chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like flu; Nausea; Lowgrade Fever; Chills; Fatigue; My arm got sore; Warm but Afebrile; body ache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile), PAIN (body ache), INFLUENZA LIKE ILLNESS (Felt like flu) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Jul-2020. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile) and PAIN (body ache). On 02-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu), NAUSEA (Nausea), PYREXIA (Lowgrade Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (My arm got sore), FEELING HOT (Warm but Afebrile), PAIN (body ache), INFLUENZA LIKE ILLNESS (Felt like flu), NAUSEA (Nausea), PYREXIA (Lowgrade Fever), CHILLS (Chills) and FATIGUE (Fatigue) 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.   The patient took acetaminophen and ibuprofen.      Company comment:  This case concerns a 47-year-old female with PMH of COVID-19, who had NS events of unexpected pain in extremity, influenza like illness, feeling hot, pain, and expected fever, chills, fatigue, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen and ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: This case concerns a 47-year-old female with PMH of COVID-19, who had NS events of unexpected pain in extremity, influenza like illness, feeling hot, pain, and expected fever, chills, fatigue, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen and ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt said - after injection med a month, pt got a rash on her face. She got a little by little rash around on her mouth.
soreness left arm; redness left arm; Labelled drug-drug interaction medication error; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Pneumococcal vaccine. On 9th October 2019, unknown after receiving Shingrix and Pneumococcal vaccine, the patient experienced labeled drug-drug interaction medication error. On 10th October 2019, the patient experienced pain in arm and erythema of extremities. The patient was treated with antihistamine and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved and the outcome of the labeled drug-drug interaction medication error was unknown.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix and Pneumococcal vaccine.  Additional details were provided as follows: The patient received Shingrix and Pneumococcal vaccine in left arm, which led to labelled drug-drug interaction medication error. The next day after vaccination the patient experienced sore and red left arm. The soreness and redness continued to get worse and eventually the redness spread from her shoulder to her elbow and was approximately 4 inches in size.  The reporter called physician and she recommended that the patient use an antihistamine. The patient used an antihistamine and cortisone cream for 2-3 days and this seemed to help with the symptoms.  The issue resolved after approximately 2-3 weeks. The reporter consented to follow up.
RECEIVED 1ST DOSE 2019 BUT NEVER GOT 2ND DOSE; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: The reporter enquired if a patient received Shingrix 1st dose in 2019 but never got 2nd dose what should be done. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Developed bodywide joint pains 48 hours after vaccination.  This lasted for three days.  Pain was relieved with Excedrine.  Has history of arthralgia with certain medications, but not vaccinations.
Pts arm became swollen, red, warm immediately following injection. She sat there a minute with big eyes and touched her throat saying "my throat" . She was always talking to her mom. I went to get the epi pen but before I gave it her color improved and she was more relaxed and talking freely. We had called EMS and they came to check her out as a precaution. Her BP, pulse ox and breath sounds were good. She stayed a while and followed up with doctors afterward.
Vaccine dripped out of the syringe and the patient didn't receive the full dose, with no adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age/gender patient to whom while administering INFLUENZA VACCINE dripped out of the syringe and the patient didn't receive the full dose, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, while administering INFLUENZA VACCINE (lot/expiry; unknown) dripped out of the syringe and the patient didn't receive the full dose, with no adverse event (incorrect dose administered) (dose, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  At time of reporting, the outcome was Unknown   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 the 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.
Soreness; Itching; swelling at site; vaccine site swelling/redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, DICLOFENAC SODIUM (VOLTREX [DICLOFENAC SODIUM]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness). On an unknown date, the patient experienced PAIN (Soreness). The patient was treated with PREDNISONE (oral) at a dose of 20 mg once a day and CEFALEXIN (KEFLEX [CEFALEXIN]) (oral) at a dose of 500 mg every eight hours. On 12-Jan-2021, VACCINATION SITE SWELLING (swelling at site) and VACCINATION SITE ERYTHEMA (vaccine site swelling/redness) had resolved. At the time of the report, PAIN (Soreness) had resolved and VACCINATION SITE PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement: 136/88 (High) 136/88 mmHg. On 08-Jan-2021, Body temperature: 37.2 (normal) (99 F). On 08-Jan-2021, Heart rate: 64 (Low) 64 times per minute. On 08-Jan-2021, Oxygen saturation: 100 (normal) 100%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
p/vax pt became limp, pale, cyanotic around the mouth, diaphoretic, unresponsive, BP dropped & resp slowed;appeared to have a fainting episode;BP 74/40 c/o nausea;
Rt deltoid swelled after injection & states on 9-29-11 the deltoid was the size of an egg.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 49-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported Reporter stated that no adverse reactions were reported by any patients.   This case was linked to MOD-2022-501575 (Patient Link).
