chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a mild cough /cough; Runny nose; Fatigue; brief chills; This spontaneous case was reported by a physician and describes the occurrence of COUGH (a mild cough /cough), RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and CHILLS (brief chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027h21b) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to unspecified drug).    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022 at 7:00 PM, the patient experienced COUGH (a mild cough /cough), RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and CHILLS (brief chills). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COUGH (a mild cough /cough), RHINORRHOEA (Runny nose), FATIGUE (Fatigue) and CHILLS (brief chills) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that patient did not take any medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.
101 degree fever, chills, nausea, foggy head, weakness , soreness.
12hours after injection I started with severe pain in arm of injection, left arm. Felt faint, then had diarrhea and vomiting with chills, lightheadedness, tingling like pins and needles all over body lasting probably 30min. Headache. Likely had fever but didn?t not take temperature. About an 1-2hrs later, again had diarrhea, nausea, lightheadedness, faint, chills, headache. Followed by severe fatigue several hours maybe 5.
Patient was anxious, with elevated BP 150/108 (HR 117). Final BP 143/82 (pulse 78).
Red, swollen area to (L) arm x 2 days. Pt instructed to use MOTRIN and ice packs.
Within 24 hours I got tinnitus. It is gradually getting worse. Some nights I get <3 hours of sleep because it's so loud. Some days it's difficult to think clearly or concentrate because it's so loud. Some days/nights are better/worse than others. Contacted my PCP who said she never heard of that as being related to the vaccine. Told to contact my employer's employee health. Contacted them and they also said they never heard of that as being related to the vaccine and to contact my PCP. Contacted my PCP again and she wrote for an ENT referral, which I still haven't heard from.
I started to get a headache about 6 hours after the injection. Overnight I got a high fever, extreme body aches, extreme migraine and nausea. All of these symptoms last over 24 hours. I am going on hour 46 right now and still have extreme body aches, fatigue and severe pain under my arm in my arm pit.
Pt complains of eye swelling and altered vision. States she has been seeing black spots in her vision and has some swelling around her right eye. Refrained from giving second shot due to these effects
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2013, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUN-2016, the patient was treated at an urgent care health care facility (by an unspecified health care professional) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Initial report received on 06/Sep/2006 from a health care provider. A 5-year-old female patient, with no pre-existing medical history, had received an intramuscular, right thigh fourth dose injection of IPOL, lot number Y0991-2, an intramuscular, left thigh, fifth dose injection of Daptacel, lot number C2627AA, and a subcutaneous, left thigh injection of MMR, lot number 0615F; on 25/Aug-2006. The next day, the patient developed a large local reaction of redness, swelling and itching from the front of the right thigh to her knee. She was evaluated by a physician and treated with Benadryl and Augmentin. No diagnostic testing was performed, and the patient recovered from the event. Follow-up information received on 10 October 2006 from a health care provider. The adverse reaction involved the entire R upper thigh. Additional medically relevant information was not provided.
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of GARDSIL 9 (lot # N042853, expiry date: 17-JUL-2019). The vaccines were stored at a temperature of 9°C to 25°C (10.4°C) for 1 Hour 22 Minutes. Previous temperature excursion was 9°C to 25°C (13.1°C) for 1 Hour 39 Minutes. Data logger was involved. No adverse effects reported. Sender's Comments: US-009507513-1708USA011300.
Initial unsolicited report received from a Nurse on 23-May-2018. This case involves a four-month-old patient (gender not reported) who was vaccinated with a DTAP/IPV portion of PENTACEL (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to wrong technique in product usage process. 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 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. Documents held by sender: none.
Shortness of breath started within 3 hours and has continued to this day.  Currenlty still on Prednisone (started at 20mg/day and increased to 30/40 mg per day) still.  Also on Breztre inhaled 2x/day.  Still not better after 4 weeks and continuing on medication.  Seeing a pulmonologist weekly.
20 mins p/vax pt had convuls in car; pt passed out had very low blood pressure, no pulse faint heartbeat; weak & tired 3-4 days;
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of an unknown age and gender. The patients medical history or concurrent conditions were not provided. On 27-MAY-2015, the unspecified number of unspecified patients received doses of (Oka/Merck) VARIVAX (dose and route were not provided) (lot numbers involved in the temperature excursion were K010437 expiration date 22-JUL-2016, K009457 expiration date 09-JUL-2016, K021936 expiration date 11-NOV-2016 and L001335 expiration date 13-JAN-2017) (it was unspecified what lot number were administered to patients) that were improperly stored. No adverse experience reported. This is one of two reports from the same source (MARRS#1505USA014912). Additional information has been requested.
