 25 June 2011, approximately 18 days after the last dose. On 30 June 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 29 June 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AZITHROMYCIN starting on 01 July 2011 for five days. The subject was not hospitalized. At the time of final contact on 09 July 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
SEIZURES (PARTIAL / FOCAL MOTOR) OFF & ON FOR ABOUT 35 MINUTES  FLANK PAIN
2nd dose 3 weeks after his 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: Reporter was the HCP (pharmacist) who stated that a patient received his second dose of Shingrix 3 weeks after his first dose which was earlier than the recommended 2 to 6 months.  The reporter consented to follow up. Additional Supportive Information: the patient received 2nd dose 3 weeks after his first dose, earlier than recommended schedule, which led to shortening of vaccination schedule.
Information has been received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 06-APR-2015, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUL-2016, the patient was treated by a physician for a painful rash that was diagnosed as a severe case of shingles with nerve pain and neuralgia. Although the shingles virus is an incurable condition and neuralgia is a chronic residual effect of nerve damage cause by shingles, the patient was prescribed acyclovir, sulfadiazine, silver (SILVADENE 1% TOPICAL CREAM), hydrocodone and gabapentin (reported as "Gabapentic") for the management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient given vaccination at the age of 12 instead of 18. Patient had no adverse reactions. Family was notified of results.
patient began feeling tingling sensation at injection site left arm.  A few minutes later dizziness and (now stating shortness of breath) original evaluation, assessment and patient statements did not reveal shortness of breath.  She was speaking softly, SaO2 was 98.  Provided gatoraid  and offered weather.  Husband stated she had previous similar reaction post-anesthesia. at 1515.  Patient began to feel weakness over entire body. Refused ambulance at that time. 1520- began having chest pain, tingling in legs and feet. Husband said he would take her to the ER due to BP continuing to be elevated. 1528-  Unable to stand requesting an ambulance. a1530- EMS called  at 1535 ambulance confirmed.  1540- Ambulance arrived.  Turned over care to EMS
Pain down left side of body, (side of injection) Lethargy, nausea, headache, fatigue.
Covid 19 Positive (Sore throat); Redness near the injection site; Swelling near the injection site; Tenderness near the injection site; A hot sensation near the injection site; Case reference number MOD-2021-009528 is a spontaneous case report sent by a Physician on 19-JAN-2021 00:00:00 , which refers to a Female aged 57 Years .  The patients past medical history included: No adverse event   . .  On 31/DEC/2020  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  9 days later,  the patient developed Injection site redness,swelling, tenderness, warmth,Sore throat.The patient experienced the following serious criteria:. The eventual diagnosis made on was Injection site erythema . .   The patient was treated for the event with Monoclonal antibodies ,Antibiotics  .The action taken for Moderna COVID-19 Vaccine was  Unknown . The Physician did not declare any relatedness between Redness near the injection site and Moderna COVID-19 Vaccine.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for Safety Update narratives and signal review) Brief 3 line summary of above for Council listing: Report Source- Physician,  Age- 57 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment- Monoclonal antibodies,Antibiotics  Diagnosis\Outcome- Covid 19 Positive (Sore throat) - Unknown,A hot sensation near the injection site - Unknown,Tenderness near the injection site - Unknown,Swelling near the injection site - Unknown,Redness near the injection site - Unknown.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 positive (sore throat), is assessed as unlikely related.
2.25 inch erythematous indurated site reaction. No symptoms of anaphylaxis.
Patient received 2nd dose of Pfizer COVID vaccine (Lot# EL9261). Within the 15 min wait time the patient reported swelling of tongue. ( 1040 am) Immediately reported and responded. Patient alert and verbalized she felt "ok". Patient then reported increase in symptoms and was treated with 100 mg of Benadryl IM left deltoid. B/P 110/60, HR 77 and Pulse Ox 98%. Patient then reported a "tickle in the back of my throat" Patient immediately treated with Epinephrine 0.5 mg IM right thigh @ 1059. B/P 137/65, HR 73, Pulse OX 99% EMS arrived and patient transported.
This spontaneous report as received from a nurse refers to a 64 year old patient of unknown gender. No medical history provided. On 15-APR-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510, exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Swelling in the lymph nodes of right arm pit and surrounding area, plus tenderness.  Site of injection pain, severe for 1.5 days.
