chrisvoncsefalvay/vaers-outcomes huggingface dataset:
L DELTOID SWELLING/ REDNESS/ ON SMALL0POX SITE, CELLULITIES DIAGNOSIS, PATIENT RECIEVED BACTRIM DS #14 T1 PO BID,F/U PRN.
Patient had swelling under arms and around breast area.  Became large, red ad painful.  Came for 2nd dose and was referred to primary who stated he could still receive the 2nd dose.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to my stomach), FEELING ABNORMAL (not so great) and NAUSEA (nauseous) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination. The patient's past medical history included Back surgery in May 2021. Concurrent medical conditions included Osteomyelitis (She had to use crutches and doctor believe this may contributed to problems in her back.) since 2017, UTI since 2021, Respiratory disorder NOS since 2021, Thyroid disorder (thyroid medication) and Acid reflux (esophageal) (acid reflux medication). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to my stomach) and NAUSEA (nauseous). On an unknown date, the patient experienced FEELING ABNORMAL (not so great). At the time of the report, ABDOMINAL DISCOMFORT (sick to my stomach) and NAUSEA (nauseous) had resolved and FEELING ABNORMAL (not so great) outcome was unknown.    Concomitant medication included thyroid medication, acid reflux medication, water pill. Treatment medication was not provided by the reporter. Patient had experienced symptoms which was right away and lasted a day or a day and a half. Patient felt not so great.
A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 29-Jan-2015. The medical assistant reported that the patient received expired FLUMIST quadrivalent which started on 29-Jan-2015. The outcome of the event of patient received expired FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
achiness; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 11-OCT-2023, the patient received Arexvy. On 11-OCT-2023, less than a day after receiving Arexvy, the patient experienced pain (Verbatim: achiness) and headache (Verbatim: headache). The outcome of the pain and headache were not resolved.   It was unknown if the reporter considered the pain and headache to be related to Arexvy.     It was unknown if the company considered the pain and headache to be related to Arexvy.   Additional Information: GSK receipt date: 12-OCT-2023 The reporter was the patient who received his Arexvy vaccine yesterday (day before reporting) and had started having a headache and achiness.  This was an ongoing AE (adverse event).  The reporter said it was very mild. The consent to follow up requested.
Staff member was given an expired dose of Pfizer (1400). Vaccine was given at 1448. No S/S to report. No treatment necessary. This report is late as my co-worker (who gave the vaccine) only noticed today that this was the third expired dose she gave on the same date. She originally thought it was two doses which have already been reported.
She felt like her throath was closing up; numbness; paresthesia; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (She felt like her throath was closing up), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (She felt like her throath was closing up), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and HEADACHE (headache). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (She felt like her throath was closing up), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and HEADACHE (headache) outcome was unknown.        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.    relevant concomitant products usage were not reported by the reporter.
outbreak of shingles; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient inquired if she can she be on an antiviral when receiving her second dose of the vaccine. She is aware that our trial participants with a history of HIV were on antivirals as well. The patient mentioned that she had an outbreak of shingles which occurred after she had her first COVID vaccination. She stated that she doesn't associate it with the COVID vaccine however. She was supposed to start treatment on Valtrex shortly has not started it yet. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported event cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
STABLE ANGINA ANGINA, UNSPECIFIED 3/6/2023 &  1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a pharmacist concerning a 62 year old male patient with diabetes and heart problems who on 25-NOV-2009 was vaccinated SQ in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664654/0823Y) for diabetes and heart problems. The patient's relevant concomitant medications and relevant past drug history were unknown. On 26-NOV-2009 the patient developed nausea and a slight elevation in temperature which lasted only for a few hours, and erythema of the left arm which continued to spread over the last few days. On 29-NOV-2009 the pharmacist assessed the erythema and described it as warm to the touch with mild swelling which extended downward from the injection site beyond his elbow and appeared to be continuing to spread. No relevant laboratory testing had been performed. On 29-NOV-2009 it was unknown if the patient would continue to receive further doses of PNEUMOVAX 23. At the time of the report the patient was no longer experiencing nausea or an elevated temperature and the erythema on his left arm was described by the pharmacist as red, warm to the touch, with mild swelling which covered 2/3 of his upper arm and continued to spread downward from the injection site to beyond the elbow. Follow up information has been received from a pharmacist concerning a 62 year old male patient with diabetes, high blood pressure and a history of heart surgery who on 25-NOV-2009 was vaccinated SQ in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 664654/0823Y). There was no illness at the time of vaccination. Subsequently the patient experienced slight temperature, erythema and mild swelling. On 04-DEC-2009 the patient recovered. No further information is available.
Severe Dizziness.  Doctor prescribed Mecline 25 Mg RX Tablets take 1 tab by mouth three times daily
Patient received first dose of pfizer vaccine at 2:15 pm. During 15 minute observation patient reported headache. V/S taken. BP 168/108, P-84, Sat-100, T-36.4. Patient referred to ED.
