chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication was not provided. On 24-OCT-2013 the patients were vaccinated with M-M-R II lot number J002505. Dose, route and frequency were not provided. On 24-OCT-2013, the patients were vaccinated with M-M-R II stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007698, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008060, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Patient developed epistaxis (unilateral, left side), chills and back pain. The chills and back pain only occurred on 9/21 and did not last more than a day. The epistaxis was 9/21 and 9/22.
Above 4 vaccines administered in error (child had original record and separate record).  Original record was NOT seen and or/acknowledged (by father) until after vaccines administered.
The vaccine was given in error. The patient had received the Pfizer Bivalent vaccine the week before. The patient did not experience any adverse effects by the time they left the store.
Narrative:  Patient received Moderna Covid vaccine #1 on 3/5/21 and #2 on 4/2/21. On 3/9/21, he did have reports of poor appetite and weakness to his PCP and on 3/17/21, home health nurse reported an injury to his shin and bilateral pitting edema. On 4/8/21, he presented to our urgent care clinic with reports of shortness of breath and had a chest xray done that showed a right pleural effusion. PMH is significant for CHF and a liver mass seen on MRI 11/2020. He was then transferred to a facility and admitted that same day. On 4/16/21, a hospice consult was placed and he discharged home with home hospice services. On 5/5/21, it was reported that he passed away. Time from second vaccine to date of death was 33 days. No autopsy reports available.
Patient presented to clinic for a booster dose of Moderna. Patient had received her 1st dose on 5/20/21 and 2nd dose on 6/16/21. She received her booster dose, (Moderna, 0.25 ml dose) on 11/09/21 , approximately 37 days before she should of received her booster dose.
Initial physician report received on 22 Nov 2010: This 10-15 patients were vaccinated with MENVEO of unknown batch which were stored between 30 and 40 F for approximately 2 months on unspecified date. Follow up physician report received on 03 Dec 2010: The physician stated that only 6 patients were vaccinated with MENVEO which was stored at 30 F. All the patients were identified. This patient was vaccinated with MENVEO on 16 Oct 2010. No adverse events were reported.
Patient had no issues during 30 minute monitoring at the clinic.  Around 45 minutes later reported a headache.  Blood pressure was taken and it was 158/78, which she reported to be normal for her.  Was asked about signs of allergic reaction including rash, tongue , throat or lip swelling.  Only reported the headache.  Went home an hour post vaccination and started to feel worse.  Was driving by the hospital and felt a little short of breath and still had a headache so she decided to stop for evaluation.  At this point she did not contact the immunzing pharmacist but rather called her coworkers to let them know, who told the immunizing pharmacist.  Pharmacist called patient later and she said that she was given some benadryl and a few other medicines but the ED told her they could not determine it was related to the vaccine and likely anxiety contributed.  Pharmacist discussed wtih patient that she should seek out medical advice before the next dose was due and arrange to get it at a health care facility and not work.  Patient's coworkers also reached out to Pharmacist and let her know the ED was unable to determine tha tiw as related to the vaccine.
Sore left arm; Low grade fever , 100.7 degrees Farenheight; Slight headache; Generalized weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Generalized weakness), PAIN IN EXTREMITY (Sore left arm), PYREXIA (Low grade fever , 100.7 degrees Farenheight) and HEADACHE (Slight headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    Concurrent medical conditions included Arthritis and Immunocompromised. Concomitant products included METHOTREXATE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient started INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On 29-Sep-2021, the patient experienced ASTHENIA (Generalized weakness), PYREXIA (Low grade fever , 100.7 degrees Farenheight) and HEADACHE (Slight headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, ASTHENIA (Generalized weakness), PAIN IN EXTREMITY (Sore left arm), PYREXIA (Low grade fever , 100.7 degrees Farenheight) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 100.7 (High) 100.7 degrees Farenheight.         The patient received his flu shot at the same time that he received his third dose of Moderna Covid-19 vaccine. The side effects were generalized weakness, low grade fever of 100.7 degrees Fahrenheit and a slight headache. Patient also reported a sore left arm. Treatment information was not provided.   This case was linked to MOD-2021-339370, MOD-2021-339390 (Patient Link).
hands soreness/fingers soreness/sore arm; a lot of body aches; back soreness; Soreness in ankle, elbow, knee,hands and fingers; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hands soreness/fingers soreness/sore arm), PAIN (a lot of body aches), BACK PAIN (back soreness), ARTHRALGIA (Soreness in ankle, elbow, knee,hands and fingers) and HEADACHE (severe headache) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hands soreness/fingers soreness/sore arm), BACK PAIN (back soreness), ARTHRALGIA (Soreness in ankle, elbow, knee,hands and fingers) and HEADACHE (severe headache). an unknown date, the patient experienced PAIN (a lot of body aches). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (hands soreness/fingers soreness/sore arm), PAIN (a lot of body aches), BACK PAIN (back soreness), ARTHRALGIA (Soreness in ankle, elbow, knee,hands and fingers) and HEADACHE (severe headache) outcome was unknown.            Patient reported that she received steroid injection in past.She drank plenty of fluids.Action taken with mRNA-1273 in response to the events was not applicable.