First dose 10/14/2019: Approximately 3-4 hours after first dose vaccine I began feeling lightheaded, nauseated, and began getting a headache. The following day I was listless and no energy. I had trouble concentrating.  Second dose 12/17/2019: Approximately one hour after receiving  the second dose of the vaccine I began feeling like I did after the first vaccine, only more intense. I went to bed at 7:00 pm. The following morning I woke at 6:00 am but I couldn't move. I laid there for 3-5 minutes when I realized if I concentrated hard enough, I could move a little. After 20 minutes I was able to make it to the living room floor where I laid all day drifting in and out of consciousness. As I was drifting in and out throughout the day, I was sweating profusely. I couldn't take deep breaths as my chest felt very constricted as if there was an enormous weight on it. I seriously thought I was going to die. I did not have the need to go to the bathroom all day. At approximately 6:00 pm I had enough energy to make it to bed where I remained all night drifting in and out of consciousness. I didn't really know where I was. My chest still felt constricted until the following day. I woke at 5:30 am and was able to move easier than the previous day. My chest still felt constricted but not as much as the previous day
Pt has been having arm pain for 2 months since she got Hep B shot on 7/2/14.
No additional adverse events reported; Expired vaccine used; This spontaneous report was received from a medical assistant referring to an 8-week-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 17-MAY-2021, the patient was vaccinated with an expiration dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported; dose: 2 milliliter, lot # 1661000, expiration date was 13-MAY-2021) orally for prophylaxis. This dose was found supported by memo with no previous temperature excursions. No additional information given. No additional adverse events were reported.
CDC recommendation person 11 years of age or older who has never received Tdap vaccine should count a dose of DTaP as the once-in-a-lifetime dose of Tdap. The next tetanus/diphtheria vaccination will be a routine Td booster 10 years later.
*painful lymph nodes all on left side esp in neck *pain in spleen *pain in hips, knees, and ankles b/l *pain behind shoulder blade area left side *numbness and tingling in hands and feet which has transitioned to  just tingling in b/l finger tips *abnormal vaginal bleeding
Initial report was received 11 August 2008 from another manufacturer who received the report from a health care professional.  A female patient (age not provided) "felt sick and had malaise symptoms for ten months after she [had received a] flu vaccine (manufacturer and lot number not reported) for the first time.  When she was given the flu vaccine the second time she had the same symptoms for six months".  The patients recovery status was not reported.  No further information was provided.
This spontaneous report was received from a physician regarding multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L023230 with expiration date 28-JUL-2017 or lot #L007560 with expiration date 15-JUN-2017 or lot #L013429 with expiration date 21-JUL-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient complaining of extreme soreness to her right arm and shoulder and now states that it hurts to move her arm.
Pt reported nausea and "feeling hot" following injection. VSS. Oral fluids administered. Repeat VSS. Symptoms resolved. Pt released and escorted to exit.
recv vax on approx 1AUG98 & on 10AUg98 devel a vesicular rash w/less than 50 lesions around the inj site;15AUG98 devel petechia, contracted ITP;hosp; 23AUG98 platelets 3,000;p/immunoglobulin G platelet count 5,000 on 24AUG98;
patient said she developed an itchy rash on her back and trunk that she noticed this morning (7/25) and went to the doctors shortly after. patient was then instructed to take benadryl and the md ruled out shingles reactivation. patient had not tried anything for the itching so far today. on visual inspection the skin looked slightly raised an blotchy consistent with hives. patient said she was not experiencing any other symptoms at this time.
Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 6 year old male patient who received one dose each of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 11-Nov-2019, the patient received a one dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, [Lot number and other dosing details are not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No symptoms reported; Administering VARIVAX to a patient that is immunocompromised. No symptoms reported; This spontaneous report was received from a Pharmacist and refers to a 47-year-old immunocompromised patient of unspecified gender. The patient's medical history was not reported. Concomitant therapies were not reported.  On 05-OCT-2023 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot #W031812, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  The patient was also receiving adalimumab (HUMIRA) (contraindicated product administered).  No symptoms or further details reported.
Pt came in to the pharmacy and asked about ADR. She reported soreness on her armpit in the arm she got the vaccine. Pt does not have any redness, or heat at the site of injection. Also the muscle soreness at the injection site.
Patient's arm was sore after receiving the vaccine, 3 days later she woke up with numbness. She went to the hospital and was diagnosed with a blood clot in her arm. She was placed on warfarin and the clot dissolved. Her OBGYN lowered her dose of birth control. Her PCP advised her to still get her second dose.