One week after pain and burning sensation. Red stripe up his arm and up his chest. Stretching his arm and has pain, neck pain,  has a knot where got vaccinated.
there was a leakage when she received the vaccine; felt exhausted; developed a headache in and off; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (there was a leakage when she received the vaccine), FATIGUE (felt exhausted) and HEADACHE (developed a headache in and off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included TRAMADOL, MONTELUKAST, METOPROLOL, ESCITALOPRAM, CLONAZEPAM, LEVOTHYROXINE, FOLIC ACID and ROSUVASTATIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE EXTRAVASATION (there was a leakage when she received the vaccine), FATIGUE (felt exhausted) and HEADACHE (developed a headache in and off). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 29-Jan-2021, INJECTION SITE EXTRAVASATION (there was a leakage when she received the vaccine) had resolved. On 01-Feb-2021, FATIGUE (felt exhausted) and HEADACHE (developed a headache in and off) had resolved. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 08-jul-2021contain No significant information
No adverse event; Vaccine administered beyond use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use by date).    No concomitant medication information was reported.  The vaccine was received at the clinic on 07-Jun-2022.  The vaccine beyond use date was reported as 07-Jul-2022.  No treatment information was provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with VARIVAX (merck) (route, dose and lot # were unknown) instead of a dose of ZOSTAVAX on 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of event was unknown. It was unknown, if the patient sought medical attention. Additional information has been requested.
Experienced diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Experienced diarrhea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (Experienced diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Experienced diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: NNI
Received shot on 12/14/07 at 12:00 P.M.  Ate a meal at 4:00 P.M. that afternoon. 40 minutes later began vomiting and started having problems breathing.  Went to the emergency room at hospital because conditions only got worse.  Was given a breathing treatment and something for the vomiting.
The patient reported that she had a red and swollen arm that appeared about 1 week after her first dose.  It resolved in a couple days and she did not require medical care.
I experienced a delayed injection site reaction that is characterized by erythema, induration, tenderness and pruritus. I take cetirizine chronically due to allergies.   I have treated with ice packs which help with the discomfort. I have not sought medical attention since this seems to be a known side effect that has been reported to typically resolve in about a week.
c/o fever & chills also achiness as well as redness, edema @ inj site lasting 1 1/2 days;applied cold packs to inj site & took ibuprofen;
Pt received both doses of the Moderna COVID-19 vaccine (on 2/16/2021 and 3/16/2021, respectively).  Pt became ill with COVID and tested positive on 9/29/2021.  She went to urgent care for cough and chest congestion on 9/29/2021.  On 10/5/2021, she presented to the ED with worsening symptoms of hypoxia and was admitted.  Still admitted today.
I got the second dose and around two weeks later, I started having bumps on the right side of my face that were sensitive and sore and would scab over. In early June, it was diagnosed as shingles.
My feet and ankles swelled tremendously for the first time ever. Will b getting an ultrasound to look for blood clots
On the first  day of the vaccine Patient had  headache and could not move her arm. Patient also started having chest pains;. She had to lay down. She started having the normal chest pains. The next day patient stated that the chest pains became mild. The chest pains have lighten up but her chest sore every time that she would breathe.
pt recvd vax 1OCT79 & 9OCT79 pt presented to MD w/high t104;examined in MD ofc;on way home devel a sz like episode characterized by stiffening of the body, rolling of eyes & vomiting;t103, lethargic upon admission;reddish mac rash
LETHARGIC; FEVER; MUSCLE ACHES; BAD HEADACHE; This spontaneous report received from a patient 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, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced lethargic. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, fever, muscle aches, and bad headache on 12-MAR-2021. This report was non-serious.
Approx 30 minutes after receiving vaccine, started to feel tingling and numbness in lips. Vaccine site observer noted redness on neck and frequently clearing her throat. Escorted to Emergency Dept  where she was treated with IV FAMOTIDNE, diphenhydrAMINE and methyIPRENNISolone which resolved her symptoms, plus ACETAMINOPHEN PO for reported headache. She  was observed for approx 2 hours until symptoms resolved then discharged home.
Patient was administered third Pfizer vaccine 10/29/21 at 3:25pm. Within 5 minutes of the vaccine, patient's husband reported patient was having an adverse reaction. Patient reported syncope, lightheadedness, sweating, and nausea but did not report symptoms swelling in the throat, rash, etc that would be typical of a anaphylactic shock. At this point, EMS was called. Patient was instructed to lay down to help resolve symptoms for a couple minutes with little improvement so we decided to bring her in to counseling room to do a blood pressure reading but by that time EMS had arrived and taken over the situation. Patient was eventually taken to hospital by ambulance.