Narrative: Per primary provider required hospitalization due to atrial fibrillation with RVR and heart rate in eh 150s. Was subsequently seen by cardiology with additional work-up. Cardiologist noted, "Unclear if presumed new systolic heart failure is related to longstanding atrial fib with RVR (tachycardia cardiomyopathy) or CAD with ischemia causing atrial fib and LV dysfunction. I explained both scenarios to pt and daughter." per 3/10/2021 Note. Per primary provider patient was verbally informed they though potentially related to vaccine.
Full on flu; 101.4 temperature/fever at 99.0; Body ache; Continued sniffing; neck pain; dry chest cough; shortness of breath; shortness of breath; Bad headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN9581 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 16Feb2021 14:15 (at the age of 62-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included some disc issues; had shortness of breath and tightening in throat that had been going on all year with different intensities; had anxiety/panic disorder that came on from shortness of breath after had a cold in Dec2019. Concomitant medications included fish oil; ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin B NOS (MULTIPLE VITAMINS) and herbs all taken for unspecified indication within 2 weeks of vaccination. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL330 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 26Jan2021 14:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation and experienced dry cough. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening after the 2nd shot the patient woke up with a bad headache and chills. By the morning (17Feb2021 02:00), he felt like he had full on flu. The patient had a 101.4 temperature (the patient was in the high 97 range), a really bad head ache also in his neck where he had some disc issues, full on body aches, continued sniffling and dry cough (that started with the initial shot when he received 1st dose). On day two still achy though after taking Tylenol every 4-6 hours his headache was gone and fever at 99.0. On day three (18Feb2021), everything seemed to settle down. Still dry chest cough (could be allergies but started when he received the first shot). The patient undergone both the antibody and swab test that were negative, but he was never having a shortness of breath like this. The patient received Tylenol for the events of headache and fever and did not receive any treatment for the other events. The clinical outcome of the events sniffling, dry cough, headache, chills, fever, body ache and flu like symptoms was recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
pt had hosp admission 9/3 - 9/8/21 for positive COVID test and COVID pneumonia; dc'd to home; continued to have SOB; came to ED with AHRF secondary to pneumonia, left pneumothorax and thrombocytopenia; transferred to Medical Center for higher level of care; O2 given; IV ABX; poor oral intake; transitioned to comfort care and pt died in the hospital
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 6th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced shivering, muscle fatigue, influenza-like symptoms and nausea. On an unknown date, the outcome of the shivering, muscle fatigue, influenza-like symptoms and nausea were recovering/resolving. It was unknown if the reporter considered the shivering, muscle fatigue, influenza-like symptoms and nausea to be related to SHINGRIX. Additional details were reported as follows: The patient experienced Shivering, muscle fatigue, flu like symptoms, slight nausea after receiving SHINGRIX. The patient experienced pretty much everything adverse events except headache. The patient reported he feels a little better in morning of the reporting date. The patient was inquiring about the duration of the time the side effects he reported yesterday might last. As per the Package Insert (PI), advised the caller the side effects could last 3 to 5 days, on average around 2 to 3 days. The patient also inquired if he would had a similar reaction to the 2nd vaccine and he was advised that he most likely would had a similar reaction. The patient did not think the follow up would be necessary.
Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Soreness at the injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Soreness at the injection site). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE ERYTHEMA (Redness at the injection site) and INJECTION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a medical assistant concerning a 41 year old female patient with asthma who on 07-DEC-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml, intramuscularly in the left deltoid. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported) administered in the same arm in the same day as PNEUMOVAX 23. The medical assistant stated that patient had had the flu shot in the past with no negative event noted. On 09-DEC-2010 the patient contacted the office and reported that she experienced swelling in the upper shoulder left side and pain in her deltoid where the PNEUMOVAX 23 was administered. The patient also reported feeling tired and weak. The medical assistant stated that patient came into the office on 08-DEC-2010 and physician examined patient and noted swelling in the left clavicle, swelling in a lymph node and swelling at the injection site. Physician treated patient with prednisone, MOTRIN, AUGMENTIN and BENADRYL. The medical assistant stated that patient returned to the office on 11-DEC-2010 and was better. There was no laboratory diagnostics studies performed. Follow-up information was received from the medical assistant concerning the 41 year old female patient with asthma, allergy to VICODIN and codeine and no history of being allergic to PNEUMOVAX 23 who on 07-DEC-2010 at 8:00 a.m. was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667916/1066Z, expire date 12-MAR-2010), 0.5 ml., intramuscularly in the left deltoid. Suspect vaccine included FLULAVAL (Lot #, expire date and route not reported) administered in the same arm in the same day as PNEUMOVAX 23. The medical assistant stated that on 08-DEC-2010 at 3:15 p.m., (also reported as four hours) after receiving PNEUMOVAX 23 and FLULAVAL, the patient developed painful swelling over the left clavicle. Medical assistant added that the swelling was very painful. The patient also had pains in the left deltoid where the PNEUMOVAX 23 and FLULAVAL were given. There was no breathing difficulty. The patient had no history of being allergic to this vaccine. On 11-DEC-2010, the patient recovered. This is one of two reports from the same source. Additional information is not expected.