3 days p/vax pt devel an inj site rxn characterized by redness,swelling & warmth;pt recovered;
Acute Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute Myocarditis) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute Myocarditis) to be related.    No concomitant and treatment medications were provided.  Company Comment: This is a literature non-study case concerning a 22-year-old male patient with no reported medical history, who was hospitalized due to the expected, serious (medically significant) adverse event of special interest of Myocarditis (reported as Acute myocarditis), after receiving the second dose of mRNA-1273 vaccine. Date of vaccination and onset of event was not specified. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event Acute myocarditis was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-513579, MOD-2022-513533, MOD-2022-513581 (Patient Link).; Sender's Comments: This is a literature non-study case concerning a 22-year-old male patient with no reported medical history, who was hospitalized due to the expected, serious (medically significant) adverse event of special interest of Myocarditis (reported as Acute myocarditis), after receiving the second dose of mRNA-1273 vaccine. Date of vaccination and onset of event was not specified. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event Acute myocarditis was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Involunatry muscle twitching; Involuntary little like muscle spasm in my upper arm; I can like feel it the muscle like contracting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 22-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER8727) at the age of 22 years 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: MUSCLE TWITCHING (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Involunatry muscle twitching"; MUSCLE SPASMS (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Involuntary little like muscle spasm in my upper arm"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset 22Mar2021, outcome "not recovered", described as "I can like feel it the muscle like contracting". Therapeutic measures were not taken as a result of muscle twitching, muscle spasms, muscle contractions involuntary.  Additional Information: On 22Mar2021 and 23Mar2021, the patient had like involuntary muscle twitching like involuntary little like muscle spasm in the upper arm where she got the injection. It had not ever happened before and was not sure that's related. It felt like the muscles in her upper left arm are kind of doing like a little involuntary muscle spasm and it felt like a muscle twitching feeling basically. It was like if she put her other hand on it, she can feel like the muscle like contracting. It happened a little, like 20 minutes at a time and then stop for couple of hours and then come back. It happened earlier today but it was not happening right now (23Mar2021).  No follow-up attempts are possible. No further information is expected.
10-20-14 swelling red itching at injection site. 10-22-14 rash on both arms. 10-24-14 dizzy and weakness in legs and back.
This spontaneous report was received from a Nurse Practitioner refers to a 29 year old female patient. On 23-AUG-2013, the patient was vaccinated with dose 2 of VARIVAX (Merck) lot# H020250, expiry: 06-NOV-2014 (reported as 18-NOV-2014) 0.5 ml, subcutaneously. On 31-AUG-2013, the patient experienced varicella-like rash. The lesions are itchy and are located on bilateral hands, chest, and between her thighs. The rash was improving without requiring medical treatment. No treatment was received. Patient sought medical attention-office visit. No laboratory tests were performed. The nurse practitioner adds that the patient did not experience adverse symptoms after administration of her first dose of VARIVAX (Merck) 0.5 ml, subcutaneously in November 2012. The therapy was not discontinued. The outcome of varicella-like rash was reported as recovering. Additional information has been requested.
Shoulder very sore and unable to lift arm. No redness or swelling. Did not seek medical treatment until December. X-rays and MRI were normal. Doctor "thinks it is coincidental" with receiving the shot. Received a cortisone shot without improvement and is now doing physical therapy. Able to raise arm up but not to the side.
Adverse effects of the first vaccine - Left arm - Fever 102 / Body aches worse than any flu ever.  Sick for three days.  Several days to recover.  Arm was sore for over a week.  Adverse effects from second vaccine - right arm - 9 hours after shot on 6/4/21 - every joint in my body hurt for two days.  My hands were the worst.  All I could do was cry and hold them up.  I could no even use them.  I did not have a Fever.  My arm was sore, but not as long.  My hands have not stopped hurting since June 4th.  They hurt ALL the time.  I wake up 3-4 times a night because they hurt so much.   I've missed work because of the pain.  I am wearing compression gloves all the time.  I have not had a chance to get to the Dr. yet, but hope to go in the next week or so.  I DID NOT HAVE THIS PROBLEM BEFORE THE MY SECOND VACCINE.   They NEVER STOP HURTING.   I was tested last year for Arthritis and did not have ANY of the markers for it.  I was fine before this.
Within a minute or two of getting the vaccine  my throat felt like it started to close up.  It has felt like that since the vaccination and has not let up.  The nurse who administered the dose notified someone within the pharmacy.  They had me wait an additional 15 minutes and checked on me.  No change.  I was told to go to hospital if the symptom got worse.
pt recv vax & later that day devel fever, h/a, fatigue, sore & tight muscles;
temperature 102 deg. - hives - severe pain at site and lymph nodes under arm - fatigue