I had a pretty high fever for 24 to 36 hours; feeling a high heart rate, higher than normal heart rate; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported by the patient that after receiving the second dose of vaccine on an unspecified date (on Saturday) around 1 pm and for 6 or so hours he/she was feeling okay and then had a pretty high fever for 24 to 36 hours and now that he/she was like 5 or so days out have like pretty, still feeling a high heart rate, higher than normal heart rate and was curious if there was any sort of advice about how to handle that, can he/she certainly go to the emergency room. The patient underwent lab tests and procedures which included heart rate which was higher than normal heart rate on an unspecified date. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Pt was given flu shot @ 9AM on 4NOV91; mom reports pt was given APAP on ret to home; by 1PM appeared flushed, tired w/general malaise, tachycardia; t103 ax @ 10PM; started vomiting 11PM & vomited 6-7 x
Upper arm pain and weakness began less than an hour after injection. Two days after receiving the vaccine, this has persisted, but seems to be lessening. It seems identical to the pain received after the first dose. Chills began about 12-13 hours after injection, and this caused some difficulty sleeping. Possibly a low-grade fever about 12-13 hours after injection, seemed to have a feverish feeling on-and-off the following day. Lethargy/loss of appetite began 20 hours after injection (i.e., upon "waking" the following day); this subsided after about 28-30 hours. This was more than just general tiredness/sleepiness.
THE REFRIGERATOR WAS LEFT OPEN AND UNOPENED VIAL STORED  FOR 15 MINUTES WHICH HAD A TEMPERATURE EXCURSION OF 47.44 DEGREES F; ADMINISTRATION OF VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, administered on 18-NOV-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced administration of vaccine that was stored outside of the recommended storage conditions. On an unspecified date, the patient experienced the refrigerator was left open and unopened vial stored for 15 minutes which had a temperature excursion of 47.44 degrees f.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The outcome of the administration of vaccine that was stored outside of the recommended storage conditions and the refrigerator was left open and unopened vial stored for 15 minutes which had a temperature excursion of 47.44 degrees f was not reported. This report was non-serious.
Tested positive for COVID but had recent lab work done in the ED from prior visit on the 28th of May 2022.
1ST DOSE PFIZER 8/17/2021 2ND DOSE PFIZER 9/14/2021 3RD DOSE PFIZER 1/07/2022- ADMINISTERED 2 MONTHS EARLY PER THE 6 MONTH WINDOW
Right arm (injection site) became red, swollen, painful. C/O right sided neck pain and stiffness. Feeling of malaise. Symptoms persisted almost 5 days. 4 weeks later, neck still feels stiff and right arm is sensitive to sunlight.
Initial report was received from a healthcare professional, who was also the patient, on 05 April 2013. This case has the same reporter as case number 2013-04711. A 78-year-old female patient had received an injection of FLUZONE (lot number, route and site not reported) in August of 2012 and experienced the flu in March of 2013. The reporter did not have any information regarding the strain and substrain of flu the patient experienced since they did not do any testing. The patient had no illness at the time of vaccination. Outcome was recovered. Documents held by sender: None.
DTaP was given in left deltoid 9/29/03. Mother reports that today (10/1/03) she noticed the redness and swelling of the upper left arm where injection was given. The area is checked by a nurse and there is redness, warmth and swelling of a 2 1/2" x 3 1/2" area of left upper arm. Treated with children's Motrin and cool compresses.
This spontaneous report as received from medical assistant refers to an unspecified number patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dosing details unknown) (lot # M047303, expiry date 29-MAY-2018, lot # N012491, expiry date 17-OCT-2018) for prophylaxis. The vaccine was exposed to a temperature between 6 degree Fahrenheit (F) to 14 degree F for 50 minutes. The vaccine was previous exposed to a temperature between 6 to 14 degree F for 7 hours and 40 minutes. The sterile diluent (lot, and expiration date unknown) used for reconstitution did not underwent a temperature excursion. No adverse effects were reported. Data logger was involved. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008993.
Migraine, body aches, chills, nausea beginning at 0300 the next day after receiving vaccine
After receiving the Vaccine on Friday I noticed that I have an enlarged lymph node near my left collar bone. I received the vaccine in my left arm.
Severe pain in right shoulder with decreased range of motion that has lasted for 10 days.  He has been treated with sling, prednisone, and gentle range of motion exercises.  It is minimally improved.  He has been referred to  orthopedist for consideration of MRI and/or intra-articular steroid injection
pt recvd vax & felt dizzy & lightheaded for 20 sec;lab tests showed: anti-HBsag neg; pt was vax w/ a booster dose of hepatitis; next anti HBsag neg; pt had another booster & showed anti HBsag pos;
At routine check-up, irregular hearbeat noted.  Also noted at urgent care visit later that month (for Covid.) EKG showed PVC.  Reportedly not life-threatening, but have never been told of heartbeat irregularity before.