Information has been received from a physician concerning a 16 year old male who on 14-OCT-1994 was vaccinated with the first dose of MMR II, on 20-MAR-1998 was vaccinated with the second dose of MMR II. On 13-NOV-2009 the patient experienced mumps. Laboratory tests on 28-DEC-2009 included serum IgM <1:10, serum IgG 3.34 and serum amylase 35. Follow up information has been received and indicated that the 16 year old male patient (also reported as 14 year old) was vaccinated with his first dose of MMR II on 14-OCT-1994 and with his second dose of MMR II on 20-MAR-1998. On 07-DEC-2009 (previously reported as 13-NOV-2009) the patient experienced mumps, on 08-DEC-2009 the patient was diagnosed. The patient was afebrile and had L parotitis. The first blood work performed on 08-DEC-2009 included: IgM: <1:10; IgG: 3.58 and serum amylase value of 50. No further information is expected.
Started yesterday, injection itchy, felt like a small lump or welt, she scratched it, and it turned red
fever x few days;  scattered pruritic papules, in area of vaccination site as well as elsewhere.
Large bruise at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (Large bruise at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Large bruise at injection site). At the time of the report, VACCINATION SITE BRUISING (Large bruise at injection site) outcome was unknown.            No concomitant medications reported. No treatment reported
Blue Fingers the next day. A few weeks later have tingling in whole body, mostly legs and hands. Blurred vision. Black and blue marks on in back of lower legs. Veins protruding in hands and continue to be blue.
delayed in transit/no AE; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA260949.  This case involves a 18 month old male patient who received 0.5 ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6645LA, expiry date:30-Jun-2020) via intramuscular route in the left thigh), on 13-Sep-2019 which was delayed in transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Contamination therapy included Pentacel on 13-Sep-2019.   It was an actual medication error due to Incorrect product storage.  It was unknown if any adverse event occurred.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  List of documents held by sender: none.
Could not raise my arm above my shoulder, extremely painful, hand was numb, could not make a fist with my hand...after 3 week, I went to my Md. he gave me a steroid shot and it relieved alot of the pain, however the hand still goes numb if I hold it up, and I can not sleep on that side of my body, I still have tenderness in the arm and numbness in the hand and lack of strength in the arm and hand.
Febrile sz 6 days p/recving vax had 2-4 min convulsion; pt still had fever but has recovered from sz;
sore arm; low grade fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as DOSE 1, SINGLE for covid-19 immunization. The patient experienced sore arm, low grade fever, chills and body aches on an unspecified date. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Crohn?s disease in remission since 2019 began to flare the a few hours after vaccine administration (pain, nausea, blood in stool) and symptoms appeared to resolve after a couple of days but worsened again about a month after the vaccine (pain, blood in stool, diarrhea, possible anemia).
sore injection site left arm/ left arm was sore for two days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore injection site left arm/ left arm was sore for two days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Stools watery (history of watery stools 20 years ago.).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore injection site left arm/ left arm was sore for two days). On 03-Apr-2021, MYALGIA (sore injection site left arm/ left arm was sore for two days) 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 medication information provided. No treatment information provided.   This case was linked to MOD-2021-319120 (Patient Link).
Reported tingling, numbness, tightness in jaw and redness to bilateral arms.  Administered Benadryl 50mg po.  Observed for 30minutes with improvement in symptoms.  Vitals signs stable.
Starting 9/22 developed numbness in bilateral toes and feet. The numbness gradually ascended over the next few days until on 9/26 it had reached the mid chest. Also had hyperreflexive deep tendon reflexes in the bilateral UE and LE and reflexive up-going toes on the left. The numbness gradually improved over the course of about a month.
I had fatigue, a low-grade fever, I took a home COVID-19 test that came back positive. I called my doctor to let him know that I had taken a home COVID-19 test that came back with a positive result. He prescribed me the Paxlovid that I started taken immediately. It took me about two weeks to completely get over COVID-19.