Fever on 5/31/19 On 6/6/19 started with hives.  Seen in our office on 6/6/19, in the ER on 6/7/19 and again in our office on 6/8/19
rash on belly/groin; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old male patient (consumer) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 29Apr2021 (At the Age of 63-Years-Old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was reported none. The patient's concomitant medications were not reported. The patient(consumer) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 10:30 (At the Age of 63-Years-Old) as DOSE 1, SINGLE for covid-19 immunization. On 30Apr2021 06:00 the patient experienced rash on belly and rash on groin. Patient wanted to report side effects that he received both shots. Patient reported after the second shot it continued on both elbows and to the groin and belly area. Patient reported it is clearing up and is not getting any worse. Patient reported he had a wellness check on 28April. Patient reported that he showed the doctor his elbows. The doctor mentioned that it looked like psoriasis. Patient Reported that the doctor told him that he could prescribe something. Is for Pfizer COVID-19 vaccine. Patient reported he put lotion on it which makes the itching better. The outcome for belly rash and groin rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Left leg had swelling and redness that started 24 hrs. after KINRIX vaccine was given. Symptoms worsened over next two days. No fever on exam left lateral thigh had swelling and warmth with area of redness 10 cm in diameter and is firm. Dr felt it was a localized reaction to immunizations.
Menstrual period started 5/3 and continued without stop until 6/29. This had never happened to me. All the bleeding caused me to have low iron, which made me exhausted.
Rash on arms and feet. Swelling and pain in feet.  Taking Benadryl. Ongoing for the last 24 hours.
Pain to left arm at injection site.  Painful range of motion when abducting arm above shoulder level.  Denies any redness or swelling.
Fever, chills, body aches, and fatigue began the night of the injection.  I am currently 20 days out and am intermittently experiencing all.  I have had a fever every day.  The other symptoms have gone a few day over the last few weeks.
The patient did not develope side effects; The patient was administered a second unnecessary dose of PNEUMOVAX 23; This spontaneous report has been received from a registered nurse (RN) concerning to a 67-year-old patient.      The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  On 19-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose/route/frequency of administration, lot number, and expiration date were not reported) for prophylaxis.  On 29-JUN-2022, the patient was vaccinated with an unnecessary second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (extra dose administered) (lot number U034712 with expiration date 30-JUL-2023) (strength, dose/route/frequency of administration date were not reported) for prophylaxis. The patient did not develop side effects. No additional adverse events (AEs) were reported (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA002428:
PROGRESS NOTE 1/20/2022 This is a   66-year-old male with a complicated PMHx of RLE DVT, spastic paresis 2/2 cervical myelopathy, left pontine infarct in 2018, recurrent stroke in October 21, residual right-sided hemiparesis, recent admission for COVID-pneumonia is being admitted for acute respiratory failure 2/2 COVID, who aspirated on soda at his facility and started to have shortness of breath 1 day prior to admission.  He is being treated for pneumonia, possibly secondary to aspiration.   PLAN Acute respiratory failure w/ hypoxia COVID PNA Probable sepsis Bacteremia Suspected superimposed bacterial PNA Respiratory acidosis Tested positive for covid on 1/11 (previous hospitalization) On arrival to the ER he was hypoxic, tachycardic, tachypenic, given his recent dx of RLE DVT (1/11) there was high concern for a PE and was started on heparin drip. Initially placed on BiPAP, and later was able to transition to CPAP which he tolerated much better. CTA resulted neg for PE but did show extensive b/l PNA. Heparin drip was stopped.  has a slightly elevated procalcitonin, LA 4.4, otherwise normal wbc, afebrile -Started on cefepime and Vanco in ER, continue. -Blood cultures positive for gram-positive cocci.   received 2L IVF in the ER, will hold further given that he is covid + IV Decadron ordered Check CRP 6.4, liver enzymes only mildly elevated, LA elevated on arrival has now resolved.   RLE DVT Diagnosed previous admission, he was not started on anticoagulation due to concern for GI bleed, had a neg EGD.  However in setting of his acute illness and recent covid, stable hgb, continue lovenox 40mg and continue with his  PTA dual anti platelet therapy. Monitor hgb.    Chronic anemia hgb 9.7, likely from dehydration.  Today, back to baseline at 8. Monitor for bleeding Resume PTA protonix   H/o CVAx2 w/ chronic L sided hemiparesis Resume PTA antiplatelet therapy. Neuro status at baseline.   CODE STATUS: Full Code  DVT prophylaxis: lovenox GI prophylaxis: protonix
Flu symptoms starting on the 12th of November, worsened throughout week, dissipating by the 20th of November. Had cough, fatigue, nausea, sweating, chills, body and muscle aches, loss of appetite, vomiting, congestion, runny nose, brain fog, and headaches.