Pt with acute chest pain, left upper lobe pulmonary embolism seen on chest xray. Treatment with xarelto.
Pt was in office for 2nd dose of COVID vaccine but the first one was never documented that is was received. Pt was too early for Bivalent dose per CDC guidelines. Covid dose two was admin on 2/2/23.
Fever, diarrhea, chills,  body aches, exhaustion, lethargy. Symptoms lasted 36 hours. Awakened with intestinal cramping at midnight. All symptoms were gone after 36 hours with no residual side effects. I had the same adverse events after each booster. Both boosters were Pfizer.  Tested positive for covid-19 on August 22, 2022. Milder but similar symptoms lasted for 10 days, tested negative on the  12th  day. Remained quarantined at home for the duration of positive tests.
Patient was admitted to Hospital on 3/1/21. Blood Sugar of 758. Patient diagnosis with Acute respiratory failure with hypoxia and acute heart failure and Metabolic encephalopathy. Patient put on ventilator and passed away on 3/2/21 at 17:04.
got real hot on the inside that lasted for 2 days; very weak; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (got real hot on the inside that lasted for 2 days) and ASTHENIA (very weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Diabetes.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (got real hot on the inside that lasted for 2 days) and ASTHENIA (very weak). At the time of the report, FEELING HOT (got real hot on the inside that lasted for 2 days) had resolved and ASTHENIA (very weak) was resolving.        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.   Concomitant medications were not reported. Treatment information was not provided.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 2 month old female patient with none pertinent medical history, drug reactions or allergies and none concomitant medication. On 13-SEP-2017, the patient was vaccinated with a dose of ROTATEQ orally, (dose, lot number and expiration date were not reported) as vaccine. On the same date maybe 20 or 30 minutes after vaccination, the patient spitted up while she was still in the office (infantile spitting up). None laboratory diagnostics were performed. No treatment was given for the event. At the time of the report, the patient recovered from the infantile spitting up on an unknown day in September 2017. The relatedness between the event and therapy with ROTATEQ was not reported.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot number was not reported) via an unspecified route of administration on 25Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness in the arm, rapid heartbeat and dizziness and wanted to know that whether this were emergency symptoms. The patient underwent lab tests and procedures which included heart rate increased: rapid on unspecified date. The outcome of events was unknown. Information on Lot/Batch number has been requested.
Pain all over her body; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain all over her body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (Pain all over her body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Pain all over her body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant product use included unspecified blood pressure medication. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-039060 (Patient Link).
Patient in office to receive first monkeypox vaccine. After vaccine administration patient reports feeling "a little dizzy." Nurse requested assistance from additional nurses in clinic. Patient became unresponsive while sitting in chair. Nurse beside patient at time so was able to keep patient from falling. Patient unresponsive <30 seconds.  Additional nurses helped to wake patient with physical and verbal stimuli and then proceeded to lower patient to the floor. Patient alert and oriented x3 upon awakening.  Initial blood @1336pressure reading 141/80 HR 84. Next blood pressure reading @1343 127/78 HR 71. Patient drinking juice and sitting up at this time. Patient reports that this has happened to him in the past and that he feels fine now. Patient kept in clinic 30 minutes after episode.
The following day after giving vaccine, child was at school running from building to building on playground equipment. At end of recess when heading in for lunch, he hit knee hard against a piece of equipment.  When he was about to go into the school, his vision turned yellow, became pale and very sweaty  then  fainted.  Teacher was able  to  catch him.  EMS and parent called,  Evaluated at school. Mother called and reported incident to clinic at 2:10 pm.  She requested incident be reported to VAERS.
Developed intermittent hives, face swelling, and eyelid swelling approx. 6 hours after Flu mist.  Grandmother gave child Benadryl and took him to private MD office.  Was seen by RNP who diagnosed him with urticaria and referred him to see allergist.  RNP told Grandmother that she didn't think symptoms were related to Flu mist.
Illness with Covid-19 verified with at-home test result positive.  Symptoms were diarrhea, abdominal pain, congestion, cough, fever, muscle and joint aches, headache, sore throat, and sinus pain and pressure.