Information has been received from a health professional concerning a 6 year old female who on 28SEP1998 was vaccinated with a dose of varicella virus vaccne live. On 21FEB2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
The patient called the pharmacy 8/26/20 and stated she had experienced nausea and vomiting starting the evening after she received the vaccinations.  She stated she had vomited twice on 8/25/20 but was beginning to feel better on 8/26/20.  She also stated she has a slight headache and some minor injection site pain.
Arm pain at injection site, getting worse by the hour. Have not taken any pain relievers in order to provide unbiased data.
VERY SORE left arm, from the day after vaccination to now, five months later.  I cannot reach out to the left to reach the toilet paper, I cannot reach into the refrigerator or microwave with my left arm, it hurts to reach into my medicine cabinet to get my toothbrush, it hurts to reach for a hanger in a closet.  I cannot lift my left arm straight out to the side.  I can move it more when it is bent at the elbow.
I got my vaccine in the evening before I left work.  That evening I felt very tired then woke up in the middle of the night with chills, severe aches in my back/neck/shoulders, headache and weakness.  The chills and fever went away, but the achiness and pressure headaches lasted for over 4 weeks!
This is a non-serious spontaneous case, initially received from other health professional on 20-Dec-2017 and concerns a 44-year-old, adult female pregnant patient of body weight 143 kg and height 60.7 cm. The patient had no family history of major congenital malformations. The patient had no history of tobacco, alcohol or illicit drug use. The patient had 3 previous pregnancies from which 2 pregnancies had full term live births and 1 pregnancy had spontaneous abortion. The patient's current condition included UTI (urinary tract infection) (since an unspecified date). The patient's concomitant medications included VITAFOL and MACROBID for UTI (urinary tract infection). The patient's LMP (last menstrual phase) date was 05-Apr-2017. The patient had a singleton pregnancy. On 22-Aug-2017, amniocentesis was done which found to be normal and cystic fibrosis mutation analysis was performed and found to be normal (no major congenital malformations noted). On 17-Oct-2017, at gestation age of 28 weeks, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, route of administration, dose, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy). On an unspecified date, the patient had UTI, anemia and low free thyroxine. The patient started the treatment with MACROBID capsule (2nd course, 100 mg, bid [two times a day]) (from 24-Oct-2017 to 31-Oct-2017) for UTI,  Ferrosol tablet (325 mg, qd [every day), and SYNTHROID tablet (50 mcg, qd) (from 24-Oct-2017 to continued). At the time of this report, the outcome of the events was not reported. The EDD (estimated date of delivery) was reported as 10-Jan-2018. Non-significant case correction received 20-Dec-2017 on 06-Feb-2018: The case comment was corrected.
21SEP pt devel fever 104.1, face began swelling, difficulty breathing, coughing continuously, congested; to MD 24SEP w/rash over chest & back, throat swollen; rx: Amoxicillin & APAP & vaporizer; 21OCT91 pt still has cough & congestion;
This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injured was not reported. This report was non-serious.
Patient came to the pharmacy around 3PM for her 2nd dose of HAVRIX (first dose was 6/26/18). Pharmacist reviewed all screening questions and deemed patient eligible for vaccination. 5 minutes after vaccine, patient was found unconscious on floor near front of drugstore. Store associates helped patient and called 911. Patient lost consciousness one additional time before paramedics arrived and once more when paramedics arrived. Total time lapse of about 20 minutes. Patient was able to provide pharmacist name, DOB, date and location during time waiting for paramedics. Stated that she has had episodes of low blood pressure in the past but never with vaccines. Paramedics arrived and transported patient to hospital.
took the shot and I also got them/ suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the Shingles shot and got shingles again. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.