Headache, Myalgia, Fever, CHILLS, FATIGUE Narrative:  RESTING AT HOME AND TAKING IBUPROFEN, INCREASED FLUIDS
Hives; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and PRURITUS (Itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (Hives) and PRURITUS (Itchy). At the time of the report, URTICARIA (Hives) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The first injection in my left arm, I didn?t feel at all. Only a mild ache for a day resulted. This time was different. Immediately when the needle went in, it felt like a swarm of hornets stinging. The injection site itches and burned like poison ivy. By the next morning, I had a sizable red welt and it felt achey, as well as tender to the touch.
The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date; No adverse event; Dose administered to patient after 30-day Use by Date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 12-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date).    Concomitant medications were not reported.  Number of doses/vials that were administered to the patients were around 50 doses from 5 vials.  The vial was initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details was not provided.
No Additional AE.  No PQC; HCP calling to report AE for patient that received expired (10/20/2023) dose of PNEUMOVAX 23.  No previous TE.; This spontaneous report has been received from a nurse, regarding a 71-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-OCT-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PENUMOVAX23) injection, as a single dose of prophylaxis (lot number: W007035, which was determined to be valid as syringe formulation, with an expiration date on 20-OCT-2023) (strength, dose, route and anatomical location of administration were not reported) (Expired product administered).  No additional adverse event was reported.
Cough; Runny nose; Dizziness; Itchy throat; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery. Concomitant products included AMOXICILLIN for an unknown indication.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat), HEADACHE (Headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose), DIZZINESS (Dizziness), THROAT IRRITATION (Itchy throat), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products used included vitamins.  The patient explained they still having these symptoms but feeling a little better. The patient has taken ibuprofen and robitussin to help with the symptoms.
COMPLETED SERIES OUTSIDE OF RECOMMENDED TIME FRAME.  HE GOT HIS FIRST DOSE ON 1-23-2021.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 73-year-old female patient who received SHINGRIX. Concurrent medical conditions included hypothyroidism (Diagnosed prior to receiving SHINGRIX) and atrial fibrillation (Diagnosed prior to receiving SHINGRIX). Concomitant products included Calcium, Diltiazem, famotidine, iron, Levothyroxine, Vit B Complex and vitamin D. On 23rd April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, several hours after receiving SHINGRIX, the patient experienced sweating. On 23rd April 2018, the patient experienced chills. On 24th April 2018, the patient experienced headache and fever. On an unknown date, the outcome of the chills was recovering/resolving and the outcome of the headache and fever were not recovered/not resolved and the outcome of the sweating was recovered/resolved. The reporter considered the chills, headache, sweating and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4 pm, the patient received the vaccine SHINGRIX vaccine. By 8 pm, 4 hours after receiving SHINGRIX, the patient experienced chills. The patient was perspiring throughout the night. 1 day after receiving SHINGRIX, the patient woke up this morning and experienced a low grade fever and headache. The patient asked whether she should receive her 2nd vaccine since she had these symptoms. The reporter referenced the patient information to provide adverse reaction information, and suggested that she follow up with her doctor to make him aware of her symptoms and regarding her inquiry.
Information has been received from a registered nurse (R.N.) concerning a 20-year old Caucasian male with no pertinent medical history or allergies, who on 11-JUL-1997 was vaccinated subcutaneously with a first 0.5 ml dose of Varivax (lot# 617355/0567D). There was no concomitant medication. On 24-MAY-2006 a titer for varicella was drawn and came back with a negative value of 0.15 Elfa units. Unspecified medical attention was sought. It was reported that the patient did not have any symptoms. No outcome was reported. No product quality complaint was involved. The patient was re-vaccinated with two doses of Varivax on 21-JUL-2006 and 21-AUG-2006 (both with lot# 649269/0986P). The patient's vaccination records included the following vaccinations: diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) given on 24-JAN-1986, 26-MAR01986, 27-MAY-1986, 17-JUN-1987 and 12-APR-1991; poliovirus vaccine inactivated (unspecified) (manufacturer unspecified) given on 24-JAN01986, 26-MAR-1986, 17-JUN-1987 and 12-APR-1991; MMR (manufacturer unspecified) given on 16-MAR-1987 and 12-APR-1991; Hib conj vaccine (manufacturer unspecified) given on 16-MAR-1987 and 12-APR-1991; Hib conj vaccine (manufacturer unspecified) given on 11-DEC-1987; hepatitis B virus vaccine given on 29-JUN-1994 (lot# 610862/0594A), 31-AUG-1994 (lot# 611797/0444A) and 20-FEB-1995 (lot# 612921/1152A) and MENOMUNE-A/C/Y/W-135 (lot# UE157AA) given on 08-JUN-2004. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 12/30/20, 01/27/21 and boosted 3/15/22.